Long Term Investigation of Paroxetine Hydrochloride in Patients with Depression, Depressive Episodes or Panic Disorder

Accession number;06A0417275
Title;Long Term Investigation of Paroxetine Hydrochloride in Patients with Depression, Depressive Episodes or Panic Disorder
Author;NAKAMURA JUN(School of Medicine, Univ. Occupational and Environmental Health, JPN)   MATSUDA YASUYUKI(Glaxo Smith Kline K.K., JPN)   ISHIDA ATSUKO(Glaxo Smith Kline K.K., JPN)   YOKOMORI JUNJI(Glaxo Smith Kline K.K., JPN)   KATO JUN(Glaxo Smith Kline K.K., JPN)   UECHI YASUYUKI(Glaxo Smith Kline K.K., JPN)   NAGATA TSUTAE(Glaxo Smith Kline K.K., JPN)   
Journal Title;Ther Res
Journal Code:Y0681A
ISSN:0289-8020
VOL.27;NO.5;PAGE.869-886(2006)
Figure&Table&Reference;FIG.6, TBL.11, REF.28
Pub. Country;Japan
Language;Japanese
Abstract;Clinical usefulness of the long term use of Paxil (paroxetine hydrochloride) in patients with depression, depressive episodes, or panic disorder under actual clinical use in Japan was yet to be fully investigated. For this purpose, a long-term investigation over one year with Paxil was conducted to evaluate the efficacy and safety in 322 patients with depression, depressive episodes, or panic disorder. For depression or depressive episodes, the final overall improvement rate was 62.2% in 230 subjects eligible for the efficacy analysis and 90.2% in subjects who received Paxil for one or more years. For panic disorder, the final overall improvement rate in 59 subjects who underwent the efficacy analysis was 67.8%, and 83.3 % in subjects who received Paxil for one or more years. These results suggested that Paxil demonstrated excellent improvement rate in its long term use. Adverse drug reaction was reported in 64(21.9%)out of 292 subjects eligible for safety analysis. The major adverse drug reactions were known and of mild intensity such as nausea and somnolence. Among the adverse drug reactions, 71.9% occurred within two months of administration. No increasing trend of adverse drug reaction was noted in the subsequent long term administration, and Paxil were well-tolerated. In summary, Paxil have demonstrated considerably high efficacy and safety in the long-term administration in subjects with depression, depressive episodes, or panic disorder. (author abst.)