REAL-WORLD EVIDENCE FOR ENDOXIFEN IN THE TREATMENT OF PATIENTS WITH BIPOLAR I DISORDER: A 12-WEEK OPEN-LABEL STUDY

Dr. Pragna Patel*, Dr. Amit B. Jain, Dr. Nilanj Dave

ABSTRACT

Objective: To understand the profile of bipolar I disorder (BD-I) patients prescribed Endoxifen in real world and evaluate effectiveness and tolerability of Endoxifen in Indian setting. Method: This was a real-world, retrospective, observational study carried out by ‘Study Investigator group’. Analysis of data was done for patients having at least 3 months follow up details with Endoxifen therapy. No additional evaluation or investigation was performed for this study. Results: Data of 258 BD-I patients (166 males/92 females) with mean age of 33.9±11.68 years from 25 centres across India were evaluated in this study. Psychotic symptoms and suicidal tendency were present in 43.3% and 17.1% patients respectively at baseline. Endoxifen was prescribed as an acute treatment in 80% patients and for maintenance in 20% patients. Endoxifen monotherapy was used in 35% patients while commonly co-prescribed medications included valproate, olanzapine, risperidone, lithium and quetiapine. 95% patients received dose of 8mg/day of endoxifen. With 3 months of treatment, endoxifen led to significant improvement (p<0.0001) in various clinical scores viz. YMRS (34.04±10.5 to 10.07±7.37), MADRS (24.13±15.63 to 8.61±8.38) and BPRS (53.14±18.54 to 25.98±10.72). Clinical response and remission were achieved by 77.5% and 68.6% patients respectively. Endoxifen was well tolerated with most adverse events being mild to moderate in severity. Most patients reported satisfactory to excellent compliance with Endoxifen. Conclusion: Endoxifen is found to be effective and safe in real world clinical practice when prescribed in manic or mixed episodes of BD-I patients.

Keywords: real-world, endoxifen, mania, bipolar I disorder.