ALABANG, MUNTINLUPA – A local post-marketing surveillance (PMS) study has re-affirmed the efficacy and safety of the anti-hypertension medication, Nebivolol.
“Ninety-seven percent of patients taking Nebivolol achieved consistent and sustained reduction in blood pressure, with only 3% of patients reporting mild to moderate side effects. The results of the second interim analysis of the PMS study demonstrate the efficacy and safety of Nebivolol in the real-world setting,” said Dr. Fatima Collado, Principal Investigator of the Nebivolol PMS study.
Dr. Collado presented the results during a scientific meeting organized by A. Menarini Philippines on April 25, 2016 at the Crimson Hotel in Alabang. The event was attended by local internists, cardiologists, and other medical specialists.
A respected cardiologist and vascular medicine specialist, Dr. Collado is the Head of the Dr. Homobono Calleja Heart and Vascular Institute at St. Luke’s Medical Center-Quezon City. She is the founding President of the Philippine Society of Vascular Medicine and former Chair of the Council for Stroke and Peripheral Vascular Disease.
Nebivolol belongs to a class of anti-hypertension drugs called beta blockers, which lowers blood pressure by blocking the effects of the hormone epinephrine, also known as adrenaline. Beta blockers make the heart beat slower and with less force, thereby reducing blood pressure. Beta blockers are among the medications recommended by the majority of current treatment guidelines for the management of hypertension. One unique feature of Nebivolol, compared to other beta blockers, is its ability to stimulate nitric oxide production that induces vasodilation therefore contributing to a decreased blood pressure, which is among its other clinical benefits.
“On top of its proven efficacy in lowering blood pressure, thus preventing cardiovascular events in patients who have suffered a recent heart attack, Nebivolol also has a better tolerability profile (fewer, milder side effects) compared to older beta blockers,” Dr. Collado said.
The Nebivolol PMS study started in March 14 and has involved 1,154 patients with hypertension who were prescribed and took Nebivolol in actual, real-world clinical practice. Its primary objective was to evaluate the safety of Nebivolol by assessing the incidence of adverse events (side effects) at two follow-up visits (Day 14 and Day 48 after the initial visit). Its secondary objective was to assess the overall efficacy of Nebivolol in lowering blood pressure.
Demographic data showed that the mean average age of the patients was 52, with the youngest reported age of 18 and the oldest being 93. There were slightly more females than males in the study population, with 618 females compared to 518 males. It was noted that 71.23% of the patients were taking maintenance medications for conditions other than hypertension; 32.15% were smokers. In addition, 50% of the patients had hyperlipidemia (high cholesterol), 20% had diabetes, and 3% had atrial fibrillation (irregular and often rapid heart rate that can increase the risk of stroke, heart failure and other heart-related complications). The most common side effects reported were headache (8 patients), dry mouth (3 patients), and difficulty of breathing (3 patients), all of which were expected adverse events based on clinical trials.
The PMS study is an important tool to monitor the safety of a pharmaceutical drug after it has been released into the market. Drugs are approved on the basis of clinical trials involving a relatively small number of people who have been selected for this purpose, i.e. they normally do not have other medical conditions that may exist in the general population. The value of post-marketing surveillance lies in the fact that it can further refine the safety profile of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
“A. Menarini is committed to providing Filipino patients with safe, effective and affordable medicines. This post-marketing surveillance study is important because it further refines the proven safety and efficacy of Nebivolol when administered to real-world patients,” said Dr. Digna Almeida, Medical Director, A. Menarini Philippines.
– Medical Observer