If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Quetiapine Fumarate Improves Sleep Quality in Patients With Major Depressive Disorder: Presented at ECNP By Jenny Powers ISTANBUL, Turkey -- September 15, 2009 -- Patients with major depressive disorder (MDD) experienced improved sleep quality, better overall functioning, and were at reduced risk of having a depressive event following treatment with quetiapine fumarate extended release (XR), according to research reported here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress. Coinvestigator David V. Sheehan, MD, University of South Florida, Institute of Research in Psychiatry, Tampa, Florida, presented study results here on September 13 on behalf of a research team led by Henrik Svedsäter, MD, AstraZeneca R&D, Mölndal, Sweden. Patients with MDD often display decreased functioning abilities and experience sleep disturbance that may lead to relapse. The National Health and Nutrition Examination Survey estimated that 80% of MDD patients display functional impairment, including loss of workdays and/or inability to work. In addition, 72% of patients in remission from MDD report sleep disturbance. Current first-line pharmacotherapy for MDD has no effect on accompanying sleep disorders, resulting in patients receiving one therapy for MDD and a second pharmacological intervention for their sleep disorder. Quetiapine has been approved by the US Food and Drug Administration and is currently being evaluated in Europe for the treatment of bipolar syndrome and MDD. Quetiapine ER given once daily (50 to 300 mg) has been shown to be effective as long-term monotherapy in both adult and elderly MDD patients. This study focused on patient-reported outcomes to determine the secondary impact of once-daily, extended-release quetiapine fumarate (quetiapine XR) on patient quality of sleep and ability to function in a double-blind, parallel-group maintenance study of quetiapine XR monotherapy in patients with MDD. Patients were randomised to receive either placebo (n = 385) or open-label quetiapine XR (n = 391) for 4 to 8 weeks followed by a 12- to 18-week stabilisation phase wherein patients received quetiapine XR at doses of 50, 150, or 300 mg/day. The primary outcome variable was time from randomisation to first depressive event, and the secondary outcome variables included least squares mean change from baseline to mean postrandomisation score. Daily function was measured using the Sheehan Disability Scale (SDS) and sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Quetiapine XR patients experienced a significantly increased time to a depressive event compared with placebo (hazard ratio = 0.34; 95% confidence interval, 0.25-0.46; P < .001). Quetiapine XR-treated patients also had an improved quality of life as reflected by non-work-related SDS domain scores (“social life/leisure” -0.19 vs 0.13 for quetiapine XR vs placebo, P < .05; “family life/home responsibilities” -0.22 vs 0.10 for quetiapine XR vs placebo, P < .05). The quetiapine XR group either improved or did not worsen in respect to individual work-related SDS domain scores; however, the placebo group had worsening scores in all 3 of those domains (“work/school” 0.00 vs 0.19 for quetiapine XR vs placebo, P = .219; “workdays lost” -0.03 vs 0.07 for quetiapine XR vs placebo, P = .171; “days underproductive” -0.07 vs 0.03 for quetiapine XR vs placebo, P = .271). Furthermore, quality of sleep declined in the placebo group compared with the quetiapine XR group, reflected by a mean increase in the PSQI global scores (1.35 and 0.06 for quetiapine XR vs placebo). The mean overall SDS scores (n = 285 vs n = 352, placebo vs quetiapine, respectively) were not substantially different between treated and placebo groups. Dr. Sheehan explained that a fundamental parameter was being unemployed, and the baseline group contained many already unemployed persons, so no statistical difference in change in employment status could be detected. The authors concluded that patients with MDD maintained better overall ability to function and better sleep quality with once-daily quetiapine XR (50 to 300 mg/day) treatment. Dr. Sheehan emphasised that these positive results were obtained using a monotherapy, which eliminates costly dual treatment, yielding fewer side effects at a low dose, with less treatment cost to patients. Funding for this study was provided by AstraZeneca Pharmaceuticals. [Presentation title: Effects of Extended Release Quetiapine Fumarate on Long-Term Functioning and Sleep Quality in Patients With Major Depressive Disorder]
|
