 | What Your Doctor Is Reading | | |
Update From the Medical Journals: November 2008
December 1, 2008  By Mary Pickett, M.D.
Harvard Medical School What's the latest news in the medical journals this month? Find out what your doctor is reading. Statin Drug Lowers Heart Risk for People With Normal Cholesterol, But Is Its Use Justified? People with high cholesterol have an increased risk for heart attacks and strokes. Cholesterol-lowering drugs called "statins" can lower this risk. But do statin drugs also help people with normal cholesterol who have other risk factors for heart disease? A huge study called the JUPITER trial tried to answer this question. (The name stands for the "Justification" of "Use" of statins in "Prevention.") It was published in the November 20 issue of the New England Journal of Medicine. The study enrolled about 18,000 people whose LDL cholesterols were normal, or less than 130. But their C-reactive protein (CRP) levels were high. CRP measures inflammation. It is another risk factor for heart disease. (CRP is measured with a blood test. But it's not as common as checking cholesterol levels.) The question was whether rosuvastatin would protect people with elevated CRP levels against heart attack, stroke and death. The participants were randomly divided into two groups. One group was treated with rosuvastatin (Crestor), and the other group was given a daily placebo (sugar pill). After about two years of treatment, patients in the rosuvastatin group had nearly 50% fewer strokes, were hospitalized about half as often for heart procedures, and were 20% less likely to have died compared with patients in the placebo group. In total there were 157 events in the placebo group, and 83 events in the rosuvastatin group. The results impressed researchers enough that they stopped the trial to quickly publish them. Now, many doctors wonder whether more people should be taking statin drugs. Nevertheless, they are hesitant to expand their use of statins when they weigh the benefits against the risks. Assuming that the drug alone accounts for the impressive results, a closer look at the numbers shows that doctors would have to treat 120 people with normal cholesterol and a high CRP with a statin for about 2 years to prevent one heart attack, stroke or death among them. This is a high "need to treat" number. That's why it's important to consider the side effects. Serious side effects from statins don't occur very often. But we don't know the long-term effects of lowering LDL cholesterol to 55 mg/dL or less, as occurred with half of the people in this study. It's also important to consider the cost of taking a drug like rosuvastatin. Rosuvastatin costs about $3.45 a day. That's more than most statins. It would cost approximately $300,000 to prevent a stroke or heart attack in one person over just two years. This cost does not include blood tests and doctor visits to monitor the safety of the drug. Other statins are less expensive, but the total cost is still very high. In this study, more than 3 out of 4 patients were overweight and had a body mass index of 25 or higher. Also, 1 out of 6 people smoked. Diet and exercise habits had room to improve. Many doctors agree that lifestyle changes are more important ways for us to reduce risk, instead of writing more prescriptions. Should more people have their CRP levels measured? Probably not. Other types of inflammation, such as infection or autoimmune diseases, can elevate a person's CRP, so a high level does not always indicate heart disease. Also, cholesterol levels, family history, blood pressure, diabetes and smoking are also good indications of your risk for heart disease and the need for a statin. It's probably best to consider the test if the results would tip you significantly toward — or away from — a decision to use a statin, after you have considered your other risk factors. Back to top More News in Brief - Family History of Breast Cancer Increases Risk Significantly Even When Gene Tests Are Negative. Research presented at the annual meeting of the American Association for Cancer Research on November 17 showed that women with a strong family history of breast cancer are still at increased risk for developing the disease even if they don't have either the BRCA1 or BRCA2 breast cancer gene. Women with a family history of breast cancer have felt reassured by a negative test for mutations of the BRCA1 and BRCA2 genes, believing that the negative test placed them in a far safer category. But according to this new study, negative test results have been falsely reassuring in the case of women from families that have multiple cases of breast cancer. Women who participated in the study had either two or more first- or second-degree relatives who developed breast cancer when they while under the age of 50, or three or more first- or second-degree relatives who got the disease at any age. The researchers followed 1,492 women from 365 families who tested negative for BRCA1 and BRCA2 mutations. After five years, the number of breast cancer cases that had been newly identified among these women (without BRCA genes) added up to a rate that was 4.3 times what is normally seenamong women with average risk. Based on the results of this study, women who test negative but have a strong family history of breast cancer should consider taking extra precautions against breast cancer. This includes taking the medication tamoxifen during some of the years that follow menopause, and a yearly breast MRI scans (magnetic resonance imaging scans), in addition to mammograms.
- Ginkgo Does Not Help Prevent Alzheimer's. Americans spent more than $100 million last year on ginkgo biloba, hoping that this dietary supplement might prevent Alzheimer's dementia. On November 19, however, a study in the Journal of the American Medical Association showed that ginkgo does not protect against this disease. Researchers randomly assigned 3,000 people 75 years and older to take either ginkgo or placebo pills. None of these older adults had dementia at the beginning of the study. They were followed for 6 years, with screening surveys every six months. At the end of six years, there was no significant difference between the groups in the number who had been diagnosed with Alzheimer's disease.
- Anti-Acid Drugs May Weaken the Effects of Plavix. A preview ("abstract") of a study presented at the American Heart Association's annual meeting and published in the October 28 supplement to Circulation suggests that taking certain anti-acid stomach medications, might reduce the effect of the blood-thinning medicine clopidogrel (Plavix). Clopidogrel is given to patients who have recently received a coronary artery stent, to prevent a clot from developing. But anti-acid medications called "proton pump inhibitors," which include omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex) suppress a liver enzyme that activates Plavix. In the study, researchers looked at the prescription history of patients who received a coronary artery stent during the last one to two years. They selected 14,383 patients who took at least 80% of their prescribed Plavix doses to enroll in the study. Then they separated the patients into two groups: The group taking an anti-acid medication and the group not taking one. During the first year after receiving the stent, the chance of having a stent-clotting complication or other clotting problem, such as a stroke, was 21.2% in the group with no anti-acid treatment. Patients who took anti-acid medicines along with their Plavix had a 32.5% chance of a complication — a risk that was about 70% higher. More study will probably be needed to further explore this possible drug-drug interaction. It raises significant concerns, because Plavix and these anti-acid drugs are so widely prescribed.
Back to top Mary Pickett, M.D. is an Associate professor at Oregon Health & Science University where she is a primary care doctor for adults. She supervises and educates residents in the field of Internal Medicine, for outpatient and hospital care. She is a Lecturer for Harvard Medical School and a Senior Medical Editor for Harvard Health Publications.
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