Brand Name Drug: Vanlev
Active Ingredient Drug: omapatrilat
Indication: Treatment of hypertension
Company Name: Bristol-Myers Squibb Company
Introduction
The most clinically advanced member of a new class of antihypertensive drugs continues to prove itself highly effective. 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, which filed an NDA for the drug in December 1999.
Studies have shown that Vanlev offers promise for reducing systolic blood pressure (SBP). Although physicians have traditionally focused on reducing the diastolic blood pressure (DBP) of hypertensive patients, mounting evidence suggests that SBP may be even more important than DBP in predicting future cardiovascular disease. In fact, the US National Heart, Lung, and Blood Institute is placing increased emphasis on diagnosing and controlling elevated SBP, particularly in middle-aged and older adults.
How It Works
Vanlev (omapatrilat) belongs to the new family of antihypertensive drugs known as vasopeptidase inhibitors (VPIs). It is a single molecule that simultaneously inhibits two key enzymes that regulate blood pressure: neutral endopeptidase (NEP) and angiotensin-converting enzyme. By inhibiting NEP, Vanlev increases levels of atrial natriuretic peptide, a vasoactive peptide that helps lower blood pressure. As a result, Vanlev reduces vasoconstriction and promotes vasodilation by enhancing the body’s own natural vasodilator peptides.
Vanlev (omapatrilat): Clinical Study Results
At the ASH meeting, several researchers presented data from studies in animals and patients attesting to the efficacy 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 SBP and DBP than 20 mg/day of lisinopril in 57 patients with salt-sensitive hypertension. The patients received the drugs over a 4-week period. The average reduction in SBP was 15.4 mmHg for Vanlev vs. 7.2 mmHg for lisinopril, while the corresponding decreases for DBP were 9.3 mmHg and 5.1 mmHg, respectively. 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.
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 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: After 10 weeks, reductions in ambulatory SBP, DBP, and mean BP were 5.9, 4.4, and 4.9 mmHg lower, respectively, for patients taking Vanlev than for those who received amlodipine.
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.
The largest trial ever conducted on Vanlev (omapatrilat) is about to begin. Called OPERA (Omapatrilat in Persons with Enhanced Risk of Atherosclerotic Events), it will assess the benefit of treating patients with stage I 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 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.
Jennifer is a clinical pharmacologist. She helps doctors of all medical specialties choose medications. Jennifer consults about drug dosage, interactions, and side effects.