JAMA internal medicine
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JAMA internal medicine · Jan 2014
Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.
The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. ⋯ For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.
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JAMA internal medicine · Jan 2014
Randomized Controlled TrialGabapentin treatment for alcohol dependence: a randomized clinical trial.
Approved medications for alcohol dependence are prescribed for less than 9% of US alcoholics. ⋯ Gabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia, dysphoria, and craving, with a favorable safety profile. Increased implementation of pharmacological treatment of alcohol dependence in primary care may be a major benefit of gabapentin as a treatment option for alcohol dependence.
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JAMA internal medicine · Jan 2014
Randomized Controlled TrialAn education program for risk factor management after an acute coronary syndrome: a randomized clinical trial.
Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve. ⋯ Compared with conventional care, the House of Education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome.