Journal Club 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 Matsuda, Masafumi 2015 年 11 月 26 日 8:30-8:55 ８階 医局 SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med Nov 9. [Epub ahead of print]

A complete list of the members of the Systolic Blood Pressure Intervention Trial (SPRINT) Research Group is provided in the Supplementary Appendix, available at NEJM.org. This article was published on The members of the writing committee ( Jackson T. Wright, Jr., M.D., Ph.D., Jeff D. Williamson, M.D., M.H.S., Paul K. Whelton, M.D., Joni K. Snyder, R.N., B.S.N., M.A., Kaycee M. Sink, M.D., M.A.S., Michael V. Rocco, M.D., M.S.C.E., David M. Reboussin, Ph.D., Mahboob Rahman, M.D., Suzanne Oparil, M.D., Cora E. Lewis, M.D., M.S.P.H., Paul L. Kimmel, M.D., Karen C. Johnson, M.D., M.P.H., David C. Goff, Jr., M.D., Ph.D., Lawrence J. Fine, M.D., Dr.P.H., Jeffrey A. Cutler, M.D., M.P.H., William C. Cushman, M.D., Alfred K. Cheung, M.D., and Walter T. Ambrosius, Ph.D.) the Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Case Western Reserve University (J.T.W., M.R.), and Division of Nephrology and Hypertension, Louis Stokes Cleveland Veterans Affairs (VA) Medical Center (M.R.), Cleveland; Sticht Center on Aging (J.D.W., K.M.S.), Section on Nephrology (M.V.R.), and Department of Biostatistical Sciences (D.M.R., W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans (P.K.W.); Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute (J.K.S., L.J.F., J.A.C.), and Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (P.L.K.), Bethesda, MD; Divisions of Cardiovascular Diseases (S.O.) and Preventive Medicine (C.E.L.), University of Alabama at Birmingham, Birmingham; Department of Preventive Medicine, University of Tennessee Health Science Center (K.C.J.), and the Preventive Medicine Section, VA Medical Center (W.C.C.), Memphis; School of Public Health, University of Colorado, Aurora (D.C.G.); and Division of Nephrology and Hypertension, University of Utah, Salt Lake City (A.K.C.). November 9, 2015DOI: /NEJMoa

Background The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.

Methods We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood- pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.

Figure 1. Eligibility, Randomization, and Follow-up. Discontinued intervention refers to participants who discontinued the study treatment but did not withdraw consent or become lost to follow-up.

Figure 3. Primary Outcome and Death from Any Cause. Shown are the cumulative hazards for the primary outcome (a composite of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from cardiovascular causes) (Panel A) and for death from any cause (Panel B). The inset in each panel shows the same data on an enlarged y axis. CI denotes confidence interval.

Results At 1 year, the mean systolic blood pressure was mm Hg in the intensive-treatment group and mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.

Conclusions Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT )

A SPRINT to the Finish Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., Edward W. Campion, M.D., and John A. Jarcho, M.D. November 9, 2015DOI: /NEJMe The manuscript reporting on SPRINT arrived in our office 4 weeks after the trial was stopped. That manuscript was reviewed rapidly by multiple outside peer reviewers, a statistical consultant, and several editors. This clinical trial will change practice, and we are proud to publish it and to defend the importance of the expedited peer-review and publication process that it has undergone. The report is now in the public domain, and the investigators’ data interpretation, analysis, and clinical discussion are open to examination and comment. We understand that in the months ahead the underlying data from this taxpayer-funded trial will be put in the public domain by the NHLBI. We agree with the importance of making those data open and available to others. But with the article now published, physicians and the public have a detailed, critical, peer- reviewed report from the investigators who conducted the study and know it best.

Redefining Blood-Pressure Targets — SPRINT Starts the Marathon Vlado Perkovic, M.B., B.S., Ph.D., and Anthony Rodgers, M.B., Ch.B., Ph.D. November 9, 2015DOI: /NEJMe

Message SPRINT の予備解析結果 : 降圧目標に関する新たなエビデンス 2015 年 9 月 11 日に米国 National Institutes of Health から Systolic Blood Pressure Intervention Trial (SPRINT) の予備解析結果 (preliminary results) が発表されました。 SPRINT は、 50 歳以上で 1 つ以上の心血管病リス クを持つか 75 歳以上である高血圧患者を対象に、降圧目標に関して 120mmHg 未満と 140mmHg 未満の群間で予後への影響を見た研究です。対 象者は 9250 人で、そのうち慢性腎臓病合併 2648 人、心血管病既往 1877 人、 75 歳以上 2636 人でした。 2018 年 12 月まで実施予定でしたが、極めて早期に 終了となったのは、 120mmHg 未満群で 140mmHg 未満群と比較して心血管 病のイベントが約 30% 、死亡が約 25% 少なかったという予備解析結果が明ら かになったためです。 日本高血圧学会の高血圧治療ガイドラインでは、通常 140/90mmHg 未満を 降圧目標とし、糖尿病や蛋白尿を伴う慢性腎臓病ではさらに厳格な 130/80mmHg 未満を目標として推奨しています。一方、 75 歳以上では 150/90mmHg 未満を目標とし、忍容性があれば 140/90mmHg 未満を目指 すことを推奨しています。 今回の SPRINT の予備解析結果は、降圧治療における、より厳格な降圧目標の 達成を支持するものですが、 NIH も解析結果はまだ予備段階のものであること を強調しています。 通常の降圧目標を 140mmHg 未満よりさらに厳格な 120mmHg 未満とすべき かどうかについては慎重な判断が求められます。 日本高血圧学会