Latest clinical trial data shows statin has benefit against plaques that cause heart attacks.
ROSUVASTATIN, a statin, has received approval in Malaysia as an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total cholesterol and LDL-C to target levels.
Atherosclerosis is a disease resulting from excessive plaque formation in arteries, and is the leading cause of heart attacks and strokes. Statins are a class of drugs used to help patients manage their cholesterol levels and lower the risk of heart attacks and strokes.
Based on results of the breakthrough METEOR clinical trial in 2007, rosuvastatin showed that it slowed progression of plaque build-up in arteries in people showing early signs of the disease and who are at low risk.
The approval of this additional indication for rosuvastatin in Malaysia follows the US Food and Drug Administration approval of rosuvastatin, in November last year, as a treatment to slow the progression of atherosclerosis in patients with elevated cholesterol, making rosuvastatin the only statin with this indication in the US.
Director of the Heart Foundation of Malaysia, Datuk Dr Khoo Kah Lin, said of this significant development: “Atherosclerosis is the leading cause of cardiovascular disease. This approval of rosuvastatin to treat atherosclerosis in heart patients is very good news for doctors and patients alike.
“Many clinical trials with rosuvastatin have shown it to be more efficient in lowering bad cholesterol than other statins.
Furthermore, rosuvastatin also increases the level of good cholesterol, low levels of which are associated with a higher cardiovascular risk.
“This influences the way in which we as doctors diagnose and treat patients with dangerous levels of cholesterol,” said Dr Khoo.
In an earlier clinical trial, ASTEROID (2006), rosuvastatin was the first statin to show regression of atherosclerosis in patients with advance disease using intravascular sound (IVUS) imaging. This technique places a small probe in the coronary artery to obtain images that can be analysed to determine the amount of plaque in arteries.
“The results from ASTEROID in 2006 were significant because it showed that rosuvastatin was the only statin to achieve regression of atherosclerosis in a major clinical trial using IVUS.
Prior IVUS trials have demonstrated only slowing or halting the disease, but not convincing evidence of regression of atherosclerosis. This means that patients who already have the disease now have clinically proven treatment that can really help their condition,” Dr Khoo explained.
Further breakthrough evidence from ASTEROID was presented at a major cardiology conference in March 2008. In addition to the 2006 data based on IVUS, data determined by quantitative coronary angiography (QCA) showed for the first time that a statin monotherapy has achieved regression of atherosclerosis using coronary angiographic data in a major clinical trial.
Dr Khoo explained: “Important data from these two imaging techniques measured different parameters and were focused on different segments of the coronary arteries. Both demonstrate similar improvements and are consistent with regression of atherosclerosis by rosuvastatin, confirming that patients with established disease have a very good chance to achieve regression of atherosclerosis, which is the underlying cause of heart disease.”
Dr Khoo added that achieving cholesterol goals remain a challenge for many doctors and patients, but with the right treatment regimen and compliance, it was possible.
“There is a volume of clinical evidence to show that statins are the gold standard in cholesterol management to reduce heart disease. Beyond that, METEOR, supported by ASTEROID, demonstrates that rosuvastatin has a significant impact on atherosclerosis across the spectrum of the disease – in both the early and established stages.
“Not only is achieving cholesterol goals important, but also how you achieve them. The new QCA data shows for the first time that a statin monotherapy has achieved regression of atherosclerosis, which means that doctors and patients now have irrevocable evidence that shows rosuvastatin offers the best option for patients at risk of heart disease,” Dato’ Dr Khoo emphasised.
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