Hypertension is an important global public
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1 IN THE LITERATURE Blood Pressure Target in Individuals Without Diabetes: What Is the Evidence? Commentary on Verdecchia P, Staessen JA, Angeli F, et al; on behalf of the Cardio-Sis Investigators. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet. 2009;374(9689): Hypertension is an important global public health problem affecting more than a quarter of the world s population, with the number of adults with hypertension predicted to increase by about 60% to a total of 1.56 billion worldwide by Epidemiologic studies have shown that hypertension is associated with increased cardiovascular morbidity and mortality, 2,3 and hypertension is an important modifiable risk factor because treatment to decrease blood pressure decreases the incidence of coronary artery disease and stroke. 4 Hypertension guidelines recommend decreasing systolic (SBP) and diastolic blood pressure (DBP) to 140/90 mm Hg except in individuals with diabetes, chronic kidney disease (CKD), and established cardiovascular disease, for whom the target is 130/80 mm Hg. 5,6 In recent years, there has been a trend toward evaluating lower blood pressure targets in the general population based on extrapolation from observational studies that suggest an increase in cardiovascular events in those with highnormal blood pressure ( /85-89 mm Hg). 7 In this context, it is important to consider results of the Cardio-Sis (Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica) clinical trial conducted by Verdecchia et al, 8 which was published in 2009 in the Lancet, to assess whether tight SBP control compared with usual control would be beneficial in hypertensive patients without diabetes. Originally published online as doi: /j.ajkd on July 5, Address correspondence to Mark J. Sarnak, MD, MS, Box 391, Tufts Medical Center, 800 Washington St, Boston, MA msarnak@tuftsmedicalcenter.org 2010 by the National Kidney Foundation, Inc /10/ $36.00/0 doi: /j.ajkd WHAT DOES THIS IMPORTANT STUDY SHOW? Cardio-Sis was a multicenter open-labeled trial that enrolled 1,111 nondiabetic participants 55 years or older with SBP 150 mm Hg and one additional cardiovascular risk factor. Participants were randomly assigned to a target SBP of 140 mm Hg (usual control) or 130 mm Hg (tight control). The primary end point was prevalence of electrocardiographic left ventricular hypertrophy (LVH) at 2 years, and the secondary end point was a composite of cardiovascular events. At baseline, mean age was 67 years, all participants were white, 21% had LVH, and mean blood pressure was 163/90 mm Hg. 9 At the end of follow-up, mean blood pressures were 135.6/78.7 and 131.9/ 77.4 mm Hg in the usual- and tight-control groups, respectively; 87% of participants (equal between groups) had readable electrocardiograms for the intent-to-treat analysis. Of patients in the usual- and tight-control groups, 17% and 11.4% had evidence of LVH, respectively (odds ratio, 0.63; 95% confidence interval, ). The risk of composite cardiovascular events was significantly lower in the tight-control (4.8%) compared with the usualcontrol group (9.4%; hazard ratio, 0.50; 95% confidence interval, ) and was accounted for mainly by lower rates of both coronary revascularization and new-onset atrial fibrillation in those randomly assigned to tight control. Other adverse events were similar between the 2 groups. Participants in the tight-control group were more likely to receive diuretics (P 0.009), and use of angiotensin receptor blockers was 17% higher in the tight-control group (P 0.07). The investigators concluded that tight control of SBP to 130 mm Hg compared with usual control to 140 mm Hg in hypertensive nondiabetic individuals with one additional cardiovascular risk factor decreased the likelihood of LVH and clinical events. 434 American Journal of Kidney Diseases, Vol 56, No 3 (September), 2010: pp
