Death is inevitable but premature death is not. Sir Richard Doll

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1 Welcome to the Diabetes Care for You webinar Please log onto the conference call so you can hear our presenter From any SCFT Cisco phone dial From a mobile phone or any other phone dial From any phone when prompted enter meeting code 1013# enter attendee access code 1013# Please would you mute once joined to avoid any background noise being heard by everyone (and unmute when you want to ask a question) You re welcome to use speakerphones so a group can listen in. Thank you

2 Lipids in Diabetes

3 Death is inevitable but premature death is not. Sir Richard Doll

4 Mechanisms of Dyslipidemia in the Metabolic Syndrome FACTORS: Environmental Biological Inherited Abdominal fat Hypertrophic adipocytes Defect in the incorporation of FFAs into TG FFA: free fatty acids TG: triglycerides LPL: lipoprotein lipase HDL: high density lipoprotein CETP: cholesterol ester transfer protein CE: cholesterol ester VLDL: very low density lipoprotein Insulin resistance FFA trapping and retention by adipose tissue FFA in plasma Clearance LPL, APO CIII Proteolysis of Apo B-100 TG Catabolism HDL-C TG in HDL TG CETP CE VLDL apo B TG CETP CE Hepatic Lipase TG in LDL-C HDL-C levels Small dense LDL-C Kolovo GD. Postgrad Med J. 2005;81;

5 Fat Cells Atherogenic Dyslipidemia of DM-2 1 FFA Liver CE on TGRL CE 2 HDL IR X TG Apo B VLDL CE VLDL (CETP) (CETP) TG TG HDL Lipid-poor Apo A-1 Insulin LDL Hepatic lipase or lipoprotein lipase (remove PL&TG) SD LDL 3 SD LDL Kidney CETP=cholesterol ester transfer protein. Ginsberg HN. J Clin Invest. 2000;106(4):

6 Atherogenic Dyslipidemia (=Dyslipidemia of Diabetes Mellitus/ Insulin Resistance) Hypertriglyceridemia (HTG) Low HDL-C Small, dense LDL (Increased VLDL-C) (Non HDL-C)

7 Multiple CV Risk Factor Modification in Type 2 Diabetes*: UKPDS 23 Position Variable P Value First LDL C < Second HDL C Third A 1c Fourth Systolic BP Fifth Smoking *Adjusted for age and gender in 2693 Caucasian patients on time to first event Adapted from Turner RC et al. BMJ. 1998;316: P values are significance of risk factor after controlling for all other risk factors in model.

8 Benefits of Non-fasting Lipids Patient convenience no need to go to lab early in the morning and fasting; no need for retesting if not fasting Reduced wait times and reduced early morning patient burden in clinical laboratories Safety prevention of hypoglycemic episodes in diabetics Enhances compliance and avoids delay in lipid screening and follow up tests Enhanced predictive value for CVD and mortality of nonfasting lipids Identification of high remnants/insulin resistance Removal of need to perform fasting blood work generally HbA1c is accepted as a diagnostic test and follow up test by CDA and ADA that does NOT have to be accompanied by a fasting glucose High fasting glucose usually results in HbA1c test

9 Rotherham Guideline for the management of Non-Familial Hypercholesterolaemia Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December 2014 Type 1 Diabetes Offer lifestyle advice Over 40yrs of age? Diabetic for more than 10 years? Established nephropathy? Other CVD risk Factors? Chronic Kidney Disease (CKD) egfr < 60mls/min and/or albuminuria) Primary Prevention Patients aged 85yrs and over Assess CVD risk using QRISK2 tool*, obtain baseline lipid profile and LFTs Risk > 10% over 10 years Other Patients Risk < 10% over 10 years NO Consider whether statin treatment is appropriate based on clinical judgement. YES Decision to treat Give Atorvastatin 20mg OD if not contraindicated (plus other interventions, as appropriate) Monitor lipid profile 3 months after initiation. Is there >40% reduction from baseline? YES NO Offer lifestyle advice and reassess as appropriate NB - All patients on statins should have their treatment reviewed on an annual basis. Maintain current statin prescription Discuss adherence and timing of statin dose Optimise diet and lifestyle measures Consider increasing Atorvastatin if not already on maximal dose *CVD risk using QRISK2 may be underestimated in the following patient groups: Those treated for HIV Those with serious mental health problems Those taking medicines which may predispose to hyperlipidaemia such as corticosteroids, antipsychotics or immunosuppressants. Those already taking lipid modification or antihypertensive therapies. Those who have recently stopped smoking BMI > 40kg/m 2

