Should Crestor & Statins Become Mass Market?
AstraZeneca plc (NYSE: AZN) is seeing a possible serious win this morning on good news from its Crestor presentation showing that it cuts heart attack and stroke risks even in healthy adults.
The company showed sata from its JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvast) demonstrated that CRESTOR® 20 mg significantly reduced major cardiovascular (CV) events by a dramatic 44% compared to placebo among men and women with elevated hsCRP but low to normal cholesterol levels. CV events were defined in the study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes.
Some other results were huge as well. The combined risk of heart attack, stroke or CV death was reduced by nearly half (47%), risk of heart attack was cut by more than half (54%), risk of stroke was cut by nearly half (48%), and total mortality was significantly reduced by 20%. These results were accompanied by a median LDL-C reduction of 50% resulting in an on-treatment median LDL-C of 55 mg/dL.
This data is being presented at American Heart Association Scientific Sessions and were also published online by the New England Journal of Medicine.
“The JUPITER trial confirmed that CRESTOR 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,” according to Howard Hutchinson, Chief Medical Officer for AstraZeneca.
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.
Jon C. Ogg
November 10, 2008