AN OPEN COMPARATIVE AND RANDOMIZED STUDY ON VALPROATE’S EFFECT IN THE LONG-TERM TREATMENT OF BIPOLAR DISORDERS VERSUS LITHIUM CARBONATE AND CARBAMAZEPINE
Bipolar disorder is a chronic disorder, with a large diversity range of clinical manifestations that affects around 1% of total population around the world.
Objective: Evaluation of differences in efficacy between Sodium Valproate and Lithium Carbonate and Carbamazepine in maintenance treatment of patients with bipolar disorder during a 2 years follow-up period.
Design: an open comparative and randomized study.
Setting: UHC Tirana “Mother Teresa”, Psychiatric Service, Emergency Ward Participants: A total of 235 inpatient and outpatient, diagnosed with bipolar disorder I and II (at least two mood episodes) based on DSM-IV-TR. Main Outcome measures: Time survival analyses to any events (relapse/recurrence) for entire population in study, comparing three separated groups (n=60) valproate (Vp) versus lithium (Li) versus carbamazepine (Cbz).
Results: Cumulative survival of Vp was 26% higher than Cbz (p=0.001) and 4.3% than Li (p=0.4304). The mean survival time for Vp was 35 +/- 7% higher than Cbz and 10 +/- 6% higher than Li, while median time for Vp was respectively 53 +/- 7% and 14 +/- 13% higher than Cbz and Li groups. Hazard ratio of Cbz has been 108.5% higher than Vp (B=0.735, p=0.001), for Li was 20.4% higher than Vp (B=0.186).
Concerning the predictors: Vp was more effective than Li in non-classic BD I (p=0.031), also superior to Li in mixed, rapid cycling subtypes and in co-morbidities. Vp was more effective than Cbz in classic BD-I (p=0.0312).
Conclusions: Vp is significantly more effective than Cbz in long-term treatment of BD, Vp is superior than Li in non-classic form of BD.
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