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Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010
Date:6/13/2010

nce between telmisartan and placebo did not reach significance either (HR 1.17, 95%CI 0.97, 1.41). In the PRoFESS trial, another large-scale trial with more than 20,000 patients, the telmisartan arm showed fewer cases of malignancies than the placebo arm (HR 0.92, 95%CI 0.79, 1.05.) Considering the analysis of all three trials an effect of telmisartan on malignancies was not observed.

In ONTARGET, the one treatment arm with a combination of telmisartan and ramipril was associated with a modestly increased risk of malignancies. Consistent with our commitment to transparency, data from ONTARGET, TRANSCEND and PRoFESS have all been published and been widely shared with regulatory authorities since 2008. It should be noted that product labelling for telmisartan does not recommend the combination of telmisartan and ACE-inhibitors such as ramipril.

"Our research efforts have centred on the need to protect patients, especially older patients from cardiovascular risks such as myocardial infarction or stroke. Telmisartan fulfills this need. It is the only ARB which has cardiovascular protection in its label and has become a valuable treatment option in the management of hypertension and cardiovascular risk. Doctors and patients appreciate its excellent safety profile. In pre-clinical trials, clinical trials and day-to-day patient exposure with telmisartan, we have not seen any significant finding related to malignancies. Patients should consult with their physicians before making any decision regarding their antihypertensive therapy," said Prof. Dr Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.

It should be noted that in the US, telmisartan is indicated for hypertension and cardiovascular risk reduction in ACE-intolerant patients.

Peer-reviewed meta-analyses of aggregate published data li
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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