The availability of statins has revolutionized the management
|
|
- Martina Gilbert
- 5 years ago
- Views:
Transcription
1 CONTROVERSIES IN CARDIOVASCULAR MEDICINE The Argument Against the Appropriateness of Over-the-Counter Statins Philip J. Barter, MBBS, PhD, FRACP; Kerry-Anne Rye, PhD The availability of statins has revolutionized the management of patients at high risk of having a cardiovascular (CV) event. Statins reduce the risk of future CV events in virtually everyone in whom they are used. The benefit is apparent in those with and without manifest CV disease and is independent of age, gender, and the presence of disorders such as hypertension and diabetes. The benefit also is independent of the baseline level of low-density lipoprotein (LDL) cholesterol. In fact, to date, there is no group (with the possible exception of those with end-stage renal disease) in whom CV risk is not reduced by statin use. Furthermore, the available members of this drug class are well tolerated and have an excellent safety record, with serious adverse effects such as myopathy and liver damage occurring in only a small percentage of people taking these agents. Response by Gotto p 1320 On the basis of the available evidence base, most current guidelines recommend the use of statins in all high-risk people, with high risk being variously defined as those either with existing CV disease or with a calculated 5-year risk that is comparable to that in people with manifest disease. Given the evidence of efficacy and safety, it has been suggested that statins should be provided over the counter (OTC) in pharmacies without the need for a prescription to make them accessible to a much wider group of people. This approach has already been adopted in the United Kingdom, where low-dose (10 mg) simvastatin is now available OTC. The question arises: Is it desirable to make statins available OTC? This article argues against making statins available OTC on 3 grounds: (1) The risk of adverse effects may no longer be outweighed by the benefits if statins are used in people at low CV risk; (2) high-risk people may not achieve the low LDL targets shown to be desirable to maximize risk reduction; and (3) other lipid abnormalities such as a low high-density lipoprotein (HDL) cholesterol may not be identified or treated. Balance Between Benefits and Adverse Effects There is no such thing as a drug without some serious adverse effects in at least some people. However, if the incidence of adverse effects is low relative to the potential benefit provided by the drug (high benefit-to-risk ratio), the possibility of even serious adverse events should not (and generally does not) prevent the drug from being used. Clearly, the benefit-to-risk ratio associated with statin use is high in someone whose risk of having a CV event also is high. In those individuals at much lower risk, on the other hand, the benefit-to-risk ratio associated with statin use is also lower; indeed, in low-risk people, it is possible that statin-induced adverse effects may exceed the potential benefits. This is especially pertinent when we consider that, once an individual has begun to use them, statins are likely to be used for many years. The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From The Heart Research Institute and the Department of Medicine, University of Sydney, Sydney (P.J.B., K.-A.R.), and the Department of Medicine, University of Melbourne, Melbourne (K.-A.R.), Australia. Correspondence to Professor Philip Barter, The Heart Research Institute, 145 Missenden Rd, Camperdown, NSW 2050, Australia. barterp@hri.org.au (Circulation. 2006;114: ) 2006 American Heart Association, Inc. Circulation is available at DOI: /CIRCULATIONAHA
2 1316 Circulation September 19, 2006 Factors That Increase the Risk of Myopathy in People Taking Statins Factor Reference Older age 9 Diabetes 24 Coadministration of statins with other drugs Fibrates (especially gemfibrozil) 5, 6 Macrolide antibiotics (clarithromycin, 7 erythromycin) Cyclosporin 8 Protease inhibitors 35 Azole antifungals 35 The best-known serious adverse effect of statins is a myopathy that, in some people, may result in potentially fatal rhabdomyolysis. Significant myopathy is relatively uncommon, occurring in 0.5% of patients taking these agents. 1 It is dose dependent and is a major factor in determining what should be the highest recommended dose of each member of the class. Progression of myopathy to the potentially fatal condition of rhabdomyolysis is a rare occurrence, with a reported frequency of 1 in to patient-years of exposure. 1 Rhabdomyolysis has been observed with all statins, although its frequency varies with the different members of the class. 2,3 The higher relative frequency of rhabdomyolysis associated with use of cerivastatin 4 led to this agent being withdrawn from the market. There are well-documented circumstances in which the risk of rhabdomyolysis in people taking statins is increased 5 9 (Table). The best known of these instances relates to the potential of statins to interact adversely when coadministered with fibrates 5,6 and macrolide antibiotics such as erythromycin. 7 The risk of serious myopathy associated with the use of statins also is increased in people taking cyclosporine after renal or heart transplant. 8 Although it is most unlikely that a transplant patient would use OTC statins, there is a real danger that someone taking OTC statins could inadvertently be prescribed an agent such as erythromycin. The possibility of this occurring in someone at low risk of having a CV event creates a setting in which the benefit-to-risk ratio may be unacceptably low. Adverse effects of statins also are greater in the elderly, 9 in whom the potential dangers of OTC statins may be especially high. The fact that many elderly people are already taking many other medications may add to the risk of serious adverse effects associated with unmonitored use of statins in such people. The most common argument used to support the availability of OTC statins is that doing so will make these agents accessible to a much wider range of people than is recommended by current guidelines. It is argued that these agents are so safe and so effective that there is no justification for limiting them only to high-risk people. However, before accepting this proposition, we should consider just how great the potential benefits are of using statins in someone whose CV risk is low. Consider someone whose 5-year CV risk is 2%. Treatment with, for example, 20 mg simvastatin would be predicted to reduce the concentration of LDL cholesterol by 40 mg/dl. According to a recent meta-analysis, 10 an LDL cholesterol reduction of this magnitude would translate into an 20% reduction in CV risk, thus converting the 5-year CV risk in this person from 2% to 1.6%. The risk of a serious adverse event associated with the unmonitored use of a statin in such a person may well exceed this small benefit. The reality is that it is impossible to calculate either the benefit-to-risk ratio or the cost-effectiveness of OTC statin in people whose CV risk is low. If, however, CV risk is high, it is essential that therapy be closely monitored to ensure that recommended LDL cholesterol targets are achieved. Failure to Achieve Recommended LDL Targets A direct involvement of LDL cholesterol in the development and progression of atherosclerotic cardiovascular disease is one of the best-proven cases in modern medicine. A strong, positive relationship between the concentration of LDL cholesterol and the future risk of CV events has been observed in many large-scale population studies, 11,12 and the benefits of reducing LDL cholesterol levels have been proved beyond doubt in intervention studies. 