2 In the Literature 435 HOW DOES THIS STUDY COMPARE WITH PRIOR STUDIES? From the outset, it is important to note the distinction between blood pressure target trials versus blood pressure agent trials. Target trials aim for different blood pressure levels and by design are likely to lead to a difference in prevalence of agent used during the trial. Agent trials compare different antihypertensive agents with either each other or placebo and in general aim to achieve similar blood pressure targets. Few trials have assessed blood pressure targets in the present era of usual (140/90 mm Hg) versus low (140/90 mm Hg) blood pressure control in either diabetic or nondiabetic individuals. The recent ACCORD (Action to Control Cardiovascular Risk in Diabetics) study randomly assigned 4,733 diabetic participants to SBP 120 mm Hg versus 140 mm Hg and noted no difference in the primary outcome of major cardiovascular events. 10 Trials in nondiabetic individuals that have compared tight versus usual blood pressure control in the general population and patients with CKD are listed in Table 1. In the HOT (Hypertension Optimal Treatment) trial, the largest clinical trial in the general population comparing different DBP targets, major cardiovascular events were similar among groups, perhaps because similar blood pressures were achieved in all 3 groups (mean follow-up DBPs, 85.2, 83.2, and 81.1 mm Hg). 11 However, there was a significant benefit associated with the lower DBP target in the subgroup with diabetes. In the JATOS (Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients), no difference was noted in cardiovascular events in the tight- (SBP 140 mm Hg) versus moderatecontrol (SBP mm Hg) groups. 13 In another study, in individuals with prevalent LVH and SBP in the reference range (defined as SBP 130 mm Hg in those with diabetes, kidney impairment, or established cardiovascular disease and 140 mm Hg for other participants), targeting SBP 10 mm Hg below the baseline versus maintaining the baseline SBP led to a significant decrease in left ventricular mass index using cardiac magnetic resonance scanning. Limitations of this study included small numbers, use of a surrogate outcome, and potential bias because 16 of 51 patients randomly assigned were not available for the follow-up magnetic resonance scanning and there was differential loss to follow-up between the randomized groups. 14 Trials such as the MDRD (Modification of Diet in Renal Disease) Study, 15 AASK (African American Study of Kidney Disease and Hypertension), 19 and REIN-2 (Ramipril Efficacy in Nephropathy) 21 focused on kidney outcomes and randomly assigned patients with CKD to tight and usual blood pressure targets. In the MDRD Study, there was no difference in the decrease in glomerular filtration rate between the 2 blood pressure groups at 3 years 16 ; however, there was an interaction with baseline urine protein excretion. In the subgroup with protein excretion 1 g/d, lower target blood pressure was associated with a significantly slower decrease in glomerular filtration rate. 15 In addition, in longterm follow-up, patients assigned to the lower blood pressure target had delayed onset of kidney failure. 17 The primary limitation of the latter analysis was the lack of blood pressure measurements during long-term follow-up. Primary results from the AASK and REIN-2 trials showed no benefit of a lower blood pressure target for the primary outcome; however, in AASK, there was a slight trend favoring the lower blood pressure target in the subgroup with baseline urine protein-creatinine ratio 0.22 (300 mg/d). 19 Furthermore, preliminary results of longterm follow-up of the AASK cohort study suggested that a lower blood pressure target decreases the incidence of a composite outcome (doubling of creatinine level, end-stage renal disease, or death) in those with urine proteincreatinine ratio 0.22 (300 mg/d). 22,20 A recently published Cochrane review investigated whether a lower blood pressure target (135/85 mm Hg) was associated with a decrease in morbidity (cardiovascular and kidney outcomes) and mortality compared with a standard blood pressure target (140 to 160/90 to 100 mm Hg) in 7 trials. 23 Five of the 7 were in nondiabetic individuals and are listed in Table 1. 11,16,18,19,21 All trials used mean arterial pressure or DBP as targets for treatment. The conclusions reached were that a lower blood pressure target did not decrease cardiovascular or kidney-related morbidity or all-cause mortality. 23
