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| |  Aceon Tablets Available In U.S. For 24-Hour Control of Hypertension MARIETTA, GA. -- October 7, 1999 -- Aceon® Tablets, a once-daily medication for the treatment of essential hypertension, is now available in the United States, Solvay Pharmaceuticals, Inc., announced today. An important addition to the antihypertensive armamentarium in the United States, perindopril already is a leading antihypertensive therapy in Europe. It was first marketed in France ten years ago as Coversyl®, and will be launched in the United States as Aceon Tablets. Based on extensive clinical experience, Aceon Tablets has been shown to be effective and well-tolerated. In clinical studies in more than 3,400 hypertensive patients, perindopril was proven to provide continuous 24-hour blood pressure control throughout the entire dosing interval with a single daily dose. In a pivotal clinical study, perindopril demonstrated approximately equivalent blood pressure reduction at six and 24 hours after administration. According to the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-VI), therapies that provide continuous 24-hour efficacy with a single daily dose are the optimal treatment choice. Twenty-four hour coverage offers protection against sudden increases of blood pressure after waking from overnight sleep. "We all experience normal increases and decreases in blood pressure throughout the day," says Michael Weber, MD, chairman, department of medicine, The Brookdale University Hospital and Medical Center, and investigator for perindopril. "For example, when we wake from sleep each morning, most people experience a sudden rise in blood pressure. For the hypertensive patient, this could be a concern if their medication doesn’t provide full 24-hour coverage. "Now with perindopril (Aceon Tablets), we have another well-tolerated treatment option that provides the continuous 24-hour blood pressure effect needed to protect patients during those early morning hours," continues Dr. Weber.
Hypertension in the United States As many as 50 million Americans have hypertension, according to the American Heart Association. Blood pressure is the result of two forces. One is created by the heart as it pushes blood into the arteries and through the circulatory system; the other is the force of the arteries as they resist blood flow. Elevated blood pressure indicates that the heart is working harder than normal, putting it and the arteries under a greater strain. Healthy arteries have an elastic quality that allows them to expand and contract in response to the pressure of the blood as it is pushed from the heart through the arteries. The risk of hypertension increases as elasticity decreases due to age and other risk factors. Aceon Tablets is the first antihypertensive therapy in its class with product labeling describing an increase in compliance (elasticity) of large arteries in patients, consistent with the results of animal studies. This suggests a direct effect on the arterial smooth (elastic) muscle, which plays a major role in regulating blood pressure. This is a new and evolving area of research that is attracting a great deal of interest from researchers and clinicians. "Even with the many effective antihypertensive therapies available in the U.S., we have not reduced the incidence of cardiovascular disease as much as we should have," explains Joel Neutel, M.D., chief of the division of clinical pharmacology and hypertension at the Veterans Affairs Medical Center, Long Beach, CA. "Since no two patients with high blood pressure are alike, the more safe and efficacious therapies that we have to treat this disease, the more effective we can be in controlling hypertension in the individual patient." Aceon® Tablets is a member of the class of drugs called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors act to reduce blood pressure by interfering with the conversion of angiotensin I to the artery-constricting angiotension II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure. As a therapeutic category, ACE inhibitors account for 37.5 percent of the total antihypertension prescriptions in the U.S.
Marketing and Availability Recognizing the U.S. potential for such a widely used and established antihypertensive, Solvay Pharmaceuticals has now licensed Aceon Tablets and will market it nationwide. The introduction of Aceon Tablets marks Solvay Pharmaceuticals’ entry into the U.S. cardiovascular market. Perindopril was approved by the U.S. Food and Drug Administration in December 1993, and is currently available in 113 countries. "We are pleased to enter the U.S. cardiovascular market with such a promising hypertension therapy that has been used so successfully in other countries," said David A. Dodd, President and CEO of Solvay Pharmaceuticals, Inc. "This new antihypertensive therapy is the first of several cardiovascular products that Solvay Pharmaceuticals will bring to the U.S. market."
Dosage and Administration In patients with essential hypertension including the elderly, the recommended initial dose of Aceon Tablets is 4 mg once a day. The usual maintenance dose range is 4 to 8 mg, administered as a single daily dose. In hypertensive patients with minimally impaired kidney function, the initial dose should be 2mg per day and increased up to 8 mg per day until blood pressure control is achieved. Aceon Tablets may also be administered in two divided doses. In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitors may cause excessive hypotension, and may be associated with ologuria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease, such an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident.
Common Side Effects and Other Important Information When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected Aceon Tablets should be discontinued as soon as possible. See the package insert for WARNINGS: Fetal/Neonatal Morbidity and Mortality. Aceon Tablets is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitor, as well as those with a history of angioedema related to previous treatment with an ACE inhibitor. In clinical trials, cough was the most frequent adverse event possibly or probably related to treatment occurring in 6 percent of patients treated with Aceon Tablets compared to 1.8 percent in patients receiving placebo. Other commonly reported side effects included: proteinuria, palpitation, sinusitis, viral infections, dyspepsia, fever, upper extremity pain, and hypertonia. Like other ACE inhibitors, Aceon Tablets can cause symptomatic hypotension. Aceon Tablets has been associated with hypotension in 0.3 percent of uncomplicated hypertensive patients in the U.S. placebo-controlled trials. Symptomatic hypotension associated with the use of ACE inhibitors is more likely to occur in patients who have been volume and/or salt-depleted, therefore, these conditions should be corrected before initiating therapy with Aceon Tablets. Adjusted doses of Aceon Tablets may be used safely in hypertensive patients with minimal renal impairment, type 1 diabetes mellitus, and congestive heart failure. In controlled trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Also, black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to nonblacks. Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment, especially patients with a collagen vascular disease such as lupus erythematosus or scleroderma. Available data are insufficient to show whether Aceon® Tablets cause agranulocytosis at similar rates.
Related Link: Solvay Pharmaceuticals, Inc.
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