MANILA, Philippines - Patients with progressive hardening and narrowing of the arteries called atherosclerosis, are in constant fear of heart attacks, strokes and other cardiovascular (CV) complications hanging over their heads like the sword of Damocles.
It was therefore welcome news for doctors and heart patients when the Philippine Food and Drug Administration (Phil FDA) recently approved a new indication for AstraZeneca’s rosuvastatin for the prevention of cardiovascular complications like stroke, heart attack and CV death. Rosuvastatin is already approved for the treatment of cholesterol problems or dyslipidemia, and prevention of atherosclerosis in adults.
This FDA approval and its clinical implications were discussed thoroughly by two of the country’s top cardiologists, Dr. Romeo Divinagracia and Dr. Anastacio Aquino, who are both past presidents of the Philippine Heart Association-Philippine College of Cardiology.
“Given the current burden of CVD (cardiovascular disease) here in the country, this new indication of rosuvastatin will benefit those at-risk patients from having a CV event for the first time,” said Divinagracia.
Recent statistics have shown that CVD remains the number one killer in the country and in many parts of the world. The trend is also alarming.
“Statistics from the Department of Health (DOH) said cases of CVD in the country are rising, so we have to be wary about it,” warned Divinagracia.
Aside from the DOH data, the World Health Organization also released reports that by 2030, almost 23.6 million people will die from CVD, mainly from heart disease and stroke.
The reports said these are projected to remain the single leading cause of death, adding that the largest increase in the number of deaths will occur in Southeast Asia.
The problem with CV events (like heart attack, stroke or sudden death) is they don’t have warning signs at all, said Aquino.
“The terrible thing about atherosclerosis is when it manifests, it’s already too late,” said Aquino.
He explained that when there are already manifestations of atherosclerosis, it means the coronary arteries are already obstructed by at least 75 percent, with only 25 percent remaining patent.
“When the patient is the breadwinner of the family, you will see the impact on the family,” said Aquino. “So here we’re emphasizing the importance of preventing that first event because if it happens already (the stroke or heart attack), the risk of having another one is much greater, and the treatment needed would have to be more aggressive.”
Based on a recent survey conducted by the National Nutrition and Health Survey, a lot of Filipinos are at risk of having atherosclerosis because they have significant risk factors: 50 percent have low levels of HDL-C or good cholesterol; 34 percent are smokers; and 17.4 percent have hypertension.
With the new approved indication for rosuvastatin, many CV events can be prevented from occurring since the drug can now be prescribed to patients with an increased risk of atherosclerotic cardiovascular disease based on identified CVD risk markers.
Risk markers include: age; hypertension; low levels of high-density lipoprotein cholesterol (HDL-C) also known as good cholesterol and high levels of low density lipoprotein cholesterol (LDL-C) or bad cholesterol; smoking; elevated levels of high-sensitivity C-reactive protein (hsCRP); or a family history of premature coronary heart disease.
With regular use of rosuvastatin, major CV events including cardiovascular death, stroke, myocardial infarction, unstable angina or arterial revascularization could be prevented in many patients.
The new FDA indication was based on the findings of JUPITER — Justification for the Use of statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial.
In this landmark study, rosuvastatin 20 mg, given to almost 9,000 patients, significantly reduced the occurrence of heart-related complications by 44 percent compared to placebo.
This is one of the greatest risk reductions ever seen in a large placebo-controlled statin (cholesterol-lowering drug) trial.
Almost 18,000 patients, who were at risk of cardiovascular diseases, were given either rosuvastatin or placebo. Majority of the patients had at least one of the risk factors.
For children aged 10 to 17 with familial hypercholesterolemia, efficacy and safety of rosuvastattin was supported by the PLUTO study wherein the drug at 5, 10 and 20 mgs, significantly reduced LDL-C levels.
Given for 52 weeks, rosuvastatin was well tolerated by the patients included in the study.
The JUPITER and PLUTO studies, which supported the new indications for rosuvastatin, are part of the GALAXY program, a global research initiative composed of different studies to support the efficacy and tolerability of rosuvastatin.
The program continues to expand, breaking new frontiers on the benefits of rosuvastatin. It is a testament to AstraZeneca’s research and development thrust toward making quality and safe medications.
As Dr. Chinnie Tan, medical director of AstraZeneca, emphasized: “The mission of AstraZeneca is to make meaningful difference to patients’ health through great medicines.”