Extreme all-cause mortality in JUPITER requires reexamination of vital records

Victor L. Serebruany

Research output: Contribution to journalArticle

Abstract

Objective: To compare all-cause mortality in JUPITER with other statin trials at 21 months of follow-up. Background: Outcome advantages including all-cause mortality reduction yielded from the JUPITER trial support aggressive use of rosuvastatin and, perhaps by extension, other statins for primary prevention. Despite enrolling apparently healthy subjects and early trial termination at 21 months of mean follow-up, JUPITER revealed very high all-cause mortality in both the placebo (2.8%) and rosuvastatin (2.2%) arms. Methods: Comparison of all-cause mortality prorated for 21 months in 10 primary prevention studies and 1 acute coronary syndromes statin trial. Findings: The all-cause mortality in JUPITER was more than twice that of the average of primary prevention studies, matching well only with specific trials designed in diabetics (ASPEN or CARDS), early hypertension studies (ALLHAT-LLT) or a trial in patients with acute coronary syndromes (PROVE IT). Since the 'play of chance' is unlikely to explain these discrepancies due to excellent baseline match, excess death rates and all-cause mortality rates in both JUPITER arms must be questioned. It may be important that the study sponsor self-monitored sites. Conclusions: Excess all-cause mortality rates in the apparently relatively healthy JUPITER population are alarming and require independent verification. If, indeed, the surprising outcomes in JUPITER are successfully challenged, and considering established harm of statins with regard to rhabdomyolysis as well as, potentially, diabetes, millions of patients may find better and safer options for primary prevention of vascular events.

Original languageEnglish (US)
Pages (from-to)84-88
Number of pages5
JournalCardiology
Volume120
Issue number2
DOIs
StatePublished - Dec 2011

Fingerprint

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Mortality
Primary Prevention
Acute Coronary Syndrome
Rhabdomyolysis
Blood Vessels
Healthy Volunteers
Placebos
Hypertension
Population
Rosuvastatin Calcium

Keywords

  • Clinical trial
  • Mortality
  • Outcomes
  • Rosuvastatin
  • Site monitoring

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

Cite this

Extreme all-cause mortality in JUPITER requires reexamination of vital records. / Serebruany, Victor L.

In: Cardiology, Vol. 120, No. 2, 12.2011, p. 84-88.

Research output: Contribution to journalArticle

Serebruany, Victor L. / Extreme all-cause mortality in JUPITER requires reexamination of vital records. In: Cardiology. 2011 ; Vol. 120, No. 2. pp. 84-88.
@article{fbec19eff8404f82aa4e4b5ea34f8e6a,
title = "Extreme all-cause mortality in JUPITER requires reexamination of vital records",
abstract = "Objective: To compare all-cause mortality in JUPITER with other statin trials at 21 months of follow-up. Background: Outcome advantages including all-cause mortality reduction yielded from the JUPITER trial support aggressive use of rosuvastatin and, perhaps by extension, other statins for primary prevention. Despite enrolling apparently healthy subjects and early trial termination at 21 months of mean follow-up, JUPITER revealed very high all-cause mortality in both the placebo (2.8{\%}) and rosuvastatin (2.2{\%}) arms. Methods: Comparison of all-cause mortality prorated for 21 months in 10 primary prevention studies and 1 acute coronary syndromes statin trial. Findings: The all-cause mortality in JUPITER was more than twice that of the average of primary prevention studies, matching well only with specific trials designed in diabetics (ASPEN or CARDS), early hypertension studies (ALLHAT-LLT) or a trial in patients with acute coronary syndromes (PROVE IT). Since the 'play of chance' is unlikely to explain these discrepancies due to excellent baseline match, excess death rates and all-cause mortality rates in both JUPITER arms must be questioned. It may be important that the study sponsor self-monitored sites. Conclusions: Excess all-cause mortality rates in the apparently relatively healthy JUPITER population are alarming and require independent verification. If, indeed, the surprising outcomes in JUPITER are successfully challenged, and considering established harm of statins with regard to rhabdomyolysis as well as, potentially, diabetes, millions of patients may find better and safer options for primary prevention of vascular events.",
keywords = "Clinical trial, Mortality, Outcomes, Rosuvastatin, Site monitoring",
author = "Serebruany, {Victor L.}",
year = "2011",
month = "12",
doi = "10.1159/000330507",
language = "English (US)",
volume = "120",
pages = "84--88",
journal = "Journal of Cardiovascular Medicine",
issn = "1558-2027",
publisher = "Lippincott Williams and Wilkins Ltd.",
number = "2",

}

TY - JOUR

T1 - Extreme all-cause mortality in JUPITER requires reexamination of vital records

AU - Serebruany, Victor L.

