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Research

Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2197 (Published 20 May 2010) Cite this as: BMJ 2010;340:c2197

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Looks Like a Nice Balanced Profile for a Polypill

This Epidemiological Study of about 2 million people is also an
Unintended Pharmaco-Epidemiological Study with overall quite acceptable
NNTs and NNHs over 5 years for both high risky (20%) men and women, with
the only one except of a NNH of 91 (74 to 112 95% CI) for myopathy in men.

Regarding one of the most serious and the most unpredictable side effect:
acute renal failure; it was a not so frequent (NNH>300) and also
reversible phenomenom once the statin was stopped. The other very much
serious adverse effect, liver dysfunction, could be attenuated by reducing
alcohol intake and avoiding one of the least effective statins,
fluvastatin. Taken altogether these findings are in concordance with the
changing landscape of increasing the number of indications for statins
suggested by the JUPITER Trial and point strongly towards the direction of
the polypill with at least 3 to 4 drug components: a statin, plus one ACE-
Inhibitor, plus Aspirin, and/or another class of an anti-hypertensive
agent; for the public health management of primary and secondary
prevention of cardiovascular risk.

References:

1. Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to
prevent vascular events in men and women with elevated C-reactive
protein. N Engl J Med 2008; 359: 2195-207.

2. Russel R. Mechanism of Disease: Atherosclerosis - an inflammatory
disease. N Engl J Med 1999; 340: 115-26.

3. Grundy SM, CleemanJI, Merz CNB, et al. Implications of recent
clinical trials for the National Cholesterol Education Program Adult
Treatment Panel III Guidelines. Circulation 2004; 110: 227-39.

Competing interests:
None declared

Competing interests: No competing interests

18 June 2010
Jose Mario Franco de Oliveira
Associate Professor of Medicine. Departmen of Medicine
Medical School Univ. Federal Fluminense. Rio de Janeiro. Brazil. 24030-210