Statin Therapy and Risk of Fracture: Results From the JUPITER Randomized Clinical Trial | Journal Scan

Study Questions:

Does statin therapy reduce the risk of fracture, and are the baseline levels of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP) associated with the risk of fracture?

Methods:

The JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial was an international, randomized, double-blind, placebo-controlled study enrolling 17,802 men >50 years old and women >60 years old with hs-CRP level of at least 2 mg/L. Participants were screened from 2003 to 2006 and observed prospectively for up to 5 years (median follow-up, 1.9 years).

Results:

During the study, 431 incident fractures were reported and confirmed. Among participants allocated to rosuvastatin, 221 fractures were confirmed, compared with 210 among those allocated to placebo. The incidence of fracture in the rosuvastatin and placebo groups was 1.20 and 1.14 per 100 person-years, respectively (adjusted hazard ratio, 1.06; 95% confidence interval, 0.88-1.28; p = 0.53). Overall, increasing baseline hs-CRP level was not associated with an increased risk of fractures (adjusted hazard ratio for each unit increase in hs-CRP tertile, 1.06; 95% CI, 0.94-1.20; p for trend, 0.34).

Conclusions:

Among men and women with elevated hs-CRP level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease, statin therapy did not reduce the risk of fracture. Higher baseline hs-CRP level was not associated with an increased risk of incident fracture.

Perspective:

Observational studies suggested a protective effect, but these findings are in consort with similar analysis in other statin trials. When looking for nonlipid or nontarget benefit or risk from statins, it is difficult to conclude there is no effect, considering the limited duration of follow-up and the potential that larger studies may have different results. An example would be that statins cause tendonitis and rupture of the Achilles tendon, which is suggested by large clinical data sets.

Clinical Topics: Dyslipidemia, Nonstatins, Novel Agents, Statins

Keywords: Achilles Tendon, Biological Markers, Cardiovascular Diseases, C-Reactive Protein, Fluorobenzenes, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pyrimidines, Sulfonamides, Tendinopathy


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