A randomized, controlled trial of duloxetine alone vs. duloxetine plus a telephone intervention in the treatment of depression.
ABSTRACT We hypothesized that combining antidepressant medication with a standardized telephone adherence support intervention would lead to superior outcomes in the treatment of depression compared with antidepressant medication alone.
Patients with depression were randomized to receive the antidepressant duloxetine alone (DLX), or duloxetine plus a standardized telephone intervention (DLX+TI), for 12 weeks of open-label treatment. The primary outcome measure was remission (HAMD 17 total score <or=7) at study endpoint. Safety and tolerability were assessed via reporting of treatment-emergent adverse events (AEs), vital signs and laboratory measures. The TI was delivered approximately 1, 4, and 9 weeks after initiation of duloxetine.
The DLX (N=485) and DLX+TI (N=477) groups did not differ significantly at baseline. At study endpoint, remission rates (42.8% vs. 43.5%, P=0.87), response rates (56.6% vs. 58.4%, P=0.58) and other secondary outcomes were similar between the groups. A similar proportion of patients in each group completed the study, and adverse event discontinuation rates were not significantly different (10.7% vs. 13.0%, P=0.318). More AEs were reported by patients in the DLX+TI group, however, and constipation (3.5% vs. 10.1%, P<0.001) and hot flush (0.2% vs. 1.7%, P=0.020) were reported by more DLX+TI patients. Adherence to medication was high (>90% at every visit) in both groups.
A telephone intervention in combination with antidepressant medication (duloxetine) did not improve depression outcomes compared with antidepressant alone in this clinical trial, perhaps due to high drug adherence in both treatment groups. Addition of a telephone intervention was, however, associated with increased reporting of AEs.
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ABSTRACT: Medication nonadherence is a major obstacle to translating treatment efficacy from research settings into effectiveness in clinical practice for patients with affective disorders. Adherence to beneficial drug therapy is associated with lower mortality compared with poor adherence. Reduced adherence is associated with increased suicide risk, especially when lithium is discontinued. The aim of this paper is to review the prevalence, predictors and methods for improving medication adherence in unipolar and bipolar affective disorders. Studies were identified through Medline and PsycInfo searches of English language publications between 1976 and 2009. This was supplemented by a hand search and the inclusion of selected descriptive articles on good clinical practice. Estimates of medication nonadherence for unipolar and bipolar disorders range from 10 to 60% (median: 40%). This prevalence has not changed significantly with the introduction of new medications. There is evidence that attitudes and beliefs are at least as important as side effects in predicting adherence. The limited number of empirical studies on reducing nonadherence indicate that, if recognized, the problem may be overcome. Clinical data highlight the importance of extended courses of medication in improving the long-term prognosis of patients with affective disorders.Expert Review of Neurotherapeutics 08/2009; 9(7):985-1004. DOI:10.1586/ern.09.62 · 2.83 Impact Factor
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ABSTRACT: 5-Hydroxytryptamine (5-HT; serotonin) was discovered more than 60 years ago as a substance isolated from blood. The neural effects of 5-HT have been well investigated and understood, thanks in part to the pharmacological tools available to dissect the serotonergic system and the development of the frequently prescribed selective serotonin-reuptake inhibitors. By contrast, our understanding of the role of 5-HT in the control and modification of blood pressure pales in comparison. Here we focus on the role of 5-HT in systemic blood pressure control. This review provides an in-depth study of the function and pharmacology of 5-HT in those tissues that can modify blood pressure (blood, vasculature, heart, adrenal gland, kidney, brain), with a focus on the autonomic nervous system that includes mechanisms of action and pharmacology of 5-HT within each system. We compare the change in blood pressure produced in different species by short- and long-term administration of 5-HT or selective serotonin receptor agonists. To further our understanding of the mechanisms through which 5-HT modifies blood pressure, we also describe the blood pressure effects of commonly used drugs that modify the actions of 5-HT. The pharmacology and physiological actions of 5-HT in modifying blood pressure are important, given its involvement in circulatory shock, orthostatic hypotension, serotonin syndrome and hypertension.Pharmacological reviews 03/2012; 64(2):359-88. DOI:10.1124/pr.111.004697 · 18.55 Impact Factor
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ABSTRACT: BACKGROUND: Suboptimum medication adherence is common in the United States and leads to serious negative health consequences but may respond to intervention. PURPOSE: To assess the comparative effectiveness of patient, provider, systems, and policy interventions that aim to improve medication adherence for chronic health conditions in the United States. DATA SOURCES: Eligible peer-reviewed publications from MEDLINE and the Cochrane Library indexed through 4 June 2012 and additional studies from reference lists and technical experts. STUDY SELECTION: Randomized, controlled trials of patient, provider, or systems interventions to improve adherence to long-term medications and nonrandomized studies of policy interventions to improve medication adherence. DATA EXTRACTION: Two investigators independently selected, extracted data from, and rated the risk of bias of relevant studies. DATA SYNTHESIS: The evidence was synthesized separately for each clinical condition; within each condition, the type of intervention was synthesized. Two reviewers graded the strength of evidence by using established criteria. From 4124 eligible abstracts, 62 trials of patient-, provider-, or systems-level interventions evaluated 18 types of interventions; another 4 observational studies and 1 trial of policy interventions evaluated the effect of reduced medication copayments or improved prescription drug coverage. Clinical conditions amenable to multiple approaches to improving adherence include hypertension, heart failure, depression, and asthma. Interventions that improve adherence across multiple clinical conditions include policy interventions to reduce copayments or improve prescription drug coverage, systems interventions to offer case management, and patient-level educational interventions with behavioral support. LIMITATIONS: Studies were limited to adults with chronic conditions (excluding HIV, AIDS, severe mental illness, and substance abuse) in the United States. Clinical and methodological heterogeneity hindered quantitative data pooling. CONCLUSION: Reduced out-of-pocket expenses, case management, and patient education with behavioral support all improved medication adherence for more than 1 condition. Evidence is limited on whether these approaches are broadly applicable or affect long-term medication adherence and health outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.Annals of internal medicine 09/2012; 157(11). DOI:10.7326/0003-4819-157-11-201212040-00538 · 16.10 Impact Factor