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Back To Vidyya AstraZeneca Receives FDA Approval To Market Atacand HCT(TM)

Combination Product Offers Patients New Advance In Controlling Blood Pressure

AstraZeneca announced today the approval of Atacand HCT ® (candesartan cilexetil- hydrochlorothiazide) by the U.S. Food and Drug Administration (FDA) for second-line treatment of hypertension. Atacand HCT combines the angiotensin II receptor blocker (ARB) Atacand ® with the diuretic hydrochlorothiazide providing physicians with another treatment option for those patients who are unable to control their hypertension with a single agent.

Despite the availability of numerous antihypertensive medications, controlling blood pressure in the hypertensive population remains a problem. Recent public health surveys suggest that only one in five people in the United States with hypertension have their blood pressure adequately controlled. To help improve this situation, physicians are turning to fixed- dose combination antihypertensives when desired blood pressure targets are not achieved on monotherapy. Atacand HCT offers dosing flexibility and effective blood pressure control for patients uncontrolled on a single agent.

The combination of candesartan cilexetil-hydrochlorothiazide has been evaluated in twelve controlled clinical trials involving approximately 4,600 hypertensive patients. In controlled clinical trials, the dosing combinations of 32-12.5 mg and 16-12.5 mg resulted in placebo-adjusted decreases in systolic and diastolic blood pressures of 14-18/8-11 mmHg. Overall, Atacand HCT was well tolerated, maintaining a blood pressure lowering effect over a full 24-hour period.

Atacand HCT is available in two combinations: 32 mg Atacand-12.5 mg hydrochlorothiazide and 16 mg Atacand-12.5 mg hydrochlorothiazide. Atacand HCT is not indicated for initial therapy.

The overall incidence of adverse events reported with Atacand HCT was comparable to placebo. The most common adverse events that occurred with greater incidence than placebo were upper respiratory infection, dizziness, back pain, and flu-like symptoms. As with other drugs that act directly on the renin-angiotensin system, Atacand HCT should not be used by pregnant women and should be discontinued if pregnancy is detected.

ARBs work by inhibiting the effects of angiotensin II, a peptide that constricts blood vessels and leads to hypertension. Diuretics, such as hydrochlorothiazide, aid in reducing blood pressure by enhancing the ability of the kidneys to eliminate salt and fluid from the body. Atacand was launched in the United States in October 1998 and is available in 33 countries.

Often referred to as the "silent killer," hypertension affects 50 million people in the United States and is responsible for more than 40,000 deaths annually, according to the American Heart Association. Uncontrolled hypertension has been linked to stroke, heart attack and heart failure. Although the cause of 90-95 percent of cases of hypertension is unknown, the disease can be controlled with medication.

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Editor: Susan K. Boyer, RN
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