Assessment of functional outcomes by Sheehan Disability Scale in patients with major depressive disorder treated with duloxetine versus selective serotonin reuptake inhibitors.

OBJECTIVE: We compared functional impairment outcomes assessed with Sheehan Disability Scale (SDS) after treatment with duloxetine versus selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder. METHODS: Data were pooled from four randomized studies comparing treatment with duloxetine and SSRIs (three double blind and one open label). Analysis of covariance, with last-observation-carried-forward approach for missing data, explored treatment differences between duloxetine and SSRIs on SDS changes during 8 to 12 weeks of acute treatment for the intent-to-treat population. Logistic regression analysis examined the predictive capacity of baseline patient characteristics for remission in functional impairment (SDS total score ≤ 6 and SDS item scores ≤ 2) at endpoint. RESULTS: Included were 2193 patients (duloxetine n = 1029; SSRIs n = 835; placebo n = 329). Treatment with duloxetine and SSRIs resulted in significantly (p < 0.01) greater improvements in the SDS total score versus treatment with placebo. Higher SDS (p < 0.0001) or 17-item Hamilton Depression Rating Scale baseline scores (p < 0.01) predicted lower probability of functional improvement after treatment with duloxetine or SSRIs. Female gender (p ≤ 0.05) predicted higher probability of functional improvement after treatment with duloxetine or SSRIs. CONCLUSIONS: Treatment with SSRIs and duloxetine improved functional impairment in patients with major depressive disorder. Higher SDS or 17-item Hamilton Depression Rating Scale baseline scores predicted less probability of SDS improvement; female gender predicted better improvement in functional impairment at endpoint.

Clinical meaningfulness of duloxetine's effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase 3 randomized trial.

PURPOSE: To evaluate the analgesic effect of duloxetine in Chinese patients with osteoarthritis (OA) of the knee/hip at individual patient level and report the relationship between pain intensity reduction, overall improvement, and physical functioning. PATIENTS AND METHODS: Post hoc analysis of 13-week, phase 3, parallel-group, randomized, placebo-controlled study of duloxetine in Chinese patients with OA pain. Patients were randomized (1:1, computer-generated, interactive web-response system) to duloxetine (60 mg once daily, n=202) or placebo (n=207). Patients, investigators, and study staff were blinded throughout the study. Duloxetine's efficacy was evaluated using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and the Osteoarthritis Research Society International and Outcome Measures in Rheumatology (OARSI-OMERACT) responder criteria. Analyses were conducted on all randomized patients with a baseline and at least one post-baseline observation. RESULTS: At study endpoint, the percentage of patients experiencing ≥30% pain intensity reduction (30% responders) was significantly higher in the duloxetine group than in the placebo group (63.4% vs 49.7%; P=0.008). The percentage of patients experiencing ≥50% pain intensity reduction (50% responders) in the duloxetine group was numerically higher than in the placebo group (42.8% vs 34.5%; P=0.098). Most of the 30% and 50% responders to duloxetine treatment felt either "very much improved" or "much improved" on the Patient Global Impression-Improvement at endpoint. The 30% and 50% responders to duloxetine treatment also experienced greater improvements in the Western Ontario and McMaster Universities Osteoarthritis Index physical function scores at endpoint compared with non-responders. The overall percentage of OARSI-OMERACT responders was significantly higher in the duloxetine group vs the placebo group (70.1% vs 54.9%; P=0.003). CONCLUSION: Based on IMMPACT and OARSI-OMERACT criteria, the analgesic effect of duloxetine was associated with clinically relevant benefits in Chinese patients with OA of the knee/hip. CLINICALTRIALSGOV IDENTIFIER: NCT01931475.

Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

PURPOSE: The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. MATERIALS AND METHODS: This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. RESULTS: All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001), with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score. CONCLUSIONS: Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.