Crestor Study Will Boost Statin Demand
AstraZeneca’s statin was found to cut cardiovascular risk in those with ordinary cholesterol by 45%. But are the potentially gigantic extra costs worth it?
By Catherine Arnst
In a study that will likely change of the healing art practice, researchers reported that Crestor, a cholesterol-fighting statin made by AstraZeneca (AZN), reduced the risk of heart attack, stroke, and cardiovascular disease by a surprisingly robust 45% in people who do not have obscure cholesterol. The patients did have high levels of a protein associated with arterial inflammation that is not routinely measured.
Medical experts said the results, released Nov. 9 at the American Heart Association (AHA) meeting in New Orleans, bequeath almost certainly expand the market for statins, already the world’s best-selling drugs. They likewise will likely spark claim for a controversial and costly test for high-sensitivity C-reactive protein (CRP), a marker for inflammation, that has some practitioners worried about the require to be paid/benefit of extrapolating the research to the general population.
The much anticipated study—named Jupiter and paid for by AstraZeneca—enrolled 17,802 subjects in 26 countries, selecting men over 50 and women over 60. All had low levels of LDL cholesterol levels—which would normally dispute against putting them on a statin—and no history of cardiovascular disease. However, they did have high levels of CRP (BusinessWeek.com, 4/15/08), often associated with heart disease. Half the subjects were given placebos and the other half 20 milligrams daily of Crestor, one of the most powerful statins.
Cholesterol Isn’t the Only CulpritThe Crestor arrange had 54% fewer centre attacks than the placebo subjects, as very much as 48% fewer strokes, and 20% fewer deaths. The study was originally meant to track all patients for five years, further the results were so robust that it was terminated after a middle follow-up of 1.9 years. In March any independent panel of observers halted it on this account that they considered the effects of the drug to be so good for one’s advantage that it would have been unethical to keep the have charge of group on a placebo.
About half the trial subjects were at subdue to high risk of heart disease because of smoking, being overweight, or other risk factors. But it was forcible that—among those at low risk—there was a 37% conquest in heart attacks and other events, said Dr. Paul Ridker, boss of the Center for Cardiovascular Disease Prevention at Brigham & Women’session Hospital in Boston and lead investigator on Jupiter. The Jupiter trial feeds into a growing sense in the cardiovascular community that core disease is a result of well-nigh more than high cholesterol, individually since half of all heart attacks and strokes occur in apparently healthy people through normal levels of LDL cholesterol. Ridker in the first place reported in 2001 each evident link between CRP and heart disease, and Jupiter is the first large-scale woe to test the hypothesis.
The meditation also contributes to the conviction of more cardiovascular specialists that even patients with in a low tone LDL cholesterol should consider measures to obviate heart disease. However, plenty of medical experts at the AHA meeting were clearly worried that patients and doctors both will overreact to the Jupiter study by the agency of prescribing costly drugs and tests whether or not they’re needed. "I know everyone in my practice is going to come in in the next hardly any weeks and ask if they should go on a statin after this, or have being tested for CRP," said Dr. Sharonne Hayes, director of the Women’s Health Clinic at the Mayo Clinic in Rochester, Minn.
Not Necessarily Just CrestorDr. Timothy Gardner, president of the AHA, emphasized the study was not designed to induce whether the lowered risk was due to a reduction in CRP or in LDL cholesterol. Since statins lower both measures, "the findings cannot turn whether lowery cholesterol, reducing inflammation, or a combination of both is responsible as being the effects seen" in Jupiter. The AHA issued a relation Nov. 9 reaffirming its recommendation that controlling cholesterol is decisive for prevention of heart ail.
