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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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Letter in response to Hippisley-Cox and Coupland C. BMJ 2010;340:c2197.

Dear Sir

We note with interest the recent population based cohort study
examining unintended side effects of statins and the increased risk of
acute renal failure (1).

We have carried out a retrospective study using Yellow Card data
submitted to the MHRA from 2002-2006 to examine drug-induced renal
toxicity and note that lipid lowering drugs are also frequently reported
in association with this problem, third only after recognised nephrotoxins
such as NSAIDs and drugs acting on the renin–angiotensin system and ahead
of loop diuretics (89) and potassium sparing diuretics and aldosterone
antagonists (55).

On further examination of statins reported and coded to the MedDRA
High Level Term of Renal failure and impairment, we found the average age
to be 68.59 years (SD +/- 11.40) which is higher than reported in the
Hippisley-Cox and Coupland study. Men are more frequently reported than
women but this may reflect targeted prescribing of statins in males due to
higher risk of cardiovascular disease. Unfortunately as data recorded for
co-morbidities and co-prescription of other medicines is limited, we
cannot comment on the influence of these factors (Table 1).

While these data cannot be used to ascribe absolute risk they are in
keeping with the trends observed.

As other correspondents have noted, although the cardioprotective
benefit of statins is undoubtedly proven, these drugs are not free of
adverse effects. As stated in the accompanying editorial(2), our
understanding of the unintended effects of statins continues to develop
and Yellow Card reports add to this pool of information which may help to
influence future prescribing decisions (www.yellowcard.gov.uk).

Acknowledgment
We gratefully acknowledge MHRA for their assistance in access to Yellow
Card data.

References

1. Hippisley-Cox J, Coupland C. Unintended effects of statins in men
and women in England and Wales:population based cohort study using the
QResearch database. BMJ 2010;340:c2197.

2. Alsheikh-Ali AA, Karas RH. Balancing the intended and unintended
effects of statins. BMJ 2010;340:c2240.

Competing interests:
None declared

Table 1: Frequency of occurrence of drugs (as BNF subsection) reported to the MHRA 2002-2006 for renal toxicity (Total number of Yellow Cards reporting renal toxicity =1484 in UK for 2002-2006)

Competing interests: No competing interests

02 July 2010
David N Bateman
Professor in Clinical Toxicology
Katherine Davidson, Sheena Kerr, and Moira Kinnear
Royal Infirmary of Edinburgh