The Pharmaceutical Journal Vol 267 No 7164 p321-324
8 September 2001

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Statins

Concerns about adverse reactions data

From Dr A. Rees, FRCP

With reference to your recent article “Cerivastatin withdrawal: the impacts” (PJ, 18 August, p222), in which I was quoted, I would like to draw readers’ attention to some concerns I have about the data in the accompanying table.

First, I believe the table is open to misinterpretation. The figures on the number of adverse reactions were from the date of each product launch, yet the prescription figures were only for a five-year period (1996–2000 inclusive). It could easily be misconstrued that statins that have been available the longest have higher relative levels of adverse reactions than they actually do.

I also find the figures in the “number of prescriptions” column surprising, even though I understand these are official Department of Health figures. It appears that fluvastatin has been much more widely prescribed than atorvastatin or pravastatin, which does not concur with my understandings of the usage of statins during this period.

Thirdly, it is a known phenomenon that the first drugs to become available in a new class have more adverse reactions reported, as the prescribers’ sensitivity is heightened, compared with, say, the fourth or fifth drug in the same class. It is unfair to compare these figures directly.

Finally, I think it is important that colleagues and I, as doctors, have a responsibility to prescribe on an informed basis and use large clinical trials such as 4S (Scandinavian Simvastatin Survival Study), WOSCOPS (West of Scotland Coronary Prevention Study), CARE (Cholestreol and Recurrent Events) and LIPID (Long-Term Intervention with Pravastatin in Ischaemic Disease) to determine our preferred drug use. For example, during 4S there was just one reversible case of rhabdomylosis out of 4,444 patients studied, and in fact more patients withdrew from the study as a result of drug-related adverse events taking placebo (2.6 per cent) than those taking simvastatin (2.1 per cent).

Alan Rees
Consultant Physician,
University Hospital of Wales

The Department of Health supplied an incorrect figure for the number of fluvastatin prescriptions. We published a correction last week in The Journal and PJ Online has been updated
— EDITOR.

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