Amisulpride and olanzapine combination treatment versus each monotherapy in acutely ill patients with schizophrenia in Germany (COMBINE): a double-blind randomised controlled trial

Schmidt-Kraepelin, Christian; Cordes, Joachim; Feyerabend, Sandra; Engelke, Christina; Riesbeck, Mathias; Meisenzahl‐Lechner, Eva; Gäebel, Wolfgang; Deiß, Martina; Sofie, Natalia; Galuba, Viktoria; Wiechmann, Frank; Janssen, Birgit; Kluge, Michael; Makiol, Christian; Kertzscher, Lisa; Neff, A W; Lange, Christina; Englisch, Susanne; Zink, Mathias; Becker, A.; Muszinski, Sandra; Gründer, Gerhard; Langguth, Berthold; Poeppl, Timm B.; Frank, Elmar; Kreuzer, Peter; Reske, D.; Veselinović, Tanja; Falkai, Peter; Wagner, Elias; Brockhaus-Dumke, Anke; Klos, Bettina; Jäger, Markus; Lang, Fabian; Kling-Lourenco, P.; Baumgärtner, Jessica; Hasan, Alkomiet; Dreimüller, Nadine; Hiemke, Christoph; Leucht, Stefan; Heres, Stephan; Leucht, Claudia; Assion, Hans‐Jörg; Kis, Bernhard; Zilles-Wegner, David; Kahl, Kai G.; Correll, Christoph U.; Verde, Pablo-Emilio; Kolbe, Henrike; Rottmann, Anika

doi:10.1016/s2215-0366(22)00032-3

Cited by 10 publications

(5 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…70 However, at eight and sixteen weeks, sexual dysfunction, weight, and waist circumference increase were significantly higher in patients receiving amisulpride plus olanzapine than in those receiving amisulpride plus placebo, with no differences in serious adverse events. 70 After failing to achieve remission on amisulpride, switching to olanzapine did not improve outcomes. 71 Switching to clozapine, on the other hand, has been shown to be beneficial (even after a failure in a single antipsychotic trial).…”

Section: Resultsmentioning

confidence: 98%

“…One study found that total PANSS scores improved significantly at eight weeks in the amisulpride plus olanzapine group compared with the olanzapine plus placebo group (d = 0.396). 70 However, at eight and sixteen weeks, sexual dysfunction, weight, and waist circumference increase were significantly higher in patients receiving amisulpride plus olanzapine than in those receiving amisulpride plus placebo, with no differences in serious adverse events. 70 After failing to achieve remission on amisulpride, switching to olanzapine did not improve outcomes.…”

Section: Challenges For Finding the Right Treatment And Recommendationsmentioning

confidence: 91%

See 1 more Smart Citation

Finding the Right Setting for the Right Treatment During the Acute Treatment of Individuals with Schizophrenia: A Narrative Review and Clinical Practice Guideline

Correll,

Arango,

Fagiolini

et al. 2024

NDT

Self Cite

View full text Add to dashboard Cite

Section: Resultsmentioning

confidence: 98%

Section: Challenges For Finding the Right Treatment And Recommendationsmentioning

confidence: 91%

Finding the Right Setting for the Right Treatment During the Acute Treatment of Individuals with Schizophrenia: A Narrative Review and Clinical Practice Guideline

Correll,

Arango,

Fagiolini

et al. 2024

NDT

Self Cite

View full text Add to dashboard Cite

“…It has been reported by multiple studies to be an effective and well-tolerated treatment for schizophrenia ( Puech et al, 1998 ; Leucht et al, 2013 ). More recently, the clinical significance of amisulpride has been evaluated in combination therapies with other antipsychotics such as olanzapine in treatment-resistant schizophrenia ( Schmidt-Kraepelin et al, 2022 ; Woo et al, 2022 ). On the safety prospective, amisulpride is associated with increased prolactin level, weight gain, hypotension, sexual dysfunction, and prolonged QT interval.…”

