Global benefit–risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder

Wisniewski, Stephen R.; Chen, Chi Chang; Kim, Edward; Kan, Hong; Guo, Zhenchao; Carlson, Berit X.; Tran, Quynh-Van; Pikalov, Andrei

doi:10.1002/pds.1805

Cited by 8 publications

(7 citation statements)

References 18 publications

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“…We used an analytical approach that was similar to the one proposed by Gail and colleagues, which, according to our categorization of benefit–harm methodologies, compares multiple benefit and harm outcomes on a common metric (referred to as the “trade‐off index” by others). Besides, we tested the approach proposed by Chuang‐Stein et al that can account for joint occurrence of outcomes . We focused on available clinical outcome data measured in the MUST Trial that we deemed important to patients, as opposed to biomarkers or surrogate outcomes that are not necessarily linked to clinical outcomes.…”

Section: Methodsmentioning

confidence: 99%

“…Besides, we tested the approach proposed by Chuang-Stein et al that can account for joint occurrence of outcomes. 10,12 We focused on available clinical outcome data measured in the MUST Trial that we deemed important to patients, as opposed to biomarkers or surrogate outcomes that are not necessarily linked to clinical outcomes. We did not include quality of life measures in our assessment because they reflect the consequences of many benefits and harms that are difficult to disentangle, but these measures served as a good comparison for our results of benefit-harm assessment.…”

Section: Approaches Used and Outcomes Included For Benefitharm Assessmentioning

confidence: 99%

“…3,8 Some approaches that account for such joint occurrence of outcomes have been developed, yet are not commonly applied. [9][10][11][12][13] For example, Chuang-Stein et al illustrated their method to simultaneously consider patient's response (treatment benefits) and side effects (harms) in a clinical trial of antihypertensive 10 and generated summary measures that facilitate decision-making.…”

Section: Introductionmentioning

confidence: 99%

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Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis

Holbrook

Thorne

et al. 2016

Pharmacoepidemiol Drug Saf

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Background Synthesizing evidence from comparative effectiveness trials can be difficult since multiple outcomes of different importance are to be considered. The goal of this study was to demonstrate an approach to conducting quantitative benefit-harm assessment that considers patient preferences. Methods We conducted a benefit-harm assessment using data from the Multicenter Uveitis Steroid Treatment Trial that compared corticosteroid implant versus systemic corticosteroids and immunosuppression in non-infectious intermediate, posterior, and panuveitis. We focused on clinical outcomes considered important to patients, including visual acuity, development of cataracts/glaucoma, need for eye surgery, prescription-requiring hypertension, hyperlipidemia and infections. Patient preferences elicited in a recent survey were then incorporated into our assessment of the benefit-harm balance. Results Benefit-harm metrics were calculated for each time point that summarized the numbers of outcomes, caused or prevented by implant therapy versus systemic therapy if 1000 patients were treated. The benefit-harm metric was -129 (95% CI: -242 to -14), -317 (-436 to -196), -390 (-514 to -264) and -526 (-687 to -368) at 6, 12, 18, and 24 months follow-up, respectively, suggesting that systemic therapy may have a better benefit-harm balance. However, measures of quality of life for patients treated with implant therapy were found to be better than patients treated with systemic therapy over the same time period. Conclusions Results of benefit-harm assessment were different from the prospectively collected quality of life data during trial follow-up. Future studies should explore the reasons for such discrepancies and the strength and weakness of each method to assess treatment benefits and harms.

