Boehringer denies Micardis cancer link
pharmafile | June 14, 2010 | News story | Sales and Marketing | ACE-inhibitors, ARB, Boehringer, Micardis, drug safety
Boehringer Ingelheim has given a robust rebuttal to a Lancet report implicating its hypertension drug Micardis (telmisartan) in scares about increased cancer risk.
A US meta-analysis of data from all trials of angiotensin-receptor blockers (ARBs), published in the June issue of Lancet Oncology, found one new cancer diagnosis for every 100 or so patients.
The analysis was led by Dr Ilke Sipahi of the University Hospitals Case Medical Center in Cleveland, who argues that the ubiquity of ARBs in treatment makes this an important finding.
This widely-used class of drugs, which also includes MSD’s Cozaar (losartan) and Takeda’s Amias (candesartan), was found to have increased the risk of lung cancer in particular.
However, no significant rise in cancer deaths was found – although this may have been because patients were not studied for long enough, the research suggests.
But Boehringer argues the safety profile of Micardis is “excellent” and says Sipahi et al’s finding is “mainly based” on the combination arm of telmisartan and ramipril, an angiotensin converting enzyme (ACE)-inhibitor – not on each compound separately.
“Our research efforts have centred on the need to protect patients, especially older patients from cardiovascular risks such as myocardial infarction or stroke,” said Klaus Dugi, the manufacturer’s corporate senior vice president of medicine.
The company went on say Micardis is one of the most studied anti-hypertensives in clinical trials, the data from which have all been made publically available.
Boehringer’s statement also points out that peer-reviewed meta-analyses “have well-recognised limitations, such as combining study summaries rather than analysing individual patient data”.
“In pre-clinical trials, clinical trials and day-to-day patient exposure with telmisartan, we have not seen any significant finding related to malignancies,” concluded Dugi.
Boehringer and the researchers at least agree on one point: that patients should consult their doctor before making any decision about their treatment in the light of the new analysis.
Adam Hill
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