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Tim Lambert - One of the best experts on this subject based on the ideXlab platform.
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The effect of sublingual atropine sulfate on clozapine-induced Hypersalivation: a multicentre, randomised placebo-controlled trial
Psychopharmacology, 2020Co-Authors: Omar Mubaslat, Tim LambertAbstract:Background Hypersalivation and drooling are commonly reported in clozapine-treated patients. Current management strategies have been evaluated using subjective measures. Many case reports describe the successful use of atropine in the treatment of the condition. Aims To measure the effect and safety of sublingual atropine on nocturnal unstimulated saliva secretion. Secondary aims were to evaluate the patient’s satisfaction with the atropine effect on Hypersalivation (or sialorrhea), drooling, and sleep. Method Twenty-one clozapine-treated patients with Hypersalivation, or drooling, were randomised to take a single 600-μg dose of sublingual atropine drops or a matching placebo. The saliva secretion was measured over 5 min at baseline and 2 h after the administration of the study medication. Results Sublingual atropine reduced the saliva secretion significantly more than the placebo (mean difference = − 57.21%, 95% CI: − 104.30, − 10.11, P = 0.02). A significant decrease in standing pulse rate was recorded in the participants in the atropine group (− 5.8 (− 9.54, − 2.15), P = 0.002). Subjectively, more patients in the atropine group found their pillow to have less saliva the following morning and found their sleep to be better. Conclusions Sublingual atropine drops significantly reduces nocturnal unstimulated clozapine-induced saliva secretion. More research is required to compare the effect of sublingual atropine with other anticholinergic medications and different dosage forms. Trial registration ACTRN12618000051246
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The effect of sublingual atropine sulfate on clozapine-induced Hypersalivation: a multicentre, randomised placebo-controlled trial.
Psychopharmacology, 2020Co-Authors: Omar Mubaslat, Tim LambertAbstract:Hypersalivation and drooling are commonly reported in clozapine-treated patients. Current management strategies have been evaluated using subjective measures. Many case reports describe the successful use of atropine in the treatment of the condition. To measure the effect and safety of sublingual atropine on nocturnal unstimulated saliva secretion. Secondary aims were to evaluate the patient’s satisfaction with the atropine effect on Hypersalivation (or sialorrhea), drooling, and sleep. Twenty-one clozapine-treated patients with Hypersalivation, or drooling, were randomised to take a single 600-μg dose of sublingual atropine drops or a matching placebo. The saliva secretion was measured over 5 min at baseline and 2 h after the administration of the study medication. Sublingual atropine reduced the saliva secretion significantly more than the placebo (mean difference = − 57.21%, 95% CI: − 104.30, − 10.11, P = 0.02). A significant decrease in standing pulse rate was recorded in the participants in the atropine group (− 5.8 (− 9.54, − 2.15), P = 0.002). Subjectively, more patients in the atropine group found their pillow to have less saliva the following morning and found their sleep to be better. Sublingual atropine drops significantly reduces nocturnal unstimulated clozapine-induced saliva secretion. More research is required to compare the effect of sublingual atropine with other anticholinergic medications and different dosage forms. ACTRN12618000051246
Omar Mubaslat - One of the best experts on this subject based on the ideXlab platform.