10 The CV risk reduction associated with statin use is a direct function of both the magnitude of the reduction in concentration of LDL cholesterol 10 (Figure 1) and the level of LDL cholesterol achieved by the treatment 13 (Figure 2). There is growing consensus that if a statin is indicated, it should be used in a dose sufficient to achieve levels of LDL cholesterol that are very much lower than were previously considered to be ideal. 14 Such targets are most unlikely to be achieved in people taking the low doses of statins that are likely to be available OTC. The evidence base in support of aggressive LDL cholesterol lowering is huge. It includes studies that have involved people in long-term, large-scale, controlled clinical trials. These trials have been conducted in settings of primary and secondary prevention, in men and women spanning a wide range of ages, in diabetics and nondiabetics, in those with and without hypertension, and in people with a wide range of baseline levels of LDL cholesterol. A recent meta-analysis of data from participants in 14 randomized trials of statins was reported by the Cholesterol Treatment Trialists collaborators. 10 This analysis was motivated by the fact that, in isolation, none of the individual trials had sufficient power to assess the precise relationship between the magnitude of LDL lowering and the extent of CV event reduction. The database for the meta-analysis included 8186 deaths and major CV events. The reductions in LDL cholesterol in these trials ranged from 13 to 68 mg/dl. Overall, for each 40-mg/dL reduction in LDL cholesterol, there was a 12% reduction in all-cause mortality, a 23% reduction in myocardial infarction or coronary death, a 24% reduction in the need for coronary revascularization,
3 Barter and Rye OTC Statins 1317 Figure 1. Relation between reduction in incidence of CV events and mean LDL cholesterol reduction in major statin trials. Each point represents data extracted from the primary publications of each trial. ALLHAT indicates the Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (pravastatin) 26 ; HPS, Heart Protection Study (simvastatin) 25 ; AFCAPS, Air Force/ Texas Coronary Atherosclerosis Prevention Study (lovastatin) 27 ; LIPID, Long-Term Intervention With Pravastatin in Ischemic Disease (pravastatin) 28 ; CARE, Cholesterol and Recurrent Events Trial (pravastatin) 29 ; ASCOT, Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (atorvastatin) 30 ; CARDS, Collaborative Atorvastatin Diabetes Study (atorvastatin) 31 ; WOS, West of Scotland Coronary Prevention Study (pravastatin) 32 ; and 4S, Scandinavian Simvastatin Survival Study (simvastatin). 33 and a 17% reduction in fatal or nonfatal stroke. All of these reductions were statistically highly significant. The reduction in major vascular events was predicted by the absolute reduction in LDL cholesterol achieved. It was concluded on the basis of this meta-analysis that prolonged statin treatment with substantial LDL cholesterol reductions should be considered in all patients at high risk of any type of major vascular event. Figure 2. Event rates plotted vs LDL cholesterol levels during statin therapy in secondary-prevention studies. Event rates for HPS, CARE, and LIPID are for death from CHD and nonfatal myocardial infarction. Event rates for 4S and the TNT trial (atorvastatin 10 and 80 mg) 13 also include resuscitation after cardiac arrest. Abbreviations as in Figure 1. Adapted from Reference 13. The meta-analysis established beyond reasonable doubt that CV event reduction is proportional to the magnitude of the LDL lowering. 10 There is also growing evidence that the actual level of LDL cholesterol achieved during treatment with statins is predictive of CV events. This was best shown in the recently reported Treating to New Targets (TNT) trial. 13 This trial was designed to assess the efficacy and safety of treating people with stable coronary heart disease (CHD) to LDL cholesterol levels significantly below 100 mg/dl. A total of patients with clinically manifest CHD were randomized to double-blind therapy with atorvastatin 10 or 80 mg/d and followed up for a median of 4.9 years. The primary end point was a major CV event defined as CHD death, nonfatal non procedure-related myocardial infarction, resuscitated cardiac arrest, and fatal or nonfatal stroke. The mean LDL cholesterol level achieved during treatment was 77 mg/dl with atorvastatin 80 mg and 101 mg/dl with atorvastatin 10 mg. A primary event was recorded in 434 patients (8.7%) in the group receiving atorvastatin 80 mg and in 548 patients (10.9%) in the 10-mg group. This 22% reduction in the risk of major CV events in the 80-mg group was statistically highly significant (P 0.001). There was also a significant reduction in stroke (fatal plus nonfatal) in the 80-mg group compared with the 10-mg group. Stroke occurred in 117 patients (2.3%) receiving atorvastatin 80 mg and 155 patients (3.1%) receiving atorvastatin 10 mg, representing a 25% reduction (P 0.001) in the 80-mg group. There was no difference in total mortality between the 2 groups: 284 patients (5.7%) died in the group receiving atorvastatin 80 mg and 282 (5.6%) in the group receiving atorvastatin 10 mg, possibly reflecting the fact that the mortality in this trial was considerably lower in both the 10-mg and 80-mg groups than had been reported in any of the previously published secondary prevention trials with statins. The TNT trial added to a mounting body of evidence that lowering LDL cholesterol to levels well below the previously recommended target of 100 mg/dl results in a clinically and statistically significant additional reduction in the risk of future CV events. A similar conclusion was drawn from the results of the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) trial, in which the effects of low-dose simvastatin were compared with high-dose atorvastatin. 15 The low-dose simvastatin group achieved an LDL cholesterol of 104 mg/dl compared with 84 mg/dl in the high-dose atorvastatin group. The primary end point of the TNT trial (major CV events, defined as the combination of CHD death, nonfatal non procedure-related myocardial infarction, resuscitated cardiac arrest, and fatal or nonfatal stroke) was prespecified as a secondary end point in the IDEAL study. Consistent with the results in TNT, the combined end point of major CV events in IDEAL was 13% lower (P 0.02) in the aggressively treated group, which achieved an LDL cholesterol level of 81 mg/dl, than in the
4 1318 Circulation September 19, 2006 Figure 3. Coronary heart disease event rate in men and women as a function of HDL cholesterol levels in the Framingham Heart Study. 16 less aggressively treated group, in which the LDL cholesterol was 104 mg/dl. The case in favor of achieving very low levels of LDL cholesterol is now overwhelming. To achieve these newly recommended LDL cholesterol targets in many people, it is necessary to use the highest doses of the most effective statins. Such levels are most unlikely to be achieved by the unmonitored use of low doses of statins purchased OTC. The unmonitored use of OTC statins also will make it most unlikely that other lipid abnormalities such as a low level of HDL cholesterol will be identified and treated. Failure to Address a Low Level of HDL Cholesterol It has been known for many years that the concentration of HDL cholesterol correlates inversely with CV risk 11,16 18 (Figure 3). There is a real danger that making statins available OTC will result in a failure to identify and treat people with low levels of HDL cholesterol. The particular importance of identifying low levels of HDL cholesterol in people treated with a statin is highlighted by the observation (see below) that statins do not eliminate the increased CV risk that is attributable to the low HDL cholesterol level. Indeed, there is growing consensus that cholesterol-related CV risk needs to be attacked simultaneously on 2 fronts: by reducing the level of LDL cholesterol with a statin while raising HDL cholesterol with niacin or a fibrate. This view has been strengthened by the results of the INTERHEART (Effect of Potentially Modifiable Risk Factors Associated With Myocardial Infarction in 52 Countries) study 19 in which the ratio of apolipoprotein B to apolipoprotein A-I (reflecting the ratio of LDL to HDL) was of enormous power in predicting future myocardial infarction in a large cohort of subjects of widely differing ethnic origin. A low level of HDL cholesterol is a well-recognized component of the dyslipidemia associated with insulin-resistant states such as type 2 diabetes and the metabolic syndrome. 