Day: 01/19/2011

Escitalopram Ameliorates Hot Flashes

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Escitalopram, a selective serotonin reuptake inhibitor, reduces the frequency and severity of hot flashes in menopausal women, according to a JAMA study.

Researchers randomized 200 women to 8 weeks of treatment with either placebo or escitalopram. If by the fourth week hot flashes had not been reduced sufficiently, escitalopram recipients received a doubled dose (20 mg/day) and placebo recipients received a matching dummy pill.

By 8 weeks, the frequency of self-reported hot flashes had decreased by roughly half in the escitalopram group and by about one third among placebo recipients. Similarly, severity scores also decreased significantly more in the treatment group. Three weeks after stopping therapy, symptoms recurred in the treatment group.

Asked to comment, Dr. Andrew Kaunitz of Journal Watch Women’s Health said that the authors convincingly demonstrated escitalopram’s greater efficacy. “However,” he continued, “women with bothersome symptoms who can safely take hormone therapy should be counseled that SSRIs are, unfortunately, substantially less effective than hormone therapy in achieving symptomatic relief.

 

Source:JAMA

 


Liver-Damage Caution over the Antiarrhythmic Dronedarone

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The FDA has issued a safety alert on the antiarrhythmic dronedarone (marketed as Multaq) because of cases of severe liver injury associated with the drug. Two cases required liver transplants.

The agency says the complication is rare, but reminds clinicians to consider monitoring patients’ liver enzymes, especially during the first 6 months of treatment.

Source: FDA MedWatch


Mixing Caffeine with Alcohol Doesn’t Make Intoxication Safer

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In a laboratory setting, participants who drank caffeinated beer performed no better than those who drank beer alone.

Caffeinated alcoholic beverages and alcohol mixed with energy drinks have become popular with youth, likely because of the belief that caffeine counteracts the sedating effects of alcohol. In a randomized study conducted in a carefully controlled laboratory setting, 127 young adult, heavy episodic drinkers (age range, 21–30; 53% men; 83% students) consumed either alcohol-containing beer or nonalcoholic beer, to which caffeine or placebo was added. After consuming enough beer to reach a breath alcohol concentration of 0.12%, participants performed a 30-minute simulated driving task and a test of sustained attention and reaction time.

Participants who consumed alcohol-containing beer had significantly slower reaction times, greater speed variability and lane position deviation, and more crashes compared with those who drank nonalcoholic beer. Those who drank alcohol-containing beer mixed with caffeine performed no better than those who drank alcohol-containing beer with placebo.

Comment: The belief that caffeine mitigates alcohol-related impairment is not supported by this study. The FDA has moved to ban some caffeinated alcoholic beverages, and some states are taking similar measures. However, these bans will not prevent youth from mixing their own caffeinatedalcoholic drinks. Thus, it falls to public health authorities, universities, and clinicians to ensure that young people understand that drinking alcohol with caffeine is still risky drinking.

— Alain Joffe, MD, MPH, FAAP

Published in Journal Watch Pediatrics and Adolescent Medicine January 12, 2011

 

B Vitamins and -3 Fatty Acids for Preventing Cardiovascular Disease

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Supplementation did not prevent major CV events in patients with previous myocardial infarction, unstable angina, or stroke.

 

Despite the theoretical benefits of lowering homocysteine levels through vitamin B supplementation, randomized trials have failed to show that vitamin B therapy prevents cardiovascular events. In addition, trials of {omega}-3 fatty acid supplementation have yielded conflicting results. This double-blind placebo-controlled French trial involved 2501 patients with myocardial infarction (MI), unstable angina, or stroke within the past 12 months. Patients were randomized to receive B vitamins, {omega}-3 fatty acids, both, or neither. The B vitamins were 5-methyltetrahydrofolate (560 µg), B6 (3 mg), and B12(20 µg), and the {omega}-3 fatty acids were eicosapentaenoic acid and docosahexaenoic acid at a ratio of 2:1 (600 mg).

During median follow-up of 4.7 years, vitamin B therapy had no effect on a composite outcome of major adverse cardiovascular events and had no effect on MI, all adverse coronary events, cerebrovascular events, and revascularizations; vitamin B supplementation was associated with lower stroke risk but higher overall mortality. {omega}-3 fatty acid supplementation had no effect on major CV events together or individually.

