Background: Fluvoxamine, a selective serotonin reuptake inhibitor is widely used in the treatment of depression, one of the most common disorders prevalent in Russia. However, studies demonstrating its efficacy and sa...Background: Fluvoxamine, a selective serotonin reuptake inhibitor is widely used in the treatment of depression, one of the most common disorders prevalent in Russia. However, studies demonstrating its efficacy and safety in routine settings in Russia are scarce. Methods: This prospective, uncontrolled, open-label study was conducted at 11 centers in Russia. Total 293 patients (aged ≥ 18 years), meeting DSM-IV criteria for depression and scoring ≥ 17 on 17-item Hamilton Rating Scale of Depression (HAMD-17) received fluvoxamine 50 - 300 mg for 6 weeks. Primary efficacy measures included change from baseline in the HAMD-17 and Clinical Global Impression (CGI) scores. Secondary efficacy measure was evaluation of sleep quality changes on HAMD-17 subscale. Safety was assessed by monitoring of adverse drug reactions (ADRs). Results: Mean age of patients was 42.7 years and the majority of them were women (72%). At the end of treatment (day 42), clinically significant reduction was observed in mean HAMD-17, CGI-severity of illness and HAMD-17 sleep sub-score from 23.1, 4.5 and 3.9 at baseline to day 42;change from baseline (Δ) was: Δ-17.3 [95% CI: -18.0;-16.7]), Δ-2.1 and Δ-3.4 [95% CI: -3.53;-3.20]), respectively. At day 42, 20.8% patients reported as normal (not at all ill) on the CGI-severity scale and 85% patients reported as “much improved” or “very much improved” on the CGI-change in severity and quality of life scores. Nausea (12.6%) and somnolence (5.1%) were the most frequently reported ADRs. No deaths or serious ADRs were reported but eight patients discontinued treatment due to ADRs. Conclusion: Treatment with fluvoxamine under routine settings showed marked improvement in Russian patients with depression as measured by HAMD-17 and CGI ratings and was thus efficacious as well as safe and well-tolerated.展开更多
文摘Background: Fluvoxamine, a selective serotonin reuptake inhibitor is widely used in the treatment of depression, one of the most common disorders prevalent in Russia. However, studies demonstrating its efficacy and safety in routine settings in Russia are scarce. Methods: This prospective, uncontrolled, open-label study was conducted at 11 centers in Russia. Total 293 patients (aged ≥ 18 years), meeting DSM-IV criteria for depression and scoring ≥ 17 on 17-item Hamilton Rating Scale of Depression (HAMD-17) received fluvoxamine 50 - 300 mg for 6 weeks. Primary efficacy measures included change from baseline in the HAMD-17 and Clinical Global Impression (CGI) scores. Secondary efficacy measure was evaluation of sleep quality changes on HAMD-17 subscale. Safety was assessed by monitoring of adverse drug reactions (ADRs). Results: Mean age of patients was 42.7 years and the majority of them were women (72%). At the end of treatment (day 42), clinically significant reduction was observed in mean HAMD-17, CGI-severity of illness and HAMD-17 sleep sub-score from 23.1, 4.5 and 3.9 at baseline to day 42;change from baseline (Δ) was: Δ-17.3 [95% CI: -18.0;-16.7]), Δ-2.1 and Δ-3.4 [95% CI: -3.53;-3.20]), respectively. At day 42, 20.8% patients reported as normal (not at all ill) on the CGI-severity scale and 85% patients reported as “much improved” or “very much improved” on the CGI-change in severity and quality of life scores. Nausea (12.6%) and somnolence (5.1%) were the most frequently reported ADRs. No deaths or serious ADRs were reported but eight patients discontinued treatment due to ADRs. Conclusion: Treatment with fluvoxamine under routine settings showed marked improvement in Russian patients with depression as measured by HAMD-17 and CGI ratings and was thus efficacious as well as safe and well-tolerated.