20,21 The prevalence of these disorders (and the associated low HDL cholesterol) is increasing alarmingly, largely as a consequence of a worldwide epidemic of abdominal obesity. 22 In people with these insulin-resistant states, it may be argued that raising the level of HDL cholesterol is even more important than lowering the level of LDL cholesterol. Ideally, both LDL and HDL should be targeted. Statins reduce CV risk in virtually all groups of people in whom they have been studied. This includes people with low levels of HDL cholesterol. However, although a statin will reduce CV risk in those with low HDL cholesterol levels, the HDL cholesterol level before statin therapy is started remains predictive of CV events even after statin therapy has been initiated. This observation has been made in several largescale statin trials conducted in both a primary and secondary prevention setting. The inability of statins to eliminate the CV risk associated with low levels of HDL cholesterol was apparent in a primary prevention setting with pravastatin in the West of Scotland Coronary Prevention Study (WOSCOPS) 23 and in a secondary prevention setting with pravastatin in the pooled analysis of the Long-Term Intervention With Pravastatin in Ischemic Disease (LIPID) and the Cholesterol and Recurrent Events (CARE) trials 24 and with simvastatin in the Heart Protection Study (HPS). 25 In all of these trials, treatment with a statin largely eliminated the influence of baseline LDL cholesterol as a predictor of coronary events, regardless of whether the HDL cholesterol was high or low. In each of these studies, however, the baseline level of HDL cholesterol remained as predictive of events in the statin-treated group as in the placebo group (Figure 4). Thus, a low level of HDL cholesterol is an important target for therapy to reduce CV risk; a low level of HDL cholesterol is becoming increasingly common; and it has been a consistent finding that a low level of HDL cholesterol before statin therapy is begun remains predictive of CV events even after statin therapy has been initiated. Therefore, it is apparent that to maximize risk reduction, a low level of HDL cholesterol requires therapy beyond a statin. Such action is most unlikely to be initiated in someone taking statins OTC. Conclusions There is no doubt that statins reduce CV risk in all people who take them. When CV risk is high, the evidence supports aggressive treatment to achieve low LDL cholesterol targets. These targets are most unlikely to be attained by the use of OTC statins. Although it may be argued that these aggressive LDL cholesterol targets are less important in people whose CV risk is lower, it also is apparent that the absolute risk reduction in such people also will be much lower, with the possibility arising that serious adverse events may exceed the benefits. Thus, there is a strong case against the use of OTC
5 Barter and Rye OTC Statins 1319 Figure 4. Cardiovascular event rates in statin trials as a function of the baseline level of HDL cholesterol in the placebo and active treatment arms. The active treatment was pravastatin 40 mg in WOSCOPS, 23 pravastatin 40 mg in the LIPID and CARE trials, 24 and simvastatin 40 mg in the HPS. 25 Abbreviations as in Figure 1. statins in both high-risk and low-risk people. In addition, the unmonitored use of OTC statins inevitably will lead to an increase in the adverse effects resulting from the adverse interaction of statins with other agents. Finally, making statins available OTC will reduce the likelihood of identifying people at high risk because of a low level of HDL cholesterol. Given that a low HDL cholesterol remains predictive of risk while statins are taken, it follows that use of OTC statins will leave many people at an unacceptably high risk of having a future CV event. A question was posed at the beginning of this article: Is it desirable to make statins available OTC? Clearly, the answer is no. Source of Funding Dr Rye is a National Heart Foundation of Australia Principal Research Fellow. Disclosures Drs Barter and Rye have received research grants from Pfizer Pharmaceutical; served on the speakers bureau for and received honoraria from Pfizer, AstraZeneca, Abbott, and Fournier; and worked as a consultant or on the advisory board for Prizer, AstraZeneca, and Abbott. References 1. Mukhtar RY, Reckless JP. Statin-induced myositis: a commonly encountered or rare side effect? Curr Opin Lipidol. 2005;16: Ucar M, Mjorndal T, Dahlqvist R. HMG-CoA reductase inhibitors and myotoxicity. Drug Saf. 2000;22: Omar MA, Wilson JP. FDA adverse event reports on statin-associated rhabdomyolysis. Ann Pharmacother. 2002;36: Jamal SM, Eisenberg MJ, Christopoulos S. Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme A reductase inhibitors. Am Heart J. 2004;147: Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate statin versus gemfibrozil any statin. Am J Cardiol. 2005;95: Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003;289: Lee AJ, Maddix DS. Rhabdomyolysis secondary to a drug interaction between simvastatin and clarithromycin. Ann Pharmacother. 2001;35: Ballantyne CM, Corsini A, Davidson MH, Holdaas H, Jacobson TA, Leitersdorf E, Marz W, Reckless JP, Stein EA. Risk for myopathy with statin therapy in high-risk patients. Arch Intern Med. 2003;163: Foody JM, Krumholz HM. Are statins indicated for the primary prevention of CAD in octogenarians? Antagonist viewpoint. Am J Geriatr Cardiol. 2003;12: Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R, for the Cholesterol Treatment Trialists (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366: Shaten BJ, Kuller LH, Neaton JD. Association between baseline risk factors, cigarette smoking, and CHD mortality after 10.5 years: MRFIT Research Group. Prev Med. 1991;20: Castelli WP, Anderson K, Wilson PW, Levy D. Lipids and risk of coronary heart disease: the Framingham Study. Ann Epidemiol. 1992;2: LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK, for the Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352: Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ, for the National Heart, Lung, and Blood Institute, American College of Cardiology Foundation, and American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110: Pedersen TR, Faergeman O, Kastelein JJ, Olsson AG, Tikkanen MJ, Holme I, Larsen ML, Bendiksen FS, Lindahl C, Szarek M, Tsai J, for the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005;294: Gordon T, Castelli WP, Hjortland MC, Kannel WB, Dawber TR. High density lipoprotein as a protective factor against coronary heart disease: the Framingham Study. Am J Med. 1977;62: Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein
6 1320 Circulation September 19, 2006 cholesterol and cardiovascular disease: four prospective American studies. Circulation. 1989;79: Assmann G, Schulte H, von Eckardstein A, Huang Y. High-density lipoprotein cholesterol as a predictor of coronary heart disease risk: the PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis. 1996;124(suppl):S11 S Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L, for the INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): casecontrol study. Lancet. 2004;364: Ginsberg HN. Lipoprotein physiology in nondiabetic and diabetic states: relationship to atherogenesis. Diabetes Care. 1991;14: Barter P. Metabolic abnormalities: high-density lipoproteins. Endocrinol Metab Clin North Am. 2004;33: Zimmet P. The burden of type 2 diabetes: are we doing enough? Diabetes Metab. 2003;29:6S9 6S West of Scotland Coronary Prevention Study Group. Influence of pravastatin and plasma lipids on clinical events in the West of Scotland Coronary Prevention Study (WOSCOPS). Circulation. 1998;97: Sacks FM, Tonkin AM, Shepherd J, Braunwald E, Cobbe S, Hawkins CM, Keech A, Packard C, Simes J, Byington R, Furberg CD. Effect of pravastatin on coronary disease events in subgroups defined by coronary risk factors: the Prospective Pravastatin Pooling Project. Circulation. 2000;102: Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360: ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002;288: Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr. Primary prevention of acute coronary events with lovastatin in men and women with average Response to Barter and Rye Antonio M. Gotto, Jr, MD, DPhil cholesterol levels: results of AFCAPS/TexCAPS: Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998;279: Long-Term Intervention With Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339: Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels: Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996;335: Sever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O Brien E, Ostergren J, for the ASCOT Investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003;361: Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH, for the CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebocontrolled trial. Lancet. 2004;364: Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia: West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995;333: Scandinavian Simvastatin Survival Study Investigators. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344: Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, La Grenade L, Gurwitz JH, Chan KA, Goodman MJ, Platt R. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA. 2004;292: Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004;109(suppl I):III-50 III-57. Drs Barter and Rye articulate several cogent arguments for opposing over-the-counter (OTC) access to statins. I agree in principle with their observations: Unsupervised OTC statin use would be a misstep in high-risk patients, who should be under a clinician s care, and in low-risk patients, for whom the risk-to-benefit ratio may be unfavorable; the risk associated with low high-density lipoprotein cholesterol (HDL-C) is underappreciated; and we must give thought to raising HDL-C as a therapeutic strategy. In my opinion, addressing these issues does not necessarily require abandoning OTC statins. Although Drs Barter and Rye note that statins failed to eliminate the association of cardiovascular risk with low HDL-C in several trials, it is doubtful that any single therapy could do so. Nevertheless, in the Air Force/Texas Coronary Atherosclerosis Prevention Study, excess cardiovascular risk was greatly reduced in a below-average HDL-C population by lovastatin. It is important to emphasize that OTC statins are intended to target a specific, and sizable, population of at-risk patients: moderate-risk individuals whose risk is demonstrably undertreated at present. Can we use OTC statins to improve risk-reducing efforts in this group? Unfortunately, we cannot completely anticipate how consumers would respond to OTC statins or what the impact would be in the United States, although we can continue to watch the United Kingdom s OTC initiative for perspective. In summary, the challenge posed by the Food and Drug Administration committees may be stated as follows: Can we ensure that OTC statins will get into the hands of those who are most likely to benefit while minimizing the risks for side effects and misuse? Giving patients greater autonomy over their own therapeutic choices can be beneficial, but one must acknowledge that there are many important questions about OTC statins that remain to be answered.
APPENDIX B: LIST OF THE SELECTED SECONDARY STUDIES
APPENDIX B: LIST OF THE SELECTED SECONDARY STUDIES Main systematic reviews secondary studies on the general effectiveness of statins in secondary cardiovascular prevention (search date: 2003-2006) NICE.
More informationData Alert. Vascular Biology Working Group. Blunting the atherosclerotic process in patients with coronary artery disease.
1994--4 Vascular Biology Working Group www.vbwg.org c/o Medical Education Consultants, LLC 25 Sylvan Road South, Westport, CT 688 Chairman: Carl J. Pepine, MD Eminent Scholar American Heart Association
More informationComparison of Original and Generic Atorvastatin for the Treatment of Moderate Dyslipidemic Patients
Comparison of Original and Generic Atorvastatin for the Treatment of Moderate Dyslipidemic Patients Cardiology Department, Bangkok Metropolitan Medical College and Vajira Hospital, Bangkok, Thailand Abstract
More informationNew Features of the National Cholesterol Education Program Adult Treatment Panel III Lipid-Lowering Guidelines
Clin. Cardiol. Vol. 26 (Suppl. III), III-19 III-24 (2003) New Features of the National Cholesterol Education Program Adult Treatment Panel III Lipid-Lowering Guidelines H. BRYAN BREWER, JR, M.D. Molecular
More informationStatins in the elderly : Is there a rationale?
Statins in the elderly : Is there a rationale? Pr B Boland After a communication by Dr. Manfred Gogol EAMA, Sion, June, 2006 1 RCTs with Statins Meta-Analysis, 1999 182 abstracts or research papers 29
More informationStatins in the Treatment of Type 2 Diabetes Mellitus: A Systematic Review.
ISPUB.COM The Internet Journal of Cardiovascular Research Volume 7 Number 1 Statins in the Treatment of Type 2 Diabetes Mellitus: A Systematic Review. C ANYANWU, C NOSIRI Citation C ANYANWU, C NOSIRI.
More informationLIST OF ABBREVIATIONS
Diabetes & Endocrinology 2005 Royal College of Physicians of Edinburgh Diabetes and lipids 1 G Marshall, 2 M Fisher 1 Research Fellow, Department of Cardiology, Glasgow Royal Infirmary, Glasgow, Scotland,
More informationThreshold Level or Not for Low-Density Lipoprotein Cholesterol
... SYMPOSIA PROCEEDINGS... Threshold Level or Not for Low-Density Lipoprotein Cholesterol Based on a debate between Philip J. Barter, MD, PhD, FRACP, and Frank M. Sacks, MD Debate Summary As drugs, such
More informationHow would you manage Ms. Gold
How would you manage Ms. Gold 32 yo Asian woman with dyslipidemia Current medications: Simvastatin 20mg QD Most recent lipid profile: TC = 246, TG = 100, LDL = 176, HDL = 50 What about Mr. Williams? 56
More informationInfluences of Statins on Glucose Tolerance in Patients with Type 2 Diabetes Mellitus
Original Article 95 Influences of Statins on Glucose Tolerance in Patients with Type 2 Diabetes Mellitus Tatsuro Takano, Tadashi Yamakawa, Mayumi Takahashi, Mari Kimura, and Atsushi Okamura Department
More informationAndrew Cohen, MD and Neil S. Skolnik, MD INTRODUCTION
2 Hyperlipidemia Andrew Cohen, MD and Neil S. Skolnik, MD CONTENTS INTRODUCTION RISK CATEGORIES AND TARGET LDL-CHOLESTEROL TREATMENT OF LDL-CHOLESTEROL SPECIAL CONSIDERATIONS OLDER AND YOUNGER ADULTS ADDITIONAL
More informationATP IV: Predicting Guideline Updates
Disclosures ATP IV: Predicting Guideline Updates Daniel M. Riche, Pharm.D., BCPS, CDE Speaker s Bureau Merck Janssen Boehringer-Ingelheim Learning Objectives Describe at least two evidence-based recommendations
More information2013 Cholesterol Guidelines. Anna Broz MSN, RN, CNP, AACC Adult Certified Nurse Practitioner North Ohio Heart, Inc.