10 Rotherham Guideline for the management of Non-Familial Hypercholesterolaemia Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December 2014 Secondary Prevention Established Cardiovascular Disease (CVD) Are there potential drug interactions or high risk of adverse effects with statins? NO YES Give Atorvastatin 80mg OD (unless patient expresses a preference for a lower dose) Give Atorvastatin at 40mg/20mg/10mg OD as appropriate given potential interactions or risk factors Monitor lipid profile 3 months after initiation. Is there >40% reduction from baseline? Maintain current statin prescription Discuss adherence and timing of statin dose Optimise diet and lifestyle measures Consider increasing Atorvastatin if not already on maximal dose review in 3 months. All patients on statins should have their treatment reviewed on an annual basis

11 Rotherham Guideline for the management of Non-Familial Hypercholesterolaemia Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December Management of Intolerance to Statin Treatment Stain intolerance Studies so that when statins have been stopped for intolerance in the absence of a clinical reason up to 92% of patients are able to tolerate satins when rechallenged. (Annals of Internal Medicine 158; ) Strategy for reintroducing a statin Stop the statin and restart once symptoms have resolved to check if the symptoms are statin related Reduce the dose of the current statin if appropriate Change to an alternative statin within the same intensity group Change to an alternative statin within a lower intensity group Intolerance is not a class effect. Hence where intolerance to a second statin is evident, other statins should be tried before considering alternative agents. The agents with the best tolerability profiles are pravastatin, atorvastatin (if not already tried), the lipid lowering potential and acquisition cost should also be considered. When initiating atorvastatin or rosuvastatin in previously intolerant patients, start at the lowest available dose and up-titrate. Ezetimibe: Ezetimibe monotherapy should only be considered for prevention of CVD if multiple statins and fibrate treatment has not been tolerated (or in primary hypercholesterolaemia as per NICE TA 132) since there is minimal outcome data regarding its effectiveness in reducing morbidity or mortality in CVD. Ezetimibe may be added to statin treatment if recommended by a specialist, where treatment with statins alone has not produced optimal lipid lowering. Other lipid lowering agents: Nicotinic acid derivatives, bile acid sequestrants and omega-3 fatty acids are not recommended for use in primary or secondary prevention of CVD. Reduction in low density lipoprotein cholesterol (LDL)) Atorvastatin, simvastatin & Pravastatin have consistently the statins with the lowest acquisition costs Dose (mg/day) 5mg 10mg 20mg 40mg 80mg Fluvastatin % 27% 33% Pravastatin - 20% 24% 29% - Simvastatin - 27% 32% 37% *42% Atorvastatin - 37% 43% 49% 55% Rosuvastatin 38% 43% 48% 53% % low intensity 31-40% medium intensity Above 40% high intensity * Advice from the MHRA is that there is an increased risk of myopathy associated with 80mg dose of simvastatin. This dose should only be considered in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, and where the benefits are expected to outweigh the risks.

