Authors' objectives:

This Special Report reviews the evidence from clinical trials that evaluates the use of statins in the elderly age group. The beneficial effect of statins on cardiovascular outcomes, and the potential benefit on other non-cardiovascular outcomes, will be weighed against the adverse event profile for these medications in the elderly, in order to determine the overall benefit/risk ratio for this class of medications.

Authors' results and conclusions: One clinical trial specifically included a population of elderly patients (PROSPER), and three other clinical trials (CARE, LIPID, 4S) provided "extended" subgroup analyses of the elderly population, consisting of a separate peer-reviewed publication reporting on the elderly subgroup. These four trials provided the bulk of evidence for this Special Report on the cardiovascular benefits of statins in the elderly. All 4 of the clinical trials reported that statins were efficacious in reducing adverse cardiovascular events. These studies reported a 20;40% relative risk reduction for CHD death, and similar improvements in the rates of MI. There was a less consistent effect reported for stroke, with only one study (CARE) reporting a statistically significant decrease. All 4 of these studies also showed consistent benefits on a variety of composite cardiovascular endpoints. Three of the studies (CARE, LIPID, 4S) compared cardiovascular outcomes in the elderly with those in the non-elderly population. In general, the benefits for the elderly population were at least as great, or greater, than the non-elderly population. The relative risk reduction (RRR) was approximately equal or slightly higher for the elderly population, and the absolute risk reduction (ARR) was greater for the elderly population across the majority of outcomes. Four other clinical trials that reported "simple" subgroup analyses corroborate these findings, with similar RRRs reported for the elderly and non-elderly populations. An individual patient-level meta-analysis including over 34,000 elderly patients concluded that the absolute risk reduction for major coronary events was similar in elderly and non-elderly patients, and that the relative risk reduction was slightly less for elderly vs. non-elderly patients. Evidence on outcomes other than cardiovascular endpoints is lacking. Similarly, the data on adverse events is not robust. Adverse event data is derived from the clinical trials and three additional cohort studies. The clinical trials do not report increased rates of adverse events for patients treated with statins compared with placebo. One study reported an increase in the incidence of cancer associated with statin use, but results on cancer incidence from the other trials are mixed. The cohort studies provide limited data on the rates of adverse events and are not adequate for determining the absolute rates of events for the elderly population.

Authors' recommendations: The benefits of statins in reducing cardiovascular events extend to the elderly population. The relative benefit of statin treatment in this population is likely to be similar to that for younger patients, while the absolute benefit is likely to be greater due to the increased rate of cardiovascular events in this population. There are several limitations to these conclusions. The available evidence primarily refers to secondary prevention of coronary events. There is very little evidence for primary prevention in elderly patients. Also the available evidence does not represent the entire spectrum of age in "elderly" patients. These trials do not include the "old" old, enrolling few patients older than 75 years and virtually no patients older than 80 years. As a result, the comparisons made between the elderly and non-elderly populations are made within relatively narrow ranges of age.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)