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PJ Online | News: Statins not to be withheld in the elderly

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The Pharmaceutical Journal
Vol 269 No 7225 p735
23 November 2002

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Related websites
American Heart Association: Scientific sessions 2002 (more)
The Lancet (www.thelancet.com)


Statins not to be withheld in the elderly

The Journal attended the American Heart Association scietific sessions courtesy of Bristol-Myers Squibb

There is no longer any justification for withholding statin therapy from older patients, Professor James Shepherd, University of Glasgow, said this week at the American Heart Association annual scientific sessions in Chicago.

He was presenting data from the prospective study of pravastatin in the elderly at risk (PROSPER), a trial designed to examine whether the benefits of statin therapy in reducing cardiovascular events in middle age can be extended to the elderly.

"Until now, physicians have not had the clinical evidence to demonstrate the benefits of statin therapy in older patients," Professor Shepherd said.

Data from the trial, in which 5,804 men and women aged 70?82 years were randomised to receive either pravastatin (Lipostat) 40mg or placebo daily, show that elderly patients treated with pravastatin for three years suffer fewer coronary events than those given placebo. Pravastatin lowered low-density lipoprotein cholesterol levels by a third and reduced the combined end point of coronary death, non-fatal heart attack, and fatal stroke by 15 per cent (408 events versus 473 for placebo, P=0.014).

When risks were analysed separately, the researchers noted a 19 per cent reduction in coronary events (P=0.006) but no significant reduction in cerebrovascular events. Professor Shepherd explained that the lack of observed benefit in stroke reduction was likely to be because patients were only followed for an average of 3.2 years (previous statin trials have shown benefits in terms of stroke prevention only after five years of treatment). He added that the trial was designed to follow patients for a shorter period because it was recognised that most of the patients would be in their last decade of life.

On average, patients in the study were already being treated with three or four different medicines each day. "If we added another drug in the form of pravastatin, would we create an increased risk of drug-drug interaction as a consequence of that polypharmacy," Professor Shepherd asked.

Professor Peter Macfarlane, another of the Glasgow study investigators, told The Journal that pharmacists involved in chronic disease management could be reassured by the study. "Patients were taking up to 16 different drugs but we saw no increase in the risk of myopathy, no cases of rhabdomyolysis and no increase in liver function abnormalities," he said.

One finding that is likely to provoke some debate is the increased incidence in newly diagnosed cancer seen among patients treated with pravastatin (hazard ratio 1.25, 95 per cent confidence interval 1.04-1.51, P=0.020). However, Professor Shepherd pointed out that this finding was likely to be due to chance because there was no pattern to suggest that a particular tissue was being affected. In addition, a meta- analysis of cancer rates in randomised placebo controlled trials including PROSPER showed no association between use of pravastatin, or other statins, and an excess risk of cancer.

Results from previous observational trials have also suggested that statins might slow cognitive decline in patients with vascular disease. This was not observed in PROSPER, a finding that is in line with results from the Heart Protection Study (PJ, 6 July, p4).

Data from PROSPER, which was sponsored by Bristol-Myers Squibb, are also published this week in The Lancet (2002; 360:1623).

Heart costs analysis A suggestion in last week's Journal (p706) that a cost analysis of the Heart Protection Study was to be presented at the American Heart Association scientific sessions in Chicago this week was incorrect. An economic analysis of the PROSPER trial had originally been planned but was not presented.

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