FDA Ends Olmesartan Safety Review, But...

The FDA announced on Tuesday that it had completed its safety assessment of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when final results from the ROADMAP trial showed that individuals with type two diabetes taking olmesartan had an enhanced threat of cardiovascular death.

Now the FDA says that it “has found no clear proof of enhanced cardiovascular hazards associated” with olmesartan in diabetic sufferers. The FDA stated that it would not adjust the recommendations for the use of olmesartan but it will consist of new information about the drug in the drug’s label.

A cautious reading of the FDA announcement, even so, suggests that although the agency did not uncover clear evidence of increased cardiovascular chance it also did not find clear proof of safety. Only 1 study examined by the FDA focused on the “subgroup of interest, i.e., diabetic patients taking substantial-dose olmesartan,” and it did not offer any reassurance. Here is the FDA’s description of the review:

A massive (a lot more than 300,000 patient-many years) observational review of Medicare individuals 65 many years and older examined the price of death in individuals taking olmesartan in contrast to other ARBs. In a chosen group of diabetic patients―patients who received only the highest dose of olmesartan (forty mg every day) for longer than six months―olmesartan was related with an increased threat of death (HR 2., 95% confidence interval: 1.one to 3.8) compared to related sufferers taking other angiotensin receptor blockers. In contrast, the identical evaluation in non-diabetic individuals located that substantial-dose olmesartan was associated with a decreased chance of death (HR .46, 95% self confidence interval: .24 to .86) in contrast to equivalent patients taking other ARBs. The conflicting results in diabetics and non-diabetics are challenging to reconcile and raise uncertainty about the credibility of the findings in either group. Additionally, no distinctions were identified amongst the groups getting reduced doses of olmesartan and groups receiving other angiotensin blockers or in people getting therapy for much less than 6 months.

Right here is the FDA’s conclusion about the study:

The final results appear to help the discovering in ROADMAP however, there are issues with regards to the credibility of the benefits of the Medicare review due to the fact of the discrepant findings in diabetics and non-diabetics. The observation of a massive lower in survival in patients with diabetes taking high doses of olmesartan, coupled with a large improve in survival in non-diabetic individuals taking olmesartan—all relative to other drugs of the very same class—is not a plausible locating.

 Comment: This FDA communication is fairly odd, in my view. It does not sound like there is a lot robust evidence both way in this situation. But it appears to me that if the FDA will take four years to carry out a safety evaluation, and if the only appropriate proof it analyzes appears to help the earlier issues, then it shouldn’t just conclude the security assessment. If something the safety concern has increased, not decreased.

FDA Ends Olmesartan Safety Review, But...