Dataset Information

Indirect comparison analysis of efficacy and safety between olanzapine and aripiprazole for schizophrenia.

ABSTRACT:

Aims

Indirect comparison (IC) and direct comparison (DC) between aripiprazole and olanzapine for schizophrenia were conducted to compare their efficacy and safety. The objective was to determine the usability of IC and consistency of results delivered by the two comparisons. Factors that might influence the inconsistency of results were also investigated.

Methods

ICs and DCs were conducted using the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score as an efficacy endpoint and the dropout rate was selected as a safety endpoint. Placebo and risperidone were used as common comparators for ICs.

Results

A literature search identified 20 articles. The efficacy analysis gave results on the mean difference in PANSS change (95% CI) of -5.72 (-10.22, -1.22) in ICs using placebo as a common comparator and -7.41 (-15.96, 1.14) in DCs. When using risperidone as a common comparator, it was -9.15 (-20.12, 1.82). In rate ratio analysis of the all cause dropout rate, the IC result was 1.17 (0.83, 1.65) using placebo as a common comparator and 1.56 (0.57, 4.26) using risperidone as a common comparator. Both analyses gave consistent results between ICs and DCs. A slightly lower estimated value was observed in ICs using placebo.

Conclusions

This study demonstrated that ICs between olanzapine and aripiprazole can deliver results consistent with those of DCs. It is also suggested that the selection of a common comparator is important when control group bias is suspected in the data set.

SUBMITTER: Kunitomi T

PROVIDER: S-EPMC4004397 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Publications

Indirect comparison analysis of efficacy and safety between olanzapine and aripiprazole for schizophrenia.

Kunitomi Taro T Hashiguchi Masayuki M Mochizuki Mayumi M

British journal of clinical pharmacology 20140501 5

<h4>Aims</h4>Indirect comparison (IC) and direct comparison (DC) between aripiprazole and olanzapine for schizophrenia were conducted to compare their efficacy and safety. The objective was to determine the usability of IC and consistency of results delivered by the two comparisons. Factors that might influence the inconsistency of results were also investigated.<h4>Methods</h4>ICs and DCs were conducted using the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total sco ...[more]

PMID: 23919914

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Project description:BackgroundAntipsychotic treatment may improve clinical insight. However, previous studies have reported inconclusive findings on whether antipsychotics improve insight over and above the reduction in symptoms of psychosis. These studies assessed homogeneous samples in terms of stage of illness. Randomised studies investigating a mixed population of first- and multiepisode schizophrenia spectrum disorders might clarify this disagreement.MethodsOur data were derived from a pragmatic, rater-blinded, semi-randomised trial that compared the effectiveness of amisulpride, aripiprazole and olanzapine. A sample of 144 patients with first- or multiepisode schizophrenia spectrum disorders underwent eight assessments during a 1-year follow-up. Clinical insight was assessed by item General 12 from the Positive and Negative Syndrome Scale (PANSS). We analysed latent growth curve models to test if the medications had a direct effect on insight that was over and above the reduction in total psychosis symptoms. Furthermore, we investigated whether there were differences between the study drugs in terms of insight.ResultsBased on allocation analysis, all three drugs were associated with a reduction in total psychosis symptoms in the initial phase (weeks 0-6). Amisulpride and olanzapine were associated with improved insight over and above what was related to the reduction in total psychosis symptoms in the long-term phase (weeks 6-52). However, these differential effects were lost when only including the participants that chose the first drug in the randomisation sequence. We found no differential effect on insight among those who were antipsychotic-naïve and those who were previously medicated with antipsychotics.ConclusionsOur results suggest that antipsychotic treatment improves insight, but whether the effect on insight surpasses the effect of reduced total psychosis symptoms is more uncertain.Trial registrationClinicalTrials.gov Identifier: NCT01446328, 05.10.2011.

Project description:Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia.This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety.A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013.Studies were required to have ?24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo.Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms.Data were analyzed by applying a mixed treatment comparison competing risks model (efficacy) and using binary models (safety). There was no statistically significant difference between any study outcome, including the risk of relapse, the risk of discontinuations, and safety outcomes.Aripiprazole once-monthly is similarly efficacious to other LAIs with relatively low rates of discontinuation due to AEs and due to reasons other than AEs than other LAIs.

Project description:IntroductionThe objective of this study was to estimate the relative efficacy and safety of fixed-dose combination aclidinium/formoterol 400/12 μg twice daily compared to tiotropium 18 μg once daily in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).MethodsA systematic literature review performed in March 2014, using a predefined search strategy in MEDLINE, EMBASE and Cochrane Library, identified 17 randomized placebo-controlled trials, (tiotropium n = 15; aclidinium/formoterol n = 2). Outcomes of interest were: bronchodilation (peak and trough forced expiratory volume in 1 s (FEV1)), COPD symptoms [Transition Dyspnea Index (TDI) focal score and % of responders (>1 unit improvement)] and Health Related Quality of Life (HRQoL) [St. George's Respiratory Questionnaire (SGRQ) total score and % responders (>4 unit improvement)], % of patients with ≥1 exacerbations, adverse events (AE), serious adverse events (SAE), hospitalization and mortality, all at 24 weeks. In the absence of head-to-head trials between aclidinium/formoterol and tiotropium, a Bayesian indirect treatment comparison (ITC) was used with placebo as common control.ResultsRegarding bronchodilation, aclidinium/formoterol was found to be more efficacious than tiotropium at peak FEV1, with mean difference in change from baseline (DCFB) 143 mL [95% credible interval (CrI): 112, 174] and at trough FEV1 [DCFB 26 mL (95% CrI -2, 55)]. Aclidinium/formoterol is expected to be more efficacious than tiotropium in improving dyspnea symptoms measured by TDI [DCFB 0.54 points (95% CrI 0.09, 0.99); odds ratio (OR) of responders 1.51 (95% CrI 1.11, 2.06)]. SGRQ results are comparable for aclidinium/formoterol versus tiotropium [DCFB -0.52 (95% CrI -2.21, 1.17); OR of responders 1.16 (95% CrI 0.47, 2.87)]. The ITC results suggest similar safety profiles regarding AEs, SAEs and hospitalization.ConclusionBased on the ITC, aclidinium/formoterol is expected to be more efficacious than tiotropium in terms of lung function and symptom control while providing comparable HRQoL results and safety profile.FundingAstraZeneca.

Dataset Information

Indirect comparison analysis of efficacy and safety between olanzapine and aripiprazole for schizophrenia.

Aims

Methods

Results

Conclusions

Publications

Indirect comparison analysis of efficacy and safety between olanzapine and aripiprazole for schizophrenia.

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