US FDA approves a new indication for ROSUVASTATIN CALCIUM in prevention of heart attacks and ailments based on clinical study results
Dubai, United Arab Emirates, 25th February, 2010: Local medical experts have called for focusing on the prevention rather than treatment of heart disease, which has attained alarming proportions in the UAE and become the No. 1 killer Data. According to the Abu Dhabi Health Authority (HAAD) the cardiovascular diseases contributed to 24% of all deaths in the emirate in 2008 .
Experts say more intensive heart-related campaigns are needed to raise awareness and adopt preventive steps, including medication, as nearly 40 per cent of the residents are believed to be unaware of their heart ailments.
The call comes at a time when the US FDA has recently granted approval to for a new indication for ROSUVASTATIN. NB: ROSUVASTATIN CALCIUM is the chemical name of the drug. ROSUVASTATIN is a lipid lowering drug that belongs to a class known as statins that reduce cholesterol in blood. The new indication for ROSUVASTATIN is to reduce risk of stroke, heart attack and revascularization procedures in individuals without evident heart disease but with increased risk of cardiovascular disease based on certain indicators. Previously such patients were not eligible for such treatment.
Dr. Abdullah Shehab, Director of CME, Emirates Society of Cardiology said that just around 10 percent of UAE resident are aware of heart issues and follow a healthy lifestyle. About 50 percent are aware of their heart condition but fail to make any lifestyle changes, while 40 percent are ignorant of their condition and therefore don’t not take any remedial measures.
Dr. Shehab was speaking at a press conference to announce that the US Food and Drug Administration (FDA) had approved ROSUVASTATIN from AstraZeneca, which reduces the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease, but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.
Dr. Shehab said that while UAE has seen an improvement in diagnosis, evaluation, treatment and the medical management of cardiovascular disease, still more heart-related campaigns are needed.
”With the approval of this new indication for ROSUVASTATIN, a new phase of cardiologic prevention has begun. “Usually, we treat patients after we discover they have a cardiological disease, but this medicine can tackle the early signs of the diseases,” he added.
In the UAE, the cardiovascular diseases are the number one cause of death and the numbers are rising. By 2015, almost 20m people in the world will die from cardiovascular ailments, mainly from heart disease and stroke.
The FDA approval was based on the findings of a landmark JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study which evaluated the impact of ROSUVASTATIN 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population. In JUPITER, ROSUVASTATIN significantly reduced the relative risk of heart attack by 54% (p<0.001), stroke by 48% (p=0.002), and arterial revascularization by 46% (p<0.001) vs placebo.
“Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from a new phase of therapy under this approved indication,” said Dr Fadel Shaker, Medical Manager AstraZeneca Gulf. “This new indication adds to the significant body of evidence physicians use to evaluate ROSUVASTATIN as a treatment option.”
Dr. Azan Binbrek of Cardiology Department, Rashid Hospital in Dubai said: “We should play an active role in the community by promoting health awareness about diseases and their prevention, such as cardiovascular diseases. We primarily ask our patients to lose weight, do regular exercise and stop smoking. UAE still has a long way to go in the prevention of cardiovascular diseases because this is multi disciplinary where it is the joint responsibility of the government and media and schools have a role to play in planting healthy lifestyle for the kids and keep junk food out of their reach and train them to have exercise as part of their daily lives.”
Speaking about the highest factors for cardiovascular diseases, Dr Binbrek said that the UAE is the second in the world in diabetes where around 25 per cent of people in the UAE are diabetic, 25 per cent have high blood pressure and 20-25 percent have high cholesterol not to mention smoking that is dramatically and worryingly increasing amongst teenagers in the age of 15 to 18, figures that were not so high in the past years.
The major cardiovascular diseases include coronary heart disease (heart attacks), cerebrovascular disease (strokes), hypertension, heart failure and rheumatic heart disease.
Dr. Binbrek added: “The UAE has a very high rate of heart attacks, strokes and heart failure due to the huge lifestyle changes, and we must try to prevent these diseases.”
Dr. Binbrek concluded: “I was the principle investigator for an international study including the Middle East, East Europe and South America about cardiovascular diseases and we found that in milligram to milligram, ROSUVASTATIN is the most powerful statin that we have.”
Dr. Shehab pointed out that some doctors themselves had a bad lifestyle, with many of them being obese, heavy smokers, junk food consumers and avoiding exercise. Dr. Shehab said the UAE is at high risk for more cardiovascular diseases because risks factors like diabetes, smoking, hypertension, lack of exercise and high cholesterol are highly prevalent.