The costs and consequences of donepezil versus placebo treatment in patients with mild to moderate Alzheimer’s disease (AD) were evaluated as part of a 1-year prospective, double-blind, randomized, multinational clinical trial. Patients received either donepezil (n = 142; 5 mg/day for 28 days followed by 10 mg/day according to the clinician’s judgement) or placebo (n = 144). Unit costs were assessed in 1999 Swedish kronas (SEK) and converted to US dollars (USD). Donepezil-treated patients gained functional benefits relative to placebo on the Progressive Deterioration Scale (p = 0.042) and Instrumental Activities of Daily Living scale (p = 0.025) at week 52. Caregivers of donepezil-treated patients spent an average of 400 h less annually providing care than caregivers of placebo-treated patients. Mean annual healthcare costs were SEK 137,752 (USD 16,438) per patient for the donepezil group and SEK 135,314 (USD 16,147) in the placebo group. With the average annual cost of donepezil at SEK 10,723 (USD 1,280) per patient, the SEK 2,438 (USD 291) cost difference represented a 77% cost offset. When caregiver time and healthcare costs were included, mean annual costs were SEK 209,244 (USD 24,969) per patient in the donepezil group and SEK 218,434 (USD 26,066) in the placebo group, a total saving associated with donepezil treatment of SEK 9,190 (USD 1,097) per patient [95% CI of SEK –43,959 (USD –5,246), SEK 25,581 (USD 3,053); p = 0.6]. The positive effects on the efficacy outcome measures combined with no additional costs from a societal perspective indicate that donepezil is a cost-effective treatment, representing an improved strategy for the management of patients with AD.

BACKGROUND AND OBJECTIVES:Since conventional randomized clinical trials often do not reflect the real world circumstances of prescribing behavior and patient outcomes, the use of retrospective administrative claims databases (RACD) has become more common in treatment cost comparisons among alternative pharmaceutical compounds. Several recent RACD studies have compared treatment costs for depressed patients prescribed SSRIs such as fluoxetine, sertraline and paroxetine. These cost comparisons have reached mixed conclusions. To begin to explain and reconcile the mixed SSRI cost comparison evidence, we undertake a variety of alternative multivariate analyses using a publicly available RACD.METHODS AND DATA:The 1995 to 1996 data encompasses a time period when all three SSRIs had become well-established agents. We report and compare results from multivariate linear regressions, logistic regressions, ordered probits and sample selectivity models, and examine robustness when adjustments are made for outlier observations and skewed distributions.RESULTS AND CONCLUSIONS:While choice of initial SSRI is nonrandom, the effect of sample selectivity on total depression-related and total health care expenditure is neutral across SSRIs. Although most cost measures are numerically greatest for fluoxetine, depression-related outpatient and hospitalization costs do not significantly differ by choice of initial SSRI. These findings are robust to alternative assumptions, specifications, and procedures. Antidepressant medication costs, however, are significantly higher when fluoxetine is the initial SSRI rather than sertraline or paroxetine, reflecting the larger proportion of fluoxetine patients prescribed a daily dosage of two or more capsules. Both total depression-related and total health care log-transformed costs are significantly lower for sertraline than fluoxetine.

OBJECTIVE To compare depression-related treatment costs and total healthcare costs for patients diagnosed with depression and treated with either sertraline, paroxetine, or fluoxetine. PATIENTS AND METHODS Claims records from a national database of patients diagnosed with depression who began treatment with an SSRI in 1995, following an antidepressant medication-free period of at least 6 months, were included. Treatment course and associated depression-related treatment and total healthcare costs during the subsequent 12-month treatment period were examined using univariate and multivariate methods. RESULTS Nine-hundred five (905) patients taking sertraline, 492 on paroxetine, and 945 on fluoxetine met inclusion criteria. The groups were similar and representative with respect to gender and age. Mean dose over the 12-month treatment period increased 24%, indicating significant titration in all cohorts. Patients treated with paroxetine had shorter treatment duration (157.0 days) than did patients treated with fluoxetine (192.6 days) or sertraline (166.9 days, P < 0.001). Patients receiving index treatment with paroxetine were most likely to switch to another SSRI (21.3%); those taking sertraline were second most likely to switch (16.1%); and those on fluoxetine were least likely (12.4%, P = 0.001). Mean costs for depression-related outpatient visits and hospitalizations were similar. Mean antidepressant prescription costs differed, being $586, $419, and $446 for fluoxetine, paroxetine and sertraline cohorts, respectively (P < 0.001). In this sample, the fluoxetine cohort did not have lower nonpharmaceutical healthcare costs to offset higher pharmaceutical acquisition costs. Conclusions from median and multivariate analyses were robust to these findings. CONCLUSIONS During this study period when fluoxetine, paroxetine, and sertraline were all well-established agents, similar depression-related treatment courses and cost characteristics among all 3 drugs were observed.

Background: This study examined the validity of the early-late onset subtyping distinction in dysthymic disorder. Methods: Participants were 340 out-patients meeting DSM-III-R criteria for dysthymia and a concurrent major depressive episode (MDE). The sample was drawn from a 12-site double-blind randomized parallel group trial comparing the efficacy of sertraline and imipramine in the treatment of chronic depression. All patients received comprehensive evaluations using semi-structured interviews and rating scales. Results: 73% of the sample met criteria for the early-onset, and 27% for the late-onset, subtype. The early-onset patients had a significantly longer index MDE, significantly higher rates of personality disorders and lifetime substance use disorders, and a significantly greater proportion had a family history of mood disorder. The subgroups did not differ in symptom severity or functional impairment at baseline, nor in response to a 12-week trial of antidepressants. Limitations: Further work is needed to extend these findings to dysthymic disorder without superimposed MDEs. Conclusions: These results support the distinction between early-onset and late-onset dysthymic disorder.