2013 Cholesterol Guidelines Anna Broz MSN, RN, CNP, AACC Adult Certified Nurse Practitioner North Ohio Heart, Inc. Disclosures Speaker Gilead Sciences NHLBI Charge to the Expert Panel Evaluate higher quality
More informationDiabetes is the most common endocrine
Clinical Care/Education/Nutrition O R I G I N A L A R T I C L E Secondary Prevention of Cardiovascular Events With Long-Term Pravastatin in Patients With Diabetes or Impaired Fasting Glucose Results from
More informationChanging lipid-lowering guidelines: whom to treat and how low to go
European Heart Journal Supplements (2005) 7 (Supplement A), A12 A19 doi:10.1093/eurheartj/sui003 Changing lipid-lowering guidelines: whom to treat and how low to go C.M. Ballantyne Section of Atherosclerosis,
More informationReduction in Cardiovascular Events With Atorvastatin in 2,532 Patients With Type 2 Diabetes
Pathophysiology/Complications O R I G I N A L A R T I C L E Reduction in Cardiovascular Events With Atorvastatin in 2,532 Patients With Type 2 Diabetes Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering
More informationWhat the Statin Trials Have Taught Us
What the Statin Trials Have Taught Us David D. Waters, MD a,b, * It has taken a century since Anitschkow began feeding cholesterol to rabbits to study the role of cholesterol in atherosclerosis to be fully
More information( Diabetes mellitus, DM ) ( Hyperlipidemia ) ( Cardiovascular disease, CVD )
005 6 69-74 40 mg/dl > 50 mg/dl) (00 mg/dl < 00 mg/dl(.6 mmol/l) 30-40% < 70 mg/dl 40 mg/dl 00 9 mg/dl fibric acid derivative niacin statin fibrate statin niacin ( ) ( Diabetes mellitus,
More informationCoronary artery disease remains the leading
UNMET NEEDS IN THE TREATMENT OF ATHEROSCLEROSIS: WHY ARE WE NOT DONE YET? * Evan A. Stein, MD, PhD ABSTRACT Heart disease remains the leading cause of death in the United States. Despite advances in surgical,
More informationThe role of statins in patients with arterial hypertension
Invited review The role of statins in patients with arterial hypertension Trygve B. Tjugen 1, Sigrun Halvorsen 1, Reidar Bjørnerheim 1, Sverre E. Kjeldsen 1, 2 1University of Oslo, Department of Cardiology,
More informationThe All Wales Medicine Strategy Group (AWMSG) is asked to support implementation of the following prescribing indicators.
ENCLOSURE 5 APPENDIX 1 Paper presented to AWMSG in June 2006 AWPAG considered comments recorded in AWMSG minutes in July 2006 Paper subsequently updated and brought back to AWMSG for endorsement This paper
More informationStatins reduce the incidence of coronary events in patients
Comments, Opinions, and Reviews Statin Therapy for Stroke Prevention Abdullah Nassief, MD; James D. Marsh, MD Background and Purpose Statins are widely used to reduce the risk of stroke in patients with
More informationLDL cholesterol and cardiovascular outcomes?
LDL cholesterol and cardiovascular outcomes? Prof Kausik Ray, BSc (hons), MBChB, FRCP, MD, MPhil (Cantab), FACC, FESC Professor of Cardiovascular Disease Prevention St Georges University of London Honorary
More informationThis is a lipid lowering drug strategy which should only be used within an overall lifestyle and clinical management strategy.
Treatment Guideline Statin Prescribing Objective These guidelines represent the views of the Gloucestershire Hospitals NHS Foundation Trust, which were arrived at after consideration of the available evidence
More informationCardiovascular outcomes trials with statins in diabetes
Cardiovascular outcomes trials with statins in diabetes FARIHA NAEEM, GERARD MCKAY, MILES FISHER REVIEW Abstract Treatment with statins is one of the most effective ways of reducing cardiovascular events
More informationMedical evidence suggests that
COMBINATION THERAPY TO ACHIEVE LIPID GOALS David G. Robertson, MD* ABSTRACT Coronary heart disease (CHD) remains the leading cause of death in the United States despite recent advances in treatment and
More informationThe implications of a growing evidence base for drug use in elderly patients. Part 1. Statins for primary and secondary cardiovascular prevention
British Journal of Clinical Pharmacology DOI:10.1111/j.1365-2125.2006.02609.x The implications of a growing evidence base for drug use in elderly patients. Part 1. Statins for primary and secondary cardiovascular
More informationCholesterol lowering intervention for cardiovascular prevention in high risk patients with or without LDL cholesterol elevation
TrialResults-center.org www.trialresultscenter.org Cholesterol lowering intervention for cardiovascular prevention in high risk patients with or without LDL cholesterol elevation A systematic review and
More informationStatin Therapy in the Management of Diabetes Mellitus; How Relevant?
American Medical Journal 4 (1): 36-42, 2013 ISSN 1949-0070 2013 doi:10.3844/amjsp.2013.36.42 Published Online 4 (1) 2013 (http://www.thescipub.com/amj.toc) Statin Therapy in the Management of Diabetes
More informationThe TNT Trial Is It Time to Shift Our Goals in Clinical
The TNT Trial Is It Time to Shift Our Goals in Clinical Angioplasty Summit Luncheon Symposium Korea Assoc Prof David Colquhoun 29 April 2005 University of Queensland, Wesley Hospital, Brisbane, Australia
More informationRaising high-density lipoprotein cholesterol: where are we now?
