[Hypercholesterolemia in men and women of various age. Part II. The problem of efficacy and safety of statins].
Kardiologiia. 2007;47(11):75-85. PMID: 18260968
Presidential Medical Center of Russia, ul Marshala Timoshenko 15, Moscow, Russia.
Hypocholesterinemic drugs from the statins class are effective means of primary and secondary prevention of ischemic heart disease (IHD) in middle aged men who comprised predominant majority of patients participating in randomized controlled trials (RCT). Proofs of favorable influence of statins on origination and progression of IHD in women and elderly people are less convincing. In majority of RCTs of therapy with statins results of which were analyzed separately for men and women no lowering of rates of coronary events were found among women and people older then 65 - 70 years. Moreover in some trials increases of all cause mortality were observed in statin treated patients at the account of deaths from non-cardiovascular causes (cancer deaths in particular). In the PROSPER trial pravastatin not only turned out useless in men and women aged 70 - 82 years, but significantly increased rate of breast cancer. In ALLHAT-LLT in patients aged 65 years and older and in women pravastatin lowered neither total number of nonfatal myocardial infarctions and IHD deaths, nor total mortality. In SPARCL and TNT in which efficacy and safety of high dose statin (e.g. atorvastatin 80 mg/day) was assessed there occurred augmentation of risk of hemorrhagic stroke and mortality from noncardiovascular causes including cancer and infections. One of meta-analyses of RCTs revealed significant increase in breast cancer risk associated with treatment with statins, in another meta-analysis more close relationship was noted between statins and development of cancer in elderly patients. Thus the problem of efficacy and safety of long-term therapy with statins remains open and requires further investigation.