presented data over the weekend at the American Heart Association meeting that could widen the use of its cholesterol drug Crestor as a preventive treatment.
The study, dubbed JUPITER, looked at 17,802 patients with low-to-normal cholesterol levels but with elevated hs-CRP (high-sensitivity C-reactive protein), a relatively new test that predicts a person's risk of heart attack and stroke. In the study, the risk of major cardiovascular events was reduced by 44% in the study arm taking Crestor, compared to the placebo group.
AstraZeneca shares were rising 2.5% to $43.71 in recent trading.
The JUPITER study was proposed to evaluate patients through four years of follow-up, but a data and safety monitoring board saw significant and strong enough benefit to conclude the study after 1.9 years of follow-up.
The risk of heart attack was cut by 54% in the patients taking Crestor, while the combined risk of heart attack, stroke or cardiovascular death was nearly halved. Deaths were reduced by 20% in the Crestor arm of JUPITER.
"As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients," said Howard Hutchinson, chief medical officer for AstraZeneca in a release.
AstraZeneca garnered $921 million in revenue from Crestor, its top-selling cardiovascular drug, in the third quarter.
There has been considerable pressure to get more extensive information on how cholesterol drugs affect not just cholesterol, but ultimately patients' risk of outcomes like heart attack and stroke.
Vytorin, a combination of a traditional statin and cholesterol-lowering drug Zetia, lost substantial market share after a study showed it lowered "bad" cholesterol, but didn't result in a statistically significant reduction of plaque buildup in the arteries or major cardiovascular events.
"JUPITER provides yet more evidence about the effectiveness of statin therapy in reducing cardiovascular risk, even among persons who would not currently be considered for pharmacotherapy," wrote Mark Hlatky, M.D., in an editorial in the
New England Journal of Medicine
titled, "Expanding the Orbit of Primary Prevention -- Moving beyond Jupiter."
Hlatky, however, notes possible concerns: An increase in blood sugar and statistically significant increase incidence of diabetes in patients taking Crestor (3% vs. 2.4%). The author also seeks longer-term data on the effects of reducing LDL ("bad") cholesterol to levels reached in the study. Finally, he says, the drug costs roughly $3.45 a day, much more than that of generic statins.
"Guidelines for primary prevention will surely be reassessed on the basis of the JUPITER results, but the appropriate size of the orbit of statin therapy depends on the balance between the benefits of the treatment and its long-term safety and cost," he wrote.