Clinical therapeutics
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Clinical therapeutics · Jun 2009
Randomized Controlled Trial Multicenter Study Clinical TrialDesvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies.
Major depressive disorder (MDD) is a common, chronic illness associated with substantial disability and economic burden. Although a number of effective antidepressants are available, the need for new medications that are effective and well tolerated remains. ⋯ The current study failed to meet its primary efficacy end point based on the a priori analysis plan. Desvenlafaxine was generally well tolerated. A post hoc pooled analysis of this trial and 2 previously published trials with both desvenlafaxine 50 and 100 mg/d found both doses to be effective for MDD compared with placebo. ClinicalTrials.gov Identifier: 00384033.
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Clinical therapeutics · Jun 2009
ReviewCertolizumab pegol for the management of Crohn's disease in adults.
Crohn's disease (CD) is an inflammatory disorder that can affect any portion of the gastrointestinal tract, from the mouth to the rectum. The American Gastroenterological Association recommends that treatment with anti-tumor necrosis factor (TNF)-alpha be considered in patients with moderate to severe CD refractory to concomitant aminosalicylates, corticosteroids, or immunosuppressive treatment, or who have contraindications to or poor tolerance of these agents. Anti-TNF-alpha agents available in the United States for the management of CD are infliximab, adalimumab, and certolizumab pegol. The latter is a recombinant humanized antibody Fab' fragment against TNF-alpha. It is conjugated with a 40-kDa polyethylene glycol molecule to increase the t(1/2) of the treatment to approximately 2 weeks. ⋯ Based on the findings from the present review, certolizumab pegol had moderate efficacy in the treatment of moderate to severe, active CD. In well-designed Phase III clinical trials, certolizumab pegol was associated with significantly greater response rates compared with placebo at weeks 6 and 26 of induction treatment. In patients who responded to the 6-week induction, certolizumab pegol administered as a monthly subcutaneous injection was effective in maintaining CD response and remission. Findings from studies of certolizumab pegol in refractory CD are awaited.
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Clinical therapeutics · Jun 2009
Randomized Controlled Trial Multicenter StudyEfficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: a phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period.
This trial investigated the efficacy and long-term tolerability of intranasal fentanyl spray (INFS) 50 to 200 microg in the treatment of breakthrough pain in opioid-tolerant patients with cancer. ⋯ In these opioid-tolerant patients with cancer, INFS at doses of 50, 100, and 200 microg was associated with an onset of activity at 10 minutes and effective treatment of breakthrough pain compared with placebo. All doses were generally well tolerated and clinically efficacious.
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Clinical therapeutics · Jun 2009
Randomized Controlled Trial Comparative StudyCelecoxib in the treatment of primary dysmenorrhea: results from two randomized, double-blind, active- and placebo-controlled, crossover studies.
Celecoxib, a cyclooxygenase-2 inhibitor, has established analgesic efficacy for the treatment of acute pain resulting from a variety of causes. ⋯ In these 2 identically designed studies in women aged 18 to 44 years, celecoxib 400 mg (followed by 200 mg q12h) was more effective, as measured using pain scores, in the treatment of primary dysmenorrhea compared with placebo. In each study, the primary efficacy measures-TOTPAR[8] and SPID[8] scores-were significantly improved with celecoxib and naproxen sodium compared with placebo. SPID[8] in both studies and TOTPAR[8] in study 2 were significantly improved with naproxen sodium compared with celecoxib. Both celecoxib and naproxen sodium were well tolerated and provided relief from menstrual pain within 1 hour of administration.
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Clinical therapeutics · Jun 2009
Review Comparative StudySystematic review and quality assessment of economic evaluations and quality-of-life studies related to generalized anxiety disorder.
The objectives of this article were to systematically review, summarize the results of, and assess the quality of economic evaluations and humanistic studies related to patients with generalized anxiety disorder (GAD). ⋯ Current evidence suggests that GAD is associated with substantial economic and humanistic impact on patients and health care systems. Future research should address economic evaluations from the private-payer perspective, studies related to the cost of underdiagnosed or untreated GAD, and full economic evaluations that incorporate longer clinical courses of the disorder.