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| |  FDA-Approved Diovan HCT Combines Two Hypertension Drug Classes EAST HANOVER, NJ -- March 10, 1998 -- The United States Food and Drug Administration has granted marketing approval to Novartis Pharmaceuticals Corp.’s Diovan HCT(TM) (valsartan and hydrochlorothiazide) for second-line treatment of hypertension. Diovan HCT is a combination of an angiotensin II receptor blocker (ARB) -- a first-line treatment that lowers blood pressure with an overall incidence of side effects comparable to placebo -- and a diuretic, which is commonly used with other therapies to provide additional blood pressure lowering. Diovan (valsartan) and Diovan HCT offer physicians a range of options for first and second-line treatment of hypertensive patients. For initial monotherapy, once-daily Diovan 80 mg is effective for the majority of patients. If additional antihypertensive effect is required, physicians can either increase the dosage to 160 mg once-daily, or choose Diovan HCT, which will be available in once-daily doses of 80 mg or 160 mg valsartan and 12.5 mg hydrochlorothiazide. In clinical trials involving more than 1,500 patients, Diovan HCT was proven to be efficacious in reducing both systolic and diastolic blood pressure, providing greater blood pressure-lowering effect than monotherapy. Like Diovan, Diovan HCT was shown to be safe and well-tolerated, with an overall side effect profile comparable to placebo. Diovan works by selectively and specifically blocking the angiotensin II hormone from binding to the AT1-receptor. Diovan acts directly on the vascular tissue, blocking the cardiovascular effects of angiotensin II, thereby causing dilation of blood vessels and lowering of blood pressure. Thiazide diuretics, such as hydrochlorothiazide (HCT), affect mechanisms in the renal system that impact electrolyte reabsorption, directly increasing excretion of sodium and chloride and thereby decreasing blood pressure. Diovan was launched in the U.S. in March, 1997, and is currently available in approximately 40 countries for the treatment of essential hypertension. Diovan is as effective as other leading antihypertensive therapies (enalapril 20 mg, lisinopril 10 mg and amlodipine 5 mg) in treating high blood pressure, with an overall incidence of side effects comparable to placebo. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan and Diovan HCT should be discontinued as soon as possible. In clinical trials, there were no significant differences between adverse events in Diovan patients vs. placebo patients. Adverse events occurring more frequently with Diovan than placebo included viral infection (three percent versus two percent), fatigue (two percent versus one percent) and abdominal pain (two percent versus one percent). The most common adverse events seen with Diovan were headache and dizziness. In clinical trials, there were no significant differences between adverse events in Diovan HCT patients vs. placebo patients. Adverse events occurring more frequently with Diovan HCT than placebo included dizziness (nine percent versus seven percent), viral infection (three percent versus one percent), fatigue (five percent versus one percent), pharyngitis (three percent versus one percent), coughing (three percent versus zero percent) and diarrhea (three percent versus zero percent). The most common adverse events seen with Diovan HCT were headache and upper respiratory infection. More information on: Novartis Pharmaceuticals, and Diovan
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