Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial.

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.

Cost effectiveness study of a year follow-up of selective serotonin reuptake inhibitor (SSRI) and augmentor combination compared with SSRI and placebo.

We describe a method for evaluating the value of increased cost of pharmacological augmentation that, taken for 6 weeks, accelerates the action of an antidepressant. We test the hypothesis that, if onset of action is taken into account, any added direct costs of the augmenting agent are offset by longer term cost effectiveness. Data to illustrate the method were based on a double-blind randomized placebo controlled study, in which 80 patients originally took part. Patients received the selective serotonin reuptake inhibitor (SSRI) antidepressant paroxetine and an augmenting agent (pindolol) or placebo. After 6 weeks, patients were offered SSRI alone on an open label basis for up to 6 months. At that point they were discharged to their general practitioner or local psychiatric services and subsequently assessed by us at one year. We have used techniques of decision analysis, cost effectiveness and cost benefit and have included a sensitivity analysis. The direct costs over one year of SSRI and augmenting agent, if taking the acceleration effect into account, represented greater cost effectiveness than the SSRI antidepressant alone. The cost effectiveness analysis was positive in both cases. We conclude that the direct costs of treatment are higher than those of previous calculated with SSRIs; but the rate of onset must be taken into account. The application of the model appears valid and useful, and may be used as part of the evaluation of other augmentation regimes.