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Section: Methodsmentioning

confidence: 99%

Section: Approaches Used and Outcomes Included For Benefitharm Assessmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis

Holbrook

Thorne

et al. 2016

Pharmacoepidemiol Drug Saf

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“…(Barry et al, 2009;Callahan et al, 1998;Laursen et al, 2016) The efficacy of atypical antipsychotics in this population may account for their increasing use. (Olfson et al, 2015;Wang and Farley, 2013;Wisniewski et al, 2009) But despite their clinical benefits, all atypical antipsychotics can cause varying degrees of weight gain and cardiometabolic risk leading to increased cardiovascular disease and related mortality. (Colton and Manderscheid, 2006;Hjorthøj et al, 2017;Newcomer, 2004;Yood et al, 2009) Among the atypical antipsychotics, risk of weight gain, dyslipidemia and diabetes is highest with clozapine and olanzapine.…”

Section: Introductionmentioning

confidence: 99%

Getting to precision psychopharmacology: Combining clinical and genetic information to predict fat gain from aripiprazole

Oughli

Lenze

Locke

et al. 2019

Journal of Psychiatric Research

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Introduction: All atypical antipsychotics are associated with some degree of weight gain. We applied a novel statistical approach to identify moderators of aripiprazole-induced fat gain using clinical and genetic data from a randomized clinical trial (RCT) of treatment resistant depression in older adults. Materials and methods: Adults aged ≥ 60 years with non-response to a prospective trial of venlafaxine were randomized to 12 weeks of aripiprazole augmentation (n=91) or placebo (n=90). Dual energy x-ray absorptiometry (DEXA) measured adiposity at baseline and 12 weeks. Independent moderators of total body fat gain were used to generate two combined multiple moderators, one including clinical data alone and one including both clinical and genetic data to characterize individuals who gained fat during aripiprazole augmentation.

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“…Aripiprazole displays linear kinetics (target concentrations of 150–300 ng/mL) 4 and has an elimination half‐life of approximately 75 h. Steady‐state plasma concentrations are achieved in about 14 days. The drug, aripiprazole, is metabolized to dehydroaripiprazole via the cytochrome P450 enzymes 3A4 and 2D6, and it was known the metabolite, dehydroaripiprazole, is also active 1.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aripiprazole and its active metabolite, dehydroaripiprazole, in plasma by capillary electrophoresis combining on‐column field‐amplified sample injection and application in schizophrenia

et al. 2010

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A sensitive high-performance CZE combining on-column field-amplified sample injection (FASI) has been developed for simultaneous determination of aripiprazole and its active metabolite, dehydroaripiprazole, in human plasma. A sample pretreatment by means of liquid-liquid extraction (LLE) (diethyl ether) with subsequent quantitation by FASI-CZE was used. The separation of aripiprazole and dehydroaripiprazole was performed using a BGE containing 150 mM phosphate buffer (pH 3.5) with 40% methanol and 0.02% PVA as a dynamic coating to reduce interaction of analytes with the capillary wall. Before sample loading, a methanol plug (0.3 psi, 6 s) was injected to permit FASI for stacking. The samples were injected electrokinetically (10 kV, 30 s) to introduce sample cations and the applied voltage was 20 kV with on-column detection at 214 nm. Several parameters affecting the separation and sensitivity of the drug and its active metabolite were studied, including reconstitution solvent, organic modifier, pH and concentration of phosphate buffer. The linear ranges of the method for test drug and its active metabolite, in plasma using amlodipine as an internal standard, were over the range 5.0-100.0 ng/mL. One female volunteer (25 years old) was orally administered a single dose of 10 mg aripiprazole (Abilify, Otsuka) and blood samples were drawn over a 60 h period for pharmacokinetic study. The method was also applied to monitor the concentration of aripiprazole and dehydroaripiprazole in plasma collected after oral administration of 20 or 30 mg aripiprazole (Abilify, Otsuka) daily at steady state in one schizophrenic patient.

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Global benefit–risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder

Abstract: Compared with ADT monotherapy, adjunctive aripiprazole was associated with an improved benefit-risk profile in MDD.

Cited by 8 publications

References 18 publications

Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis

Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis

Getting to precision psychopharmacology: Combining clinical and genetic information to predict fat gain from aripiprazole

Simultaneous determination of aripiprazole and its active metabolite, dehydroaripiprazole, in plasma by capillary electrophoresis combining on‐column field‐amplified sample injection and application in schizophrenia

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