Strategy for Assessing New Drug Value in Orphan Diseases: An International Case Match Control Analysis of the PROPEL Study.

Background: Although randomized studies are designed to assess overall survival (OS) benefit, the conduct of regulatory studies in patients with orphan diseases can be timely and costly without offering the same commercial return on the investment. The peripheral T-cell lymphomas (PTCL) represent a rare group of heterogeneous lymphoid malignancies with very poor prognosis. PROPEL was a pivotal phase II study that led to the accelerated approval of pralatrexate for patients with relapsed or refractory PTCL.

Rapid efficacy of the highly selective α(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies.

Purpose: We evaluated the efficacy and safety of silodosin for treatment of benign prostatic hyperplasia symptoms in 2 randomized, placebo controlled, phase 3 studies.

Materials And Methods: Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast for 12 weeks. The primary end point was International Prostate Symptom Score change from baseline to last observation.

Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter?

Objective: The uroselective α-blocker silodosin significantly improved International Prostate Symptom Score (IPSS) in two 12-week, double-blind (DB), placebo-controlled Phase III studies in men aged ≥ 50 years with symptoms of benign prostatic hyperplasia (BPH) and maintained symptom improvement during a 9-month open-label (OL) extension. This post-hoc analysis evaluated the effects of estimated prostate volume (EPV) on silodosin-mediated symptom improvement.

Methods: Patients were stratified by EPV (<30 mL or ≥ 30 mL) calculated from prostate-specific antigen (PSA) concentrations using a published algorithm.

West China hospital set of measures in Chinese to evaluate back pain treatment.

Objective: Chinese is the most commonly spoken language in the world, and back pain is as prevalent in China as it is elsewhere. Nevertheless, there is a paucity of measures in Chinese to evaluate back pain treatment. We assemble a set of Chinese measures to evaluate outcomes in diverse domains.

Lack of pharmacodynamic interaction of silodosin, a highly selective alpha1a-adrenoceptor antagonist, with the phosphodiesterase-5 inhibitors sildenafil and tadalafil in healthy men.

Objectives: To evaluate the orthostatic effects and safety of coadministration of silodosin with the phosphodiesterase-5 inhibitors sildenafil and tadalafil.

Methods: In this placebo-controlled, open-label crossover study, 22 healthy men aged 45-78 years received 8 mg silodosin for 21 days. On days 7, 14, and 21, subjects also received a single dose of sildenafil 100 mg, tadalafil 20 mg, or placebo in random sequence.

Effect of silodosin on specific urinary symptoms associated with benign prostatic hyperplasia: analysis of international prostate symptom scores in 2 phase III clinical studies.

Purpose: Pooled results from 2 randomized, placebo-controlled, US phase III studies (NCT00224107, NCT00224120) showed that silodosin, a uroselective α-blocker, significantly improved International Prostate Symptom Scores (IPSS) in men with symptomatic benign prostatic hyperplasia (BPH). This analysis evaluated the effect of silodosin on each symptom assessed by IPSS questionnaire.

Materials And Methods: Study participants (N = 923) were men aged ≥50 years with IPSS ≥13 and Qmax 4-15 mL/s.

Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study.

Objectives: To evaluate long-term safety of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia (BPH).

Methods: Patients enrolled in this open-label extension study had completed 1 of 2 identical double-blind, placebo-controlled 12-week studies of silodosin treatment for symptomatic BPH. For 40 weeks, patients received silodosin 8 mg once daily with breakfast.

Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity.

Purpose: We evaluated the efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity.

Materials And Methods: Children with neurogenic detrusor overactivity 6 to 15 years old and previously receiving oxybutynin were assigned randomly at a 3:1 ratio to treatment with transdermal or oral oxybutynin. Initial dosages (transdermal 1.

Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies.

Purpose: We evaluated the efficacy and safety of silodosin for treatment of benign prostatic hyperplasia symptoms in 2 randomized, placebo controlled, phase 3 studies.

Materials And Methods: Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast for 12 weeks. The primary end point was International Prostate Symptom Score change from baseline to last observation.

Back pain claim rates in Japan and the United States: framing the puzzle.

Study Design: This is a cross-national comparison of workers' compensation claims for back pain in Japan and the United States (US).

Objectives: The main objective is to juxtapose rates of back pain claims in Japan and Washington state. Because the Washington state rate closely matches rates for other US states as well as the rate for the US as a whole, it is used to represent the US rate.