Vanlev Drug for Hypertension
Brand Name: Vanlev
Active Ingredient: omapatrilat
Indication: Treatment of hypertension
Company Name: Bristol-Myers Squibb Company
Introduction
The most clinically advanced member of a new class of drugs for lowering blood pressure continues to prove itself highly effective in people with hypertension. Investigators who have conducted several different studies of the drug Vanlev (omapatrilat) presented their most recent findings at the Fifteenth Scientific Meeting of the American Society of Hypertension (ASH) in New York City.
Vanlev (omapatrilat) is manufactured by the Bristol-Myers Squibb Company.
Studies have shown that Vanlev offers promise for reducing systolic blood pressure (the top number in a blood pressure reading, indicating blood pressure when the heart is contracting). Physicians have traditionally focused on reducing the diastolic blood pressure of hypertensive patients (the lower number in a blood pressure reading, representing blood pressure when the heart is relaxed). But mounting evidence suggests that systolic blood pressure may be even more important than diastolic blood pressure in predicting future cardiovascular disease. In fact, the US National Heart, Lung, and Blood Institute is placing increased emphasis on diagnosing and controlling elevated systolic blood pressure, particularly in middle-aged and older adults.
How Does It Work?
Vanlev (omapatrilat) belongs to the new family of antihypertensive drugs known as “vasopeptidase inhibitors.” It is a single molecule that simultaneously inhibits two key enzymes that regulate blood pressure: neutral endopeptidase and angiotensin-converting enzyme. As a result, Vanlev reduces the constriction of blood vessels and promotes their dilation (opening).
Vanlev (omapatrilat): Clinical Study Results
At the ASH meeting, several researchers presented data from studies in animals and patients attesting to the effectiveness of Vanlev. Dr. Vito M. Campese and his colleagues from the University of Southern California School of Medicine reported that 40 mg/day of Vanlev was more effective for reducing both systolic and diastolic blood pressure than 20 mg/day of the drug lisinopril in 57 patients with salt-sensitive hypertension. “Hypertensive patients differ in how well they respond to various types of blood pressure-lowering medication, and salt-sensitivity is an important variable,” said Dr. Campese. The patients received the drugs over a 4-week period. A similar study by investigators at L’Institut Cardiovasculaire in Paris, France reported a greater benefit for 80 mg/day of Vanlev compared to 40 mg/day of lisinopril in 347 patients treated for 10 weeks.
Dr. Joseph L. Izzo, Jr., and his fellow investigators at the State University of New York at Buffalo presented data on 348 elderly patients with mild to moderate hypertension who received 10-40 mg/day of Vanlev or a placebo over a 13-week period. Diastolic and systolic blood pressure reductions were significantly greater in the patients who received Vanlev than the placebo group, with the greatest reductions in blood pressure observed in patients who received the 40 mg dose.
Doctors at the Universidad Complutense and Unidad de Hipertension in Madrid, Spain, led by Dr. Luis Miguel Ruilope, reported the results of a trial comparing Vanlev (up to 80 mg/day) with the antihypertensive drug amlodipine (up to 10 mg/day) in 430 patients with mild to moderate hypertension who were treated for 10 weeks. Blood pressure reductions were significantly greater in the Vanlev group than the amlodipine group.
“Despite the variety of antihypertensive agents currently available, many people with hypertension are still unable to reduce their blood pressure to the recommended treatment goal [of 140/90],” said Dr. Ruilope. “These data show that omapatrilat holds promise in providing physicians and patients with a significant new advance in fighting this disease.”
The largest trial ever conducted on Vanlev is about to begin. Called OPERA (Omapatrilat in Persons with Enhanced Risk of Atherosclerotic Events), it will assess the benefit of treating patients with early systolic hypertension. The trial will involve 12,600 patients at 900 sites around the world to assess the long-term benefits of Vanlev, including its effects on cardiovascular disease and death, stroke, heart attack, and heart failure.
Adverse Events
In all trials, Vanlev (omapatrilat) was associated with few adverse side effects, and those that were observed were mild. The most common side effects were dizziness, upper respiratory tract infection, and cough.
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