3 Table 1. Trials in Nondiabetic Individuals Comparing Usual Versus Low Blood Pressure Target Baseline Target BP Outcomes 436 Study N Age (y) Creatinine (mg/dl) Usual Low Follow-up (y) Primary Outcome Result of Primary Outcome d Comment General Population HOT 11 18, / DBP 90 DBP 85 or Composite CVD & mortality In those with diabetes, a benefit of the lower target BP BBB 12 2, /95 NA DBP DBP Several outcomes including Few clinical CVD events, insufficient statistical power composite CVD JATOS 13 4, /89 NA SBP SBP Composite CVD Interaction between age and treatment effect, with suggestion of benefit for lower target in those 75 y and harm in those 75 y Simpson et al /70-73 a NA Baseline SBP b SBP 10 compared with baseline b 1.0 LVMi by cardiac MRI 31% dropout with a slightly higher proportion in those randomly assigned to tight control Cardio-Sis 8 1, / SBP 140 SBP c LVH by ECG MDRD /80 a 2.38 MAP 107 if 60 y Study MAP 113 if 61 y Chronic Kidney Disease MAP 92 if 60 y MAP 98 if 61 y 2.2 Rate of decrease Toto et al /76-77 a 2.3 DBP DBP Rate of decrease AASK 19,20 1, / a MAP MAP c Rate of decrease Interaction between baseline proteinuria and treatment effect, with benefit in those with higher baseline proteinuria Lower BP target also decreased kidney failure in long-term follow-up 16 Small study Trend for benefit in the lower BP target in those with UPCr 0.22 (300 mg/d) In preliminary results, lower BP target also decreased the composite outcome (doubling of creatinine, ESRD, or death) in those with UPCr 0.22 (300 mg/d) in long-term follow-up 20 REIN /84 c 2.7 DBP 90 DBP 130/ ESRD At first interim analysis, study was stopped for futility Abbreviations: AASK, African American Study of Kidney Disease and Hypertension; BBB, Behandla Blodtryck Bättre; BP, blood pressure; Cardio-Sis, Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica; CVD, cardiovascular disease; DBP, diastolic blood pressure; ECG, electrocardiographic; ESRD, end-stage renal disease; GFR, glomerular filtration rate; HOT, Hypertension Optimal Treatment; JATOS, Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; LVH, left ventricular hypertrophy; LVMi, left ventricular mass index; MAP, mean arterial pressure; MDRD, Modification of Diet in Renal Disease; MRI, magnetic resonance imaging; N, number of participants; NA, not available; REIN-2, Ramipril Efficacy in Nephropathy; SBP, systolic blood pressure; UPCr urine protein-creatinine ratio. a Different mean values were reported for the comparison groups. b Baseline SBP 130 mm Hg in those with diabetes, kidney impairment, or established CVD and 140 mm Hg for other participants. c Median. d () indicates benefit in the lower BP group, () no difference between the groups. Shastri and Sarnak
4 In the Literature 437 WHAT SHOULD CLINICIANS AND RESEARCHERS DO? Cardio-Sis is the second largest trial evaluating target SBP on cardiovascular outcomes in individuals without diabetes. The trial, although very well executed and internally valid, has limitations. These include lack of generalizability to nonwhites, use of a surrogate primary end point, and relatively short follow-up for clinical outcomes. Furthermore, the difference in composite events was driven primarily by a difference in risk of coronary revascularization and new-onset atrial fibrillation, and, as acknowledged by the investigators, awareness of the randomization code (open-label trial) may have introduced bias in clinical decisions, especially for coronary revascularization. Last, use of angiotensin receptor blockers was higher in the tight-control group and therefore may have conferred cardiovascular protection (regression of prevalent LVH or prevention of incident LVH) independent of the blood pressure lowering effect. Therefore, results of Cardio-Sis, although encouraging, need to be confirmed in large clinical trials with hard clinical outcomes before recommending changes to current guidelines. More definitive evidence about blood pressure targets in the nondiabetic population, as well as in those with CKD, will be available from SPRINT (Systolic Blood Pressure Intervention Trial), which will randomly assign as many as 10,000 participants to target SBP 120 mm Hg compared with SBP 140 mm Hg. Inclusion criteria will be nondiabetic individuals 55 years or older with SBP 150 mm Hg and an additional cardiovascular disease risk factor, and the primary outcome will be cardiovascular disease. The trial will focus on 3 high-risk groups: patients with clinical cardiovascular disease other than