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Pfizer critical of generic plan for three million statin patients

Published on 30/11/05 at 10:35am

More than three million extra patients could be prescribed statins in England and Wales in response to new guidance - but most of these should receive generic simvastatin, says NICE.

The clinical and cost effectiveness body has recommended statins be used extensively in 'primary prevention' - in patients who have never suffered a heart attack but are at serious risk of having one in the future.

The guidance, if fully implemented, could expand prescribing massively, with the current number of patients taking a statin in England and Wales estimated at 1.8 million.

But NICE found there was no compelling evidence to show any one statin was superior, concluding that when initiating statin therapy doctors should usually start with the lowest priced drug.

In most cases this will be generic simvastatin, which is already England's most prescribed drug with over 12 million prescriptions written in 2004.

NICE estimates around 3.3 million adults in England and Wales have between a 15% (approximately equivalent to a 20% 10-year CVD risk) and 30% 10-year CHD risk, and will be eligible to start taking statins under the new guidance.

Despite the large-scale expansion in the potential market, the guidelines have attracted criticism from Pfizer, manufacturer of Lipitor.

Pfizer's head of medical affairs Dr Bruce Charlesworth welcomed the expansion in the number of patients to be treated, but said starting patients on a statin was only part of the picture.

Pfizer's Lipitor is the leading statin in the UK and the world and the company says NICE's guidance should have looked at which drugs were most effective in reducing LDL-C or bad cholesterol.

"It is disappointing that NICE has not reflected on the wealth of expert opinion on the importance of setting targets and the wealth of data on the superiority of individual statins in particular conditions," said Dr Charlesworth.

Five statins currently have a UK marketing authorisation: Pfizer's Lipitor (atorvastatin), Novartis' Lescol (fluvastatin), Bristol-Myers Squibb's Lipostat (pravastatin), AstraZeneca's Crestor (rosuvastatin) and simvastatin, which is available as Merck Sharp & Dohme's Zocor and in a cheaper generic form.

Pfizer's recently published IDEAL head to head study of Lipitor versus Zocor found its drug lowered LDL-C significantly more than its competitor.

But the study failed to show Lipitor to be more effective than simvastatin at preventing heart disease-related death, heart attack and cardiac arrest, undermining Pfizer's aim to build a strong case against its generic competitor

Related articles:

Study results not IDEAL for Lipitor

Wednesday, November 16, 2005




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