Local medical experts have called for more health research at the regional level to make new drugs more effective for local patients. The call comes at a time when a new international study has shown that a new drug has proven to significantly reduce major cardiovascular (CV) events.
Dr. Abdullah Shehab, Director of CME, Emirates Society of Cardiology said consistent and ongoing research in cardiology was essential, so that it takes into consideration the peculiar traits and habits of the local population.
"International research is important, but we need to know better our people's statuses. Private and public sectors should join forces to conduct more research. Clinical research related to specific cases is completely absent in the GCC. Heart-related ailments are too common in the region, and the commonality of diabetes and obesity are other influential factors. The new study is significant because it is backed by evidence that ROSUVASTATIN is a safe and effective medicine for normal populations."
Dr. Afzalhussein Yusufali, Consultant Cardiologist, Dubai Hospital, Dubai Healthcare Authority, said: ""This is a landmark study and will almost change the way we practice medicine in the future. It allows us to help people who might have been missed out because their cholesterol levels were thought to be normal with a powerful cholesterol lowering drug. This brings their cholesterol levels to be even lower and prevents heart attacks and death significantly. The UAE has a very high rate of heart attacks, strokes and heart failure due to the huge lifestyle changes, and we must try and prevent these diseases. Research has started in this part of the world, but still is in early stages. We adopt latest systems, but we have a long way to go in terms of research that will directly impact the society."
The comments came during the release of new data from the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study that has demonstrated that ROSUVASTATIN 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.
The results, released by AstraZeneca also showed that for patients in the trial taking rosuvastatin:
• the combined risk of heart attack, stroke or CV death was reduced by nearly half (47%, p<0.001).
• risk of heart attack was cut by more than half (54%, p<0.001).
• risk of stroke was cut by nearly half (48%, p=0.002).
• total mortality was significantly reduced by 20% (p=0.02).
These results were accompanied by a median LDL-C reduction of 50% (p<0.001) resulting in an on-treatment median LDL-C of 55 mg/dL. On the basis of the data, if the results are projected over a period of 5 years, 25 patients would need to be treated to prevent one major cardiovascular event (NNT=25).
"These results provide new information about ROSUVASTATIN’s effects on CV risk. The JUPITER trial confirmed that ROSUVASTATIN dramatically reduces LDL-C cholesterol levels and has now demonstrated a nearly 50% reduction in the risk of heart attack and stroke in a population of patients who had elevated hsCRP but low to normal cholesterol levels,” said Dr. Khalid Shirazy, Medical & Regulatory Manager, AstraZeneca Gulf. "As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients."
As previously guided, AstraZeneca expects to file a regulatory submission including the JUPITER data in the first half of 2009 and if approved, will begin promotional activities within the approved labeling.
Rosuvastatin is not indicated for the prevention of cardiovascular events. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual recommended starting dose of rosuvastatin is 10 mg.
Rosuvastatin 20 mg was well tolerated in nearly 9,000 patients during the course of the study. There was no difference between treatment groups for major adverse events, including cancer or myopathy. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials.
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated high-sensitivity C-reactive protein (hsCRP) and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca’s extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
Studies have previously shown that ROSUVASTATIN was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.
ROSUVASTATIN has now received regulatory approval in over 95 countries. Nearly 15 million patients have been prescribed ROSUVASTATIN worldwide. Data from clinical trials and real world use shows that the safety profile for ROSUVASTATIN is in line with other marketed statins.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
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