Women, older persons, and ethnic minorities: factors associated with their inclusion in randomised trials of statins 1990 to 2001

Open Access
Publisher Website
Google Scholar
Abstract
We conducted a Medline search up to 1 August 2001 for randomised trials of statins in adults with a minimum treatment duration of six months (or 26 weeks) which reported lipid changes or stenosis change or cardiovascular events. We considered unpublished and non-English language studies and checked references in relevant papers. To be eligible, trials had to compare a statin with a non-statin drug, an inactive control or “usual care”. Adjuvant drug treatment for excessively high lipids during the trial was acceptable. We included factorial trials if appropriate data could be derived. Trials in which all patients had renal failure or diabetes were not eligible. For clarity, we drew upon only one treatment comparison (for example, statin arm versus placebo arm) per trial, taking the comparison first reported. Data were extracted by one researcher (CB), with extraction duplicated by a colleague for key variables. We coded trials to “USA” if all or some of the patients were located in the USA. We also coded trials according to whether support had been provided by the pharmaceutical industry. Trials in which coronary or carotid artery stenosis was measured we coded to “angiographic”. Analysis was in STATA 7, using Fisher‘s exact test and the Kruskal Wallis test. We report probability values of p ≤ 0.05.