Women should not be prescribed statins as they fail to provide any overall health benefit

This article was published in the British Medical Journal 2007 May 12; 334(7601): 983 Study title and author:

Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No

Malcolm Kendrick, general practitioner

24 Prestwick Close, Tytherington, Macclesfield, Cheshire SK10 2TH

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1867901/?tool=pubmed

Dr. Kendrick believes there is little or no evidence of health benefits for women taking statins.

 

He makes the following observations:

(a) To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women.

(b) The primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women.

(c) Women should not be prescribed statins. Not only do statins fail to provide any overall health benefit in women, they represent a massive financial drain on health services. This money could be diverted to treatments of proved value.

(d) Statins carry a substantial burden of side effects.

(e) Mass medicalisation is a dangerous road with many psychological and societal consequences.

(f) In the Scandinavian simvastatin survival study three more women died taking statins than the women who took the placebo.

(g) In the studies of primary prevention neither total mortality nor serious adverse events have been reduced.

(h) A meta-analysis published in the Lancet found that statins even failed to reduce coronary heart disease events in women.

(i) Another meta-analysis of statins in primary prevention suggested that overall mortality may actually be increased by 1% over 10 years (in both men and women).

(j) Data from 124,814 women in 19 studies and trials found that cholesterol levels had no impact on total death rates and heart disease.

(k) Studies have suggested that side effects from statins may be much more common than is recognised.

(l) One study found that 80% of athletes could not tolerate statins.

(m) Research by Golomb and McGraw found that doctors often dismiss most (probable) statin related events. Patients who met the criteria for definite or probable adverse events reported that their doctors tended to dismiss symptoms, deny specific statins adverse events, and failed to appreciate the effect of the adverse reaction on their quality of life.

(n) More evidence comes from the US Food and Drug Administration adverse event reporting system. Between November 1997 and May 2004 simvastatin was reported as a direct cause of 49,350 adverse events and 416 deaths.Adverse events are greatly under-reported, so the actual figures are likely to be much higher.

(o) Of further concern, as statins are increasingly prescribed to younger women, is the potential for birth defects, with severe neurological abnormalities reported. Spending millions on a treatment that has no proved benefit and may cause serious harm goes against the rationale of evidence based prescribing.

 

Women should not be prescribed statins as they fail to provide any overall health benefit.

Statin exposure causes birth abnormalities

This post includes a synopsis of a paper published in the New England Journal of Medicine 350, 1579-82 2004

Study title and authors:
Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure
Robin J. Edison, M.D., M.P.H. Maximilian Muenke, M.D.
National Institutes of Health Bethesda, MD 20892-1852

Books:

This paper can be accessed at: http://www.nejm.org/doi/pdf/10.1056/NEJM200404083501524

The paper reviewed 52 cases of first-trimester statin exposure reported to the Food and Drug Administration (FDA).

The review found:
(a) Among these cases, there were 20 reports of malformation, including 5 severe defects of the central nervous system (2 of which were holoprosencephaly) and 5 unilateral limb deficiencies.
(b) One patient had both of these malformations. The two simvastatin-exposed cases of limb deficiency were complex lower-limb anomalies including both long-bone shortening and aplasia or hypoplasia of the foot structures. The infant in one of these cases and a lovastatin-exposed infant also had rare forms of the VACTERL association (i.e., three or more of the following findings: vertebral, anal, cardiac, tracheal, esophageal, renal, and limb defects).
(c) It is thought that only a small proportion of statin adverse events are reported to the FDA.
(d) There would be no expected cases of most of the malformations listed in the paper; yet three rare anomalies are each observed twice.

Dr Edison concludes that these findings support the need for controlled studies evaluating the potential birth defects effects of statin drugs.
 

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