Clinical therapeutics
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Clinical therapeutics · Aug 2006
Comparative StudyThe decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study.
The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. ⋯ Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.
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Clinical therapeutics · Aug 2006
Randomized Controlled Trial Multicenter Study Comparative StudyLevofloxacin 750 mg QD for five days versus amoxicillin/clavulanate 875 mg/125 mg BID for ten days for treatment of acute bacterial exacerbation of chronic bronchitis: a post hoc analysis of data from severely ill patients.
This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50% to 65% of the predicted value plus comorbidities, or > or =4 exacerbations per year. A total of 369 patients were included in the intent-to-treat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). ⋯ A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).
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Tigecycline, the first glycylcycline to be approved by the US Food and Drug Administration, is a structural analogue of minocycline that was designed to avoid tetracycline resistance mediated by ribosomal protection and drug efflux. It is indicated for the treatment of complicated skin and skin-structure infections and complicated intra-abdominal infections and is available for intravenous administration only. ⋯ In clinical trials, tigecycline was effective for the treatment of complicated skin and skin-structure infections and complicated intra-abdominal infections. With the exception of gastrointestinal adverse events, tigecycline was generally well tolerated. With a broad spectrum of activity that includes multidrug-resistant gram-positive and gram-negative pathogens, tigecycline may be useful in the treatment of conditions caused by these pathogens.
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Clinical therapeutics · Aug 2006
Randomized Controlled TrialInfluence of age on flurbiprofen axetil requirements for preventing pain on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, vehicle-controlled, parallel-group, dose-ranging study.
Pain on injection is a recognized adverse event (AE) of propofol administration for the induction of general anesthesia. Preceded by venous occlusion, flurbiprofen axetil, a prodrug of the NSAID flurbiprofen, has been associated with a reduction in pain induced by propofol injection. A review of the literature determined that no published data were available on the influence of age on the requirements for flurbiprofen axetil dose. ⋯ In this small clinical trial in Japanese surgical patients undergoing general anesthesia, flurbiprofen axetil requirements for the reduction of pain during injection of propofol were found to be 50 mg in young adults (age 20-40 years) and 25 or 50 mg in older adults (age 60-80 years), regardless of weight, preceded by venous occlusion for 2 minutes.
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Clinical therapeutics · Aug 2006
Comparative StudyCost-effectiveness analysis of linezolid compared with vancomycin for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus.
This study compared the cost-effectiveness of linezolid and vancomycin in the treatment of patients with nosocomial pneumonia (NP) caused by methicillin-resistant Staphylococcus aureus (MRSA). ⋯ The higher acquisition cost of linezolid was almost completely offset by improved survival and a reduction in health care costs associated with improved survival. As a result, linezolid was almost cost-neutral compared with vancomycin in the treatment of NP caused by MRSA.