20151126SPRINT - 埼玉医科大学総合医療センター内分泌

Journal Club
SPRINT Research Group.
A Randomized Trial of Intensive versus Standard
Blood-Pressure Control.
N Engl J Med. 2015 Nov 9. [Epub ahead of print]
2015年11月26日 8:30-8:55
８階医局
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
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: 10.1056/NEJMoa1511939
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 bloodpressure 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 121.4 mm
Hg in the intensive-treatment group and 136.2 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, NCT01206062.)
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, peerreviewed report from the investigators who conducted the study and
know it best.
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: 10.1056/NEJMe1513991
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: 10.1056/NEJMe1513301
Message
日本高血圧学会
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。
http://www.jpnsh.jp/topics/456.html

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