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Cardiovascular risk seen in Lipitor to simvastatin switch

A UK Primary Care Database study says that switching patients from Lipitor to generic simvastatin could cause a 30 per cent increase in the relative risk of heart attacks and death

A UK Primary Care Database study has suggested that switching patients from Pfizer's Lipitor (atorvastatin) to generic simvastatin could cause a 30 per cent increase in the relative risk of heart attacks, strokes and certain types of heart surgeries and death compared with patients who maintained Lipitor therapy.

The analysis was presented at the European Society of Cardiology Congress 2007 and was also published in latest issue of The British Journal of Cardiology.

The data, which included records from October 1997 to June 2005, were derived from a retrospective analysis of The Health Improvement Network (THIN) medical database of anonymous patient records entered by UK general practitioners.

The analysis included 11,520 patients, 2,511 of whom had taken Lipitor for six months or more and were then switched to simvastatin. This data set was compared with 9,009 patients who were taking Lipitor for six months or more and remained on the treatment.

The reasons for the therapy switch were not available from the database. As patients were not randomly assigned to each group, the two treatment groups were matched based on certain risk factors, while statistical adjustments were made to address any residual imbalances.

A secondary analysis of the same data showed that patients who were switched from Lipitor to simvastatin were more than twice as likely to discontinue their treatment compared with those kept on Lipitor therapy (20.5 per cent versus 7.6 per cent). Again, the reasons for the switch were not available.

Dr Michael Berelowitz, senior vice-president of Pfizer's global medical division, commented: "Today, many healthcare payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy. The study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin."

30th September 2008

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