Key Characteristics of Database Studies on Drug Effectiveness in the Postmarketing Stage: A Systematic Review.

Background: In recent years, real-world data (RWD) have been actively used in the field of pharmaceutical research. Database (DB) study, one of the observational studies using RWD, is a comprehensive, continuous, and rapid research method that plays an important role in the postmarketing stage of drugs, although the interpretation of the results may be limited. DB studies are often focused on drug safety, and previous research reviewing DB studies on drug effectiveness across different disease areas have been limited.

Elucidation of the Pattern of the Onset of Male Lower Urinary Tract Symptoms Using Cluster Analysis: Efficacy of Tamsulosin in Each Symptom Group.

Objective: To present a new grouping of male patients with lower urinary tract symptoms (LUTS) based on symptom patterns and clarify whether the therapeutic effect of α1-blocker differs among the groups.

Methods: We performed secondary analysis of anonymous data from 4815 patients enrolled in a postmarketing surveillance study of tamsulosin in Japan. Data on 7 International Prostate Symptom Score (IPSS) items at the initial visit were used in the cluster analysis.