scholarly journals Long-term Safety and Dosing of OnabotulinumtoxinA: A Prospective, Observational Study

2019 ◽  
Vol 46 (6) ◽  
pp. 742-752 ◽  
Author(s):  
Theodore Wein ◽  
Mandar Jog ◽  
Meetu Bhogal ◽  
Sonja Dhani ◽  
Robert Miller ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Observational Study ◽  
Therapeutic Indication ◽  
Prospective Observational Study ◽  
Muscular Weakness ◽  
Canadian Study ◽  
Safety Population ◽  
Risk Balance

ABSTRACT:Background:Although therapeutic treatments are intended to help alleviate symptoms associated with disease, safety must be carefully considered and monitored to confirm continued positive benefit/risk balance. The objective of MOBILITY was to study the long-term safety of onabotulinumtoxinA for treatment of various therapeutic indications.Methods:A prospective, multicenter, observational, Phase IV Canadian study in patients treated with onabotulinumtoxinA for a therapeutic indication. Dosing was determined by the participating physician. Adverse events (AEs) were recorded throughout the study.Results:Patients (n= 1372) with adult focal spasticity, blepharospasm, cerebral palsy, cervical dystonia, hemifacial spasm, hyperhidrosis, or “other” diagnoses were enrolled into the safety cohort. Eighty-three patients (6%) reported 209 AEs; 44 AEs in 24 patients (2%) were considered treatment-related AEs. Seventy-two serious AEs were reported by 38 patients (3%); 10 serious AEs in 5 patients (0.4%) were considered treatment related. Most commonly reported treatment-related AEs were muscular weakness (n= 7/44) and dysphagia (n= 6/44).Conclusions:In patients with follow-up for up to six treatments with onabotulinumtoxinA, treatment-related AEs were reported in <2% of the safety population over the course of nearly 5 years. Our findings from MOBILITY provide further evidence that onabotulinumtoxinA treatment is safe for long-term use across a variety of therapeutic indications.

scholarly journals Prospective Observational Study of Imatinib Therapy in Japanese Patients with Advanced Gastrointestinal Stromal Tumors: Long-term Follow-up and Second Malignancy

2012 ◽  
Vol 42 (7) ◽  
pp. 578-585 ◽  
Author(s):  
Tatsuo Kanda ◽  
Takashi Ishikawa ◽  
Seiichi Hirota ◽  
Kazuhito Yajima ◽  
Shin-ichi Kosugi ◽  
...  
Keyword(s):  
Observational Study ◽  
Gastrointestinal Stromal Tumors ◽  
Prospective Observational Study ◽  
Japanese Patients ◽  
Imatinib Therapy ◽  
Long Term Results ◽  
Second Malignancies ◽  
Stromal Tumors

Abstract Objective Limited data are available concerning long-term results of imatinib therapy in patients with advanced gastrointestinal stromal tumors. We aimed to clarify the long-term outcomes of imatinib therapy in Japanese patients with advanced gastrointestinal stromal tumors. Methods A prospective, observational study of imatinib therapy for unresectable and metastatic gastrointestinal stromal tumors was conducted in our institution. Imatinib was initiated at a dose of 400 mg daily and continued until disease progression. Safety, efficacy and long-term tolerability and survival were evaluated in an intent-to-treat population. The median follow-up period in this study was 68 months. Results Seventy patients were enrolled between December 2001 and December 2009. Treatment-related Grade 3/4 adverse events occurred in 49 patients (70.0%). Although 14 patients required adverse effect management with hospitalization, only 5 patients (7.1%) withdrew from the treatment owing to imatinib intolerance. The tumor response and clinical benefit rates were 61.4 and 85.7%, respectively. Thirty-seven patients (52.9%) maintained the treatment at 400 mg daily imatinib, whereas 33 patients (47.1%) had their dose reduced to 300 mg daily or less. The overall survival rate at 5 years was 60.9% and the median survival time was 70 months. The median progression-free survival time of all the 70 enrolled patients was 30 months. Seven patients (10.0%) suffered from second malignancies, including three patients with genitourinary carcinomas. Conclusions Despite the need for dose reduction, the long-term results of imatinib therapy for advanced gastrointestinal stromal tumors were good in Japanese patients. Physicians should pay attention to the occurrence of second malignancies during imatinib therapy for gastrointestinal stromal tumor patients.

