The Effect of Glycopyrrolate on Nocturnal Sialorrhea in Patients Using Clozapine: A Randomized, Crossover, Double-Blind, Placebo-Controlled Trial
| Autor: | Man, Wai Hong, Colen-de Koning, Jantine C A, Schulte, Peter F J, Cahn, Wiepke, van Haelst, Ingrid M M, Doodeman, Hieronymus J, Egberts, Toine C G, Heerdink, Eibert R, Wilting, Ingeborg, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
| Rok vydání: | 2017 |
| Předmět: |
Hypersalivation
Adult Male glycopyrrolate Placebo-controlled study Anticholinergic agents Muscarinic Antagonists Placebo law.invention Outcome Assessment (Health Care) 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Taverne Outcome Assessment Health Care medicine Journal Article Humans Pharmacology (medical) sialorrhea Clozapine Glycopyrrolate nocturnal sialorrhea Sialorrhea Cross-Over Studies clozapine business.industry Mental Disorders hypersalivation Middle Aged Crossover study 030227 psychiatry Psychiatry and Mental health Anesthesia Randomized Controlled Trial Female medicine.symptom business 030217 neurology & neurosurgery Antipsychotic Agents |
| Zdroj: | Journal of Clinical Psychopharmacology, 37(2), 155. Lippincott Williams and Wilkins |
| ISSN: | 1533-712X 0271-0749 |
| Popis: | BACKGROUND: Nocturnal sialorrhea is one of the most frequent adverse events in clozapine treatment. Symptomatic management of sialorrhea usually consists of off-label treatment with anticholinergic agents. The aim of the current study is to evaluate the efficacy and safety of glycopyrrolate in patients using clozapine that experience sialorrhea. METHODS: In a double-blind randomized crossover trial, patients with nocturnal sialorrhea (n = 32) were randomized to treatment with glycopyrrolate 1 mg or placebo. This double-blinded phase was followed by an optional open label extension phase with glycopyrrolate 2 mg. Exposure periods consisted of 6 consecutive days and were separated with 1 washout week. The primary outcome was clinical improvement of nocturnal sialorrhea assessed by the Patient Global Impression of Improvement (PGI-I). RESULTS: The proportion of patients with a clinical improvement according to PGI-I did not significantly differ between 1 mg and placebo (18.8% vs 6.3%, P = 0.289); however, in patients using glycopyrrolate 2 mg once daily versus placebo, it did (43.5% vs 6.3%, P = 0.039). Glycopyrrolate was not associated with severe adverse events or worsening of cognitive adverse events. CONCLUSIONS: Glycopyrrolate 1 mg was not superior to placebo, whereas 2 mg showed a significant clinical improvement of nocturnal sialorrhea compared with placebo. Glycopyrrolate seemed to be a tolerable anticholinergic agent in the treatment of clozapine-associated sialorrhea. |
| Databáze: | OpenAIRE |
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