Abstract:
BACKGROUND:Sialorrhea, or drooling, is seen in the pediatric population, especially in patients with cerebral palsy and other neurodevelopmental disabilities. If medication use is warranted, anticholinergic agents are the drug of choice; however, adverse effects limit their use. Glycopyrrolate, a synthetic anticholinergic that acts at peripheral muscarinic receptors, has been used off-label for excessive drooling in children with neurodevelopmental disabilities for years. Product formulations restricted the use of glycopyrrolate. However, an oral solution was approved by the US Food and Drug Administration for children ages 3 to 16 years with neurologic disorders for chronic severe drooling in 2010; it became available for use in 2011. OBJECTIVE:This article provides an overview of the pharmacology, clinical efficacy, and tolerability of glycopyrrolate when used for sialorrhea in children. METHODS:To evaluate the efficacy and safety profile of glycopyrrolate for the treatment of sialorrhea in children, a comprehensive search was performed of the MEDLINE database (1966-February 25, 2012) and International Pharmaceutical Abstracts as well as references from additional review articles identified. Searches were conducted using the terms glycopyrrolate, sialorrhea, drooling, secretion, and pediatrics. The terms drug-induced and Parkinson disease-associated sialorrhea were excluded from the search. The pharmaceutical manufacturer of the oral solution was contacted for medical and study information. RESULTS:Oral bioavailability of glycopyrrolate varies widely, with a median of 3.3%. Mean C(max) in children was determined to be 0.37 μg/mL, and mean T(max) was 3.1 hours. The clearance in children ranges from 0.6 to 1.43 L/kg/h. The t(½) ranges from 22 to 130 minutes and 19 to 99 minutes in infants and children, respectively. Six studies describing the use of glycopyrrolate for drooling in children were identified. A double-blind, crossover trial of 27 patients (age range, 4-19 years) demonstrated a reduced mean drooling score (modified Teacher's Drooling Scale [1 = never drools to 9 = clothing, hands, and objects frequently become wet]) for glycopyrrolate (mean highest tolerated dose, 0.11 mg/kg) compared with placebo of 1.85 versus 6.33 (P < 0.001). In a parallel study of 36 patients (age range, 3-16 years), 14 of 20 patients randomized to receive glycopyrrolate solution showed improvement in the mean modified Teacher's Drooling Scale score compared with only 3 patients receiving placebo (-3.5 vs -0.1, respectively). Glycopyrrolate was initiated at 0.02 mg/kg per dose orally TID (Max dose: 3 mg) and titrated over a 4-week period. Adverse effects identified in studies include dry mouth (9%-41%), constipation (9%-39%), and behavioral changes (18%-36%). CONCLUSIONS:Glycopyrrolate is effective in decreasing sialorrhea in children with cerebral palsy or other neurodevelopmental disabilities. Adverse effects did occur, more frequently at higher doses, and should be monitored.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Eiland LSdoi
10.1016/j.clinthera.2012.02.026subject
Has Abstractpub_date
2012-04-01 00:00:00pages
735-42issue
4eissn
0149-2918issn
1879-114Xpii
S0149-2918(12)00105-1journal_volume
34pub_type
杂志文章,评审abstract::Ambulatory blood pressure monitoring (ABPM) has been available since the mid-1970s. Widespread use of ABPM in research settings has led to an appreciation of its advantages and disadvantages. ABPM is a valuable research tool because of its ability to evaluate the duration and consistency of action with new antihyperte...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1993-05-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a standardized diet, comparing the action of orlistat, fluvastatin, orlistat with fluvastatin, and placebo on anthropometric measurements, blood pressure (BP), and lipid profile. METHODS:This was a 1-year, rando...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(03)80070-x
更新日期:2003-04-01 00:00:00
abstract:BACKGROUND:The worldwide prevalence of asthma is increasing by approximately 50% per decade. Budesonide is one of several inhaled corticosteroids available for the treatment of asthma and has been extensively evaluated in clinical trials. OBJECTIVE:This article reviews the published literature on the efficacy of budes...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)80005-4
更新日期:2002-06-01 00:00:00
abstract::Twenty-four patients with pulmonary infections (7 pneumoniae, 17 exacerbations of chronic bronchitis) were treated with a combination of 250 mg of amoxicillin and 125 mg of clavulanic acid supplemented by 500 mg of amoxicillin every eight hours. All patients showed good clinical, roentgenological, and bacteriological ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract::We compared the efficacy of timolol maleate ophthalmic gel-forming solution 0.5% QD with that of levobunolol hydrochloride 0.5% BID, as measured by change in intraocular pressure (IOP), effect on heart rate, and ocular tolerability. The study had a positive-controlled, double-masked, randomized, multicenter, 12-week, ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(98)80112-4
更新日期:1998-11-01 00:00:00