12 Lipid measurement and referral (Primary prevention) Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December 2014 Before starting lipid therapy take at least 1 lipid sample, this need not be fasting this should include Total cholesterol HDL cholesterol non-hdl cholesterol Triglycerides Before Also Check Smoking status Alcohol status HbA1c BMI Liver transaminases TSH Triglyceride concentration Between 10 and 20mmol\litre, repeat with a fasting sample after 5 days but within 2 weeks) Between 4.5 and 9.9 mmol\litre CVD risk may be underestimated Exclude common causes of secondary dyslipidaemia such as Excess alcohol Uncontrolled diabetes Hypothyroidism Liver disease Nephrotic syndrome Refer for specialist advice if; Total cholesterol is above 9mmol\litre Or non-hdl cholesterol is above 7.5 mmol\litre. Triglyceride concentration above 20mmol\litre (urgent referral) Consider familial hypercholesterolaemia and refer if Total cholesterol more than 7.5 mmol\litre A family history of premature coronary heart disease Always use Non-HDL cholesterol for all risk assessment calculations = Total Cholesterol HDL Cholesterol

13 Monitoring patients on statins Creatine kinase muscle pain Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December 2014 Has the patient experienced generalised unexplained muscle pain whether or not associated with previous Yes stain therapy? Measure creatine kinase If 5 times upper of normal re-measure after 7 days No Commence statin advise patient to report immediately any muscle symptoms (pain, tenderness, weakness). If this occurs measure creatine kinase Are creatine kinase levels still 5 times above normal Do not measure creatine kinase routinely in asymptomatic patients Yes Do not start statin therapy No But creatinine kinase levels are still raised Start statin therapy but at a lower dose If patients report muscle pain or weakness and have a raised creatine kinase explore and consider other causes if they have tolerated statin therapy for more than 3 months

14 Monitoring patients on statins Recommendations taken from NICE Clinical Guideline 181: Lipid Management, December 2014 Liver transaminase Measure liver transaminase At baseline before statin starting therapy within 3 months of starting statin therapy 12 months after starting therapy Do not measure again unless clinically indicated Do not routinely stop statin therapy in patients that have raised transaminases but are less than 3 times the upper limit. Blood Glucose / HbA1c Do not stop statins because of an increase in blood glucose levels of HbA1c Pregnancy Stains are contraindicated in pregnancy Advise omen of childbearing age of the potential teratogenic risk of statin Advise woman considering pregnancy to stop stains 3 months prior to attempt to conceive.

15 Time course of Statin effects 15 LDL-C lowered* Inflammation reduced Vulnerable plaques stabilized Endothelial function restored Ischemic episodes reduced Cardiac events reduced* Days * Time course established Years

16 Placebo MI Rate per 100 Subjects per 5 Years EARLY LANDMARK TRIALS OF STATINS CLINICAL BENEFITS 2-3 YEARS Continuum of risk Secondary prevention Primary prevention 4S (simvastatin) CARE (pravastatin) LIPID (pravastatin) WOSCOPS (pravastatin) High-risk CHD patients (high cholesterol) Majority of CHD patients (broad range of cholesterol levels) Patients at high risk of CHD (high cholesterol) 2.8 AFCAPS/TexCAPS (lovastatin) Patients at low risk of CHD (low HDL-C)

17 HEART PROTECTION STUDY RCT 20,000 patients with increased risk of CHD death due to either: -MI/ACS -PVD/CVA -Diabetes Mellitus - Hypertension Age years Chol> 3.5mmol/l Randomised simvastatin 40mg and placebo 12% reduction of all cause mortality and 24% reduction vascular death, stroke reduction by 27%

18 C ARDS: C ollaborative AtoRvastatin Diabetes Study design High-risk patients with type 2 diabetes (N = 2838) Atorvastatin 10 mg Placebo Randomization complete June 2001 Early termination June 2003 Results announced June 2004 Planned completion 2005 Primary outcome: Composite of major coronary events, revascularizations, unstable angina, resuscitated cardiac arrest, and stroke Colhoun HM et al. Diabet Med. 2002;19:

19 C ARDS: Treatment effects on lipids Total-C Average difference 26% 1.4 mmol/l (54 mg/dl) LDL-C Average difference 40% 1.2 mmol/l (46 mg/dl) 6 4 mmol/l P < P < Years Years Placebo Atorvastatin Colhoun HM et al. Lancet. 2004;364:

