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PURPOSE: Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. METHODS: CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18-65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. RESULTS: A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: -33.58 ± 2.11 (GMB 120 mg) and -32.67 ± 2.04 (GMB 240 mg). CONCLUSION: Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.
Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Adolescente , Adulto , Idoso , Anticorpos Monoclonais Humanizados/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/psicologia , Qualidade de Vida/psicologia , Resultado do Tratamento , Adulto JovemRESUMO
Pain, particularly musculoskeletal (MSK) and multi-site pain, significantly impacts activities of daily living (ADL) in the elderly, leading to a decline in overall quality of life (QoL). This study, comprising 7490 participants, (mean age: 69 ± 10; females: 57%) from the sixth wave of the Korean Longitudinal Study of Aging (KLoSA), aimed to assess the association between self-reported pain and ADL impairment among the elderly population. Notably, 62% of participants reported experiencing pain, with back pain being the most prevalent (36%) and stomachache the least (0.39%). A majority (61%) of individuals reported MSK-related pain. Additionally, 20% reported pain at one site and 0.03% experienced pain at 12 sites. ADL impairment was observed in 376 (5.0%) participants. Compared to those without pain, participants reporting moderate and severe pain had higher odds of ADL impairment [2.31 (95% CI, 1.66-3.21) and 2.98 (95% CI, 1.95-4.53), respectively]. Pain experienced in the shoulder, arm, wrist, back, hip, leg, and ankle had a significant association with ADL impairment, with ORs ranging from 2.66 (95% CI, 1.80-3.93; hip pain) to 1.36 (95% CI 1.07-1.72; back pain). Furthermore, multi-site pain was associated with higher ADL impairment [1-6 sites: OR: 1.49 (95% CI, 1.11-2.01); 7-12 sites: OR: 7.16 (95% CI, 3.60-14.26)]. These findings underscore the importance of addressing MSK and multi-site pain through targeted interventions, potentially enhancing ADL and contributing to an improved QoL among the elderly population.
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BACKGROUND: Parkinson's Disease (PD) is a neurodegenerative disorder manifested by rest tremor, rigidity, bradykinesia, and postural instability. Recent pharmaco-epidemiological studies evaluating beta-adrenergic drug use and risk of PD have reported conflicting findings. OBJECTIVES: This systematic review and meta-analyses evaluate the association between beta-adrenergic (agonists and antagonists) drugs' use and PD. METHODS: An electronic literature search of eight databases was performed from inception to July 2021 to identify pharmaco-epidemiological studies (case-control and cohort) reporting the risk of PD in beta-adrenergic users compared to non-users. We used the generic inverse variance method and RevMan (5.3.5) to estimate pooled adjusted risk ratios (aRRs) of PD using a random-effects model. RESULTS: Of 3168 records, 15 studies (10 case-control; five cohort) with 6508,877 participants, including 87,011 PD cases, were included. In the pooled analysis (n = 10) including any beta-antagonist users, compared with non-users, the aRR for PD was 1.19 (CI: 1.05,1.35); for any beta-agonist users (n = 8) aRR for PD was 0.87 (CI: 0.78,0.97). Propranolol users had a significantly increased risk of PD (aRR:1.91; CI:1.20,3.06), whereas salbutamol use was associated with reduced risk of PD (aRR:0.95; CI:0.92,0.99). Significant heterogeneity (I2 >87%) was observed, but the majority (n = 13) of the studies were of high quality, based on the JBI tool. CONCLUSIONS: Beta-antagonist use was associated with a modestly increased risk of PD, whereas beta-agonist use was associated with a modest decreased risk of PD. Future epidemiological studies should address the issues of protopathic bias and indirect association using appropriate epidemiological methods.