A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: The PLATYPUS Study

Karagianis, Jamie; Grossman, Loren; Landry, John; Reed, Victoria; Haan, Lieuwe de; Maguire, Gerald A.; Hoffmann, Vicki Poole; Milev, Roumen

doi:10.1016/j.schres.2009.05.024

Cited by 27 publications

(40 citation statements)

References 32 publications

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“…As an example, a significantly greater 234 proportion of schizophrenic patients (92.9%) were compliant (>75% adherent by pill count) with their 235 olanzapine ODT with respect to the conventional tablet formulation (78.5%; P=0.015) [53].…”

mentioning

confidence: 99%

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

Cilurzo

Franzè

Selmin

et al. 2018

Drug Discovery Today

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mentioning

confidence: 99%

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

Cilurzo

Franzè

Selmin

et al. 2018

Drug Discovery Today

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“…Among the pharmacological studies, 32 used a placebo in the control arm [35–43, 45, 46, 48–55, 57–60, 62, 63, 65–67, 69, 71, 72, 74]. Seven trials evaluated an intervention against usual care [47, 56, 61, 64, 68, 70, 73].…”

Section: Resultsmentioning

confidence: 99%

The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

et al. 2017

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People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs) in adults with SMI, with or without a diagnosis of diabetes that measured fasting blood glucose or glycated haemoglobin (HbA1c). Screening and data extraction were carried out independently by two reviewers. We used random effects meta-analysis to estimate effectiveness, and subgroup analysis and univariate meta-regression to explore heterogeneity. The Cochrane Collaboration’s tool was used to assess risk of bias. We found 54 eligible RCTs in 4,392 adults (40 pharmacological, 13 behavioural, one mixed intervention). Data for meta-analysis were available from 48 RCTs (n = 4052). Both pharmacological (mean difference (MD), -0.11mmol/L; 95% confidence interval (CI), [-0.19, -0.02], p = 0.02, n = 2536) and behavioural interventions (MD, -0.28mmol//L; 95% CI, [-0.43, -0.12], p<0.001, n = 956) were effective in lowering fasting glucose, but not HbA1c (pharmacological MD, -0.03%; 95% CI, [-0.12, 0.06], p = 0.52, n = 1515; behavioural MD, 0.18%; 95% CI, [-0.07, 0.42], p = 0.16, n = 140) compared with usual care or placebo. In subgroup analysis of pharmacological interventions, metformin and antipsychotic switching strategies improved HbA1c. Behavioural interventions of longer duration and those including repeated physical activity had greater effects on fasting glucose than those without these characteristics. Baseline levels of fasting glucose explained some of the heterogeneity in behavioural interventions but not in pharmacological interventions. Although the strength of the evidence is limited by inadequate trial design and reporting and significant heterogeneity, there is some evidence that behavioural interventions, antipsychotic switching, and metformin can lead to clinically important improvements in glycaemic measurements in adults with SMI.

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“…Of the fifteen clinical studies assessing the efficacy/effectiveness of ODO, two are RCTs: one is a double-blind parallel-arm trial assessing the safety of ODO compared with SOT as its primary objective27 and the other is an open-label crossover study assessing patient preference for ODO compared with SOT 28. Four observational cohort studies have also compared patients taking ODO and SOT 29–32.…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Two RCTs27,28 and four prospective cohort studies29–32 compared the efficacy of ODO with SOT. Additionally, one relatively small (N = 38) retrospective open-label study utilized chronological sequential assignment of patients to ODO or SOT and used PANSS to compare the efficacy of these groups 35.…”

Section: Clinical Studiesmentioning

confidence: 99%

Orally disintegrating olanzapine review: effectiveness, patient preference, adherence, and other properties

Montgomery¹,

Treuer²,

Karagianis³

et al. 2012

PPA

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Orally disintegrating olanzapine (ODO) is a rapid-dissolving formulation of olanzapine which disintegrates in saliva almost immediately, developed as a convenient and adherence-enhancing alternative to the standard olanzapine-coated tablet (SOT). Clinical studies, which form the basis of this review, have shown ODO and SOT to have similar efficacy and tolerability profiles. However, ODO appears to have a number of advantages over SOT in terms of adherence, patient preference, and reduction in nursing burden. Overall, the existing clinical data suggests that compared to SOT, ODO is not only well-suited for difficult-to-treat, agitated, and/or nonadherent patients but, due to its potential ability to improve adherence and greater patient preference, may also be an appropriate formulation for the majority of patients for which olanzapine is the antipsychotic of choice.

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A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: The PLATYPUS Study

Cited by 27 publications

References 32 publications

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

Orally disintegrating olanzapine review: effectiveness, patient preference, adherence, and other properties

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