EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

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.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia