Healthy Skepticism Library item: 12723

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Rosenberg H, Allard D
Evidence for Caution: Women and statin use
: Women and Health Protection 2007 Jun
http://www.whp-apsf.ca/pdf/statinsEvidenceCaution.pdf

Abstract:

This paper investigates the evidence base for the use of statin therapy in women. Statins
are a class of prescription drugs designed to lower cholesterol. The leading statin drugs
are Lipitor (generic name atorvastatin), Crestor (rosuvastatin), Mevacor (lovastatin),
Pravacol (pravastatin), Zocor (simvastatin) and Lescol (fluvastatin). The research on this
issue is exceptionally complex and cannot be fully addressed in this short document. For
the purposes of this review, we explore three fields of inquiry:
1. Benefit: Key Issues in the Evaluation of Statin Benefit
• representation of women in primary and secondary prevention trials
• extrapolation of benefit from men
• cholesterol levels as a risk factor for coronary vascular disease in women
• other modifiable cardiovascular risk factors
• age and life stage
2. Safety: Key Issues in the Evaluation of Statin Safety
• general release of Serious Adverse Events data, total mortality, total
cardiovascular events, or incidence of cancer and disaggregation for women
• data from the Adverse Drug Reaction reporting system
• data on concomitant use of statins and hormonal drugs
• research on the prescription of statins for women of childbearing potential
(WOCBP); miscarriage, birth defects and breast-feeding
• vulnerability of women to exercise intolerance
• burden of care in relation to statin-impaired family members
3. Representation: Key Issues in the Evaluation of Information Representation
• conflict of interest (COI)
• marketing strategies and awareness campaigns
• representation of cardiac risk for women
• statistical representations including relative risk (RR), absolute risk (AR) and
number needed to treat (NTT)
Our review of these fields identifies a troubling disjuncture between the widespread use
of statin medication for women and the evidence base for that usage. What we found
instead was evidence for caution.