RIDGEFIELD, Conn., June 13 /PRNewswire/ — Telmisartan, an
angiotensin receptor blocker, is one of the best researched drugs
worldwide. It has been studied in clinical trials in more than
50,000 patients. Its positive safety profile has been confirmed
also in a market exposure of 34.5 million patient years. Convincing
safety data for patients with a high cardiovascular risk were
collected in the three long-term outcome trials ONTARGET, PRoFESS
and TRANSCEND which followed some of the patients for up to five
years. Following rigorous assessment of the data from these studies
it was concluded that there was no association with an increased
risk of cancer in the telmisartan arms.
Sipahi et al published a meta-analysis in the June issue of
Lancet Oncology, claiming that angiotensin receptor blockers (ARBs)
used to lower hypertension are associated with a modestly increased
risk of new cancer diagnosis. The finding is mainly based on the
combination arm of telmisartan and ramipril, an angiotensin
converting enzyme (ACE)-inhibitor, and not on the trial arms of
each compound separately.
Patient health and safety is the primary concern of Boehringer
Ingelheim. The company continually monitors safety data for all
medical products. Boehringer Ingelheim’s comprehensive internal
safety data analysis of primary data contradicts the conclusions
about an increased risk of potential malignancies mentioned by
Sipahi et al.
All outcome studies with telmisartan included patients with
cardiovascular risk factors due to age and comorbidities.
Specifically, in ONTARGET, with more than 25,000 patients, no
statistically significant difference with respect to malignancies
was observed in patients treated with telmisartan vs ramipril (HR
1.05, 95%CI 0.94, 1.16). In TRANSCEND, a 6,000 patient trial,