PY - 2011/12

Y1 - 2011/12

N2 - Objective: To compare all-cause mortality in JUPITER with other statin trials at 21 months of follow-up. Background: Outcome advantages including all-cause mortality reduction yielded from the JUPITER trial support aggressive use of rosuvastatin and, perhaps by extension, other statins for primary prevention. Despite enrolling apparently healthy subjects and early trial termination at 21 months of mean follow-up, JUPITER revealed very high all-cause mortality in both the placebo (2.8%) and rosuvastatin (2.2%) arms. Methods: Comparison of all-cause mortality prorated for 21 months in 10 primary prevention studies and 1 acute coronary syndromes statin trial. Findings: The all-cause mortality in JUPITER was more than twice that of the average of primary prevention studies, matching well only with specific trials designed in diabetics (ASPEN or CARDS), early hypertension studies (ALLHAT-LLT) or a trial in patients with acute coronary syndromes (PROVE IT). Since the 'play of chance' is unlikely to explain these discrepancies due to excellent baseline match, excess death rates and all-cause mortality rates in both JUPITER arms must be questioned. It may be important that the study sponsor self-monitored sites. Conclusions: Excess all-cause mortality rates in the apparently relatively healthy JUPITER population are alarming and require independent verification. If, indeed, the surprising outcomes in JUPITER are successfully challenged, and considering established harm of statins with regard to rhabdomyolysis as well as, potentially, diabetes, millions of patients may find better and safer options for primary prevention of vascular events.

AB - Objective: To compare all-cause mortality in JUPITER with other statin trials at 21 months of follow-up. Background: Outcome advantages including all-cause mortality reduction yielded from the JUPITER trial support aggressive use of rosuvastatin and, perhaps by extension, other statins for primary prevention. Despite enrolling apparently healthy subjects and early trial termination at 21 months of mean follow-up, JUPITER revealed very high all-cause mortality in both the placebo (2.8%) and rosuvastatin (2.2%) arms. Methods: Comparison of all-cause mortality prorated for 21 months in 10 primary prevention studies and 1 acute coronary syndromes statin trial. Findings: The all-cause mortality in JUPITER was more than twice that of the average of primary prevention studies, matching well only with specific trials designed in diabetics (ASPEN or CARDS), early hypertension studies (ALLHAT-LLT) or a trial in patients with acute coronary syndromes (PROVE IT). Since the 'play of chance' is unlikely to explain these discrepancies due to excellent baseline match, excess death rates and all-cause mortality rates in both JUPITER arms must be questioned. It may be important that the study sponsor self-monitored sites. Conclusions: Excess all-cause mortality rates in the apparently relatively healthy JUPITER population are alarming and require independent verification. If, indeed, the surprising outcomes in JUPITER are successfully challenged, and considering established harm of statins with regard to rhabdomyolysis as well as, potentially, diabetes, millions of patients may find better and safer options for primary prevention of vascular events.

KW - Clinical trial

KW - Mortality

KW - Outcomes

KW - Rosuvastatin

KW - Site monitoring

UR - http://www.scopus.com/inward/record.url?scp=82655172720&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=82655172720&partnerID=8YFLogxK

U2 - 10.1159/000330507

DO - 10.1159/000330507

M3 - Article

C2 - 22142620

AN - SCOPUS:82655172720

VL - 120

SP - 84

EP - 88

JO - Journal of Cardiovascular Medicine

JF - Journal of Cardiovascular Medicine

SN - 1558-2027

IS - 2

ER -