abstract:PURPOSE:The purpose of this review is to discuss the selection and use of disease- modifying treatments for patients with relapsing forms of multiple sclerosis (MS). METHODS:PubMed was searched (1966-2014) using the terms multiple sclerosis, treatment, interferon, glatiramer acetate, dimethyl fumarate, fingolimod, ter...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2014.08.006
更新日期:2014-12-01 00:00:00
abstract:BACKGROUND:Immune thrombocytopenic purpura (ITP) is characterized by platelet deficiency due to platelet destruction and/or inadequate production. Initial therapy consists of corticosteroids or intravenous immunoglobulin (IVIg). Patients with chronic refractory disease might undergo splenectomy. Although there is no tr...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2009.09.013
更新日期:2009-09-01 00:00:00
abstract::The medical records for 174 patients who underwent cholecystectomy (n = 52) or hip/knee replacement (n = 122) at four community-based medical centers were retrospectively reviewed to determine if using a nonnarcotic alternative to morphine sulfate and/or meperidine as a primary postoperative analgesic could reduce res...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:
更新日期:1993-09-01 00:00:00
abstract:BACKGROUND:In 2002, fixed-dose combination therapy (FDCT) with rosiglitazone maleate plus metformin hydrochloride became available for the treatment of type 2 diabetes mellitus (DM-2) in subjects whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione. FDCT allows a reduced pill burden and a...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2004.12.018
更新日期:2004-12-01 00:00:00
abstract::Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1993-03-01 00:00:00
abstract:BACKGROUND:Mitoxantrone, an intravenously administered immunosuppressant that inhibits T-cell, B-cell, and macrophage proliferation, is indicated for reducing neurologic disability and relapse frequency in patients with secondary progressive multiple sclerosis (SPMS), progressive relapsing MS, or worsening relapsing-re...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2006.04.013
更新日期:2006-04-01 00:00:00
abstract:BACKGROUND:Gastrointestinal (GI) symptoms and high dosing frequency have been cited as reasons for inadequate adherence to daily or weekly oral bisphosphonate therapy. Inadequate adherence may lead to poor therapeutic outcomes. OBJECTIVE:The PRIOR study evaluated adherence to and GI tolerability of monthly therapy wit...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.clinthera.2008.04.009
更新日期:2008-04-01 00:00:00
abstract:BACKGROUND:In the past decade, health insurers have increased their reliance on cost control policies such as prior authorization and 3-tier formularies. Little is known about how these policies are being applied to psychotropic medications, many of which have low rates of patient adherence. OBJECTIVE:This study repor...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.02.011
更新日期:2007-02-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to characterize comprehensive medication therapy management (MTM) involving a community pharmacy and local physicians by describing the drug-related issues encountered, identifying which medication types were associated with these issues, and listing the actions taken by physicians a...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(05)00146-3
更新日期:2005-07-01 00:00:00
abstract::Five hundred fourteen pregnant women at or near term with medically indicated inductions and unfavorable cervical induction features (Bishop score 0-4) were enrolled in an open-label randomized multicenter clinical trial to study the effect of endocervical administration of 0.5 mg of dinoprostone cervical gel as a pre...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:
更新日期:1993-09-01 00:00:00
abstract:BACKGROUND:Varenicline was designed to relieve symptoms of nicotine withdrawal, including cigarette craving, and to block the reinforcing effects of continued nicotine use. The cost-effectiveness of varenicline in some countries has not been studied. OBJECTIVE:The aim of this study was to compare the cost-effectivenes...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.07.002
更新日期:2012-08-01 00:00:00
abstract:BACKGROUND:Fenofibrate lowers serum total cholesterol and triglyceride levels while it elevates serum high-density lipoprotein cholesterol (HDL-C) level. OBJECTIVE:The aim of this study was to investigate the effects of fenofibrate on the particle size of high-density lipoprotein (HDL). METHODS:Patients with hyperlip...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(02)80064-9
更新日期:2002-10-01 00:00:00
abstract:BACKGROUND:Dementia is a cerebral disorder resulting in a progressive deterioration of intellectual function that compromises the patient's ability to function. The diagnostic criteria for dementia are primarily clinical and are based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. The Hac...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/S0149-2918(00)80056-9
更新日期:2000-07-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS:A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertens...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2017.10.013
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:Enzyme replacement therapy (ERT) with imiglucerase is a well-established, effective treatment for Gaucher disease. However, there have been no published reports regarding the excretion of imiglucerase into human breast milk and its effects on the nursing infant. OBJECTIVE:This letter reports on the successf...