20 C ARDS: 37% Reduction in primary outcome Cumulative hazard (%) Relative risk reduction 37% 95% CI, 17% 52% P = Placebo 127 events Atorvastatin 83 events Years 4.75 Placebo Atorvastatin Colhoun HM et al. Lancet. 2004;364:

21 C ARDS: C onsistent statin effects on components of primary outcome n (% randomized) Event Placebo Atorvastatin Favors atorvastatin Favors placebo Risk reduction (95% CI) Primary outcome 127 (9.0) 83 (5.8) 37% (17 52) P = Acute coronary events Coronary revascularization Stroke 77 (5.5) 51 (3.6) 36% (9 55) 34 (2.4) 24 (1.7) 31% ( 16 59) 39 (2.8) 21 (1.5) 48% (11 69) Hazard ratio Colhoun HM et al. Lancet. 2004;364:

22 Randomized Comparisons of Different Statins at Different Doses The STELLAR Trial Change in LDL-C From Baseline (%) mg * 20 mg ** 40 mg 10 mg 10 mg 20 mg 40 mg 20 mg 80 mg 40 mg 80 mg Rosuvastatin Atorvastatin Simvastatin Pravastatin 10 mg 20 mg 40 mg *P<.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; pravastatin 10, 20, 40 mg. **P<.002 vs atorvastatin 20, 40 mg; simvastatin 20, 40, 80 mg; pravastatin 20, 40 mg. P<.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg. Adapted from Jones et al. Am J Cardiol 2003;92: Over 2/3 of the highest risk patients achieved the modified NCEP III goals on 10mg rosuvastatin or 20mg atorvastatin but not 40mg simvastatin or 40 mg pravastatin

23 TNT Treatment-to-New Targets Trial 10,002 chronic stable coronary disease patients Enrollment in 250 sites from 14 countries Randomized, double-blind trial of 80mg atorvastatin versus 10 mg atorvastatin Duration of 5 years or accrual of 750 primary CVD events

24 Primary Efficacy Outcome Measure: First Major Cardiovascular Event LaRosa et al. N Engl J Med 2005;352.

25 Safety No. of patients (%) Overall treatment-related SAEs Treatment-related myalgia Atorvastatin 10 mg (n = 5006) 289 (5.8) 234 (4.7) Atorvastatin 80 mg (n = 4995) 406 (8.1) 241 (4.8) Rhabdomyolysis* 3 (0.06) 2 (0.04) AST/ALT elevation >3 x ULN 9 (0.2) 60 (1.2) * No cases were considered by the investigator with direct resposibility for the patient to be causally related to atorvastatin, and none met ACC/AHA/NHLBI criteria for rhabdomyolysis LaRosa et al. N Engl J Med 2005;352.

26 Effect of statin therapy on SITE-SPECIFIC CANCER Site-specific cancer Statin/ more statin Events (% p.a.) Control/ less statin RR (CI) per 1 mmol/l reduction in LDL-C Large bowel/intestine 549 (0.2) 567 (0.2) 0.95 ( ) Other GI 665 (0.2) 678 (0.2) 0.99 ( ) Prostate 923 (0.3) 954 (0.4) 0.97 ( ) Bladder 315 (0.1) 331 (0.1) 0.94 ( ) Other GU 406 (0.1) 391 (0.1) 1.05 ( ) Respiratory 845 (0.2) 847 (0.2) 1.00 ( ) F emale breast 273 (0.3) 244 (0.3) 1.09 ( ) Haematological 313 (0.1) 301 (0.1) 1.03 ( ) Other/unspecified 932 (0.3) 897 (0.2) 1.05 ( ) Any cancer 5221 (1.5) 5210 (1.5) 1.00 ( ) 99% or 95% CI LDL-C lowering better LDL-C lowering worse

27 Thank you for your attention

28 Thank you Our next webinar will be on Thursday 21 February pm

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