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| |  CHBPR: Oral Renin Inhibitor, Aliskiren (SP100), Shows Promise For High Blood Pressure Treatment By W. A. Thomasson Special to DG News CHICAGO, IL -- September 25, 2001 -- The oral renin inhibitor Aliskiren (SP100) effectively lowers blood pressure, according to a pilot study. Researchers reported the findings yesterday (September 24) at the annual meeting of the Council for High Blood Pressure Research in Chicago, Illinois. Authors of the study were Alice V. Stanton, MD, and colleagues at Beaumont Hospital in Dublin, Ireland, and at Speedel Pharma in Basel, Switzerland. If commercialized, Aliskiren would be the first of an entirely new class of antihypertensive drugs. Renin catalyzes the conversion of angiotensinogen to angiotensin I, which is then converted to angiotensin II by angiotensin converting enzyme (ACE). ACE, however, is not entirely specific for angiotensin I, and this lack of specificity contributes to such side effects of ACE inhibitors as rare but potentially life-threatening angioedema. Renin, by contrast, is completely specific for angiotensinogen, and renin inhibitors are expected to be virtually free of side effects. This advantage has led a number of pharmaceutical companies to investigate renin inhibitors, but none to date has succeeded in combining oral availability with commercially viable manufacturing costs. However, Frank LaSaracina, US Managing Director of Speedel, told Doctor’s Guide that he believes his company has overcome these problems. Speedel, which in-licensed developmental rights from Novartis, expects to complete its current phase IIb trial later this fall, at which point it is looking toward the possibility that Novartis will exercise its option to recover rights and proceed to phase III trials. In the study reported yesterday, four men and four women with mild to moderate hypertension received 75 mg of aliskiren per day for four weeks, after which the dose was escalated to 150 mg for an additional four weeks. At the beginning of the study (after a two-week washout period), and at the end of each treatment period, blood pressure was recorded continuously over a 24-hour period under ambulatory conditions. Compared to baseline, daytime systolic blood pressure decreased by 4 mm Hg and 7 mm Hg on the lower and higher doses, respectively. The corresponding nighttime decreases were 3 and 6 mm Hg. Decreases in diastolic pressure were similar during the daytime but smaller at night. No effect on heart rate was seen.
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