SPRINT Trial Results
2015; Lippincott Williams & Wilkins; Volume: 67; Issue: 2 Linguagem: Romeno
10.1161/hypertensionaha.115.06722
ISSN1524-4563
AutoresWilliam C. Cushman, Paul K. Whelton, Lawrence J. Fine, Jackson T. Wright, David M. Reboussin, Karen Johnson, Suzanne Oparil,
Tópico(s)Hormonal Regulation and Hypertension
ResumoHomeHypertensionVol. 67, No. 2SPRINT Trial Results Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBSPRINT Trial ResultsLatest News in Hypertension Management William C. Cushman, Paul K. Whelton, Lawrence J. Fine, Jackson T. WrightJr, David M. Reboussin, Karen C. Johnson and Suzanne Oparilfor the SPRINT Study Research Group William C. CushmanWilliam C. Cushman From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) , Paul K. WheltonPaul K. Whelton From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) , Lawrence J. FineLawrence J. Fine From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) , Jackson T. WrightJrJackson T. WrightJr From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) , David M. ReboussinDavid M. Reboussin From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) , Karen C. JohnsonKaren C. Johnson From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) and Suzanne OparilSuzanne Oparil From Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN (W.C.C.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Clinical Applications and Prevention Branch, National Heart Lung and Blood Institute, Bethesda, MD (L.J.F.); Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.); Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); Division of Cardiovascular Disease, University of Alabama at Birmingham (S.O.) and for the SPRINT Study Research Group Originally published9 Nov 2015https://doi.org/10.1161/HYPERTENSIONAHA.115.06722Hypertension. 2016;67:263–265Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2015: Previous Version 1 We thank the editors of Hypertension for the invitation to discuss aspects of the recently published Systolic Blood Pressure Intervention Trial (SPRINT; ClinicalTrials.gov identifier NCT01206062) main results.1 This commentary focuses on generalizability of the findings and what is known about serious adverse effects that may be related to the SPRINT intervention. SPRINT compared the effects of antihypertensive treatment with a systolic blood pressure (SBP) target of <120 mm Hg (intensive treatment) versus 1.5 mg/dL was an exclusion in ACCORD BP, and there was a slight difference in the primary composite outcome used in the 2 trials. The 95% confidence interval for the primary outcome in ACCORD BP included the possibility of a 27% reduction, which is consistent with the 25% CVD benefit observed in SPRINT. The factorial design used in ACCORD BP, which simultaneously compared the value of intensive with the standard glycemic therapy, may have negatively affected the opportunity to test the effect of the BP intervention. In a post-hoc analysis of the ACCORD results, the primary CVD outcome was 26% lower in participants randomized to the intensive BP and standard glycemia goals than in those assigned to the combined standard BP and glycemia treatment goals.4 Such a benefit is consistent with CVD reductions observed in other trials that studied the effect of BP lowering in patients with hypertension and diabetes mellitus.5Table. Cardiovascular Outcome Event Rates in ACCORD BP and SPRINTStandard, % per YearIntensive, % per YearHazard RatioEventACCORDSPRINTACCORDSPRINTACCORDSPRINTAll deaths1.191.401.281.031.070.73Death from cardiovascular causes0.490.430.520.251.060.57Nonfatal myocardial infarction1.280.771.130.630.870.82All stroke0.530.470.320.410.590.89Nonfatal stroke0.470.450.300.390.630.88All heart failure0.780.670.730.410.940.62ACCORD primary outcome*2.091.521.871.150.880.75ACCORD BP indicates Action to Control Cardiovascular Risk in Diabetes Blood Pressure; and SPRINT, Systolic Blood Pressure Intervention Trial.*Results for application of the ACCORD composite in both SPRINT and ACCORD.It is possible, but we believe unlikely, that there is an inherent difference in the CVD benefits of intensive SBP lowering in diabetic and non-diabetic adults. Because the ACCORD BP trial was not definitive, it would be ethical to conduct another trial of intensive BP-lowering on major CVD outcomes in diabetic participants. Enrollment of a higher risk group (eg, participants of older age and those with chronic kidney disease) and enlarging the sample size would help to ensure adequate statistical power to answer this question. In the meantime, guideline committees and the medical community will have to decide whether the SPRINT results should be generalized to patients with hypertension and diabetes mellitus.For several large groups of individuals with SBP of 130 to 180 mm Hg, the SPRINT results are directly relevant: these include nearly all adults ≥75 years and 3 groups who are ≥50 years: those with subclinical or clinical CVD; those with a 10-year CVD Framingham risk score of at least 15% and those who have chronic kidney disease with an estimated glomerular filtration rate 20 to 59 mL/min per 1.73 m2. One possible extension of the SPRINT findings might be to individuals who are ≥50 years old with a SBP of 130–180 mm Hg and who are at similar risk for CVD as some of the participants in SPRINT because of CVD risk indicators that were not part of the SPRINT inclusion criteria. One could make a case for extending the SPRINT findings to