E-DRUG: Therapeutics Letter #77: Do statins have a role in primary prevention? An update
------------------------------------
Therapeutics Letter #77, "Do statins have a role in primary prevention? An update" has been published on line at
http://ti.ubc.ca/letter77
and the printed version is being mailed this week to over 10,000 physicians and pharmacists in British Columbia, Canada.
Therapeutics Letter #77 reports the results of an analysis of all the currently available evidence for the use of statins in primary prevention, showing that the claimed mortality benefit with statins for primary prevention is more likely due to bias than being a true effect of this widely used class of drugs (an estimated 20 billion dollars per year globally for this indication).
Seven years ago (see Therapeutics Letter #48, April-June 2003) the UBC Therapeutics Initiative concluded that “statins have not been shown to provide an overall health benefit in primary prevention trials” based on the 5 RCTs available at that time. More RCTs and 5 systematic reviews designed to answer this question have been published since 2003. The 5 published systematic reviews (none of which are Cochrane reviews) vary in the RCTs included, summary effect estimates, conclusions and declared conflicts of interest of the authors. Two of them claim to have found a decrease in mortality, while the other three found no decrease in mortality. Unfortunately, these reviews still do not answer the question “Do the benefits of statins outweigh the harms in people without proven occlusive vascular disease?” This question remains critically important to patients, physicians and health care resource utilization, so the Therapeutics Initiative team performed a new systematic review starting with the 22 RCTs included in at least one of these 5 systematic reviews and using the risk of bias methodology of the Cochrane Collaboration. While all the included RCTs had some risk of bias, four of the eleven RCTs which reported mortality were found to have a high risk of bias due to loss of blinding, stopping RCTs early for benefit and/or incomplete outcome reporting. When these 4 RCTs were removed from the analysis, the claimed mortality benefit disappeared.
Therapeutics Letter #77 concludes that:
Systematic reviews and meta-analyses are challenging and require much more than locating RCTs and plugging in the numbers.
The claimed mortality benefit of statins for primary prevention is more likely a measure of bias than a real effect.
The reduction in major CHD serious adverse events with statins as compared to placebo is not reflected in a reduction in total serious adverse events.
Statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.
We invite you to go to http://ti.ubc.ca/letter77 to read this latest Therapeutics Letter and take a moment to send us your comments and feedback. Feel free to pass this on to anyone who might be interested.
Best regards,
Ciprian Jauca
Program Coordinator
Therapeutics Initiative
University of British Columbia
jauca@ti.ubc.ca
+1-604-822-0700
www.ti.ubc.ca
==x==
About the Therapeutics Initiative:
The Therapeutics Initiative (TI) was established in 1994 by the Department of Pharmacology and Therapeutics in cooperation with the Department of Family Practice at The University of British Columbia with its mission to provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy. To reduce bias as much as possible the TI is an independent organization, separate from government, pharmaceutical industry and other vested interest groups. It strongly believes in the need for independent assessments of evidence on drug therapy to balance the drug industry sponsored information sources. Over the years the TI has substantially enhanced its ability to assess the clinical evidence presented in published articles, meta-analyses by the Cochrane Collaboration and scientific material presented by the pharmaceutical industry. In pace with the extensive assessment of clinical evidence, the TI has developed effective ways of knowledge translation and dissemination of this evidence to all active players involved in drug therapy: physicians, pharmacists, nurses and policy-makers (Ministry of Health) and is committed to analyzing its own impact using the PharmaCare/PharmaNet databases without identifying individual physicians, pharmacies or patients. The Therapeutics Initiative is funded by the BC Ministry of Health through a grant to the University of British Columbia. The Therapeutics Initiative provides evidence-based advice about drug therapy, and is not responsible for formulating or adjudicating provincial drug policies.
The Therapeutics Initiative is a full member of the International Society of Drug Bulletins.
About the Therapeutics Letter:
The Therapeutics Letter is a bi-monthly bulletin targeting identified problematic therapeutic issues (brief, simple, practical messages). It presents critically appraised summary evidence primarily from controlled drug trials. Such evidence applies to patients similar to those involved in the trials, and may not be generalizable to every patient. The process of producing the Therapeutics Letter involves a literature review and development of the message by different working groups of the Therapeutics Initiative. A draft of the Letter is reviewed by specialists who are expert in the particular therapeutic area and members of the Scientific Information and Education Committee before the Letter is disseminated.
About the Cochrane Collaboration:
The Cochrane Collaboration, established in 1993, is an international network of over 20,000 people from all around the world helping healthcare providers, policy makers, patients, their advocates and carers, make well-informed decisions about human health care by preparing, updating and promoting the accessibility of Cochrane Reviews – over 4,000 so far, published online in The Cochrane Library. The Cochrane Collaboration is an independent, not-for-profit organisation, funded by a variety of sources including governments, universities, hospital trusts, charities and personal donations. However, it does not accept commercial or conflicted funding – this is vital for being able to generate authoritative and reliable information, produced by people who can work freely, unconstrained by commercial and financial interests.