scholarly journals Long-Term Follow-Up of Accelerated Transepithelial Corneal Crosslinking for Post-LASIK Ectasia: A Pilot Prospective Observational Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Mi Tian ◽  
Xiaoyu Zhang ◽  
Weijun Jian ◽  
Ling Sun ◽  
Yang Shen ◽  
...  
Keyword(s):  
Observational Study ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Statistical Significance ◽  
Corneal Thickness ◽  
Corneal Crosslinking ◽  
Epithelial Thickness ◽  
Long Term Follow Up

Background: Keratectasia after corneal refractive surgery is a rare but serious postoperative complication, and reports on accelerated transepithelial corneal crosslinking (ATE-CXL)-based treatment of patients with post-laser-assisted in situ keratomileusis (LASIK) ectasia are limited. Therefore, this study evaluated the long-term efficacy and safety of ATE-CXL for progressive post-LASIK ectasia.Methods: This prospective observational study was conducted at the Eye and ENT Hospital, Fudan University, Shanghai, China, and 25 eyes from 25 patients with post-LASIK ectasia undergoing ATE-CXL were examined. Clinical examinations were conducted preoperatively and postoperatively to assess parameters such as manifest refraction, corrected distance visual acuity (CDVA), endothelial cell density; keratometry, corneal thickness, posterior elevation and topometric indices were measured using Pentacam; sectoral pachymetry and epithelial thickness were evaluated using optical coherence tomography. A paired t-test, Wilcoxon rank-sum test, Kruskal-Wallis test, and repeated measures analysis of variance were used for statistical analysis.Results: Participants were examined for an average of 46 months. No severe complications occurred during or after ATE-CXL. CDVA improved from 0.25 ± 0.31 preoperatively to 0.15 ± 0.17 postoperatively (p = 0.011). Maximum keratometry decreased from 55.20 ± 8.33 D to 54.40 ± 7.98 D, with no statistical significance (p = 0.074), and the central corneal thickness increased from 414.92 ± 40.96 μm to 420.28 ± 44.78 μm (p = 0.047) at the final follow-up. Posterior elevation, pachymetry, and epithelial thickness remained stable (p &gt; 0.05) throughout the follow-up. No significant differences were noted in topometric indices, except the central keratoconus index, which decreased significantly (p &lt; 0.001) at the final follow-up.Conclusion: Improvements in CDVA and stabilization in corneal keratometry and posterior elevation after ATE-CXL were noted at the 46-months follow-up, demonstrating that ATE-CXL is a safe and effective treatment for progressive post-LASIK ectasia.

scholarly journals Long-term follow-up of trauma patients before and after implementation of a physician-staffed helicopter: A prospective observational study

Injury ◽  
2016 ◽  
Vol 47 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Kamilia S. Funder ◽  
Lars S. Rasmussen ◽  
Nicolai Lohse ◽  
Volkert Siersma ◽  
Rasmus Hesselfeldt ◽  
...  
Keyword(s):  
Observational Study ◽  
Prospective Observational Study ◽  
Trauma Patients ◽  
Before And After ◽  
Long Term Follow Up

New data in turner syndrome: Results from a long-term prospective observational study from diagnosis to adulthood

2020 ◽  
Author(s):  
Francesca Corzani ◽  
Carolina Cecchetti ◽  
Claudia Oriolo ◽  
Paola Altieri ◽  
Annamaria Perri ◽  
...  
Keyword(s):  
Observational Study ◽  
Turner Syndrome ◽  
Prospective Observational Study

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

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