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| |  ASH: Teveten (Eprosartan Mesylate) Effective for Systolic Blood Pressure in Elderly NEW YORK, NY -- May 23, 2000 -- Data presented in a hypertension thought leader roundtable that coincided with the annual meeting of the American Society of Hypertension (ASH), demonstrated that the latest member of the angiotensin receptor-II blocker (ARB) class, Teveten®, produced clinically important reductions in systolic blood pressure comparable to patients that were treated with the leading ACE inhibitor, enalapril. The data confirmed that among patients aged 65 or older, Teveten produced an 18.9 mm Hg SitSBP reduction compared to a 15.3 mm Hg SitSBP reduction in the enalapril group. The roundtable discussion led by Dr. Kenneth Jamerson, Professor of Medicine of the University of Michigan and Dr. Venkata Ram, Director of the Texas Blood Institute, discussed why the management of elevated systolic blood pressure should be the primary focus of care for elderly hypertensive patients. "There are treatments that have demonstrated efficacy in controlling systolic blood pressure and are good options for elderly patients," says Dr. Ram. "We have seen evidence that eprosartan is effective in controlling systolic blood pressure and also has an excellent tolerability profile-an important factor for the elderly patient as drug interactions and unwanted side effects are a common problem with the elderly." On May 4th, the National Heart, Lung and Blood Institute (NHLBI) declared that physicians are failing to properly treat hypertensive patients because they are focusing on the wrong measurement -- diastolic blood pressure. The expert panel of the NHLBI is recommending a "major paradigm shift in urging that systolic BP become the major criterion for diagnosis, staging and therapeutic management of hypertension, particularly in middle-aged and older Americans." The report stated that, "Unequivocal clinical trial data indicate that lowering systolic BP markedly improves morbidity and mortality in older people. Thus achievement of optimal public health benefits requires a nationwide call-to-action to improve our current low rates of systolic BP control." "More and more the medical community is recognizing the serious cardiovascular risks associated with elevated systolic blood pressure. Now it is time for us to start focusing more closely on how we can best help our patients lower elevated systolic blood pressure," says Dr. Jamerson. "If we do not treat uncontrolled systolic blood pressure, we will be faced with an even greater problem as more patients experience adverse outcomes, such as coronary heart failure, stroke and kidney failure." The NHLBI's Coordinating Committee recommended ACE inhibitors as agents that lower morbidity and mortality rates in older people, in whom systolic hypertension is most prevalent. "The Teveten data shows promise in better systolic blood pressure control as evidenced by the comparison group study against the ACE inhibitor, enalapril. Considering Teveten's reduction rates in sitting systolic blood pressure, we can expect this treatment to effectively reduce elevated systolic blood pressure in most patients," added Dr. Ram. Evidence from the Framingham Heart Study showed that elevated systolic blood pressure is a better predictor of stroke, heart attack and congestive heart failure than diastolic blood pressure. Two other large studies, SHEP and SYST-EUR, have shown that treating elevated systolic blood pressure resulted in a reduction of cardiovascular disease by 32 percent (SHEP) and by 31 percent (SYST-EUR). Presenters Discuss Need for Safe Treatments with Elderly Hypertensives In addition to discussing effective systolic blood pressure control, the roundtable presenters also reviewed the safety profiles of various antihypertensives medications and stressed the importance of using a tolerable regime with elderly hypertensives. Data presented during the discussion suggested that approximately 75 percent of physicians stated that drug-drug interactions are a common problem among patients, according to a recent study sponsored by the Association of Black Cardiologists and funded by Unimed Pharmaceuticals, Inc. Teveten safety data presented during the roundtable discussion demonstrated a side effect profile similar to placebo. Also important, Teveten is not generally associated with the dry cough commonly associated with ACE inhibitors. Furthermore, because Teveten is not metabolized by the cytochrome P450 isoenzyme system, there is no evidence to date for drug interactions mediated via this pathway (e.g., fluconazole, ketoconazole, warfarin). Additionally, the pharmacokinetics of Teveten are not affected by concomitant administration of ranitidine. Teveten also has no effect on pharmacokinetics of digoxin. Teveten related adverse events were of mild or moderate severity. The overall incidence of adverse experiences and generally (per medical reviewer) incidences of specific adverse events reported with Teveten? were similar to placebo and were similar in all patients regardless of age, gender, or race. Teveten, like other drugs that act directly on the renin-angiotensin system (RAS), can cause injury and even death to the developing fetus when it is used during the second and third trimesters of pregnancy. When pregnancy is detected, Teveten should be discontinued as soon as possible. Teveten is currently indicated for the treatment of hypertension. The recommended starting dose of Teveten is 600 mg daily, which may be increased up to 800 mg daily depending upon the patient's blood pressure response. Recommended dosing when used as monotherapy in patients who are not volume-depleted. The FDA cleared Teveten in December of 1998 and in addition to the US; it is currently available in Germany, Ireland, Denmark, Finland, Sweden, The Netherlands and Portugal. In May 1999, the FDA approved Teveten for once-daily dosing. Unimed Pharmaceuticals, a wholly owned subsidiary of Solvay Pharmaceuticals, Inc, sponsored the roundtable meeting. Unimed Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of cardiology, men's health, HIV and other infectious diseases. Unimed Pharmaceuticals, based in the Chicago, Illinois area, has expertise in ethical drug development, marketing and sales. Solvay Pharmaceuticals, Inc. of Marietta, GA, is a research-based pharmaceutical company active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. Related Links: Unimed Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc.
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