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The effect of sublingual atropine sulfate on clozapine-induced Hypersalivation: a multicentre, randomised placebo-controlled trial
Psychopharmacology, 2020Co-Authors: Omar Mubaslat, Tim LambertAbstract:Background Hypersalivation and drooling are commonly reported in clozapine-treated patients. Current management strategies have been evaluated using subjective measures. Many case reports describe the successful use of atropine in the treatment of the condition. Aims To measure the effect and safety of sublingual atropine on nocturnal unstimulated saliva secretion. Secondary aims were to evaluate the patient’s satisfaction with the atropine effect on Hypersalivation (or sialorrhea), drooling, and sleep. Method Twenty-one clozapine-treated patients with Hypersalivation, or drooling, were randomised to take a single 600-μg dose of sublingual atropine drops or a matching placebo. The saliva secretion was measured over 5 min at baseline and 2 h after the administration of the study medication. Results Sublingual atropine reduced the saliva secretion significantly more than the placebo (mean difference = − 57.21%, 95% CI: − 104.30, − 10.11, P = 0.02). A significant decrease in standing pulse rate was recorded in the participants in the atropine group (− 5.8 (− 9.54, − 2.15), P = 0.002). Subjectively, more patients in the atropine group found their pillow to have less saliva the following morning and found their sleep to be better. Conclusions Sublingual atropine drops significantly reduces nocturnal unstimulated clozapine-induced saliva secretion. More research is required to compare the effect of sublingual atropine with other anticholinergic medications and different dosage forms. Trial registration ACTRN12618000051246
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The effect of sublingual atropine sulfate on clozapine-induced Hypersalivation: a multicentre, randomised placebo-controlled trial.
Psychopharmacology, 2020Co-Authors: Omar Mubaslat, Tim LambertAbstract:Hypersalivation and drooling are commonly reported in clozapine-treated patients. Current management strategies have been evaluated using subjective measures. Many case reports describe the successful use of atropine in the treatment of the condition. To measure the effect and safety of sublingual atropine on nocturnal unstimulated saliva secretion. Secondary aims were to evaluate the patient’s satisfaction with the atropine effect on Hypersalivation (or sialorrhea), drooling, and sleep. Twenty-one clozapine-treated patients with Hypersalivation, or drooling, were randomised to take a single 600-μg dose of sublingual atropine drops or a matching placebo. The saliva secretion was measured over 5 min at baseline and 2 h after the administration of the study medication. Sublingual atropine reduced the saliva secretion significantly more than the placebo (mean difference = − 57.21%, 95% CI: − 104.30, − 10.11, P = 0.02). A significant decrease in standing pulse rate was recorded in the participants in the atropine group (− 5.8 (− 9.54, − 2.15), P = 0.002). Subjectively, more patients in the atropine group found their pillow to have less saliva the following morning and found their sleep to be better. Sublingual atropine drops significantly reduces nocturnal unstimulated clozapine-induced saliva secretion. More research is required to compare the effect of sublingual atropine with other anticholinergic medications and different dosage forms. ACTRN12618000051246
Brian Hallahan - One of the best experts on this subject based on the ideXlab platform.
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Metoclopramide may be effective for clozapine-induced Hypersalivation.
Evidence Based Mental Health, 2016Co-Authors: Brian HallahanAbstract:ABSTRACT FROM: Kreinin A, Miodownik C, Mirkin V, et al . Double-blind randomized, placebo-controlled trial of metoclopramide for Hypersalivation associated with clozapine. J Clin Psychopharmacol 2016;36:200–5. Clozapine-induced Hypersalivation is the most prevalent adverse effect experienced by patients treated with clozapine and negatively impacts on quality of life,1 with symptoms particularly prevalent at night-time. Pharmacotherapeutic strategies employed to date, based on multiple mechanisms including antimuscarinic agents and α-2 agonists have largely been associated with, at most, a minimal therapeutic effect.2 The development of strategies would thus be welcomed given the lack of effective treatment options, with such strategies hopefully being associated with an improvement in clinical outcome and perhaps also long-term treatment adherence. A 3-week randomised double-blind trial of metoclopramide (n=30) compared with placebo (n=28) was conducted on inpatients between January 2012 and May 2014 at two government affiliated centres in Israel. Patients were predominantly men (n=48), with an age range between 19 and 64 years (mean age: 40 years) and had a chronic disease course (mean duration of illness: 18 years). All patients were treated …
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Clozapine-induced Hypersalivation: an estimate of prevalence, severity and impact on quality of life.
