A rapid and systematic review and economic evaluation of the clinical and cost-effectiveness of newer drugs for treatment of mania associated with bipolar affective disorder

Bridle, C. and Palmer, S. and Bagnall, A.-M. and Darba, J. and Duffy, S. and Sculpher, M. and Riemsma, R. (2004) A rapid and systematic review and economic evaluation of the clinical and cost-effectiveness of newer drugs for treatment of mania associated with bipolar affective disorder. Health Technology Assessment, 8 (19). iii-109. ISSN 1366-5278

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Abstract

Objectives: To evaluate the clinical and cost-effectiveness of quetiapine, olanzapine and valproate semisodium in the treatment of mania associated with bipolar disorder. Data sources: Electronic databases; industry submissions made to the National Institute for Clinical Excellence. Review methods: Randomised trials and economic evaluations that evaluated the effectiveness of quetiapine, olanzapine or valproate semisodium in the treatment of mania associated with bipolar disorder were selected for inclusion. Data were extracted by one reviewer into a Microsoft Access database and checked for quality and accuracy by a second. The quality of the cost-effectiveness studies was assessed using a checklist updated from that developed by Drummond and colleagues. Relative risk and mean difference data were presented as Forest plots but only pooled where this made sense clinically and statistically. Studies were grouped by drug and, within each drug, by comparator used. � 2 tests of heterogeneity were performed for the outcomes if pooling was indicated. A probabilistic model was developed to estimate costs from the perspective of the NHS, and health outcomes in terms of response tare, based on an improvement of at least 50 in a patient's baseline manic symptoms derived from an interview-based mania assessment scale. The model evaluated the cost-effectiveness of the alternative drugs when used as part of treatment for the acute manic episode only. Results: Eighteen randomised trials met the inclusion criteria. Aspects of three of the quetiapine studies were commercial-in-confidence. The quality of the included trials was limited and overall, key methodological criteria were not met in most trials. Quetiapine, olanzapine and valproate semisodium appear superior to placebo in reducing manic symptoms, but may cause side-effects. There appears to be little difference between these treatments and lithium in terms of effectiveness, but quetiapine is associated with somnolence and weight gain, whereas lithium is associated with tremor. Olanzapine as adjunct therapy to mood stabilisers may be more effective than placebo in reducing mania and improving global health, but it is associated with more dry mouth, somnolence, weight gain, increased appetite, tremor and speech disorder. There was little difference between these treatments and haloperidol in reducing mania, but haloperidol was associated with more extrapyramidal side-effects and negative implications for health-related quality of life. Intramuscular olanzapine and lorazepam were equally effective and safe in one very short (24 hour) trial. Valproate semisodium and carbamazepine were equally effective and safe in one small trial in children. Olanzapine may be more effective than valproate semisodium in reducing mania, but was associated with more dry mouth, increased appetite, oedema, somnolence, speech disorder, Parkinson-like symptoms and weight gain. Valproate semisodium was associated with more nausea than olanzapine. The results from the base-case analysis demonstrate that choice of optimal strategy is dependent on the maximum that the health service is prepared to pay per additional responder. For a figure of less than £7179 per additional responder, haloperidol is the optimal decision; for a spend in excess of this, it would be olanzapine. Under the most favourable scenario in relation to the costs of responders and non-responders beyond the 3-week period considered in the base-case analysis, the incremental cost-effectiveness ratio of olanzapine is reduced to £1236. Conclusions: In comparison with placebo, quetiapine, olanzapine and valproate semisodium appear superior in reducing manic symptoms, but all drugs are associated with adverse events. In comparison with lithium, no significant differences were found between the three drugs in terms of effectiveness, and all were associated with adverse events. Several limitations of the cost-effectiveness analysis exist, which inevitably means that the results should be treated with some caution. There remains a need for well-conducted, randomised, double-blind head-to-head comparisons of drugs used in the treatment of mania associated with bipolar disorder and their cost-effectiveness. Participant demographic, diagnostic characteristics, the treatment of mania in children, the use of adjunctive therapy and long-term safety issues in the elderly population, and acute and long-term treatment are also subjects for further study. © Queen's Printer and Controller of HMSO 2004. All rights reserved.

Keywords:ammonia, carbamazepine, cholesterol, glucose, haloperidol, lithium, lorazepam, olanzapine, placebo, prolactin, quetiapine, thyroid hormone, triacylglycerol, valproate semisodium, accuracy, acne, amenorrhea, anxiety disorder, asthenia, ataxia, bipolar I disorder, blood dyscrasia, child care, clinical trial, constipation, controlled clinical trial, controlled study, cost effectiveness analysis, data base, dementia, demography, disease association, drowsiness, drug cost, drug efficacy, drug eruption, drug safety, drug withdrawal, dyspepsia, edema, elderly care, erythrocyte disorder, extrapyramidal symptom, Fanconi renotubular syndrome, fever, gynecomastia, hair loss, health care cost, health care financing, health care utilization, hearing loss, hepatitis, hirsutism, human, hyperammonemia, hypercholesterolemia, hyperglycemia, hyperprolactinemia, hypertension, hypertriglyceridemia, hypothyroidism, increased appetite, interview, length of stay, leukopenia, liver failure, mania, medical decision making, menstrual irregularity, mental health service, methodology, myalgia, national health service, nausea, otalgia, pancytopenia, parkinsonism, patient compliance, photosensitivity, priapism, probability, psychologic assessment, QT prolongation, quality control, quality of life, randomized controlled trial, rating scale, review, rhinitis, sensitivity analysis, side effect, somnolence, speech disorder, statistical analysis, Stevens Johnson syndrome, stomach disease, symptom, tachycardia, thrombocyte aggregation inhibition, thrombocytopenia, toxic epidermal necrolysis, treatment outcome, tremor, vasculitis, weight gain, xerostomia
Subjects:L Social studies > L510 Health & Welfare
B Subjects allied to Medicine > B200 Pharmacology, Toxicology and Pharmacy
Divisions:College of Social Science > School of Health & Social Care
College of Social Science > Lincoln Institute of Health
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ID Code:23915
Deposited On:01 Sep 2016 11:16

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