Monday, March 30, 2009
Statins, polypills, and more from JUPITER
Not surprisingly, the American College of Cardiology '09 meeting underway in Orlando is chock-a-block with new studies about statins. Herewith, a summary of statin-related research presented today and yesterday:
- Is there a polypill in your future? A phase II study of 2,053 healthy Indian subjects suggests the answer could be yes. Researchers tested the "Polycap"--which combines three low-dose blood pressure-lowering drugs, a statin and an aspirin--and compared it to eight other drug therapies (each comprising one or more of the drugs in the polypill). The polypill performed best, reducing risk of heart disease by 60% and stroke by 50% without any more side effects than would occur from one or two of the medications. (Hard endpoints weren't measured in the 12-week study; BP, cholesterol and heart rate were.)
Lead researcher Salim Yusuf, DPhil, FRCPC said the five-in-one pill could reduce cost and increase compliance in those already taking the medications. And, pending future trials, it may even become something that virtually everyone over 50-55 years takes, since most people have some sort of CV risk factor by that age, he said. When questioned about whether the magic pill might lead folks to skimp on diet and exercise, Dr. Yusuf responded: "I sincerely hope this wouldn't become an excuse for McDonald's to market the polypill, and put it in with their purple hamburger."
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- More news from Jupiter. New results from the famed JUPITER study suggest 20 mg of rosuvastatin per day can cut the risk of VTE by 43%. The trial of 17,802 healthy folks with LDL of less than 130 mg/dL and CRP of 2 mg/L or higher found reduced risk whether or not a person had certain "triggers" for VTE, like recent hospitalization or trauma. The study is online at NEJM.
- One more hat in the ring for routine CRP testing. An RCT of 15,548 healthy people who took 20 mg rosuvastatin or placebo found that those who took statins and reached LDL and CRP goals had a 65% lower risk of cardiovascular events. This compared to a 36% lower risk for those who took the statin but didn't achieve one or both goals. The goal was less than 70 mg/L for LDL levels, and less than 2 mg/L for CRP, but those who reached more aggressive goals showed even greater reduction in CV risk. Patients were followed for a median of 1.9 years, and had LDL of less than 130 mg/dL at enrollment, meaning they didn't qualify for statins under current guidelines.
- Still, statins don't work on everyone. Specifically, they don't work on patients with high CV risk who are undergoing hemodialysis. Researchers assigned 2,776 patients age 50-80 to either 10 mg/day of rosuvastatin or placebo for three months. By the end, there was no difference between groups on the combined endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; nor was there a difference in all-cause mortality. This, despite a 40% lowering of LDL levels in the statin group. "I think vascular disease is so different, and involves a lot of calcification that may not be treatable with statins. So for hemodialysis patients who have undergone at least 3 months in treatment, statins don't seem to be beneficial," said lead researcher Bengst Fellstrom, MD, of University Hospital in Uppsala, Sweden. The study is online via NEJM.
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