scholarly journals Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: A post hoc analysis

Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S37
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  
Keyword(s):  
Upper Limb ◽  
Treatment Effect ◽  
Duration Of Treatment ◽  
Post Hoc Analysis ◽  
Limb Spasticity ◽  
Post Hoc

scholarly journals Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  
Keyword(s):  
Upper Limb ◽  
Treatment Effect ◽  
Time Frame ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Duration Of Effect ◽  
Limb Spasticity ◽  
Post Hoc ◽  
Injection Cycle

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

Duration of treatment effect of incobotulinumtoxina (Xeomin) in upper limb spasticity

Toxicon ◽  
2016 ◽  
Vol 123 ◽  
pp. S47
Author(s):  
Petr Kaňovský ◽  
Michael Althaus ◽  
Angelika Hanschmann ◽  
Irena Pulte
Keyword(s):  
Upper Limb ◽  
Treatment Effect ◽  
Duration Of Treatment ◽  
Limb Spasticity

Duration of Treatment Effect of IncobotulinumtoxinA in Upper Limb Spasticity

2017 ◽  
Vol 98 (10) ◽  
pp. e55
Author(s):  
Michael Pellegrino ◽  
Petr Kanovsky ◽  
Michael Munin ◽  
Michael Althaus ◽  
Angelika Hanschmann ◽  
...  
Keyword(s):  
Upper Limb ◽  
Treatment Effect ◽  
Duration Of Treatment ◽  
Limb Spasticity

scholarly journals Metformin and N-terminal pro B-type natriuretic peptide in type 2 diabetes patients, a post-hoc analysis of a randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0247939
Author(s):  
Wiebe M. C. Top ◽  
Philippe Lehert ◽  
Casper G. Schalkwijk ◽  
Coen D. A. Stehouwer ◽  
Adriaan Kooy
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Natriuretic Peptide ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Initial Increase ◽  
Post Hoc Analysis ◽  
Post Hoc

Background Beyond antihyperglycemic effects, metformin may improve cardiovascular outcomes. Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease. We studied whether metformin was associated with a reduction in the serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) in these patients. Methods In the HOME trial 390 insulin-treated patients with type 2 diabetes were randomized to 850 mg metformin or placebo three times daily. Plasma samples were drawn at baseline, 4, 17, 30, 43 and 52 months. In a post-hoc analysis we analyzed the change in NT-proBNP in both groups. We used a longitudinal mixed model analysis adjusting for age, sex and prior cardiovascular disease. In a secondary analysis we assessed a possible immediate treatment effect post baseline. Results Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]). In the secondary analysis there was also no sustained time independent immediate treatment effect (initial increase of 17% [95%CI 4;30, p = 0.006] followed by yearly decrease of -4% [95%CI -7;0, p = 0.07]). Conclusions Metformin as compared to placebo did not affect NT-proBNP plasma levels in this 4.3-year placebo-controlled trial. Potential cardioprotective effects of metformin cannot be explained by changes in cardiac pressures or volumes to the extent reflected by NT-proBNP.

scholarly journals Efficacy and safety of onabotulinumtoxinA with standardized occupational therapy for treatment of pediatric upper limb spasticity: Phase III placebo-controlled randomized trial

2021 ◽  
pp. 1-11
Author(s):  
Rozalina Dimitrova ◽  
Emily McCusker ◽  
Mark Gormley ◽  
Darcy Fehlings ◽  
Katharine E. Alter ◽  
...  
Keyword(s):  
Occupational Therapy ◽  
Upper Limb ◽  
Goal Attainment ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Secondary Endpoints ◽  
Limb Spasticity ◽  
Goal Attainment Scale ◽  
Global Impression Of Change ◽  
Post Hoc

BACKGROUND: This is the first large study of onabotulinumtoxinA as treatment for pediatric upper limb spasticity. OBJECTIVE: Evaluate efficacy and safety of a single treatment with onabotulinumtoxinA plus occupational therapy (OT). METHODS: In this registrational phase 3, multinational study (NCT01603602), participants were randomized 1:1:1 to onabotulinumtoxinA 3 U/kg/OT, 6 U/kg/OT, or placebo/OT. Primary endpoint was average change from baseline at weeks 4 and 6 in Modified Ashworth Scale-Bohannon (MAS) score. Secondary endpoints included Modified Tardieu Scale (MTS), Clinical Global Impression of Change (CGI) and functional Goal Attainment Scale (GAS). RESULTS: 235 participants were randomized. At weeks 4 and 6, onabotulinumtoxinA groups had greater mean reductions in MAS (both –1.9; p <  0.001) versus placebo (–1.2). OnabotulinumtoxinA doses improved dynamic tone per MTS. Mean CGI at weeks 4 and 6 was unchanged in the overall population, but improved in a post hoc analysis of patients with a single affected UL muscle group (elbow or wrist). GAS score for passive goals was significantly higher for 6 U/kg versus placebo at week 12. Most AEs were mild/moderate in severity; overall incidence was similar between groups. CONCLUSIONS: OnabotulinumtoxinA (3 and 6 U/kg) was safe and effective in reducing upper limb spasticity in pediatric participants.

Sustained efficacy of incobotulinumtoxinA in upper-limb post-stroke spasticity: A post hoc analysis

Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S37
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  
Keyword(s):  
Upper Limb ◽  
Post Hoc Analysis ◽  
Post Stroke ◽  
Sustained Efficacy ◽  
Post Hoc

Effectiveness of Social and Correctness Reinforcers with Different Aged Children

1973 ◽  
Vol 33 (3) ◽  
pp. 787-792 ◽  
Author(s):  
Douglas D. Settles ◽  
Norman H. Hamm
Keyword(s):  
Middle Class ◽  
Treatment Effect ◽  
Sorting Task ◽  
Eighth Grade ◽  
Social Approval ◽  
Post Hoc Analysis ◽  
Post Hoc

The effectiveness of two classes of verbal reinforcers, correctness and social, were examined among 108 second-, fifth-, and eighth-grade, middle-class children using a marble-sorting task. Results indicated that correctness reinforcement was more rewarding across all levels of age than social approval; however, a post hoc analysis of the age by treatment effect indicated a significant reinforcer effect for only the eighth-grade Ss.

Sign in / Sign up

Export Citation Format

Share Document