European regulator probes ARB cancer link

pharmafile | June 28, 2010 | News story | Sales and Marketing ARB, Amias, Aprovel, Cozaar, Diovan, Micardis 

European regulators have begun an investigation into a possible risk of cancer in patients taking angiotensin II receptor inhibitors for hypertension.

The review comes after data published in June’s edition of Lancet Oncology found around one new cancer diagnosis for every 100 patients taking an ARB.

The meta-analysis reviewed nine randomised controlled trials involving almost 95,000 patients and suggested the drug class may be linked with a “modestly increased risk of new diagnoses of cancer” when compared with placebo or other heart medicines.

Angiotensin II receptor inhibitors (ARBs) help relieve blood vessel constriction (vasodilatation) and unlike older ACE inhibitors drugs they do not inhibit the breakdown of bradykinin (a peptide that causes dilation) and other kinins – avoiding the dry cough side effect common to most ACE inhibitors.

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ARBs that are currently on the market include: Boehringer Ingelheim’s Micardis, Takeda’s Amias, Sanofi/B-MS’s Aprovel, MSD’s Cozaar and Novartis’ Diovan.

The CHMP has said it will review the meta-analysis thoroughly, together with any other available non-clinical and clinical data (including data from clinical trials and epidemiological studies) on ARBs in order to clarify whether there is an increased risk of cancer in patients taking these medicines.

The committee will also issue an opinion on whether a future change to the product information or risk-management plans for these medicines might be necessary.

Ben Adams 

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