Current Status
Aliskiren is effective in lowering blood pressure, but as of 20 April 2012 the US Food and Drug Administration (FDA) issued a warning of possible risks when using aliskiren or blood pressure medicines containing aliskiren with ACE inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. They advised that such drug combinations should not be used in patients with diabetes because of the risk of causing renal impairment, hypotension, and hyperkalemia and that aliskiren should not be used with ARBs or ACE inhibitors in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate < 60 mL/min). However, they also recommend that patients should not stop taking aliskiren without talking to a healthcare professional.
Aliskiren in combination with hydrochlorothiazide was approved by the FDA in 2008 under the tradename Tekturna HCT.
In 2007, Actelion/Merck and Speedel companies announced they had the next generation of renin inhibitors in clinical research. The lead compound from Actelion/Merck has entered phase II trials. One compound from Speedel, SPP635, has completed phase IIa. The results showed it was safe and well-tolerated over a four-week period, and it reduced blood pressure by 9,8 to 17,9 mmHg. In 2008, SPP635 was continuing phase II development for hypertension in diabetic patients. More renin inhibitors from Speedel are in clinical trials. Two of them, SPP1148 and SPP676, have entered phase I. Other are in preclinical phases, the compound SPP1234 and compounds from the SPP800 series.
The next generation of renin inhibitors have shown potential improvements over previous generations where bioavailability has increased up to 30% in humans, and they have better tissue distribution.
Read more about this topic: Renin Inhibitor
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