Articles: narcotic-antagonists.
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CPT Pharmacometrics Syst Pharmacol · Oct 2017
Randomized Controlled TrialPopulation Exposure-Response Modeling Supported Selection of Naloxegol Doses in Phase III Studies in Patients With Opioid-Induced Constipation.
Naloxegol is approved for the treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain. Population exposure-response models were developed using data from a phase II study comprising 185 adults with OIC. ⋯ The model predicted that 12.5, 25, and 37.5 mg doses would produce median response rates of 40%, 50%, and 60%, and dropout rates of 13.3%, 16.7%, and 23.3%, respectively. The large overlap of predicted difference of the response rate between placebo and the 25 or 37.5 mg doses suggested little utility of using a 37.5 mg dose in phase III studies.
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Hailey-Hailey disease is a severe genetic blistering disease of intertriginous skin locations that can lead to poor quality of life and increased morbidities. Multiple therapies are available with inconsistent outcomes and potentially severe adverse effects. ⋯ We present herein 3 cases of patients with severe Hailey-Hailey disease treated with low-dose naltrexone who achieved clinical resolution of symptoms. The success of these cases suggests low-dose naltrexone as a novel therapy for Hailey-Hailey disease. The possible mechanism may involve low-dose naltrexone influencing opioid or toll-like receptor signaling to improve calcium mobilization and improve keratinocyte differentiation and wound healing. Future studies are needed to clarify the mechanism and to define the role of low-dose naltrexone for treatment of Hailey-Hailey disease.
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Familial benign pemphigus, or Hailey-Hailey disease (HHD), is a rare and debilitating genetic dermatosis characterized by chronic, recurrent vesicles, erosions, and maceration in flexural areas. Despite the reported therapeutic modalities, such as topical and systemic corticosteroids, systemic immunomodulators, topical and systemic retinoids, and laser, HHD can still be markedly difficult to control. ⋯ Low-dose naltrexone may represent a low-cost and low-risk alternative or adjunct in the treatment of HHD.
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Patients with opioid use disorder are at a high risk of overdose. To minimize that risk, a program offering intranasal naloxone rescue kits was piloted at a Veterans Administration Hospital. The purpose of this study was to characterize veterans who accepted these potentially lifesaving kits. ⋯ Outpatients were nearly a decade older, with more years of opioid use (19.0 versus 11.0), but with less utilization of inpatient services in the prior year (all p < 0.05). The main finding was that 70% of veterans accepted overdose education and naloxone rescue, but significantly higher proportions of outpatients were more receptive than inpatients (89% versus 63%, p = 0.003). Efforts to increase overdose education and naloxone rescue acceptance in all settings are encouraged.