European Heart Journal Supplements (23) 5 (Supplement D), D17 D25 Raising high-density lipoprotein cholesterol: where are we now? Baylor College of Medicine, Houston, Texas, U.S.A. KEYWORDS Apolipoprotein;
More informationApproach to Dyslipidemia among diabetic patients
Approach to Dyslipidemia among diabetic patients Farzad Hadaegh, MD, Professor of Internal Medicine & Endocrinology Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences
More informationHYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016
HYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016 NOTHING TO DISCLOSE I, Nicole Slater, have no actual or potential conflict
More informationLow HDL C and/or elevated triglycerides (TG) was seen in nearly two thirds of MI patients
PRESS RELEASE New Insights Link Low HDL Cholesterol and Elevated Triglycerides with Coronary Heart Disease and Microvascular Complications in Patients at Goal for LDL Cholesterol Surveys establish residual
More informationCardiovascular disease (CVD) is the
Epidemiology/Health Services/Psychosocial Research O R I G I N A L A R T I C L E Cost Effectiveness of Statin Therapy for the Primary Prevention of Major Coronary Events in Individuals With Type 2 Diabetes
More informationStatin Treatment for Older Adults: The Impact of the 2013 ACC/AHA Cholesterol Guidelines
Drugs Aging (2015) 32:87 93 DOI 10.1007/s40266-014-0238-5 CURRENT OPINION Statin Treatment for Older Adults: The Impact of the 2013 ACC/AHA Cholesterol Guidelines Yitzchak Weinberger Benjamin H. Han Published
More informationOn May 2001, the Third Adult
THE RISK OF DIABETES: CAN WE IMPACT CHD THROUGH THE ATP III CHOLESTEROL GUIDELINES? * Based on a presentation given by Steven M. Haffner, MD, MPH ABSTRACT Diabetes has been recognized among diabetologists
More informationSupplementary Online Content
Supplementary Online Content Navarese EP, Robinson JG, Kowalewski M, et al. Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering: a systematic review and
More information2013 Cholesterol Guidelines. Anna Broz MSN, RN, CNP, AACC Cer=fied Adult Nurse Prac==oner North Ohio Heart, Inc.
2013 Cholesterol Guidelines Anna Broz MSN, RN, CNP, AACC Cer=fied Adult Nurse Prac==oner North Ohio Heart, Inc. Disclosures Speaker Gilead Sciences NHLBI Charge to the Expert Panel Evaluate higher quality
More informationThe JUPITER trial: What does it tell us? Alice Y.Y. Cheng, MD, FRCPC January 24, 2009
The JUPITER trial: What does it tell us? Alice Y.Y. Cheng, MD, FRCPC January 24, 2009 Learning Objectives 1. Understand the role of statin therapy in the primary and secondary prevention of stroke 2. Explain
More informationFrequency of Simvastatin Prescriptions With Potentially Interacting Medications in a Veterans Affairs Health Care System
ORIGINAL RESEARCH Frequency of Simvastatin Prescriptions With Potentially Interacting Medications in a Veterans Affairs Health Care System JERILYN B. PETROPOULOS, BSPharm, PharmD, BCPS, and CRISTINA E.
More informationLandmark Clinical Trials.
Landmark Clinical Trials 1 Learning Objectives Discuss clinical trials and their role in lipid and lipoprotein treatment in cardiovascular prevention. Review the clinical trials of lipid-altering drug
More informationIntroduction. Objective. Critical Questions Addressed
Introduction Objective To provide a strong evidence-based foundation for the treatment of cholesterol for the primary and secondary prevention of ASCVD in women and men Critical Questions Addressed CQ1:
More informationSTATINS FOR PAD Long - term prognosis
STATINS FOR PAD Long - term prognosis Prof. Pavel Poredos, MD, PhD Department of Vascular Disease University Medical Centre Ljubljana Slovenia DECLARATION OF CONFLICT OF INTEREST No conflict of interest
More informationIs Lower Better for LDL or is there a Sweet Spot
Is Lower Better for LDL or is there a Sweet Spot ALAN S BROWN MD, FACC FNLA FAHA FASPC DIRECTOR, DIVISION OF CARDIOLOGY ADVOCATE LUTHERAN GENERAL HOSPITAL, PARK RIDGE, ILLINOIS DIRECTOR OF CARDIOLOGY,
More informationCLINICAL DECISION USING AN ARTICLE ABOUT TREATMENT JOSEFINA S. ISIDRO LAPENA MD, MFM, FPAFP PROFESSOR, UPCM
CLINICAL DECISION USING AN ARTICLE ABOUT TREATMENT JOSEFINA S. ISIDRO LAPENA MD, MFM, FPAFP PROFESSOR, UPCM Principles of Decision Making Knowing the patient s true state is often unnecessary Does my patient
More informationSupplementary Online Content
Supplementary Online Content Gutierrez J, Ramirez G, Rundek T, Sacco RL. Statin therapy in the prevention of recurrent cardiovascular events: a sex-based meta-analysis. Arch Intern Med. 2012;172(12):IRA120005.
