ObjectiveTo determine the efficacy, tolerability, and safety of ascending doses of Adhesive Dermally-Applied Microarray (ADAM) zolmitriptan versus placebo for acute migraine treatment.BackgroundADAM is a novel patient-administered system for intracutaneous drug administration. In a phase 1 pharmacokinetic study, zolmitriptan administered using ADAM had much faster absorption than oral administration with higher exposure in the first two hours.MethodsThis was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2b/3 study evaluating ADAM zolmitriptan 1 mg, 1.9 mg, and 3.8 mg versus placebo. Co-primary endpoints were pain freedom and freedom from most bothersome other migraine-associated symptom 2 hours post-dose.ResultsOf patients treated with ADAM zolmitriptan 3.8 mg or placebo, 41.5% and 14.2%, respectively were pain-free 2 hours post-dose (p = 0.0001) and 68.3% and 42.9% were free from their most bothersome other symptom (p = 0.0009). Due to the fixed sequential testing methodology, formal statistical significance was not established for secondary endpoints. However, the proportion of patients who were photophobia-free, phonophobia-free, and nausea-free at 2 hours post-dose was higher in the ADAM zolmitriptan 3.8 mg group compared with placebo, as were the percentages of patients who were pain-free, and who experienced pain relief up to 48 hours post-dose. Systemic adverse events were consistent with previous triptan trials, and included dizziness, paresthesia, muscle tightness, and nausea, all of which occurred in < 5% of patients in any group. Application site reactions were generally mild and resolved within 48 hours, although erythema and bruising persisted for longer periods in some patients.ConclusionADAM zolmitriptan 3.8 mg provides effective relief of migraine headache and associated most bothersome symptoms compared with placebo, and is well-tolerated.ClinicalTrials.govNCT02745392
Time to LTR was significantly longer with pregabalin CR than with placebo. Safety profile of pregabalin CR was comparable to that reported for the immediate-release formulation in patients with postherpetic neuralgia.
Patients with severe nodulo-cystic acne are known to have elevated serum antibody levels and increased immediate hypersensitivity reactions to Propionibacterium acnes. This organism is the predominant bacterium in normal pilosebaceous follicles of human skin, and can be consistently isolated from pustular lesions in acne. Previously it had been observed that delayed cutaneous hypersensitivity reactions to P. acnes were negative in patients with acne. The present study investigated the proliferative response of lymphocytes from patients with nodulo-cystic acne to phytohaemagglutinin (PHA) and P. acnes antigen stimulation. The response to PHA stimulation was within normal limits. The response to P. acnes antigen showed a significant increase over control values obtained by testing lymphocytes from acne-free subjects. Thus cell mediated immunity to P. acnes may be present in subjects with severe inflammatory acne. These findings raise the possibility that reactions to P. acnes may contribute to intensifying the inflammatory response in acne lesions.
E xcessive sleepiness affects millions of Americans. Its prevalence is estimated to be in the range of 24% to 36%, based on objective and subjective assessments of sleepiness in community-based samples. [1][2][3] Excessive sleepiness interferes with daily living by impairing social, cognitive, and physical functioning and contributes to errors and accidents at home, 4 in the workplace, 4-7 and while driving. 4,[8][9][10][11][12] The effects of excessive sleepiness on well-being and on individual and public safety highlight the importance of recognizing this symptom, identifying its causes, and implementing strategies and therapies for its appropriate management.Excessive sleepiness is associated with a variety of medical conditions and is a debilitating symptom of various disorders of sleep and wakefulness, such as obstructive sleep apnea (OSA), a disorder that is characterized by recurrent upper airway collapse, reduction in levels of blood oxygen saturation, and frequent arousals during sleep; shift work disorder (SWD), a condition that arises from a misalignment between internally driven circadian processes and externally determined sleep-wake behavior in individuals who rotate work shifts or work at night; and narcolepsy, a primary disorder of the central ner-Study Objectives: This 12-month, open-label, flexible-dose study with an extension period evaluated the tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. Methods: Armodafinil-naïve, adult patients with excessive sleepiness associated with treated OSA (n = 170), SWD (n = 108), or narcolepsy (n = 50) received armodafinil (100-250 mg) once daily (treated OSA or narcolepsy) or before night shifts (SWD). Patients with OSA were regular users of continuous positive airway pressure (CPAP) therapy. Efficacy measures included the Clinical Global Impression of Improvement (CGI-I) and the Epworth Sleepiness Scale (ESS).Results: Across the diagnosis groups, the most commonly occurring adverse event was headache (14%-24%). Forty-three patients (13%) and 13 patients (4%) were withdrawn because of adverse events and insufficient efficacy, respectively. Armodafinil did not adversely affect CPAP therapy. At the final visit, 80% (95% CI: 74.1, 86.7) of patients with treated OSA and 84% (72.7, 94.8) of patients with narcolepsy were rated on the CGI-I as at least minimally improved with regard to overall clinical condition; 98% (95.2, 100.0) of patients with SWD were rated as improved with regard to sleepiness during night shifts, including the commute to and from work. Armodafinil improved ESS total scores in patients with treated OSA (mean [SD] [95% CI] change from baseline, −7.3 [5.6] [−8.39, −6.30]) and patients with narcolepsy (−4.7 [6.0] [−7.41, −1.93]). Conclusions: Armodafinil administered for 12 months or more was generally well tolerated and improved wakefulness in patients with excessive sleepiness associated with treated OSA, SWD, or narco...
Cluster headaches are characterized by unilateral paroxysmal attacks of severe pain with associated symptoms. The headaches occur during particular sleep stages and are associated with other chronobiologic factors. Several sleep disorders have been associated with the occurrence of cluster headache; multiple hormonal influences affect the relationship between sleep and headache. Melatonin and other treatments that affect circadian rhythm have been suggested for the treatment of cluster headache. Obstructive sleep apnea can occur in patients with cluster headache; attempts to treat one disorder may influence the other. Sleep disorders such as insomnia and narcolepsy also may be associated with and influence cluster headaches. This article examines the relationship between the various sleep disorders and cluster headache, and reviews current research. Normal and abnormal sleep and details of treatments for specific sleep disorders that may decrease the frequency and severity of cluster headaches also are discussed. The relationship between obstructive sleep apnea, which is the most common sleep disorder, and cluster headache is discussed in detail.
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