Regulators in the USA are evaluating data from two clinical trials in which patients with type 2 diabetes taking Daiichi Sankyo’s blood pressure medication Benicar had a higher rate of cardiovascular-related death compared to patients taking a placebo.

The US Food and Drug Administration plans to review the primary data from “the two studies of concern”, known as ROADMAP and ORIENT, and is “considering additional ways to assess the cardiovascular effects” of Benicar (olmesartan). ROADMAP involved 4,447 patients with type 2 diabetes and at least one additional cardiovascular risk factor and one of the findings revealed 15 total cardiovascular deaths among Benicar patients, compared to three patients receiving placebo.

In the 566-patient ORIENT study, 10 heart-related deaths were observed in Benicar patients, compared to three in the placebo arm. However the FDA stressed that its review is ongoing and the agency has not concluded that Benicar increases the risk of death. Rather, it currently believes that the benefits of the drug in patients with high blood pressure continue to outweigh its potential risks, a view shared by Daiichi Sankyo.

ARBs linked to cancer risk in study
Benicar belongs to the angiotensin-receptor blocker class of drugs, which are “associated with a modestly increased risk of new cancer diagnosis”, according to a meta-analysis published in The Lancet.

The smeta-analysis looked at data from 61,590 patients from five clinical trials, common types of solid organ cancers (68,402 patients) from five studies and cancer deaths for 93 515 patients in eight trials. The figures showed that patients randomly assigned to receive ARBs had “a significantly increased risk of new cancer occurrence compared with patients in control groups”, 7.2% versus 6.0%.

The researchers noted that 85.7% of patients in the meta-analysis received Boehringer Ingelheim and Astellas' Mycardis (telmisartan) but added that “it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug”. Boehringer issued a statement, saying that “a comprehensive internal safety data analysis of Mycardis contradicts the conclusions about an increased risk of potential malignancies” mentioned in The Lancet. The drug has been studied in clinical trials in more than 50,000 patients and its positive safety profile “has been confirmed also in a market exposure of 34.5 million patient years,” the German firm added.

For more details on the meta-analysis, see tomorrow’s PharmaTimes Clinical News.