Experts play down Inergy cancer risk

pharmafile | September 5, 2008 | News story | Sales and Marketing |  Merck, cv 

Heart specialists have told patients to continue taking Schering-Plough and Merck's cholesterol-lowering drug Inergy, despite a study indicating that it could raise the risk of cancer by 50%.

Scientists compared the prevalence of cancer in a group of patients taking Inergy – a combination of simvastatin and ezetimibe – against a placebo group. The results, published in the New England Journal, found a total of 105 cancer cases among Inergy patients, compared with 70 in the placebo group.

But the British Heart Foundation has told patients not to quit the medication, and said the single study was not conclusive.

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The charity's director of prevention and care Dr Mike Knapton said: "The combined evidence of all data on cancer and ezetimibe in combination with a statin shows no increased risk of developing cancer."

He added it was crucial for continued research to definitively confirm or refute a link, but that "people should be reassured that drug regulators will act quickly if robust evidence of risk to patient health appears."

Inergy is a combination of simvastatin and Schering-Plough's non-statin Ezetrol (ezetimibe).

Ezetrol acts by decreasing cholesterol absorption in the intestine, and can be used alone when other cholesterol-lowering medications are not tolerated, or together with statins for greater control of cholesterol level.

NICE approved Inergy for wider use on the NHS in November last year, and it has been reported that 300,000 prescriptions for the drug have gone out in the last two years.

Schering-Plough and MSD said they "strongly support the efficacy and safety profile" of both Inegy and Ezetrol, and have put the new findings down as an "anomaly". They have not recommended any change to its clinical use at this time.

In the US, where the drug is known as Vytorin, the FDA plans to review the drug in the light of the new data. However, it too downplayed the need for any change in clinical practice.

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