stroke, individuals with CKD (estimated glomerular filtration rate, ml/min/1.73 m 2 ), and individuals with cardiovascular risk factors, but without prevalent cardiovascular disease. Results of this study are eagerly awaited to guide management decisions. Shani Shastri, MD Mark J. Sarnak, MD, MS Tufts Medical Center Boston, Massachusetts ACKNOWLEDGEMENTS Financial Disclosure: The authors declare that they have no relevant financial interests. REFERENCES 1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365(9455): Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996;275(20): Stamler J, Stamler R, Neaton JD. Blood pressure, systolic and diastolic, and cardiovascular risks. US population data. Arch Intern Med. 1993;153(5): Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke, and coronary heart disease. Part 2, short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet. 1990;335(8693): National Kidney Foundation. K/DOQI Clinical Practice Guidelines on Hypertension and Antihypertensive Agents in Chronic Kidney Disease. Am J Kidney Dis. 2004;43(5 suppl 1):S Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19): Vasan RS, Larson MG, Leip EP, et al. Impact of high-normal blood pressure on the risk of cardiovascular disease. N Engl J Med. 2001;345(18): Verdecchia P, Staessen JA, Angeli F, et al; on behalf of the Cardio-Sis Investigators. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet. 2009;374(9689): Cardio-Sis Study Group. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population. J Hum Hypertens. 2008;22(4): The ACCORD Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus [published online ahead of print March 14, 2010]. N Engl J Med. doi: /nejmoa Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998;351(9118): Hannson L. The BBB Study: the effect of intensified antihypertensive treatment on the level of blood pressure, side-effects, morbidity and mortality in well-treated hypertensive patients. Behandla Blodtryck Bättre. Blood Press. 1994;3(4): JATOS Study Group. Principal results of the Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS). Hypertens Res. 2008;31(12): Simpson HJ, Gandy SJ, Houston JG, Rajendra NS, Davies JI, Struthers AD. Left ventricular hypertrophy: reduc-
5 438 tion of blood pressure already in the normal range further regresses left ventricular mass. Heart. 2010;96(2): Peterson JC, Adler S, Burkart JM, et al. Blood pressure control, proteinuria, and the progression of renal disease. The Modification of Diet in Renal Disease Study. Ann Intern Med. 1995;123(10): Klahr S, Levey AS, Beck GJ, et al. The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. Modification of Diet in Renal Disease Study Group. N Engl J Med. 1994;330(13): Sarnak MJ, Greene T, Wang X, et al. The effect of a lower target blood pressure on the progression of kidney disease: long-term follow-up of the Modification of Diet in Renal Disease Study. Ann Intern Med. 2005;142(5): Toto RD, Mitchell HC, Smith RD, Lee HC, McIntire D, Pettinger WA. Strict blood pressure control and progression of renal disease in hypertensive nephrosclerosis. Kidney Int. 1995;48(3): Wright JT Jr, Bakris G, Greene T, et al. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002;288(19): Shastri and Sarnak 20. Appel L. Progression of hypertensive chronic kidney disease (CKD): long-term results from the African-American Study of Kidney Disease and Hypertension (AASK). Presented at the Oral Session 34-Hot topics: experimental and clinical studies II at the Hypertension 2008: 18th Scientific Meeting of the European Society of Hypertension and 22nd Scientific Meeting of the International Society of Hypertension; June 14-19, 2008; Berlin, Germany. legacy.vanguardistas.net/cmss/hypertensionmultilang/ html/en/multimedia/webcasts.html. Accessed March 15, Ruggenenti P, Perna A, Loriga G, et al. Bloodpressure control for renoprotection in patients with nondiabetic chronic renal disease (REIN-2): multicentre, randomised controlled trial. Lancet. 2005;365(9463): Sika M, Lewis J, Douglas J, et al. Baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Clinical Trial and Cohort Study. Am J Kidney Dis. 2007;50(1):78-89, 89 e Arguedas JA, Perez MI, Wright JM. Treatment blood pressure targets for hypertension. Cochrane Database Syst Rev. 2009:3;CD
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