Drug products: Crestor, Crestor®, Rosuvastatin Accord, Rosuvastatin Glenmark, Rosuvastatin Krka d.d., Rosuvastatin Medical Valley, Rosuvastatin Orion, Rosuvastatin Sandoz, Rosuvastatin STADA, Rosuvastatin Teva, Visacor
ATC code: C10AA07
Substances: rosuvastatin, rosuvastatin calcium
In studies with sex-divided statistics, rosuvastatin have shown similar effect in men and women.
A large register-based study has shown men and women to have similar risk of moderate to serious adverse musle effects.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Several studies have found no sex differences in rosuvastatin pharmacokinetics [1-3]. However, a small Chinese study (6 men, 6 women), found a 5% lower AUC and 6.5% lower mean Cmax in men than in women . Since no sex differences have been found for rosuvastatin pharmacokinetics [1-3], no dosage adjustment based on sex is considered necessary.
Primary preventionIn the JUPITER trial (11001 men, 6801 women), rosuvastatin treatment (20 mg/day) of healthy individuals with elevated high sensitivity CRP and low LDL cholesterol resulted in similar risk reductions in cardiovascular disease events in both men and women. However, women had greater reduction in revascularization/unstable angina and men had greater reduction in stroke. Subgroup analysis suggested that women with a family history of premature coronary disease may benefit more from rosuvastatin therapy than those without [5, 6].The efficacy of rosuvastatin 40 mg on changes in carotid intima-media thickness (CIMT) was measured in the randomized, placebo-controlled METEOR trial. Results show that rosuvastatin slowed progression of maximum CIMT over 2 years and results were consistent in men and women .
Secondary preventionThe CORONA trial included patients with systolic heart failure (EF<40%), due to ischemic heart disease (3831 men, 1180 women). In this trial rosuvastatin did not reduce death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, in patients with systolic heart failure. Rosuvastatin did reduce the number of cardiovascular hospitalizations. The treatment effect was consistent in men and women .
In the JUPITER trial, rates of muscle disorders or myopathy were similar in men and women regardless of treatment assignment [5, 6].In a large register-based cohort study (121 148 men, 104 744 women), the risk of moderate to serious myopathy was higher in men than in women for lipophilic statins such as simvastatin and atorvastatin. However, for the hydrophilic statins such as rosuvastatin and pravastatin there were no sex differences in the risk of myopathy. Adjusted hazard ratio for rosuvastatin-induced myopathy was 4.2 in men (95%CI 1.9-9.5) vs. 5.4 in women (95%CI 2.6-11.1) .Most large pivotal studies, even recent ones, have not performed relevant sex-analyses of side effects .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
A meta-analysis of controlled clinical trials (413 men, 480 women) report that among hyperlipidemic patients who receive long-term rosuvastatin treatment (10 mg/day for > 96 weeks), GFR was unchanged regardless of sex. This suggests that rosuvastatin may arrest the progression of renal disease .
Date of litterature search: 2014-05-21
Reviewed by: Mia von Euler, Expertrådet för hjärt-kärlsjukdomar
Approved by: Karin Schenck-Gustafsson