Clinical therapeutics
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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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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 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 StudyComparison of medication adherence and associated health care costs after introduction of pioglitazone treatment in African Americans versus all other races in patients with type 2 diabetes mellitus: a retrospective data analysis.
The aim of this study was to compare treatment adherence and health care costs in African Americans versus all other races (All Others) in patients with type 2 diabetes mellitus starting treatment with pioglitazone. ⋯ On multivariate analysis, this study found no significant differences in treatment adherence between African Americans versus all other races in this population of diabetic patients enrolled in a Medicaid program (query dates: July 1, 2000, to June 30, 2003). A higher adherence rate was associated with significantly lower diabetes-related and total health care costs in this population.
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Clinical therapeutics · Aug 2006
Randomized Controlled Trial Multicenter Study Comparative StudyA post hoc subgroup analysis of meropenem versus imipenem/cilastatin in a multicenter, double-blind, randomized study of complicated skin and skin-structure infections in patients with diabetes mellitus.
In a multicenter, international, double-blind, randomized clinical trial involving hospitalized patients with complicated skin and skin-structure infections (cSSSIs), meropenem and imipenem/cilastatin (both administered 500 mg intravenously every 8 hours) were not significantly different in their efficacy and safety profiles. ⋯ This subgroup analysis found that 500 mg every 8 hours intravenously of meropenem or imipenem/cilastatin appeared efficacious and well tolerated for the treatment of cSSSIs among these patients with and without DM.