Washington, February 9 -- AstraZeneca (LSE: AZN) has got the green signal by federal regulators to market its anti-cholesterol pill Crestor.
The pill is used as a precautionary measure against heart attack and stroke in patients with healthy cholesterol levels but increased risk of cardiovascular disease.
Dr Howard Hutchinson, chief medical officer, AstraZeneca stated, “Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication.
This new indication adds to the body of evidence physicians use to evaluate Crestor as a treatment option.”
Efficacy of Crestor assessed
The consent by the Food and Drug Administration (FDA) was granted on the basis of trail by JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin).
The study assessed the efficacy of 20 mg of Crestor in lowering cardiovascular events (cardiovascular death, nonfatal heart attack, nonfatal stroke, hospitalization for unstable angina, and arterial revascularization).
The study assessed the impact of the drug in a randomized, placebo-controlled trial of nearly 18,000 people with an average age of 66 and no history of atherosclerosis.
All the patients had elevated levels of C-reactive protein, which is known for inflammation that can lead to clogged arteries, causing heart attack or stroke.
Findings of the trial
The results of the clinical trial were positive. The researchers noted that Crestor lowered the risk of major heart problems or stroke in elderly patients.
It reduced major cardiovascular events by 44 percent, heart attack by 54 percent, and stroke by 48 percent compared to a placebo.
However, the investigators are unclear whether the positive results are attributed to lower cholesterol levels or C-reactive protein, since Crestor reduces both.
As an outcome of the trial, Crestor is approved for men 50 and older, and women 60 and older who have elevated C-reactive protein. Additionally, use of the drug is recommended in patients with at least one risk factor for heart trouble, such as high blood pressure or a smoking habit.
A little about Crestor
Crestor is a member of the drug class of statins and is used for the treatment of high cholesterol or dyslipidemia.
Available in tablet form (5, 10, 20, or 40 mg) for oral administration, Crestor is known to reduce LDL cholesterol, total cholesterol and triglycerides, and raise HDL cholesterol or good cholesterol.
Shionogi Co. developed the product and the pharmaceutical company AstraZeneca markets it. The drug has now received regulatory approval in over 95 countries.