journal_title:Clinical therapeutics
pub_type: 信件
doi:10.1016/j.clinthera.2010.11.008
更新日期:2010-11-01 00:00:00
abstract:PURPOSE:Frailty is a syndrome of vulnerability and physical decline with aging that increases risk for disability, hospitalizations, and death. To date, interventions for frailty have primarily focused on exercise and/or nutritional interventions, many of which show improvement in frailty-related characteristics, such ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2019.01.006
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:Spinal muscular atrophy (SMA) is an autosomal recessive motor neuron disease caused by mutations in the survival motor neuron gene (SMN1) and the leading genetic cause of infant mortality. Currently, there is no effective treatment other than supportive care. OBJECTIVE:This article provides a general overvi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2013.11.006
更新日期:2014-01-01 00:00:00
abstract:PURPOSE:The goal of this study was to review recent clinical studies of azilsartan medoxomil (AZL-M) and chlorthalidone (CLD), a combined angiotensin receptor blocker and thiazide-like diuretic, and its role in recently published guidelines. This review explores the role of AZL-M/CLD in treating patients with hypertens...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2020.05.015
更新日期:2020-07-01 00:00:00
abstract::Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2016.09.020
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:Patients' preferences for medications may be important in determining their compliance with therapy, particularly in the case of an asymptomatic chronic disease such as osteoporosis. Although preferences for certain attributes of osteoporosis medications, including dosing frequency and tolerability, can be e...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(07)80087-7
更新日期:2007-03-01 00:00:00
abstract:OBJECTIVE:This study was conducted to evaluate data on chemotherapy-associated anemia and thrombocytopenia, and cycle delays in patients with cancer in a community oncology practice. METHODS:Data on adult patients (age > or =18 years) with cancer treated in outpatient oncology clinics throughout the United States betw...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2009.11.020
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Treatment with interferon-beta (IFN-beta) has been related to worsening of muscle spasticity in patients with multiple sclerosis (MS). However, there are no specific data on the effects of glatiramer acetate (GA) on spasticity. OBJECTIVE:The aim of the present study was to assess the effects of GA on spasti...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/j.clinthera.2010.06.005
更新日期:2010-06-01 00:00:00
abstract:BACKGROUND:Idiopathic thrombocytopenic purpura (ITP) is a relatively rare acquired autoimmune disease characterized by either decreased platelet production or increased platelet destruction leading to reduced platelet counts and increased risk of bleeding. Immune modulators have been used in treatment; however, a novel...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.10.004
更新日期:2011-11-01 00:00:00
abstract::The purpose of this clinical study was to determine the efficacy, tolerability, and impact on quality of life of domperidone--a specific peripherally acting dopamine antagonist--in the management of symptoms of gastroparesis, a common and potentially debilitating condition in patients with diabetes mellitus. In the fi...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(98)80054-4
更新日期:1998-05-01 00:00:00
abstract:BACKGROUND:Anemia is a common complication of chronic kidney disease (CKD). The approved dosing interval for currently available erythropoiesis-stimulating agents (ESAs) is 2 to 3 times weekly for epoetin alfa (EPO) and every 1 to 2 weeks for darbepoetin alfa (DARB). However, clinicians sometimes use less frequent dosi...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.09.012
更新日期:2007-09-01 00:00:00