Remission, response, and relapse rates in patients with acute schizophrenia treated with olanzapine monotherapy or other atypical antipsychotic monotherapy: 12-month prospective observational study

Takahashi, Mariko; Nakahara, Naohiro; Fujikoshi, Shinji; Iyo, Masaomi

doi:10.2147/por.s64973

Cited by 9 publications

(3 citation statements)

References 28 publications

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“…7,8 In studies comparing the long-term effectiveness of several antipsychotic medications, treatment with olanzapine resulted in lower rates of hospitalization for disease exacerbation 8,9 and higher rates of remission. 10,11 Time to all-cause discontinuation was also consistently longer for olanzapine compared with other antipsychotics across multiple studies. [7][8][9]12,13 Despite its established efficacy, olanzapine is associated with a risk of significant weight gain, 8,14,15 which has limited its overall clinical utility.…”

Section: Introductionmentioning

confidence: 98%

Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study

et al. 2020

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Background. Combination olanzapine and samidorphan (OLZ/SAM), in development for schizophrenia and bipolar I disorder, is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. OLZ/SAM safety, tolerability, and efficacy from a 52-week open-label extension study in patients with schizophrenia are reported. Methods. Patients previously completing the 4-week, double-blind ENLIGHTEN-1 study switched from OLZ/SAM, olanzapine, or placebo to OLZ/SAM. Assessments included adverse events (AEs), weight, vital signs, Positive and Negative Syndrome Scale (PANSS), and Clinical Global Impression-Severity (CGI-S) scores. Baseline was prior to first dose of OLZ/SAM in the extension study. Results. In total, 281 patients enrolled, 277 received ≥1 OLZ/SAM dose, and 183 (66.1%) completed 52 weeks. Reasons for discontinuation included patient withdrawal (15.5%), loss to follow-up (6.9%), AEs (5.8%), and lack of efficacy (1.8%). AEs were reported in 136 (49.1%) patients; increased weight (13%) and somnolence (8%) were most common. Ten serious AEs were reported in eight patients (2.9%); none were considered treatment related. There were no deaths. Mean (SD) baseline weight was 79.1 (17.8) kg. Mean weight change from baseline to week 52 was 1.86 kg (2.79% increase). PANSS total and CGI-S scores continued to decline over 52 weeks (mean [95% CI] changes from baseline to week 52: −16.2 [−18.5, −14.0] and −0.9 [−1.0, −0.8], respectively). Conclusion. OLZ/SAM was generally well tolerated in this extension study; most patients completed the 52-week treatment period with sustained improvement in schizophrenia symptoms. Mean increases in weight stabilized by week 6 with limited subsequent change through end of treatment.

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Section: Introductionmentioning

confidence: 98%

Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study

et al. 2020

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“…13,14 Despite a number of available antipsychotics, there remains a need for effective therapies with acceptable tolerability profiles that support long-term use. [15][16][17] Based on data from clinical trials, 18,19 real-world settings, [20][21][22] meta-analyses, 23,24 and pooled analyses, 25 olanzapine is one of the most effective antipsychotics for the treatment of schizophrenia. 26,27 Olanzapine also effectively treats manic or mixed episodes associated with BD-I and reduces relapse risk during maintenance treatment.…”

Section: Introductionmentioning

confidence: 99%

An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder

Citrome¹,

Graham²,

Simmons³

et al. 2021

NDT

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Olanzapine effectively treats schizophrenia and bipolar I disorder (BD-I); however, its use is limited by the risk of significant weight gain and metabolic effects. OLZ/SAM, a combination of olanzapine and samidorphan, was recently approved in the United States for the treatment of adults with schizophrenia or BD-I. OLZ/SAM provides the efficacy of olanzapine while mitigating olanzapine-associated weight gain through opioid-receptor blockade. Here, we summarize OLZ/SAM clinical data characterizing pharmacokinetics, antipsychotic efficacy, weight mitigation efficacy, safety, and long-term treatment effects. In an acute exacerbation of schizophrenia, OLZ/SAM and olanzapine provided similar symptom improvements versus placebo at week 4. In stable outpatients with schizophrenia, OLZ/SAM treatment resulted in significantly less weight gain, reducing the risk for clinically significant weight gain and waist circumference increases of ≥5 cm by half, compared with olanzapine at week 24. Based on openlabel extension studies, OLZ/SAM is safe and well tolerated for up to 3.5 years of treatment, while maintaining schizophrenia symptom control and stabilizing weight. The olanzapine component of OLZ/SAM was bioequivalent to branded olanzapine (Zyprexa); adjunctive OLZ/SAM had no clinically significant effects on lithium or valproate pharmacokinetics. Additionally, OLZ/SAM had no clinically relevant effect on electrocardiogram parameters in a dedicated thorough QT study. Overall, safety and tolerability findings from clinical studies with OLZ/SAM indicate a similar safety profile to that of olanzapine, with the exception of less weight gain. As OLZ/SAM contains the opioid antagonist samidorphan, it is contraindicated in patients using opioids and in those undergoing acute opioid withdrawal. Clinical trial results from more than 1600 subjects support the use of OLZ/SAM as a new treatment option for patients with schizophrenia or BD-I.

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“…Making the patient had lower quality of life, self-care ability, high economic burden on the family and society, and progressively chronic disease. [13][14][15] Besides, misconceptions, negative perceptions, caregivers' attitudes about schizophrenia created barriers in compliance with rehabilitation for the people. 10,[16][17] From literature review, research results indicated that there were various factors associated with caregiver's schizophrenic rehabilitation compliance.…”

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confidence: 99%

The Compliance with Rehabilitation for People with Schizophrenia among Primary Caregivers in Nam Dinh Province, Vietnam

Anh

Cường

2021

bkkmedj

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Individuals with schizophrenia manifest the different expressions, behaviors and personality. Failure to comply with rehabilitation for the patient may impair the patient and caregiver's quality of life; preventing the patient from self-care, and it is an economic burden for the family and society and chronic progression of the disease. This study aims to determine the compliance with rehabilitation for people with schizophrenia among primary caregivers. MATERIALS AND METHODS: Participants of 352 primary caregivers of people with schizophrenia were recruited from

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Remission, response, and relapse rates in patients with acute schizophrenia treated with olanzapine monotherapy or other atypical antipsychotic monotherapy: 12-month prospective observational study

Cited by 9 publications

References 28 publications

Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study

Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study

An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder

The Compliance with Rehabilitation for People with Schizophrenia among Primary Caregivers in Nam Dinh Province, Vietnam

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