Warfarin vs. Aspirin Yields No Winner in Stroke Patients
By William T. Elliott, MD, FACP
There is no benefit for warfarin over aspirin in preventing second strokes in patients with cerebrovascular disease. More than 2200 patients who had suffered a noncardiogenic stroke were randomized to take either aspirin or warfarin. After 2 years of follow-up, there was no difference in the rate of death or recurrent ischemic stroke (17.8% warfarin group, 16.0% aspirin group). The dose of aspirin used was 325 mg/d, and warfarin was dosed to keep the INR between 1.4-2.8. The rate of major hemorrhage was no different between the 2 groups. It is concluded that aspirin alone or in combination with another anticoagulant is effective treatment for the prevention of recurrent ischemic stroke (N Engl J Med. 2001;345:1444-1451;1493-1495).
COX-2 Approval
A third COX-2 inhibitor has been approved by the FDA. Pharmacia Corp announced the approval of valdecoxib, a once-a-day COX-2 inhibitor, in mid-November. The drug is approved for the treatment of adult rheumatoid arthritis and for menstrual pain. Valdecoxib will be marketed jointly by Pharmacia Corp and Pfizer under the trade name "Bextra." The drug joins rofecoxib (Vioxx) and celecoxib (Celebrex) in this lucrative market. Merck has filed for approval of the fourth drug, etoricoxib (Arcoxia), which is currently under consideration by the FDA.
Birth Control Patch
In November, the FDA also approved the first transdermal birth control patch. Ortho-McNeil will be marketing the "Ortho Evra" patch which contains norelgestromin and ethinyl estradiol. The patch is applied once a week and is worn continuously for 7 days. A new patch should be applied on the same day each week to an area of skin in the lower abdomen, buttocks, upper body, or upper outer arm. After 3 weeks of application, no patch is applied for the fourth week which allows the woman to have a menstrual period. The patch appears to be as effective as birth control pills. Five percent of women report that they had at least 1 patch fall off in clinical trials, while another 2% reported skin irritation. The patch may also be less effective in women who weigh more than 200 pounds.
Urology
A new 5-alpha reductase inhibitor for the treatment of benign prostatic hyperplasia (BPH) was also approved in November. GlaxoSmithKline’s dutateride will compete with Merck’s finasteride (Proscar) which has been available for 10 years. Dutasteride is reported to inhibit both forms of the enzyme responsible for converting testosterone to dihydrotestosterone in the prostate. Whether it will prove more effective than finisteride, a drug that has shown only minimal benefit, is yet to be seen. Use of the drug for hair loss is already causing significant buzz on the internet.
NSAIDs and Alzheimer’s Risk
Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) significantly reduces the risk of Alzheimer’s disease, according to a new study. Long-term use of NSAIDs is defined as at least 2 years of regular use of the drugs. The study was a prospective, population-based cohort study of nearly 7000 patients aged 55 and older, who were free of dementia at baseline. During an average follow-up period of 6.8 years, the relative risk of Alzheimer’s disease was 0.95 in patients who used NSAIDs briefly, and 0.20 in those who use the drugs long term. NSAIDs only prevented Alzheimer’s disease; the rate of other dementias, including vascular dementia, were unchanged by the use of the drugs. Diclofenac, ibuprofen, and naproxen accounted for 83% of the anti-inflammatories used in the study (N Engl J Med. 2001;345:1515-1521).
Infectious Disease
Drotrecogin alfa (Xigris-Eli Lilly) has received approval for marketing by the FDA. The drug, which is the first biologic treatment for sepsis, is a genetically engineered version of the naturally occurring protein Activated Protein C. Drotrecogin alpha was first reviewed by the FDA in October. Concerns were voiced at that time regarding the risk of bleeding associated with the drug. Four patients bled to death during clinical trials and the company changed their study entry criteria during the course of the study to exclude patients at high risk of bleeding. The drug, however, was approved on the strength of clinical trials that showed an absolute reduction in mortality of 6% at 1 month associated with use of drotrecogin alfa. When patients were segregated by the severity of their illness, the drug was shown to be less effective in less severely ill patients, but showed an absoute redution of 13% in mortality in those at the highest risk of dying.
Antioxidants
Antioxidant vitamins are of no value in preventing coronary artery disease, and may actually attenuate the value of cholesterol lowering therapy, according to a new study. A 3 year, double-blind trial of 160 patients with coronary disease, low HDL levels, and normal LDL, randomized patients to cholesterol lowering therapy (simvastatin and niacin), antioxidant therapy (vitamin C, vitamin E, beta carotene, and selenium), cholesterol-lowering antioxidants, or placebo. LDL and HDL levels were unchanged in both the antioxidant group and the placebo group. The cholesterol-lowering therapy group showed a 42% decrease in LDL and a 26% increase in HDL. The antioxidant/cholesterol lowering group showed similar results except for a smaller increase in the protective HDL2. Both the antioxidant and placebo group showed an increase in the average stenosis of coronary arteries, and, more importantly, clinical events (death, MI, CVA, or revascularization) was 24% in the placebo group, 21% in the antioxidant group, 3% in the cholesterol lowering group, and 14% in the cholesterol lowering/antioxidant group. It was concluded that the use of antioxidants should be questioned in this group (N Engl J Med. 2001;345:1583-1592).
Children and Penicillin
More than 35% of children treated for group A Streptococcal pharyngitis with penicillin will fail therapy, according to a new study. The failure rate of either oral penicillin V or injectable benzathine penicillin G was not due to resisitance to the drugs. Penicillin-resistant strains of group A strep have never been reported. Rather, the potency of current penicillin preparations, especially benzathine pen G, seem to be lower than in the past. Penicillin is still the drug of choice for these infections, but higher doses may be required (Pediatrics. 2001;108:1180-1186).
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