–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed…
ALTITUDE Autopsy Shows What Went Wrong With Aliskiren
November 3, 2012 by Leave a Comment
In its short lifespan the direct renin inhibitor aliskiren (a.k.a., Rasilez or Tekturna) rapidly declined from being a highly promising, first-of-its kind drug to a major failure. The death blow was struck last December with the early termination of the ALTITUDE trial, after the data and safety monitoring committee found an increased risk in patients taking aliskiren. Now the final results…
First Detailed Look At Why Aliskiren Failed To Gain ALTITUDE
August 26, 2012 by 2 Comments
Last December the once-promising direct renin inhibitor aliskiren (Rasilez, Tekturna) suffered a fatal setback with the early termination of the ALTITUDE trial. The trial was stopped when the Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months. At the ESC in Munich ALTITUDE investigator Hans-Henrik…
Aliskiren (Tekturna) Gets New Warning and Contraindication From FDA
April 20, 2012 by Leave a Comment
The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to…
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