Therapeutic Advances in Psychopharmacology, 2016Co-Authors: Senan Maher, Aoife Cunningham, Shane Mcinerney, Fintan Byrne, Niamh O’callaghan, Colm Mc Donald, Brian HallahanAbstract:Objectives:The objective of this study was to evaluate the prevalence and severity of clozapine-induced Hypersalivation, and assess the impact Hypersalivation has on global functioning.Methods:Part...
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Clozapine-induced Hypersalivation: an estimate of prevalence, severity and impact on quality of life
Therapeutic Advances in Psychopharmacology, 2016Co-Authors: Senan Maher, Aoife Cunningham, Colm Mc Donald, Shane Mcinerney, N. O’callaghan, Fintan Byrne, Brian HallahanAbstract:OBJECTIVES The objective of this study was to evaluate the prevalence and severity of clozapine-induced Hypersalivation, and assess the impact Hypersalivation has on global functioning. METHODS Participants attending a dedicated clozapine clinic were invited to undertake a structured interview regarding their experiences of clozapine-induced Hypersalivation. Two psychometric instruments to measure Hypersalivation, the Nocturnal Hypersalivation Rating Scale and the Drooling Severity and Frequency Scale were used. RESULTS Clozapine-induced Hypersalivation was experienced by 92% of participants, with nocturnal Hypersalivation more prevalent compared to daytime Hypersalivation (85% versus 48%). Daytime drooling was severe in 18% of cases and was present on a frequent or constant basis for 20% of individuals. Hypersalivation had at least a moderate impact on the quality of life of 15% of study participants. CONCLUSIONS Clozapine-induced Hypersalivation is the most prevalent adverse effect experienced by patients treated with clozapine and negatively impacts on quality of life, particularly if daytime drooling is present. The development of further strategies to ameliorate this adverse effect is required given the demonstrated lack of success to date in managing this condition.
Rainer Laskawi - One of the best experts on this subject based on the ideXlab platform.
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Hypersalivation: update of the German S2k guideline (AWMF) in short form
Journal of Neural Transmission, 2019Co-Authors: Armin Steffen, Kai G Kahl, Wolfgang Jost, Tobias Bäumer, Dirk Beutner, Sabine Degenkolb-weyers, Martin Groß, Maria Grosheva, Samer Hakim, Rainer LaskawiAbstract:Hypersalivation describes a relatively excessive salivary flow, which wets the patient himself and his surroundings. It may result because of insufficient oro-motor function, dysphagia, decreased central control and coordination. This update presents recent changes and innovation in the treatment of Hypersalivation. Multidisciplinary diagnostic and treatment evaluation is recommended already at early stage and focus on dysphagia, saliva aspiration, and oro-motor deficiencies. Clinical screening tools and diagnostics such as fiberoptic endoscopic evaluation of swallowing generate important data on therapy selection and control. Many cases profit from swallowing therapy programmes to activate compensation mechanisms as long compliances are given. In children with hypotonic oral muscles, oral stimulation plates can induce a relevant symptom release because of the improved lip closure. The pharmacologic treatment improved for pediatric cases as glycopyrrolate fluid solution (Sialanar^®) is now indicated for Hypersalivation within the EU. The injection of botulinum toxin into the salivary glands has shown safe and effective results with long-lasting saliva reduction. Here, a phase III trial is completed for incobotulinum toxin A and, in the US, is indicated for the treatment of adult patients with chronic Hypersalivation. Surgical treatment should be reserved for isolated cases. External radiation is judged as a safe and effective therapy when using modern 3D techniques to minimize tissue damage. Therapy effects and symptom severity have to be followed, especially in cases with underlying neurodegenerative disease.
