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Pridopidine in early-stage manifest Huntington's disease: a phase 3 trial
Reilmann, Ralf; Feigin, Andrew; Rosser, Anne E; Kostyk, Sandra K; Saft, Carsten; Cohen, Yael; Schuring, Henk; Hand, Randal; Tan, Andrew M; Chen, Kelly; Feng, Wei; Navon-Perry, Leehee; Cruz-Herranz, Andres; Syltevik, Christine; Boot, Diderik; Squitieri, Ferdinando; Kayson, Elise; Mehra, Munish; Goldberg, Y Paul; Geva, Michal; Hayden, Michael R; ,
Huntington's disease (HD) is a rare, neurodegenerative disorder for which only symptomatic treatments are available. The PROOF-HD study was a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of pridopidine, a selective Sigma-1 receptor agonist, in HD. The primary and key secondary endpoints, change in total functional capacity (TFC) and composite Unified Huntington's Disease Rating Scale (cUHDRS) score at week 65, were not met in the overall population. The TFC least-squares mean difference between pridopidine and placebo was -0.18 (95% confidence interval -0.49 to 0.14; P = 0.26). The cUHDRS least-squares mean difference between pridopidine and placebo was -0.11 (95% confidence interval -0.40 to 0.18; P = 0.45). Sensitivity analysis in a subgroup of participants not treated with antidopaminergic medications at any time demonstrated a consistent pattern favoring pridopidine across multiple measures, including TFC and cUHDRS. Notably, pridopidine 45 mg twice daily demonstrated a favorable safety and tolerability profile. Taken together, pridopidine has the potential to address a critical unmet need in HD. ClinicalTrials.gov identifier: NCT04556656 .
PMCID:12618238
PMID: 40913168
ISSN: 1546-170x
CID: 5966262
Intraoperative Placement of Paravertebral Catheters to Manage Postoperative Pain in Opioid-Dependent Patients After Thoracolumbar Spine Fusion Surgery: A Case Report [Case Report]
Chen, Kelly Y; Abhold, Eric; Shin, John H; Sabouri, A Sassan
We introduce a regional technique that involves the intraoperative placement of bilateral paravertebral catheters under direct visualization. The patient had stage IV lung cancer and was on chronic oxycodone therapy. He presented with a T10 metastatic lesion, and underwent spinal decompression with T7-L1 fusion and T10 corpectomy. Before fascial closure, catheters were advanced into the T10 paravertebral space under direct visualization by the surgeon bilaterally. Postoperatively, his pain was well controlled, and narcotic requirements were decreased. Our case report demonstrates that for patients undergoing posterior spine surgery, intraoperative placement of bilateral paravertebral catheters can be used to help manage postoperative pain.
PMID: 31361660
ISSN: 2575-3126
CID: 5873212
The Effect of Initiatives to Overcome Language Barriers and Improve Attendance: A Cross-Sectional Analysis of Adherence in an Inner City Chronic Pain Clinic
Andreae, Michael H; White, Robert S; Chen, Kelly Yan; Nair, Singh; Hall, Charles; Shaparin, Naum
UNLABELLED:Language barriers can prevent pain physicians and patients from forming meaningful rapport and drive health care disparities. Non-adherence with scheduled pain clinic appointments deprives patients with chronic pain of needed specialist care. OBJECTIVE:We evaluated the benefit of comprehensive initiatives to overcome language barriers to improve patient adherence with initial scheduled chronic pain clinic appointments. DESIGN:After implementation of our initiative, we performed a retrospective cross-sectional analysis and fit logistic regression models to investigate the association between demographic factors and adherence. SETTING:We collected retrospective data from an observational cohort with a scheduled appointment at the adult inner-city underserved outpatient Pain Center at Montefiore Medical Center, Bronx, New York. PATIENTS:Between March 2012 and March 2014, 14,459 appointments were scheduled; 3,035 of these appointments represented initial first visits; patients had a mean age of 53 years; 15% were predominantly Spanish-speaking, 65% were female. INTERVENTIONS:Our initiative to overcome language barriers in our pain clinic included appointment reminders in the patient’s preferred language, Spanish-speaking staff, and unified locations with equitable access. OUTCOME MEASURES:Our dependent variable was adherence with a first scheduled pain clinic appointment. RESULTS:We found that after implementation of our initiative, speaking Spanish was now statistically significantly associated with higher rates of adherence with appointments (Odds Ratio 1.32, 95% confidence interval [1.06–1.64]). CONCLUSIONS:We infer from our results that coordinated initiatives to overcome language barriers can be beneficial in improving appointment adherence and access to care by enhancing rapport and communication between pain physicians and their patients. PERSPECTIVE:The results of this retrospective cross-sectional analysis of patients’ adherence with scheduled appointments in an inner-city chronic pain clinic suggests that targeted initiatives including a pre-clinic reminder phone call in the patient’s own language may help to overcome language barriers and improve access to care.
PMCID:6376453
PMID: 28204760
ISSN: 1526-4637
CID: 5873202
Buprenorphine-naloxone therapy in pain management
Chen, Kelly Yan; Chen, Lucy; Mao, Jianren
Buprenorphine-naloxone (bup/nal in 4:1 ratio; Suboxone; Reckitt Benckiser Pharmaceuticals Incorporation, Richmond, VA) is approved by the Food and Drug Administration for outpatient office-based addiction treatment. In the past few years, bup/nal has been increasingly prescribed off-label for chronic pain management. The current data suggest that bup/nal may provide pain relief in patients with chronic pain with opioid dependence or addiction. However, the unique pharmacological profile of bup/nal confers it to be a weak analgesic that is unlikely to provide adequate pain relief for patients without opioid dependence or addiction. Possible mechanisms of pain relief by bup/nal therapy in opioid-dependent patients with chronic pain may include reversal of opioid-induced hyperalgesia and improvement in opioid tolerance and addiction. Additional studies are needed to assess the implication of bup/nal therapy in clinical anesthesia and perioperative pain management.
PMCID:3999180
PMID: 24509068
ISSN: 1528-1175
CID: 5873192