More informationApplicability of Cholesterol-Lowering Primary Prevention Trials to a General Population
Applicability of Cholesterol-Lowering Primary Prevention Trials to a General Population The Framingham Heart Study ORIGINAL INVESTIGATION Donald M. Lloyd-Jones, MD; Christopher J. O Donnell, MD, MPH; Ralph
More informationCLINICAL OUTCOME Vs SURROGATE MARKER
CLINICAL OUTCOME Vs SURROGATE MARKER Statin Real Experience Dr. Mostafa Sherif Senior Medical Manager Pfizer Egypt & Sudan Objective Difference between Clinical outcome and surrogate marker Proper Clinical
More informationPotential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial
European Heart Journal (2006) 27, 2982 2988 doi:10.1093/eurheartj/ehl403 Clinical research Coronary heart disease Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian
More information22 Is Aggressive Lipid
22 Is Aggressive Lipid Lowering the Call in Era of Prevention of CAD? Abstract: Ever since the publication of the 4S study, lipid management has been the center of preventive therapy for coronary artery
More informationDepartment of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan 2
Original Article 879 Association between Lowering Low-Density Lipoprotein Cholesterol with Pravastatin and Primary Prevention of Cardiovascular Disease in Mild to Moderate Hypercholesterolemic Japanese
More informationHyperlipidemia is a well-established risk factor for cardiovascular. Stroke
Stroke Rosuvastatin in the Prevention of Stroke Among Men and Women With Elevated Levels of C-Reactive Protein Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin
More informationReview of guidelines for management of dyslipidemia in diabetic patients
2012 international Conference on Diabetes and metabolism (ICDM) Review of guidelines for management of dyslipidemia in diabetic patients Nan Hee Kim, MD, PhD Department of Internal Medicine, Korea University
More informationMeta-analysis of large randomized controlled trials to evaluate the impact of statins on cardiovascular outcomes
et al. British Journal of Clinical Pharmacology DOI:10.1111/j.1365-2125.2003.02060.x Meta-analysis of large randomized controlled trials to evaluate the impact of statins on cardiovascular outcomes Bernard
More informationReducing low-density lipoprotein cholesterol treating to target and meeting new European goals
European Heart Journal Supplements (2004) 6 (Supplement A), A12 A18 Reducing low-density lipoprotein cholesterol treating to target and meeting new European goals University of Sydney, Sydney, NSW, Australia
More informationScreening for Lipid Disorders in Adults: Selective Update of 2001 U.S. Preventive Services Task Force Review
Evidence Synthesis Number 49 Screening for Lipid Disorders in Adults: Selective Update of 2001 U.S. Preventive Services Task Force Review Prepared for : Agency for Healthcare Research and Quality (AHRQ)
More informationTABLE 1. Cardiovascular Disease Management Guidelines for the Primary Prevention of CAD a Risk category b LDL-C goal (mg/dl) c Moderately high risk (
REVIEW PRIMARY PREVENTION OF CAD Intensive Lowering of Low-Density Lipoprotein Cholesterol Levels for Primary Prevention of Coronary Artery Disease DEAN G. KARALIS, MD Coronary artery disease (CAD) is
More informationHow to Reduce Residual Risk in Primary Prevention
How to Reduce Residual Risk in Primary Prevention Helene Glassberg, MD Assistant Professor of Medicine Section of Cardiology Hospital of the University of Pennsylvania Philadelphia, PA USA Patients with
More informationCardiovascular Complications of Diabetes
VBWG Cardiovascular Complications of Diabetes Nicola Abate, M.D., F.N.L.A. Professor and Chief Division of Endocrinology and Metabolism The University of Texas Medical Branch Galveston, Texas Coronary
More informationAttainment of Combined Optimal Lipid Values With the Use of Niacin
www.medscape.com Attainment of Combined Optimal Lipid Values With the Use of Niacin Has AIM-HIGH Closed the Book on This Debate? Tyan Thomas Clin Lipidology. 2012;7(4):389-396. Abstract and Introduction
More informationCoronary heart disease (CHD) has. Clearfield The National Cholesterol Education Program Adult Treatment Panel III guidelines
the osteopathic physician. The treatment approach involves therapeutic lifestyle changes with diet, exercise, and weight loss. It requires regular, careful monitoring of serum cholesterol levels. The new
More informationThe treatment of coronary heart disease (CHD) The Health Economics of the Treatment of Hyperlipidemia and Hypertension J. McMurray
AJH 1999;12:99S 104S The Health Economics of the Treatment of Hyperlipidemia and Hypertension J. McMurray In the current economic climate it is important to demonstrate that healthcare resources are being
More informationDyslipidemia in the light of Current Guidelines - Do we change our Practice?
Dyslipidemia in the light of Current Guidelines - Do we change our Practice? Dato Dr. David Chew Soon Ping Senior Consultant Cardiologist Institut Jantung Negara Atherosclerotic Cardiovascular Disease
More informationThe CARI Guidelines Caring for Australians with Renal Impairment. Cardiovascular Risk Factors
Cardiovascular Risk Factors ROB WALKER (Dunedin, New Zealand) Lipid-lowering therapy in patients with chronic kidney disease Date written: January 2005 Final submission: August 2005 Author: Rob Walker
More informationJAMA. 2011;305(24): Nora A. Kalagi, MSc
JAMA. 2011;305(24):2556-2564 By Nora A. Kalagi, MSc Cardiovascular disease (CVD) is the number one cause of mortality and morbidity world wide Reducing high blood cholesterol which is a risk factor for
More informationNicole Ciffone, MS, ANP-C, AACC Clinical Lipid Specialist
1 Nicole Ciffone, MS, ANP-C, AACC Clinical Lipid Specialist New Cardiovascular Horizons Multidisciplinary Strategies for Optimal Cardiovascular Care February 7, 2015 2 Objectives After participating in
More informationWithdrawal of Cerivastatin Revealed a Flaw of Post-marketing Surveillance System in the United States
Bull. Natl. Inst. Health Sci., 123 Notes # Withdrawal of Cerivastatin Revealed a Flaw of Post-marketing Surveillance System in the United States Journal of American Medical Association (JAMA) Statin HMG
More informationType 2 diabetes is associated with
Lipid Management in Type 2 Diabetes Maria P. Solano, MD, and Ronald B. Goldberg, MD Type 2 diabetes is associated with a marked increased risk of cardiovascular disease (CVD). Individuals with diabetes
More informationNCEP Report. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines
NCEP Report Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines Scott M. Grundy; James I. Cleeman; C. Noel Bairey Merz; H. Bryan Brewer,
More informationLipid Panel Management Refresher Course for the Family Physician
Lipid Panel Management Refresher Course for the Family Physician Objectives Understand the evidence that was evaluated to develop the 2013 ACC/AHA guidelines Discuss the utility and accuracy of the new
More informationWeigh the benefit of statin treatment: LDL & Beyond
Weigh the benefit of statin treatment: LDL & Beyond Duk-Woo Park, MD, PhD Heart Institute, University of Ulsan College of Medicine, Asan Medical, Seoul, Korea FOURIER Further cardiovascular OUtcomes Research
More informationNearly 62 million people in the. ... REPORTS... New Therapeutic Options in the National Cholesterol Education Program Adult Treatment Panel III
... REPORTS... New Therapeutic Options in the National Cholesterol Education Program Adult Treatment Panel III Robert L. Talbert, PharmD Abstract Coronary heart disease (CHD) is a common, costly, and undertreated
More informationSince the release of the National Cholesterol PROCEEDINGS FUTURE DIRECTIONS IN DYSLIPIDEMIA MANAGEMENT * Michael B. Clearfield, DO, FACOI ABSTRACT
FUTURE DIRECTIONS IN DYSLIPIDEMIA MANAGEMENT * Michael B. Clearfield, DO, FACOI ABSTRACT Since the National Cholesterol Education Program (NCEP) Third Adult Treatment Panel (ATP III) guidelines, 3 large
More informationEfficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from participants in 14 randomised trials of statins
Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins Cholesterol Trialists (CTT) Collaborators* Summary Background
More informationDiabetes mellitus type 2 and angina pectoris : novel insights in diagnosis, prognosis and treatment Wiersma, J.J.