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Hypersalivation - Update of the S2k guideline (AWMF) in short form
Laryngo-Rhino-Otologie, 2019Co-Authors: Armin Steffen, Kai G Kahl, Wolfgang Jost, Tobias Bäumer, Dirk Beutner, Sabine Degenkolb-weyers, Martin Groß, Maria Grosheva, Samer Hakim, Rainer LaskawiAbstract:Hypersalivation describes a relatively excessive salivary flow, which wets the patient himself and his surroundings. It may result because of insufficient oro-motor function, dysphagia, decreased central control and coordination. This update presents recent changes and innovation in the treatment of Hypersalivation.Multidisciplinary diagnostic and treatment evaluation is recommended already at early stage and focus on dysphagia, saliva aspiration, and oro-motor deficiencies. Clinical screening tools and diagnostics such as fiberoptic endoscopic evaluation of swallowing generate important data on therapy selection and control. Many cases profit from swallowing therapy programmes in order to activate compensation mechanisms as long compliances is given. In children with hypotonic oral muscles, oral stimulation plates can induce a relevant symptom release because of the improved lip closure. The pharmacologic treatment improved for pediatric cases as glycopyrrolate fluid solution (Sialanar®) is now indicated for Hypersalivation within the E. U. The injection of botulinum toxin into the salivary glands has shown safe and effective results with long lasting saliva reduction. Here, a phase III trial is completed for Incobotulinum toxin A and, in the U. S., is indicated for the treatment of adult patients with chronic Hypersalivation. Surgical treatment should be reserved for isolated cases. External radiation is judged as a safe and effective therapy when using modern 3 D techniques to minimize tissue damage. Therapy effects and symptom severity has to be followed, especially in cases with underlying neurodegenerative disease.
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Hypersalivation - inauguration of the S2k Guideline (AWMF) in short form
Laryngo-Rhino-Otologie, 2013Co-Authors: Armin Steffen, K. G. Kahl, Samer G Hakim, W Jost, Rainer Laskawi, Dirk Beutner, R. Lencer, V. Mall, F-w Mehrhoff, T MeynersAbstract:Hypersalivation describes a relatively excessive salivary flow, which wets the patient himself and his surroundings. It may result because of insufficient oro-motor function, dysphagia, decreased central control and coordination. This reduces social interaction chances and burdens daily care. Multidisciplinary diagnostic and treatment evaluation is recommended already at early stage and focus on dysphagia, and saliva aspiration. Therefore, a multidisciplinary S2k guideline was developed. Diagnostic tools such as fiberoptic endoscopic evaluation of swallowing and videofluoroscopic swallowing studies generate important data on therapy selection and control. Especially traumatic and oncologic cases profit from swallowing therapy programmes in order to activate compensation mechanisms. In children with hypotonic oral muscles, oralstimulation plates can induce a relevant symptom release because of the improved lip closure. In acute Hypersalivation, the pharmacologic treatment with glycopyrrolate and scopolamine in various applications is useful but its value in long-term usage critical. The injection of botulinum toxin into the salivary glands has shown safe and effective results with long lasting saliva reduction. Surgical treatment should be reserved for isolated cases. External radiation is judged as ultima ratio. Therapy effects and symptom severity has to be followed, especially in neurodegenerative cases. The resulting xerostomia should be critically evaluated by the responsible physician regarding oral and dental hygiene.
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Botulinum toxin to reduce saliva flow: selected indications for ultrasound-guided toxin application into salivary glands.
The Laryngoscope, 2002Co-Authors: Maik Ellies, Rainer Laskawi, Saskia Rohrbach-volland, C. Arglebe, Wolfgang BeucheAbstract:Objectives/Hypothesis The study investigates the effect of local injections of botulinum toxin type A (Botox) into the major salivary glands of the head in various states of Hypersalivation. In particular, we studied pathological states with permanent as well as passing Hypersalivation disorders and present new indications for local application of botulinum toxin to the salivary glands. Study Design Retrospective clinical investigation. Methods A total of 55 to 65 units of Botox were injected under sonographic control into the left and right parotid and submandibular glands of four patients with Hypersalivation resulting from head and neck carcinoma, tracheostomy, and “idiopathic” Hypersalivation disorder. At defined time intervals following injection, flow rate, total protein and immunoglobulin A content, and the enzymatic activities of amylase, acid phosphatase, and kallikrein were determined in the saliva. The patients were clinically examined to assess the severity of their symptoms, including sonographic control of the major salivary glands. Results All four patients reported distinct improvement of their symptoms within 1 week after injection. Salivary flow rate had considerably dropped, whereas the concentrations of the salivary components were much increased. Sonography did not reveal any changes of the salivary gland parenchyma. Therapeutic side effects were absent. Conclusions Treatment of Hypersalivation by local injections of Botox into the salivary glands of the head is a reliable and efficient therapy without side effects for certain otolaryngological diseases, especially if injections are performed under sonographic control. Extension of this therapeutic concept to other indications is suggested.
