Tolerability, Drug Utilization Pattern and Effectiveness of Minocycline Oral Formulations in India: A Real-World Retrospective Study from Electronic Medical Records.

backgroundMinocycline, a second-generation tetracycline, is widely used for the management of several dermatologic and infectious conditions. Large-scale real-world studies demonstrating its tolerability, utilization patterns, and effectiveness in Indian clinical practice remain limited.

objectivesThe aim of this study was to evaluate real-world tolerability, utilization patterns, and effectiveness of oral minocycline formulations.

methodsThis retrospective, real-world, observational, multicentric electronic medical records (EMR)-based study analyzed anonymized patient data retrieved from the HealthPlix EMR database between January 2017 and February 2023. Patients of either gender aged ≥12 years prescribed oral minocycline with at least one follow-up visit were included. The primary endpoint was tolerability, assessed as the proportion of patients with physician-documented complaints. Secondary outcomes included assessment of prescribing patterns and effectiveness.

resultsA total of 2161 patients from 189 centers across India met the eligibility criteria. The mean age ± standard deviation (SD) was 30.15 ± 12.50 years, and 62.56% (1352) of the patients were females. Acne was the most common indication, documented for 1230 patients (56.92%), with acne vulgaris being the most predominant subtype. Minocycline 100 mg once daily was the most frequently prescribed regimen. The most common prescription duration at baseline was 11-20 days. Adverse events were documented in a smaller proportion of patients (n = 29; 1.34%).

conclusionIn routine real-world practice, oral minocycline was prescribed for a range of indications, predominantly acne, with prescription patterns largely aligned with contemporary recommendations. These findings suggest that oral minocycline was rationally utilized, well tolerated and associated with positive clinical outcomes in routine clinical practice. Despite inherent limitations of the retrospective design, the study provides robust real-world evidence supporting the continued use of oral minocycline in Indian clinical practice. These findings should be interpreted cautiously in the view of the retrospective design and inherent limitations of EMR-based data. REGISTRY AND THE REGISTRATION NO. OF THE STUDY: The study was registered with the Clinical Trials Registry-India (CTRI) under the registration number CTRI/2023/08/056338-Retrospectively registered.