Xanax XR is an extended release form of alprazolam, proposed for use in the treatment of panic disorder. Xanax IR is generally given on a tid or-even qid basis. The rationale for Xanax XR is improved e797 oxycodone convenience and compliance, due to the need for less frequent dosing. Thus, the sponsor has proposed that Xanax XR be given on a qd 50% decrease from baseline; (c) proportion of patients with zero panic attacks; (2) 3 measures of the CGI: (a) CGI- Severity; (b) CGI-Improvement; (c) CGI-Efficacy Index (a measure that combines efficacy and side effects); (3) mean change frombaseline in Overall Phobia Scale.
Efficacy assessments were obtained at baseline and weekly during the six weeks of the study. The primary analysis model was ANOVA with treatment and investigator as main effects, using LOCF in our usual intent-to-treatpopulation ( all randomized patients who received at least one dose of assigned treatment, and had baseline and at least one followup visit for efficacy assessment).
There were n=199 patients in the ITT sample (n=95 for pbo and n=104 forXanaxXR). There were substantial dropouts before reaching the 6 week endpoint, with the % completing to 6 weeks ranging from 54% for placebo to 74% for Xanax XR (for ITT population). The patients were about 60% female, about 96% Caucasian, and the mean age was about 35 years.
The daily Xanax XR dose for completers peaked in the 5th week, with a mean dose of approximately 5 mg.
Efficacy Results on 7 Primary Endpoints (LOCF at Week 6 for ITT) for Study 0369 Most of the OC hydrocodone here online analyses also favored Xanax XR over placebo for the primary endpoints, as did the analyses of many secondary outcomes. Kong also performed nonparametric analyses on the primary endpoints, given his concern about a failure of the normality assumption, and the results still favored Xanax XR over placebo. All 3 sites were inspected, and revealed in one of the 3 sites (Rosenthal) an absence of source documents for 28 of 37 patients. A re-analysis without Rosenthal's data resulted in generally even smaller p-values. An evaluation by investigator revealed consistent findings favoring Xanax XR for both acceptable sites. There were too few elderly or non-white e797 oxycodone patients to do age or race subgroup analyses, however, an analysis by gender showed positive results for Xanax XR in both strata. Kong expressed concern about the unusual number of early dropouts, apparently mostly for failure to return for the second visit (12 for drug and 5 for placebo).
To test for possible bias, he compared e797 oxycodone the pattern of changes in efficacy measures for dropouts and non-dropouts, and found no difference. Thus, the somewhat less impressive results on OC analyses probably represented diminished power. Levin and Kong considered this a positive study, and I e797 oxycodone agree.
5.1.3Summary of Study M/2000/0271 This was a randomized, double-blind, parallel group, 6-week, flexible-dose, multicenter (3 US and Canadian sites) study comparing Xanax XR, in a dose range of 1 to 10 mg/day, on a qd schedule, Xanax tablets (the marketed tablet), in a dose range of 1 to 10 mg/day, ona qid schedule, and placebo, in adult outpatients (18-65) meeting DSM-III criteria for panic disorder, with or without agoraphobia. The design of this study was very similar to that for 369, with identidal primary endpoints. The ITT population included roughly 70 patients per group. Both forms of Xanax were superior to placebo on all 3 CGI measures, on the Overall Phobia State measure, and on the proportions of patients with > 50% reduction from baseline in total panic attacks. However, neither group beat placebo on mean change frombaseline in total panic attacks, and only the Xanax tablets beatplacebo on the proportions of patients with 0 panic attacks at endpoint.
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