Comment: The results of this trial and others (including a recent {omega}-3 fatty acid study; JW Cardiol Aug 30 2010) indicate that dietary supplementation with B vitamins and {omega}-3 fatty acids does not prevent major CV events in patients with previous adverse coronary events or stroke.

— Paul S. Mueller, MD, MPH, FACP

Published in Journal Watch General Medicine January 18, 2011

Supplementation did not prevent major CV events in patients with previous myocardial infarction, unstable angina, or stroke.

 

Despite the theoretical benefits of lowering homocysteine levels through vitamin B supplementation, randomized trials have failed to show that vitamin B therapy prevents cardiovascular events. In addition, trials of {omega}-3 fatty acid supplementation have yielded conflicting results. This double-blind placebo-controlled French trial involved 2501 patients with myocardial infarction (MI), unstable angina, or stroke within the past 12 months. Patients were randomized to receive B vitamins, {omega}-3 fatty acids, both, or neither. The B vitamins were 5-methyltetrahydrofolate (560 µg), B6 (3 mg), and B12(20 µg), and the {omega}-3 fatty acids were eicosapentaenoic acid and docosahexaenoic acid at a ratio of 2:1 (600 mg).

During median follow-up of 4.7 years, vitamin B therapy had no effect on a composite outcome of major adverse cardiovascular events and had no effect on MI, all adverse coronary events, cerebrovascular events, and revascularizations; vitamin B supplementation was associated with lower stroke risk but higher overall mortality. {omega}-3 fatty acid supplementation had no effect on major CV events together or individually.

Comment: The results of this trial and others (including a recent {omega}-3 fatty acid study; JW Cardiol Aug 30 2010) indicate that dietary supplementation with B vitamins and {omega}-3 fatty acids does not prevent major CV events in patients with previous adverse coronary events or stroke.

— Paul S. Mueller, MD, MPH, FACP

Published in Journal Watch General Medicine January 18, 2011

 

Factors Influencing Carotid Stenting Complications

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Analysis of a phase III randomized European trial of stenting for symptomatic carotid stenosis identifies predictors of complications from the procedure.

Risk factors for complications of carotid angioplasty with stenting (CAS) remain uncertain. Now, investigators have retrospectively analyzed baseline factors that could alter the combined risk for stroke and death within the first 30 days after attempted CAS in a multicenter, randomized, controlled trial that compared CAS and carotid endarterectomy (CEA) in patients with symptomatic, moderate-to-severe carotid stenosis.

Among the 262 patients randomized to CAS, the combined risk for stroke and death was significantly higher for patients who had ≥60 degrees of angulation between the internal carotid artery and thecommon carotid artery (ICA–CCA angulation). The risk for stroke and death was significantly reduced for patients treated with a cerebral protection device.

Comment: Phase III trials of CEA taught neurologists to consider anatomy when referring patients for therapy. An increasing percentage of ICA stenosis shifts the risk-benefit ratio of CEA from unfavorable to favorable. It is increasingly apparent that anatomy also affects the risk for complications of carotid stenting. Greater ICA–CCA angulation likely increases the risk for stroke caused by guidewire-generated embolic debris. Presumably, other less easily quantifiable markers of atherosclerotic tortuosity distal to the aortic arch also influence stroke risk with CAS. Knowing whether high ICA–CCA angulation was a risk factor at lower or higher cutoffs (i.e., at 50 degrees or 70 degrees) would be valuable. The lower risk for complications associated with the use of a cerebral protection device is consistent with other trials.

This trial had a high rate of procedural complications relative to other phase III carotid stenting trials, perhaps because of differences in patient populations, but also potentially related to differences in procedural experience and expertise. Tempting as it may be to select patients for CAS based on ICA–CCA angulation, clinicians should keep in mind that this retrospective analysis did not show that CAS assisted by a cerebral protection device is superior to CEA in patients with low ICA–CCA angulation. Further trials are warranted before anyone can make confident claims of superiority of CAS over CEA for prevention of stroke in any subset of patients.

— James F. Meschia, MD

Dr. Meschia is Professor of Neurology, Mayo Clinic, Jacksonville, FL, and Mayo Foundation Director of the Division of Cerebrovascular Disease.

Published in Journal Watch Neurology January 18, 2011