Rosuvastatin failed to reduce fracture risk in JUPITER analysis

Rosuvastatin was not associated with a reduced risk for fracture in men and women with elevated high-sensitivity C-reactive protein enrolled in the JUPITER trial.

Previous observational studies have suggested a link between statin use and reduced risk for fractures, possibly because inflammation can play a role in both CVD and osteoporosis; however, there was little evidence from randomized trials, according to the study background.

Jessica M. Peña, MD, MPH, from the division of cardiology at Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, N.Y., and colleagues investigated whether statin therapy lowered the risk for fracture and whether baseline levels of high-sensitivity CRP were associated with fracture risk.

The researchers analyzed participants from the JUPITER trial, which enrolled 17,802 men aged 50 years or older and women aged 60 years or older with high-sensitivity CRP ≥2 mg/L. Participants were randomly assigned rosuvastatin (Crestor, AstraZeneca) 20 mg/day or placebo and were observed for up to 5 years. Median follow-up was 1.9 years. Incident fracture was a prespecified secondary endpoint of the JUPITER trial.

Overall, 431 incident fractures occurred during the study period. Of those, 221 occurred in the rosuvastatin group and 210 in the placebo group. The incidence of fracture was 1.2 per 100 person-years in the rosuvastatin group vs. 1.14 per 100 person-years in the placebo group (adjusted HR=1.06; 95% CI, 0.88-1.28).

“Our study does not support the use of statins in doses used for [CVD] prevention to reduce the risk of fracture,” Peña and colleagues wrote.

In addition, increasing baseline high-sensitivity CRP was not associated with increased risk for fracture (adjusted HR for each unit in high-sensitivity CRP tertile=1.06; 95% CI, 0.94-1.2; P for trend=.34).

These results may differ from findings of observational studies because the latter “may be limited by selection bias, confounding by indication, or a ‘healthy user’ phenomenon, as well as residual confounding by use of other [CV] medications, frailty and obesity,” Peña and colleagues wrote. Other factors explaining the discordance could include the possibility that “long-term statin therapy, intermittent use of statins over a long period or statin therapy in selected populations reduces the risk of fracture,” they wrote.

Disclosure: The trial was supported by AstraZeneca. See the full study for a list of the researchers’ relevant financial disclosures.

Source: www.healio.com