One year after an analysis of five studies involving some 60,000 patients found links between angiotensin receptor blockers and an increased risk of cancer, the FDA has now decided that these meds - which are used to control high blood pressure, do not pose such a risk.
The study, which was published in The Lancet Oncology and prompted the FDA review, found that 7.2 percent of patients on an ARB were diagnosed with cancer compared with 6 percent on a placebo, which was deemed statistically significant. Put another way: one extra cancer case would occur for every 105 people taking the meds for about four years (back story).
Most of the patients were taking Boehringer Ingelheim’s Micardis, a $1.5 billion seller, prompting an angry rebuttal from the drugmaker. Other ARBs that were studied included Merck’s Cozaar, which is now generic; Novartis’ Diovan; Avapro, which is sold by Bristol-Myers Squibb and Sanofi-Aventis; and Daiichi Sankyo’s Benicar.
In reaching its decision, the FDA says it evaluated 31 randomized clinical trials that compared patients taking an ARB to patients not taking an ARB. This amounted to reviewing more than 155,000 patients, which the agency called the "largest evaluation of such data to date." Here is the FDA statement.
7 Comments
I guess this is good news. This product gives a bad name to other Angiotensin Receptor Blockers. It has the lousiest outcome data and so I guess not cauaing cancer is somehow good news. Oh, it doesn't do much good either, but at over $100 a month, who ise counting?
Which product?
The one pictured.
So what did the FDA do? They just did a bigger meta-analysis. Is this how you explore the ARB-cancer link? Where is information of the timing of the cancers with Micardis?
Yup, that's how these studies are usually done. When you follow 155,000 patients and don't see any excess risk, its probably not there.
In addition to the meta analysis performed by the FDA, the Danish national health records were used for a case control study involving an independent database of 325,000 patients, and they didn't see any increased risk either.
There are very few if any substances on earth, including apple juice, that have been scrutinized for cancer risk to the extent that ARBS have.
The one with largest outcome trial for the class has bad outcome data??? ONTARGET, please stop posting and stick to cafe pharma
There is no incidence of Cancer with Micardis the orginal meta-analysis was a joke. Plenty of double counting and cherry picking studies. Worst study I have read since Benicar AT-1 pressor inhibition.