title: Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial.
abstract: Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.
authors.affiliation: Clinical Research Department, Lilly SA, Madrid, Spain. sacristan_jose@lilly.com
authors.forename: J A
authors.initials: JA
authors.lastname: Sacristán
authors.forename: I
authors.initials: I
authors.lastname: Gilaberte
authors.forename: B
authors.initials: B
authors.lastname: Boto
authors.forename: D P
authors.initials: DP
authors.lastname: Buesching
authors.forename: R L
authors.initials: RL
authors.lastname: Obenchain
authors.forename: M
authors.initials: M
authors.lastname: Demitrack
authors.forename: V
authors.initials: V
authors.lastname: Pérez Sola
authors.forename: E
authors.initials: E
authors.lastname: Alvarez
authors.forename: F
authors.initials: F
authors.lastname: Artigas
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000188:drug therapy* / Q000191:economics; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000191:economics* / Q000627:therapeutic use; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D010869:Pindolol / Q000191:economics* / Q000627:therapeutic use; D012702:Serotonin Antagonists / Q000191:economics* / Q000627:therapeutic use
chemical_list: D018687:Antidepressive Agents, Second-Generation; D012702:Serotonin Antagonists; D005473:Fluoxetine; D010869:Pindolol