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| |  Diovan Reduces Left Ventricular Hypertrophy DORVAL, QUEBEC -- July 17, 1997 -- Long-term use of Diovan(R) (valsartan), a new AT1 receptor blocker, significantly reduces left ventricular hypertrophy (LVH), a powerful predictor of cardiovascular morbidity and mortality, according to a new study conducted by The Institute for Clinical Pharmacology, University Hospital Frankfurt, Germany. Moreover, left ventricular mass index (LVMI), an indicator of LVH, was reduced to a statistically significantly greater level with Diovan than with atenolol. The results of the clinical trial, "Angiotensin II Antagonism and the Heart - Valsartan in Left Ventricular Hypertrophy," were presented today at the Eighth European Meeting on Hypertension in Milan, Italy. "Diovan has been shown to be a well tolerated and effective treatment for essential hypertension," said study investigator Petra Thürmann, MD, formerly of the Institute for Clinical Pharmacology, University Hospital Frankfurt, Germany, and currently Chair of Clinical Pharmacology of the University Witten/Herdecke, Institute of Clinical Pharmacology, who presented the results at the hypertension meeting. "This study will be of particular interest to physicians because it demonstrates that Diovan has a significant positive impact on LVH, an independent risk factor for cardiovascular disease. The results of this study are clinically relevant and statistically significant." Diovan is a new AT1 receptor blocker, also referred to as an angiotensin II antagonist or as an angiotensin II receptor blocker, which is currently marketed in more than 20 countries for the treatment of essential hypertension. It has been shown to be as effective as other leading antihypertensives (enalapril 20 mg and lisinopril 10 mg) in the treatment of high blood pressure and has an excellent tolerability profile, with an overall incidence of side effects comparable to placebo. The study compared the effects of Diovan, an AT1 receptor blocker, with those of another antihypertensive drug, atenolol, a beta-blocker, in the reduction of LVH, an enlargement of the main pumping chamber of the heart. Two critical aspects of the study design enhanced the significance of the results. First, in comparison to prior LVH studies, this trial was conducted predominantly in subjects who had not received previous antihypertensive therapy in order to minimize the effects of other antihypertensive treatment. Second, the study, which was eight months in length, was significantly longer than previous trials. After a three-week, placebo-controlled, run-in period, during which the presence of LVH was proven by echocardiography, patients were randomized to receive either Diovan (80 mg once-daily) or atenolol (50 mg once-daily) for four weeks. If, after four weeks, blood pressure was not adequately controlled (sitting diastolic blood pressure above 95 mmHg measured the morning before drug intake), the dose was doubled. In those patients with diastolic blood pressure still above 95 mmHg after an additional four weeks, a diuretic, hydrochlorothiazide, was added to treatment. About 30 percent of the patients in each treatment group required additional treatment with the diuretic. Patients underwent a second echocardiogram after three months and a third echocardiogram at the end of the study (eight months of treatment). The study population included only those patients with LVH confirmed by echocardiography. Of 69 patients randomized, 58 were evaluated for analysis of left ventricular mass index (LVMI). The Diovan group (n=29) had a mean baseline LVMI measurement of 127 +/- 23 g/m2 and the atenolol group (n=29) had a mean baseline LVMI measurement of 127 +/- 25 g/m2. Compared to baseline measurements, long-term treatment with Diovan resulted in a statistically significant reduction of LVH in patients with essential hypertension. In addition, reduction of LVMI was statistically significantly greater with Diovan than with atenolol. Both Diovan and atenolol were well tolerated and quickly produced reductions in blood pressure that were sustained over the length of the study. After eight months of treatment, blood pressure had decreased significantly in both groups, compared to baseline. Left Ventricular Hypertrophy Left ventricular hypertrophy is commonly observed in patients with hypertension, and is a predictive factor for cardiovascular disease. LVH is independent of other cardiovascular disease risk factors such as smoking and elevated plasma cholesterol levels. One of the triggers of LVH is heart wall stress, which is chronically elevated in untreated hypertensive patients and promotes myocardial muscle cell growth. In addition, hormones such as angiotensin II contribute to the development of LVH. The growth-promoting actions of angiotensin II on myocardial muscle are mediated via the AT1 receptor subtype. Therefore, drugs that block angiotensin II from binding to the AT1 receptor would be expected to be of benefit in promoting LVH regression. Diovan Information Diovan selectively blocks the angiotensin II hormone from binding to the AT1 receptor, which is located in many different tissues including vascular smooth muscle. Angiotensin II is formed from angiotensin I by angiotensin-converting enzyme (ACE). Angiotensin II leads to vasoconstriction (the narrowing of blood vessels) and to the release of aldosterone, a steroid hormone that promotes the retention of water and sodium. These effects contribute to an increase in blood pressure. Diovan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II, resulting in the dilation of blood vessels and the consequent lowering of blood pressure. Diovan is a product of the Novartis Group and was introduced to the U.S. market in February, 1997. Diovan is not yet available in Canada. Novartis Pharmaceuticals Canada Inc. is a leading research-based pharmaceutical company with a wide-ranging program for the development, manufacturing, and distribution of medicines for Canadians. More information on: Diovan, More information on: Novartis Pharmaceuticals
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