Comparison of the effects of pravastatin and atorvastatin on fracture incidence in the PROVE IT-TIMI 22 trial--secondary analysis of a randomized controlled trial.

Recent observational studies suggest that patients using statins have higher bone densities and lower fracture rates. However, this finding has not been supported by a secondary analysis of a large randomized controlled trial, assessing pravastatin. It has been suggested that the latter finding might be attributable to the failure of pravastatin, which is hydrophilic, to gain access to bone. The recently published TIMI 22 study, which compared pravastatin with more intensive therapy with the bone-active statin, atorvastatin, offers the possibility of re-assessing the effects of these agents, on fractures. This study assessed 4162 patients over a mean period of 24 months, and compared 40 mg of pravastatin daily with 80 mg of atorvastatin daily. There were 30 fractures in the pravastatin group and 31 in the atorvastatin group, producing a relative risk for any fracture of 1.02 (95% CI, 0.62-1.68) in the atorvastatin group. This study has sufficient fractures for a relative risk of fracture of 0.52 to be significant, which is of the order that has been observed in some of the observational studies. These data do not provide any support for the hypothesis that pravastatin and atorvastatin have different effects on fracture, and are consistent with the conclusions from the other controlled trials-that currently available statins do not impact on fracture risk.

RCT Entities:   Population Interventions Outcomes