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

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, the difference 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 like Sipahi  et al  have their appropriate place in scientific research. However, these analyses have well-recognised limitations, such as combining study summaries rather than analyzing individual patient data.

Telmisartan is one of the most studied anti-hypertensives in clinical trials, which have all been made publicly available. It is widely used as medication to lower blood pressure and protect patients against severe cardiovascular events such as myocardial infarction and stroke.

About Telmisartan

In the US, telmisartan is marketed as MICARDIS® (telmisartan) tablets.  MICARDIS is a prescription medicine used to treat high blood pressure (hypertension), and in certain high-risk people aged 55 years and older, to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death.  Talk to your doctor to see whether MICARDIS is appropriate for you.

IMPORTANT SAFETY INFORMATION

MICARDIS (telmisartan) tablets are not for pregnant women. Taking MICARDIS during pregnancy can cause injury and even death to your unborn baby.  If you get pregnant, stop taking MICARDIS and call your doctor right away.  If you plan to become pregnant or breastfeed, talk to your doctor about other ways to lower your blood pressure.  The most serious side effects of MICARDIS are low blood pressure and kidney problems. Other rare but serious side effects may occur. Before taking MICARDIS, tell your doctor if you have liver, kidney or heart problems, and about all other medications you are taking.  

Please see full prescribing information, including boxed WARNING, for MICARDIS.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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