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Title: Micardis Available In U.S. For Hypertension
URL: http://www.pslgroup.com/dg/E6DCE.htm
Doctor's Guide
February 22, 1999


RIDGEFIELD, CT -- Feb. 22, 1999 -- Boehringer Ingelheim Pharmaceuticals, Inc.'s Micardis(R) (telmisartan) Tablets are now available in the United States for the once-daily treatment of hypertension.

An estimated 50 million Americans suffer from high blood pressure, which if left untreated can lead to heart attack, stroke, even death. People can have hypertension for years without knowing it, which is why the disease is called the silent killer.

Micardis belongs to the newest class of antihypertensives known as angiotensin II receptor blockers or ARBs. ARBs block the receptor sites found in many tissues (for example, vascular smooth muscle, adrenal gland) for one of the body's most powerful vasoconstrictors (blood vessel constrictor), the naturally-occurring hormone angiotensin II. As a result, vasoconstriction is inhibited and blood flow is facilitated, thereby reducing blood pressure.

"Micardis is a once-daily antihypertensive that works effectively in a wide range of patients," said Michael Weber, MD, chairman of the department of medicine, Brookdale University Hospital and Medical Center, Brooklyn, N.Y.

In placebo-controlled trials involving 1,041 patients treated with various doses of Micardis for up to 12 weeks, the overall incidence of adverse events was similar to placebo. Discontinuation of therapy due to adverse events occurred in fewer patients on Micardis than in patients on placebo (2.8 percent versus 6.1 percent).

Adverse events showing an incidence of one percent or more in patients treated with Micardis and that were greater than the incidence in patients treated with placebo, regardless of cause, were: upper respiratory tract infection (seven percent versus six percent), back pain (three percent versus one percent), sinus inflammation (three percent versus two percent), diarrhea (three percent versus two percent) and sore throat (one percent versus zero percent).

The usual starting dose for Micardis is 40 mg once daily. A dosage increase to 80 mg may lead to a greater reduction in blood pressure. At doses of 40 and 80 mg, the antihypertensive effect of once-daily administration of Micardis is maintained for 24 hours. Dose adjustment is not required in patients with mild-to-moderate renal (kidney) insufficiency and dosing is not affected by differences in age or gender.

As with all ARBs, Micardis should not be used by pregnant women because drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. Micardis should be used with caution in patients with impaired liver function, biliary obstructive disorders, constricted renal arteries or severe congestive heart failure.

Additionally, patients on dialysis may experience a decrease in blood pressure upon standing (orthostatic hypotension); therefore, their blood pressure should be closely monitored. Volume- and/or salt-depletion should be corrected in patients prior to administering Micardis or low blood pressure may occur.

The most recent data from the National Center for Health Statistics show that only 53.6 percent of all hypertensives are being treated for the disease and only 27.4 percent have adequately controlled blood pressure. Risk factors for hypertension include being overweight, high use of salt, age, and heredity. People at risk for hypertension should consult their physician about appropriate treatment.

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