Inspra. (New & Approved).
A selective aldosterone blocker for treating hypertension, used alone or in combination with other antihypertensives. The first drug in this class to be approved.
Recommended Dosage: Starting dose of 50 mg once a day, increasing to 50 mg twice a day if necessary.
Special Considerations: The most common side effects reported in trials included dizziness (3%), and fatigue, flulike symptoms, diarrhea, and cough (all occurring at a rate of 2%). Contraindicated in patients with serum potassium above 5.5 mEq/L; type 2 diabetes with microalbuminuria; serum creatinine above 2 mg/ dL in men or 1.8 mg/dL in women; or a creatinine clearance below 50 mL/min. Also contraindicated in people on potassium supplements, potassium-sparing diuretics (amiloride, spironolactone, or triamterene), and drugs that are strong inhibitors of CYP45O 3A4, such as ketoconazole or itraconazole.
Comment: Inspra blocks the binding of aldosterone. In studies of more than 3,000 patients, Inspra lowered blood pressure, as monotherapy and when used with other antihypertensives. In a 16-week trial of about 500 black and white patients with mild to moderate hypertension, use of Inspra (50-200 mg) was tied to greater reductions in blood pressure than use of the angiotensin receptor blocker Cozaar (losartan), but only in black patients.
Dr. Elijah Saunders, head of the hyper tension division at the University of Maryland, Baltimore, noted that black patients don't respond as well as white patients to ACE inhibitors and angiotensin receptor blockers, so Inspras usefulness in black patients is important. Inspra's selectivity means that it lacks some of the side effects of Aldactone (spironolactone) such as gynecomastia. Based on animal data and some human data, Inspra presumably offers the benefits of Aldactone, such as fluid reduction. Dr. Saunders has done studies for Pharmacia and is on its speaker's bureau.
Inspra is expected to become available sometime in 2003, a company spokesman said. The company plans to file an application this year for approval of the drug for treating post-MI heart failure.
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|Publication:||Internal Medicine News|
|Article Type:||Brief Article|
|Date:||Feb 15, 2003|
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