Day: 02/22/2013

Use of Hydroxyethyl Starch for Fluid Resuscitation Poses ‘Serious Safety Concerns’.

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Critically ill patients treated with hydroxyethyl starch face increased risks for kidney damage and mortality, according to a JAMA meta-analysis. The dangers, once considered of borderline significance, became apparent when the data of a disgraced researcher were removed from the analysis.

The researchers examined mortality and renal-outcome data from some 40 trials comparing hydroxyethyl starch with other fluids given to patients for volume resuscitation. Seven of those trials — by a researcher whose later work was retracted after a government investigation — were removed. After that removal, results changed from showing no mortality advantage with starch to a significant mortality risk. Kidney damage, as reflected by the need for renal-replacement therapy, also increased.

Editorialists point out the serious consequences to patients of scientific misconduct. They conclude: “The harms of hydroxyethyl starch most likely outweigh the benefits.”

Source: JAMA

Opioids Play a Role in Most Pharmaceutical Overdose Deaths.

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Opioids play a “predominant role” in pharmaceutical overdose deaths, according to a research letter published in JAMA.

Using 2010 national data from death certificates, researchers found that most (58%) drug overdose deaths involved pharmaceutical drugs. The drugs most commonly implicated in overdose deaths were opioids (75%), benzodiazepines (29%), antidepressants (18%), and antiepileptic and antiparkinsonism drugs (8%). In overdose deaths related to other drugs, opioids were often used in combination, which is why the percentages exceed 100.

The authors say these results likely underestimate the problem and conclude: “Tools such as prescription drug monitoring programs and electronic health records can help clinicians to identify risky medication use and inform treatment decisions, especially for opioids and benzodiazepines.”

Source: JAMA

Ramipril for Peripheral Arterial Disease?

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PAD patients with intermittent claudication who took ramipril could walk longer and with less pain.

Currently, medical therapy is limited for patients with peripheral arterial disease (PAD) and intermittent claudication. To assess whether the angiotensin-converting–enzyme (ACE) inhibitor ramipril improves ambulatory function in PAD patients, researchers conducted a trial in which walking times on a treadmill and other measures of function were compared in 212 Australian PAD patients (mostly men; mean age, 65.5) who were randomized to daily ramipril (10 mg) or placebo for 6 months.

All patients underwent treadmill testing at baseline and at the end of the trial. At 6 months, pain-free and maximum walking times were 75 seconds and 225 seconds longer, respectively, in the ramipril group than in the placebo group. Ramipril recipients also reported greater improvements in walking distance, walking speed, stair climbing, and physical health–related quality of life.

Comment: In this trial, ramipril improved walking ability and quality of life in PAD patients with intermittent claudication. Prior small studies of ACE inhibitors have yielded mixed results, but this is the largest study to date. How ACE inhibitors improve walking ability is unclear, but the authors postulate several mechanisms, including vasodilation, improved endothelial function, and changes in skeletal muscle structure and function. An editorialist cautions that these findings should be replicated in more ethnically diverse cohorts (and in women), but, given the limited arsenal of treatments currently available, these data are good news for patients suffering from PAD.

Source:Journal Watch General Medicine

Studies of Extended Anticoagulant Therapies for VTE Highlight Tradeoffs.

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For the extended treatment of venous thromboembolism, the newer anticoagulants dabigatran and apixaban show advantages and disadvantages compared with older therapies, according to three studies in the New England Journal of Medicine. (Physician’s First Watch covered the apixaban study when it was published online last December.)

The dabigatran studies, conducted by the manufacturer, included patients who had completed 3 months of initial therapy and whose risks for recurrence were judged to be either at equipoise or increased.

In one study, patients were randomized to dabigatran or warfarin treatment for up to 36 months. Regarding VTE recurrence, dabigatran (1.8%) was noninferior to warfarin (1.3%), and rates of major bleeding did not differ statistically. However, acute coronary syndromes were more frequent with dabigatran (0.9% vs. 0.2%).

The other study compared dabigatran with placebo for up to 12 months. Dabigatran proved superior to placebo in preventing VTE recurrence (0.4% vs. 5.6%). Dabigatran was associated with an almost threefold increased risk for major bleeds.

An editorialist examines the tradeoffs presented by the newer therapies and urges trials that compare them directly with one another, with warfarin, and with aspirin.

Source: NEJM