Key result
All-cause mortality in the JUPITER trial (2.2% for rosuvastatin, 2.8% for placebo) was more than twice the average of other primary prevention studies at 21 months.
Why the study?
Is the all-cause mortality reported in the JUPITER trial consistent with other statin trials for primary prevention?
Is the all-cause mortality reported in the JUPITER trial consistent with other statin trials for primary prevention?
Absolute Event Rate: 2.2% vs 2.8%
The unusually high all-cause mortality rates in the JUPITER trial compared to other primary prevention trials call into question the trial's findings and the aggressive use of statins for primary prevention.
Questions JUPITER applicability to typical primary prevention; leaves open whether statin mortality benefits are overstated in lower-risk groups.
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.
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Victor L. Serebruany (2011) conducted a review in Primary prevention. Rosuvastatin (JUPITER trial) vs. Placebo / other statin trials was evaluated on All-cause mortality. All-cause mortality in the JUPITER trial (2.2% for rosuvastatin, 2.8% for placebo) was more than twice the average of other primary prevention studies at 21 months.
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