younger individuals with hypertension, especially those at high risk for CVD. Examples might include younger individuals with chronic kidney disease or subclinical or clinical CVD, a substantially increased CVD risk score, or genetic CVD risk factors such as familial hypercholesterolemia. For many individuals, the number needed to treat will likely be higher than that noted in SPRINT, but they may still derive a benefit from a lower SBP than is currently recommended, especially if this could be accomplished with few serious adverse effects. Another group to whom the SPRINT intensive therapy goal may be appropriate, but difficult to achieve, are those who have an average SBP of >180 mm Hg.There are several groups, who in aggregate constitute a large percent of the adult population, for whom extension of the SPRINT findings would be more speculative. This includes adults with an average untreated SBP of 120 to 129 mm Hg, and those with an average SBP of 130 to 139 mm Hg who have a Framingham 10-year CVD risk score <15%. Practical considerations related to sample size and duration of follow-up make conduct of trials like SPRINT in these populations an unlikely possibility. For now, practitioners will have to decide whether the SPRINT results should be extrapolated to individuals with these characteristics.No matter who are chosen for application of the SPRINT intensive BP-lowering treatment strategy, it is important to be mindful of the manner in which BP was measured in the trial: an average of 3 office BP readings taken with proper cuff size, participants seated with their back supported, 5 minutes of rest before measurement, and no conversation during the rest period or BP determinations. In SPRINT, this was achieved using an automated manometer (Omron Healthcare, Lake Forest, IL) that was preset to wait for 5 minutes before measurement, as well as to take and average the 3 readings. BP measurements taken without observing these conditions are likely to overestimate BP6 and result in overtreatment, with the potential for higher rates of serious adverse effects and greater utilization of resources. This issue should be carefully considered in the development of any practice-based performance measures for BP control in hypertension that are derived from the SPRINT results. Finally, although the intensive treatment goal in SPRINT was <120 mm Hg, the majority of our participants did not achieve an SBP that was consistently below this level. The expectation in many practice settings that average SBP in most adults with hypertension be controlled below a particular goal should be considered carefully if the SPRINT intensive treatment SBP goal is applied to this type of performance measure.The results of SPRINT are likely to have a major impact on the treatment of hypertension. However, there are many important lessons to be learned from SPRINT to apply the results in a safe and effective manner.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the U.S. Department of Veterans Affairs, or the United States Government.Correspondence to William C. Cushman, Preventive Medicine Section (111Q), Veterans Affairs Medical Center, University of Tennessee Health Science Center, 1030 Jefferson Ave, Memphis, TN 38104. E-mail [email protected] or [email protected]References1. SPRINT Research Group, Wright JT Jr, Williamson JD, et al. A randomized trial of intensive versus standard blood-pressure control.N Engl J Med. 2015; 373:2103–2116. doi: 10.1056/NEJMoa1511939.CrossrefMedlineGoogle Scholar2. Ambrosius WT, Sink KM, Foy CG, et al; SPRINT Study Research Group. The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).Clin Trials. 2014; 11:532–546. doi: 10.1177/1740774514537404.CrossrefMedlineGoogle Scholar3. Accord Study Group. Effects of intensive blood pressure control in type 2 diabetes.New Engl J Med. 2010; 362:1575–1585.CrossrefMedlineGoogle Scholar4. Margolis KL, O'Connor PJ, Morgan TM, Buse JB, Cohen RM, Cushman WC, Cutler JA, Evans GW, Gerstein HC, Grimm RH, Lipkin EW, Narayan KM, Riddle MC, Sood A, Goff DC. Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.Diabetes Care. 2014; 37:1721–1728. doi: 10.2337/dc13-2334.CrossrefMedlineGoogle Scholar5. Ferrannini E, Cushman WC. Diabetes and hypertension: the bad companions.Lancet. 2012; 380:601–610. doi: 10.1016/S0140-6736(12)60987-8.CrossrefMedlineGoogle Scholar6. Myers MG, Godwin M, Dawes M, Kiss A, Tobe SW, Kaczorowski J. Measurement of blood pressure in the office: recognizing the problem and proposing the solution.Hypertension. 2010; 55:195–200. doi: 10.1161/HYPERTENSIONAHA.109.141879.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Cuffee Y, Wang M, Geyer N, Saxena S, Akuley S, Jones L and Wilson R (2021) Vitamin D and family history of hypertension in relation to hypertension status among college students, Journal of Human Hypertension, 10.1038/s41371-021-00577-6, 36:9, (839-845), Online publication date: 1-Sep-2022. 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Hope L, Giunta J, Winer N and McFarlane S (2015) Hypertension Principles of Diabetes Mellitus, 10.1007/978-3-319-20797-1_31-1, (1-13), . February 2016Vol 67, Issue 2 Advertisement Article InformationMetrics © 2015 American Heart Association, Inc.https://doi.org/10.1161/HYPERTENSIONAHA.115.06722PMID: 26553234 Originally publishedNovember 9, 2015 PDF download Advertisement SubjectsClinical StudiesHigh Blood PressureHypertension
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