• Lipid Disorders
• Prevention & Screening Clinical Trials

Results of a subgroup analysis from the JUPITER trial (NCT00239681), presented by Robert Glynn, MD, PhD, Brigham and Women's Hospital, Boston, MA, showed a significant reduction in major cardiovascular (CV) events in older, apparently healthy individuals who were treated with rosuvastatin compared with placebo.

The JUPITER study comprised 17,802 apparently healthy men aged ≥50 years and women aged ≥60 years with LDL <130 mg/dL who were at increased vascular risk due to elevated high-sensitivity C-reactive protein (hsCRP; ≥2 mg/L). The primary endpoint of the study was major CV events, which were defined as the combined risk of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes. JUPITER was stopped early after a median follow-up of 1.9 years, on the basis of overwhelming evidence of efficacy with respect to the primary endpoint. The results of JUPITER have been previously published [Ridker et al. N Engl J Med 2008].

The current analysis was based on the subgroup of 5695 subjects who were aged ≥70 years (median 74 years; range 70 to 97) at the time of enrollment. When compared with younger patients, those who were aged ≥70 years were more frequently female (51% vs 32%), less often obese (body mass index ≥30 kg/m², 32% vs 40%), less frequently current smokers (8% vs 19%), and more frequently had a Framingham risk score >10 (69% vs 41%). Overall, the relative treatment effects of rosuvastatin in individuals ≥70 years were comparable with those seen in the younger patient group. There was no difference between the age groups in the achieved lipid or hsCRP levels (Table 1). There was a significant 39% risk reduction in the primary composite endpoint of CV death, MI, stroke, unstable angina, or revascularization) (HR, 0.61; 95% CI, 0.46 to 0.82; p<0.001) in older patients who were randomized to rosuvastatin compared with those on placebo. Significant reductions were also seen for MI (HR, 0.55; 95% CI, 0.31 to 1.0; p=0.046), stroke (HR, 0.55; 95% CI, 0.33 to 0.93; p=0.023), and the incidence of revascularization or unstable angina (HR, 0.51; 95% CI, 0.33 to 0.80; p=0.003). The older subgroup was at higher risk for the primary endpoint (incidence rate 1.99/100 person-years vs 1.06/100 person-years in younger group) and showed a greater rate of difference on therapy compared with placebo (0.77/100 person-years vs 0.52/100 person-years in the younger group), with an estimated number needed to treat (NNT) for 5 years of 19 versus 29 for subjects aged <70 years to prevent 1 primary endpoint event.

The overall risk of serious adverse events was similar for the older subgroup (HR, 1.05; 95% CI, 0.93 to 1.17; p=0.44), with the exception of incident diabetes, for which the risk that was associated with treatment was significant in younger subjects (HR, 1.26; 95% CI, 1.02 to 1.56; p=0.03) but not in the older subgroup (HR, 1.25; 95 % CI, 0.90 to 1.74; p=0.18).

Overall, these results provide reassuring data regarding the efficacy and safety of statin therapy in elderly patients. The trial discussant, Professor Philippe Gabriel Steg, MD, INSERM U-698, Paris, France, said that the trial provides “solid evidence that the benefit seen from rosuvastatin in the overall trial is seen in the elderly subgroup, including a reduction in stroke.” Prof. Steg did offer caution that these findings “pertain to a special population: high-risk CV patients with low LDL and elevated hsCRP” and asked whether the results could be extended to patients without elevated hsCRP and to very elderly patients.

• © 2009 MD Conference Express