UvA-DARE (Digital Academic Repository) Diabetes mellitus type 2 and angina pectoris : novel insights in diagnosis, prognosis and treatment Wiersma, J.J. Link to publication Citation for published version
More informationRECOGNITION OF THE METABOLIC SYNDROME
THE METABOLIC SYNDROME IN CLINICAL PRACTICE Michael H. Davidson, MD* ABSTRACT Patients with the metabolic syndrome remain at significantly elevated risk of morbidity and mortality associated with coronary
More informationTailored Statin Treatment for Type 2 Diabetes. Han, Ki Hoon Asan Medical Center University of Ulsan
Tailored Statin Treatment for Type 2 Diabetes Han, Ki Hoon Asan Medical Center University of Ulsan 1 Cardiovascular disease ; No1. death (2001) respiratory tract infection Other NCD S HIV/AIDS deaths during
More informationSTATIN THERAPY IN THE ELDERLY: THERE ARE MILES TO GO BEFORE WE SLEEP
STATIN THERAPY IN THE ELDERLY: THERE ARE MILES TO GO BEFORE WE SLEEP Peter P. Toth, MD, PhD, FAAFP, FICA, FNLA, FCCP, FAHA, FACC Director of Preventative Cardiology CGH Medical Center, Sterling, Illinois
More informationSupplementary appendix
Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Cholesterol Treatment Trialists Collaboration.
More informationThe Clinical Unmet need in the patient with Diabetes and ACS
The Clinical Unmet need in the patient with Diabetes and ACS Professor Kausik Ray (UK) BSc(hons), MBChB, MD, MPhil, FRCP (lon), FRCP (ed), FACC, FESC, FAHA Diabetes is a global public health challenge
More informationDyslipidemia Management - Summary. Adults at any age with the following risk factors should be screened for lipids at any age:
Dyslipidemia Management - Summary How do I assess Dyslipidemia? Screening of plasma lipids is recommended in adult men 40 and women that are 50 years of age or who are postmenopausal. Adults at any age
More informationDrug Class Review on HMG-CoA Reductase Inhibitors (Statins)
Drug Class Review on HMG-CoA Reductase Inhibitors () Final Report June 2004 Mark Helfand, MD, MPH Susan Carson, MPH Cathy Kelley, PharmD Oregon Evidence-based Practice Center Oregon Health & Science University
More informationOriginal paper. Abstract. Abdullah S. Asia 1*, Al-Mahdi A. Modar 2, Hadi M. Ali 3
Original paper Frequency Of Potential Adverse Effects Of A Semisynthetic Statin (Simvastatin) Compared To A Synthetic Statin (Atorvastatin) Used To Reduce Cardiovascular Risk For Patients In Basra 1*,
More informationRHABDOMYOLYSIS AFTER ADDITION OF DIGITOXIN TO CHRONIC SIMVASTATIN AND AMIODARONE THERAPY
RHABDOMYOLYSIS AFTER ADDITION OF DIGITOXIN TO CHRONIC SIMVASTATIN AND AMIODARONE THERAPY H Nägele (1)*, S.Behrens (1), S. Hashagen (1), M Azizi (2) 1) St. Adolfstift, Medical Clinic, Reinbek, Germany (Director:
More informationHow much do we pay for a benefit? A Descriptive Cost Analysis of the Use of Statins. The Need for a National Cost- Effectiveness Analysis
Point of View How much do we pay for a benefit? A Descriptive Cost Analysis of the Use of Statins. The Need for a National Cost- Effectiveness Analysis José Luiz da Costa Vieira, Vera Lúcia Portal, Emílio
More informationCalculating RR, ARR, NNT
Calculating RR, ARR, NNT In a trial RR = Event rate (eg # of people with one stroke/ total people) in treatment group/event rate in the control group. ARR = Event rate in control group minus the event
More informationAn update on lipidology and cardiovascular risk management. Lipids, Metabolism & Vascular Risk Section - Royal Society of Medicine
An update on lipidology and cardiovascular risk management Lipids, Metabolism & Vascular Risk Section - Royal Society of Medicine National and international lipid modification guidelines: A critical appraisal
More informationDyslipidemia is a strong risk factor for myocardial infarction, 1
Safety of Simvastatin and Goal Attainment for Low-Density Lipoprotein Cholesterol in Sultan Qaboos University Hospital Khalid Al-Siyabi, 1 Hatem Farhan, 2 Khalid Al-Rasadi, 3 Amaal Al-Salhi, 4 Ali T. Al-Hinai,
More informationWhen it comes to the FIELD study, what is...is
Future Lipidology ISSN: 1746-0875 (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/tlip19 When it comes to the FIELD study, what is...is James McKenney To cite this article: James McKenney
More informationHow to use statins in patients with chronic liver disease
REVIEW CME CREDIT MARK W. RUSSO, MD Center for the Study of Hepatitis C, Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY IRA M. JACOBSON, MD Center for the Study
More informationPatients with type 2 diabetes are at
Clinical Care/Education/Nutrition O R I G I N A L A R T I C L E Effect of Lowering LDL Cholesterol Substantially Below Currently Recommended Levels in Patients With Coronary Heart Disease and Diabetes
More informationEffective Treatment Options With Add-on or Combination Therapy. Christie Ballantyne (USA)
Effective Treatment Options With Add-on or Combination Therapy Christie Ballantyne (USA) Effective treatment options with add-on or combination therapy Christie M. Ballantyne, MD Center for Cardiovascular
More informationUpdate on Dyslipidemia and Recent Data on Treating the Statin Intolerant Patient
Update on Dyslipidemia and Recent Data on Treating the Statin Intolerant Patient Steven E. Nissen MD Chairman, Department of Cardiovascular Medicine Cleveland Clinic Disclosure Consulting: Many pharmaceutical
More information4/7/ The stats on heart disease. + Deaths & Age-Adjusted Death Rates for
+ Update on Lipid Management Stacey Gardiner, MD Assistant Professor Division of Cardiovascular Medicine Medical College of Wisconsin + The stats on heart disease Over the past 10 years for which statistics
More informationDiabetes mellitus is a leading cause of morbidity and
Clinical Guidelines Lipid Control in the Management of Type 2 Diabetes Mellitus: A Clinical Practice Guideline from the American College of Physicians Vincenza Snow, MD; Mark D. Aronson, MD; E. Rodney
More informationModern Lipid Management:
Modern Lipid Management: New Drugs, New Targets, New Hope Kirk U. Knowlton, M.D Director of Cardiovascular Research Co Chief of Cardiology Why lower LDL C in those without evidence of CAD (primary prevention)
More informationPIEDMONT ACCESS TO HEALTH SERVICES, INC. Guidelines for Screening and Management of Dyslipidemia
PIEDMONT ACCESS TO HEALTH SERVICES, INC. Policy Number: 01-09-021 SUBJECT: Guidelines for Screening and Management of Dyslipidemia EFFECTIVE DATE: 04/2008 REVIEWED/REVISED: 04/12/10, 03/17/2011, 4/10/2012,
More information