Section: Resultsmentioning

confidence: 99%

A systematic review on sex differences in adverse drug reactions related to psychotropic, cardiovascular, and analgesic medications

et al. 2023

View full text Add to dashboard Cite

Background and objective: Adverse drug reactions (ADRs) are the main safety concerns of clinically used medications. Accumulating evidence has shown that ADRs can affect men and women differently, which suggests sex as a biological predictor in the risk of ADRs. This review aims to summarize the current state of knowledge on sex differences in ADRs with the focus on the commonly used psychotropic, cardiovascular, and analgesic medications, and to aid clinical decision making and future mechanistic investigations on this topic.Methods: PubMed search was performed with combinations of the following terms: over 1,800 drugs of interests, sex difference (and its related terms), and side effects (and its related terms), which yielded over 400 unique articles. Articles related to psychotropic, cardiovascular, and analgesic medications were included in the subsequent full-text review. Characteristics and the main findings (male-biased, female-biased, or not sex biased ADRs) of each included article were collected, and the results were summarized by drug class and/or individual drug.Results: Twenty-six articles studying sex differences in ADRs of six psychotropic medications, ten cardiovascular medications, and one analgesic medication were included in this review. The main findings of these articles suggested that more than half of the ADRs being evaluated showed sex difference pattern in occurrence rate. For instance, lithium was found to cause more thyroid dysfunction in women, and amisulpride induced prolactin increase was more pronounced in women than in men. Some serious ADRs were also found to exert sex difference pattern, such as clozapine induced neutropenia was more prevalent in women whereas simvastatin/atorvastatin-related abnormal liver functions were more pronounced in men.

show abstract

“…Combining different types of antipsychotics is common in schizophrenia treatment [14]. And also patients took drugs to treat physical illnesses and to improve sleep.…”

Section: Discussionmentioning

confidence: 99%

The eGFR parameter model helps predict blood drug concentration of amisulpride in patients with schizophrenia

Wang,

Qu,

Wang

2024

Preprint

View full text Add to dashboard Cite

Objective This study aimed to examine inter-patient variability in amisulpride levels, using a multiple regression model with a dataset acquired from Chinese patients with schizophrenia. Methods Plasma concentrations of amisulpride (153 data from 128 patients) were analyzed by four-covariate model and eGFR model and were validated using goodness-of-fit and external prediction ability analyses. The amisulpride levels were detected by 2D-LC-UV system. Results The eGFR model adequately characterized amisulpride levels with adjusted R2 0.457. The dose and eGFR values significantly affected concentrations, as follows: amisulpride concentration = 838.561–9.169*eGFR + 1.273*dose. To remain below the laboratory alert level, recommended dose should remain below 300 mg/d, 500 mg/d, and 700 mg/d for patients with eGFR of 60 ml/min/1.73 m2, 90 ml/min/1.73 m2, and 120 ml/min/1.73 m2, respectively. Once and twice daily treatment regiments yielded comparable trough concentration values. Conclusion The eGFR model is simpler and more accurate in predicting the concentration of AMI, and provides an evaluation method for safe and individualized use of AMI.

show abstract

Amisulpride and olanzapine combination treatment versus each monotherapy in acutely ill patients with schizophrenia in Germany (COMBINE): a double-blind randomised controlled trial

Cited by 10 publications

References 26 publications

Finding the Right Setting for the Right Treatment During the Acute Treatment of Individuals with Schizophrenia: A Narrative Review and Clinical Practice Guideline

Finding the Right Setting for the Right Treatment During the Acute Treatment of Individuals with Schizophrenia: A Narrative Review and Clinical Practice Guideline

A systematic review on sex differences in adverse drug reactions related to psychotropic, cardiovascular, and analgesic medications

The eGFR parameter model helps predict blood drug concentration of amisulpride in patients with schizophrenia

Contact Info

Product

Resources

About