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

In practice, only a minority of people with coronary heart disease in the UK who could benefit from cholesterol lowering are currently being prescribed statins.1,2 Clinical trials of cardiovascular medicines, moreover, have also been characterised as “uninclusive”, with women, older persons, and ethnic minorities tending to be under represented.3,4 To explore this further, we examined a series of statins trials to ascertain levels of inclusion of these groups and to determine whether factors such as geographical region, commercial support, and specialised clinical investigation were associated with inclusion.

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 We considered unpublished and non-English language studies and checked references in relevant papers.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 …