An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia
Clozapine remains as the gold standard for the management of treatment resistant schizophrenia. Nevertheless, mortality and morbidity associated with Clozapine is partly contributed by its adverse effect of constipation in view of its prominent anticholinergic properties. Despite the evidence that a...
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| Format: | Article |
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MDPI AG
2020-12-01
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| Series: | Healthcare |
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| Online Access: | https://www.mdpi.com/2227-9032/8/4/533 |
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| author | Ishwary Damodaran Koh Ong Hui Amer Siddiq Amer Nordin Anne Yee Jesjeet Singh Gill Benedict Francis Fatin Liyana Azhar Ahmad Hatim Sulaiman |
| author_facet | Ishwary Damodaran Koh Ong Hui Amer Siddiq Amer Nordin Anne Yee Jesjeet Singh Gill Benedict Francis Fatin Liyana Azhar Ahmad Hatim Sulaiman |
| author_sort | Ishwary Damodaran |
| collection | DOAJ |
| description | Clozapine remains as the gold standard for the management of treatment resistant schizophrenia. Nevertheless, mortality and morbidity associated with Clozapine is partly contributed by its adverse effect of constipation in view of its prominent anticholinergic properties. Despite the evidence that approximately 60% of patients on Clozapine will experience constipation, there is no proper guideline as to the best laxative in the treatment of Clozapine induced constipation. Hence this study was conducted to evaluate the efficacy and safety of Prucalopride and Lactulose in the treatment of Clozapine induced constipation. This was a four week, prospective, open-label head to head comparison study between Prucalopride and Lactulose in the treatment of Clozapine induced constipation. Male and female patients on Clozapine between the age of 18–60 with an established diagnosis of treatment resistant schizophrenia with ≤2 spontaneous complete bowel movement per week were recruited in this study. Eligible patients were assigned into two groups. Patients received Prucalopride 2 mg once daily or Lactulose 10 g once daily for four weeks. Efficacy was analyzed in 58 patients. The proportion of patient with ≥3 spontaneous complete bowel movement (SCBM) was higher in the Prucalopride 2 mg group, reaching significance at Week 4 with <i>p</i>-value of (<i>p</i> = 0.029). The proportion of patient with ≥3 SCBM at Week 1 was 71.4% in the Prucalopride 2 mg group and 60% in the Lactulose 10 g group. The proportion of patient with ≥3 SCBM at Week 4 was 85.7% in the Prucalopride 2 mg group and the proportion remained at 60% in the Lactulose 10 g group. The improvement in the dissatisfaction and treatment satisfaction subscales of the patient assessment of constipation—quality of life (PAC-QOL) were higher in the Prucalopride 2 mg group compared to the Lactulose 10 g group. The common adverse events associated with Prucalopride 2 mg were abdominal pain and loose stools which was transient and subsided within a few days. Over four weeks, in this population of patients with Clozapine induced constipation, Prucalopride 2 mg significantly improved the bowel movement and it was safe. |
| first_indexed | 2024-03-10T14:21:04Z |
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| id | doaj.art-198a640d757c49fa8274cfae6bfc2666 |
| institution | Directory Open Access Journal |
| issn | 2227-9032 |
| language | English |
| last_indexed | 2024-03-10T14:21:04Z |
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| spelling | doaj.art-198a640d757c49fa8274cfae6bfc26662023-11-20T23:19:29ZengMDPI AGHealthcare2227-90322020-12-018453310.3390/healthcare8040533An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant SchizophreniaIshwary Damodaran0Koh Ong Hui1Amer Siddiq Amer Nordin2Anne Yee3Jesjeet Singh Gill4Benedict Francis5Fatin Liyana Azhar6Ahmad Hatim Sulaiman7Hospital Bentong, Jalan Tras, Bentong 28700, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaDepartment of Psychological Medicine, University Malaya Medical Centre, Kuala Lumpur 59100, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, MalaysiaClozapine remains as the gold standard for the management of treatment resistant schizophrenia. Nevertheless, mortality and morbidity associated with Clozapine is partly contributed by its adverse effect of constipation in view of its prominent anticholinergic properties. Despite the evidence that approximately 60% of patients on Clozapine will experience constipation, there is no proper guideline as to the best laxative in the treatment of Clozapine induced constipation. Hence this study was conducted to evaluate the efficacy and safety of Prucalopride and Lactulose in the treatment of Clozapine induced constipation. This was a four week, prospective, open-label head to head comparison study between Prucalopride and Lactulose in the treatment of Clozapine induced constipation. Male and female patients on Clozapine between the age of 18–60 with an established diagnosis of treatment resistant schizophrenia with ≤2 spontaneous complete bowel movement per week were recruited in this study. Eligible patients were assigned into two groups. Patients received Prucalopride 2 mg once daily or Lactulose 10 g once daily for four weeks. Efficacy was analyzed in 58 patients. The proportion of patient with ≥3 spontaneous complete bowel movement (SCBM) was higher in the Prucalopride 2 mg group, reaching significance at Week 4 with <i>p</i>-value of (<i>p</i> = 0.029). The proportion of patient with ≥3 SCBM at Week 1 was 71.4% in the Prucalopride 2 mg group and 60% in the Lactulose 10 g group. The proportion of patient with ≥3 SCBM at Week 4 was 85.7% in the Prucalopride 2 mg group and the proportion remained at 60% in the Lactulose 10 g group. The improvement in the dissatisfaction and treatment satisfaction subscales of the patient assessment of constipation—quality of life (PAC-QOL) were higher in the Prucalopride 2 mg group compared to the Lactulose 10 g group. The common adverse events associated with Prucalopride 2 mg were abdominal pain and loose stools which was transient and subsided within a few days. Over four weeks, in this population of patients with Clozapine induced constipation, Prucalopride 2 mg significantly improved the bowel movement and it was safe.https://www.mdpi.com/2227-9032/8/4/533clozapine induced constipationprucalopridelactuloseefficacysafety |
| spellingShingle | Ishwary Damodaran Koh Ong Hui Amer Siddiq Amer Nordin Anne Yee Jesjeet Singh Gill Benedict Francis Fatin Liyana Azhar Ahmad Hatim Sulaiman An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia Healthcare clozapine induced constipation prucalopride lactulose efficacy safety |
| title | An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia |
| title_full | An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia |
| title_fullStr | An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia |
| title_full_unstemmed | An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia |
| title_short | An Open-Label, Head to Head Comparison Study between Prucalopride and Lactulose for Clozapine Induced Constipation in Patients with Treatment Resistant Schizophrenia |
| title_sort | open label head to head comparison study between prucalopride and lactulose for clozapine induced constipation in patients with treatment resistant schizophrenia |
| topic | clozapine induced constipation prucalopride lactulose efficacy safety |
| url | https://www.mdpi.com/2227-9032/8/4/533 |
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