The Pharmaceutical Journal
Vol 273 No 7315 p304
4 September 2004

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New data from 4S trial show statins safe in long term

Reassuring data have been published on the long-term safety of statins.

Post-trial follow-up of patients in the Scandinavian Simvastatin Survival Study (4S), one of the major secondary prevention statin trials, has shown no difference in cancer mortality between the simvastatin and placebo groups.

There has been some concern about a possible increased risk of cancer associated with pronounced cholesterol lowering. Although many trials have shown statins to have a good safety profile, the 4S researchers say that the average duration of such trials is fairly short in terms of studying cancer incidence. For this reason, they decided to extend post-trial follow-up of 4S participants.
National registers were used to assess cause-specific mortality and cancer incidence in the original treatment groups for a median follow up of 10.4 years (5.4 years for the original trial, then a further 5 years).

The results of this five-year extension study are published in The Lancet (2004;
364:771). The data were analysed by intention to treat and there was no statistically significant difference between the two groups in cancer mortality or cancer incidence.

After the double-blind part of the trial, most patients in both groups took a statin but the survival benefit of patients allocated simvastatin in the initial trial period persisted, largely because of lower coronary mortality.

Tim O’Donoghue, a pharmacist at Greenlight Pharmacy, London, said the results are good news for those pharmacists who are actively taking up the challenge to prescribe OTC simvastatin. “No customer has specifically asked us about cancer,” he added.