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| |  FDA Approves Micardis HCT (Telmisartan/Hydrochlorothiazide) For Hypertension RIDGEFIELD, CT -- November 21, 2000 -- Boehringer Ingelheim announced the approval of Micardis HCT Tablets (telmisartan/hydrochlorothiazide) by the U.S. Food and Drug Administration (FDA) for the second-line treatment of hypertension. Micardis HCT combines the angiotensin II receptor blocker, Micardis (telmisartan) 40 and 80 mg, with a 12.5 mg fixed-dose of hydrochlorothiazide (HCTZ). Micardis HCT offers physicians another treatment option for patients who are unable to control their hypertension with a single agent and require a more intense blood pressure lowering effect. According to the National Heart Lung and Blood Institute, there are 50 million adults in the United States with hypertension. Currently, only 68 percent of them are aware of their condition, 54 percent of those who are aware are being treated, and 27 percent of those being treated do not have their blood pressure under control. In clinical trials, Micardis HCT 80/12.5 mg significantly reduced diastolic and systolic blood pressures by an average of 14.9 mmHg and 23.9 mmHg, respectively (compared to 2.9 mmHg and 3.8 mmHg, respectively, for placebo). African Americans and the elderly are at particular risk to not adequately respond to antihypertensive monotherapy. In clinical trials, Micardis HCT 80/12.5 mg decreased diastolic blood pressure by 13.3 mmHg and systolic blood pressure by 21.5 mmHg in African Americans (compared to 3.4 mmHg and 0.1 mmHg, respectively, for placebo). In patients over 65, Micardis HCT 80/12.5 mg demonstrated a 16 mmHg reduction in diastolic blood pressure and a 25.3 mmHg reduction in systolic blood pressure (compared to 5.2 mmHg and 3.7 mmHg, respectively, for placebo). "Micardis HCT can help those patients who have been unsuccessful at controlling their hypertension," said Manfred Haehl, Senior Vice President, Medical and Drug Regulatory Affairs, Boehringer Ingelheim. "Micardis offers 24-hour blood pressure control. The approval of the Micardis HCT combination provides this benefit to an extended patient population." MICARDIS, which is indicated for the once-daily treatment of hypertension, works by blocking the receptor for angiotensin II. Angiotensin II is one of the body's most powerful vasoconstrictors (blood vessel constrictors). Binding sites for angiotensin II are found in many tissues (e.g., vascular smooth muscle, adrenal gland). Blockade of these binding sites inhibits vasoconstriction and facilitates blood flow, thereby reducing blood pressure. HCTZ is a diuretic commonly prescribed in combination with other antihypertensives. HCTZ flushes excess water and sodium from the body by increasing urine formation. This decreases the amount of fluid in the blood vessels, thereby increasing blood flow and reducing blood pressure. The combination of telmisartan/hydrochlorothiazide has been assessed in more than 1700 patients with mild-to-moderate essential hypertension. Data from clinical hypertension trials indicate that the overall adverse event rate for patients treated with the combination products was similar to placebo. The most frequently reported adverse events overall were upper respiratory infection, pain, dizziness and headache. As with all combination products containing angiotensin receptor blockers, Micardis HCT should not be used by pregnant women because drugs that act directly on the renin-angiotensin system can have adverse effects on the developing fetus. Micardis HCT is not recommended for patients with severe renal or hepatic impairment. Micardis HCT Tablets are marketed in the United States by Boehringer Ingelheim Pharmaceuticals, Inc. and Abbott Laboratories, Inc. Related Links: Boehringer Ingelheim Pharmaceuticals, Inc. and Abbott Laboratories, Inc.
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