Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study

The objective of this subanalysis was to examine the safety and tolerability of onabotulinumtoxinA after each of nine treatment cycles.MethodsOnabotulinumtoxinA 155 U was administered every 12  weeks. Safety and tolerability, overall and by treatment cycle, were assessed. Treatment-emergent adverse events reported between successive treatments were attributed to the preceding treatment. The safety population received one or more doses of onabotulinumtoxinA. The primary efficacy outcome w as the reduction in headache days at week 108 compared with baseline.ResultsOf 716 patients enrolled, 373 patients (52.1%) completed the study and 343 (47.9%) withdrew; 481 patients (67.2%) received 60  weeks of treatment and 402 (56.1%) received 108 weeks of treatment. In total, 436 (60.9%) patients reported treatment-emergent adverse events; most were mild/moderate in severity. Thirty-two patients (4.5%) discontinued the study after experiencing treatment-emergent adverse events. The incidence of treatment-emergent adverse events typically decreased with repeated onabotulinumtoxinA treatment: first cycle, 24.2%; fourth cycle, 18.4%; ninth cycle, 12.2%. Neck pain (2.7%), eyelid ptosis (1.8%), musculoskeletal stiffness (1.4%), injection-site pain (1.3%), and headache (1.3%) were the most c ommon treatment-emergent adverse events after the first cycle. Seventy-five patients (10.5%) reported serious treatment-emergent adverse events, 13 (1.8%) withdrew. Treatment-related adverse ...
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research

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This article enhances provider knowledge and acceptance of the most effective and prevalent mind-body modalities: meditation, guided imagery, clinical hypnosis, and biofeedback. The scientific evidence is strongest for mind-body applications for chronic pain, primary headache, cardiac rehabilitation, and cancer rehabilitation, with preliminary evidence for traumatic brain injury and cerebrovascular events. Mind-body interventions are well-tolerated by patients and should be considered part of standard care in physical medicine and rehabilitation settings.
Source: Physical Medicine and Rehabilitation Clinics of North America - Category: Rehabilitation Authors: Source Type: research
Conclusions and relevanceCOVID-19 pandemic had an overall negative impact on patients with migraine. Several risk factors for poor outcome were identified. Long-term strategies should be validated and implemented to deliver quality care for patients with migraine, with emphasis on psychosocial well-being.
Source: The Journal of Headache and Pain - Category: Neurology Source Type: research
AbstractBackgroundWe evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).MethodsIn a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675  mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 da...
Source: The Journal of Headache and Pain - Category: Neurology Source Type: research
Millions of people are suffering from chronic pain conditions, such as headache, arthritis, cancer. Apart from western medicines, traditional Chinese medicines are also well accepted for pain management, espec...
Source: BMC Complementary and Alternative Medicine - Category: Complementary Medicine Authors: Tags: Research article Source Type: research
hat H Abstract PURPOSE: Individuals with poor physical and mental health may face elevated risk for suicide, particularly suicide by firearm. METHODS: This retrospective cohort study used statewide, longitudinally-linked ED patient record and mortality data to examine 12-month incidence of firearm suicide among emergency department (ED) patients presenting with a range of physical health problems. Participants included all residents presenting to a California ED in 2009-2013 with nonfatal visits for somatic diagnoses hypothesized to increase suicide risk, including myocardial infarction, congestive heart fail...
Source: Annals of Epidemiology - Category: Epidemiology Authors: Tags: Ann Epidemiol Source Type: research
Abstract Chronic headache pain is one of the most commonly reported comorbid pain conditions with post-traumatic stress disorder (PTSD) patients and resistant to effective treatment, yet no combined preclinical model of the two disorders has been reported. Here, we used a modified chronic headache pain model to investigate the contribution of single prolonged stress (SPS) model of PTSD with sodium nitroprusside (SNP)-induced hyperalgesia. Injection of SNP (2 mg/kg, i.p.) occurred every other day from day 7 to day 15 after initiation of SPS in rats. Paw withdrawal threshold (PWT) to von Frey stimuli and tail f...
Source: Cellular and Molecular Neurobiology - Category: Cytology Authors: Tags: Cell Mol Neurobiol Source Type: research
ConclusionsFD of DAS and DMN may reflect disruption of cognitive control of pain in CM. Since the normal microstructure of the thalamus and its positive connectivity with the cortical networking found in our CM patients reminds similar results obtained assessing the same structures but with the methods of neurophysiology, in episodic migraine during an attack, this may be yet another evidence in supporting CM as a never-ending migraine attack.
Source: The Journal of Headache and Pain - Category: Neurology Source Type: research
Conclusions: CMV hepatitis in immunocompetent individuals has a satisfactory outcome, but occasionally results in complications in other organs. The sIL-2R level has potential as a surrogate marker of hepatic inflammation in immunocompetent patients with CMV hepatitis. PMID: 32908853 [PubMed - in process]
Source: Canadian Journal of Gastroenterology - Category: Gastroenterology Tags: Can J Gastroenterol Hepatol Source Type: research
CONCLUSIONS: On an aggregate level, perceived stress peaks during the pain phase of the migraine cycle. However, on an individual and episode basis, there are 3 dominant patterns of perceived stress variation across the migraine cycle. Elucidating how patterns of perceived stress vary across the migraine cycle may contribute insights into disease biology, triggers and protective factors, and provide a framework for targeting individualized treatment plans. PMID: 32918830 [PubMed - as supplied by publisher]
Source: Headache - Category: Neurology Authors: Tags: Headache Source Type: research
ConclusionsThe ONS-induced sensory location, the size of the spatial sensory field, as well as the sensory quality are significantly correlated with the reported clinical effectiveness. The results suggest that besides surgical technique, the individual and continuous programming of the stimulation parameters is clinically relevant in increasing the therapeutic effectiveness.
Source: Pain and Therapy - Category: Anesthesiology Source Type: research
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