Current medical research and opinion
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Comparative Study
Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.
The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). ⋯ This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study.
Doripenem is a new carbapenem that has broad-spectrum activity against bacterial pathogens commonly responsible for nosocomial pneumonia (NP). It has several advantages over currently available carbapenems and other classes of drugs used in this indication. This prospective, randomized, open-label, multicenter study was designed to establish whether doripenem was noninferior to piperacillin/tazobactam in NP. ⋯ Adults (n=448) with signs and symptoms of NP, including non-ventilated patients and those ventilated for <5 days, were stratified by ventilation mode, illness severity (Acute Physiology and Chronic Health Evaluation II score), and geographic region and then randomly allocated to treatment with doripenem 500 mg every 8 h by a 1-h intravenous (IV) infusion or piperacillin/tazobactam 4.5 g every 6 h by 30-min IV infusion. After receiving IV study drug for at least 72 h, eligible patients could be switched to oral levofloxacin 750 mg once daily. Antibiotic therapy was continued for a total of 7-14 days. The primary endpoint was the clinical cure rate, assessed 7-14 days after treatment completion, in clinically evaluable patients and in the clinical modified intent-to-treat population (cMITT).
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Randomized Controlled Trial Multicenter Study
Efficacy, safety, and tolerability of desvenlafaxine 50 mg/day and 100 mg/day in outpatients with major depressive disorder.
To assess the efficacy, safety, and tolerability of 50- and 100-mg/day doses of desvenlafaxine (administered as desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor, for the treatment of major depressive disorder (MDD). ⋯ These results demonstrate efficacy, safety, and tolerability of desvenlafaxine 50 mg/day for treating MDD. The significant findings on secondary measures support the efficacy of desvenlafaxine 100 mg, as seen in other trials. Conclusions may be limited by the exclusion of MDD patients with comorbid conditions and the short-term desvenlafaxine treatment duration.
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The purpose of this study was to estimate costs and quality of life (QoL) of late-stage glaucoma patients in 4 European countries. ⋯ The study was limited by its observational, uncontrolled design. The finding that late-stage glaucoma is associated with higher home help costs than health care maintenance costs suggests that potential savings from a better preventive treatment are to be found for social care payers rather than health care payers.
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Recently enacted federal legislation, the Food and Drug Administration Amendments Act of 2007 (FDAAA), mandates public registration and disclosure of results of "applicable" clinical trials of drugs, biologics and devices on www.clinicaltrials.gov. The law calls for registering more information about more trials than has been the policy of many medical journal editors to date. Beginning December 2007, results disclosure will occur in three stages initially with links to information from the FDA and NIH about FDA-approved products, as well as to Medline citations. A Basic Results Database will appear in September 2008, and an Expanded Results Database two years later. Results for trials of FDA-approved products must be posted within 12 months of trial completion. Such postings will not be peer reviewed or contain explanatory text or discussion. Sponsors who file regulatory submissions (IND, NDA, 510(k), PMA, etc.) to the FDA must certify compliance with FDAAA's registration and disclosure provisions. The FDA's determination of such compliance will be made public, and if non-compliance is not cured within 30 days, sponsors may be fined up to $10,000/day. ⋯ FDAAA requirements differ in a number of ways from those of the International Committee of Medical Journal Editors (ICMJE) and other journal editors, creating potential conflicts for sponsors and investigators who must comply with the law, and a need for better alignment of editors' policies with the law. The public will have access to massive amounts of clinical trial data as a result of FDAAA but it is unclear this will be useful to patients and prescribing physicians.