Ekkehard Haen - One of the best experts on this subject based on the ideXlab platform.
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elevated clozapine concentrations in clozapine treated patients with Hypersalivation
Clinical Pharmacokinectics, 2020Co-Authors: Georgios Schoretsanitis, Maxim Kuzin, John M Kane, Christoph Hiemke, Michael Paulzen, Ekkehard HaenAbstract:BACKGROUND AND OBJECTIVE Hypersalivation is a common, clozapine-related adverse drug reaction with a serious impact on quality of life. Pharmacokinetic correlates of clozapine-related Hypersalivation have evaded attention. The purpose of this study was to compare pharmacokinetic parameters between clozapine-treated patients with vs. without Hypersalivation from a large therapeutic drug monitoring database. METHODS Out of a large therapeutic drug monitoring dataset of clozapine-treated patients, we compared a group of patients with Hypersalivation (n = 72) and a control group of patients without any adverse reactions in this regard (n = 323). Comparisons included plasma concentrations and concentrations-by-dose as well as demographic characteristics between groups. Post-hoc analyses were performed separately in smokers and non-smokers. We used the non-parametric Mann-Whitney U test and the chi-square test, while effects of confounders were assessed using a bootstrapping analysis of covariance. RESULTS Patients with Hypersalivation had higher clozapine plasma concentrations and concentrations-by-dose (p < 0.001 for the Mann-Whitney U test in both cases). Groups did not differ regarding demographic characteristics except for clozapine daily dose and percentage of smokers (p = 0.005 for the Mann-Whitney U test and p = 0.028 for the chi-square test, respectively). There were fewer smokers across patients with Hypersalivation compared with patients without and daily doses were higher in patients with Hypersalivation. After analysis of covariance, differences remained for both plasma concentrations and concentrations-by-dose (p < 0.001 for both). Post hoc analyses in smokers and non-smokers separately reported similar findings. CONCLUSIONS Elevated clozapine plasma concentrations and higher concentrations-by-dose were observed in patients with Hypersalivation. A potential role for therapeutic drug monitoring in the prevention or management of clozapine-related Hypersalivation is suggested.
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Elevated Clozapine Concentrations in Clozapine-Treated Patients with Hypersalivation
Clinical Pharmacokinetics, 2020Co-Authors: Georgios Schoretsanitis, Maxim Kuzin, John M Kane, Christoph Hiemke, Michael Paulzen, Ekkehard HaenAbstract:Background and Objective Hypersalivation is a common, clozapine-related adverse drug reaction with a serious impact on quality of life. Pharmacokinetic correlates of clozapine-related Hypersalivation have evaded attention. The purpose of this study was to compare pharmacokinetic parameters between clozapine-treated patients with vs. without Hypersalivation from a large therapeutic drug monitoring database. Methods Out of a large therapeutic drug monitoring dataset of clozapine-treated patients, we compared a group of patients with Hypersalivation ( n = 72) and a control group of patients without any adverse reactions in this regard ( n = 323). Comparisons included plasma concentrations and concentrations-by-dose as well as demographic characteristics between groups. Post-hoc analyses were performed separately in smokers and non-smokers. We used the non-parametric Mann–Whitney U test and the chi-square test, while effects of confounders were assessed using a bootstrapping analysis of covariance. Results Patients with Hypersalivation had higher clozapine plasma concentrations and concentrations-by-dose ( p