scholarly journals Tolerability and safety of novel half milliliter formulation of glatiramer acetate for subcutaneous injection: an open-label, multicenter, randomized comparative study

2010 ◽  
Vol 257 (11) ◽  
pp. 1917-1923 ◽  
Author(s):  
G. Anderson ◽  
D. Meyer ◽  
C. E. Herrman ◽  
C. Sheppard ◽  
R. Murray ◽  
...  
Keyword(s):  
Comparative Study ◽  
Glatiramer Acetate ◽  
Subcutaneous Injection ◽  
Open Label

scholarly journals Glatiramer Acetate Treatment in Multiple Sclerosis-Associated Fatigue—Beneficial Effects on Self-Assessment Scales But Not on Molecular Markers

Biomolecules ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 393
Author(s):  
Oliver Neuhaus ◽  
Wolfgang Köhler ◽  
Florian Then Bergh ◽  
Wolfgang Kristoferitsch ◽  
Jürgen Faiss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Neurotrophic Factors ◽  
Common Symptom ◽  
Mrna Levels ◽  
Open Label ◽  
Immunological Parameters ◽  
Beneficial Effects

Although fatigue is a common symptom in multiple sclerosis (MS), its pathomechanisms are incompletely understood. Glatiramer acetate (GA), an immunomodulatory agent approved for treatment of relapsing-remitting MS (RRMS), possesses unique mechanisms of action and has been shown to exhibit beneficial effects on MS fatigue. The objective of this study was to correlate clinical, neuropsychological, and immunological parameters in RRMS patients with fatigue before and during treatment with GA. In a prospective, open-label, multicenter trial, 30 patients with RRMS and fatigue were treated with GA for 12 months. Inclusion criterion was the presence of fatigue as one of the most frequent and disabling symptoms. Before and during treatment, fatigue was assessed using the Fatigue Severity Scale (FSS), the MS-FSS, and the Modified Fatigue Impact Scale (MFIS). In addition, fatigue and quality of life were assessed using the Visual Analog Scales (VAS). Laboratory assessments included screening of 188 parameters using real-time PCR microarrays followed by further analysis of several cytokines, chemokines, and neurotrophic factors. Fatigue self-assessments were completed in 25 patients. After 12 months of treatment with GA, 13 of these patients improved in all three scales (with the most prominent effects on the MFIS), whereas 5 patients had deteriorated. The remaining 7 patients exhibited inconsistent effects within the three scales. Fatigue and overall quality of life had improved, as assessed via VAS. Laboratory assessments revealed heterogeneous mRNA levels of cytokines, chemokines, and neurotrophic factors. In conclusion, we were not able to correlate clinical and molecular effects of GA in patients with RRMS and fatigue.

Increase in serum levels of uric acid, an endogenous antioxidant, under treatment with glatiramer acetate for multiple sclerosis

2000 ◽  
Vol 6 (6) ◽  
pp. 378-381 ◽  
Author(s):  
C S Constantinescu ◽  
P Freitag ◽  
L Kappos
Keyword(s):  
Multiple Sclerosis ◽  
Uric Acid ◽  
Free Radicals ◽  
Glatiramer Acetate ◽  
Serum Levels ◽  
Open Label ◽  
Autoimmune Encephalomyelitis ◽  
Natural Inhibitor ◽  
Endogenous Antioxidant ◽  
Average Serum

Free radicals including peroxynitrite are induced in Multiple Sclerosis (MS). Antioxidant and peroxynitrite inhibitor uric acid (UA), suppresses the MS animal model experimental autoimmune encephalomyelitis (EAE). MS patients have lower average serum UA than controls. An inverse relationship exists between MS and gout. Glatiramer acetate (GA) suppresses EAE and is beneficial in relapsing MS. We investigated serum UA changes during open-label treatment of relapsing MS with GAA. Ten patients (six females, four males, aged 19 to 39 years, mean age 32 years) completed 6 months of GAA (Copaxone® 20 mg s.c. daily). Of these, nine completed 12 months. After 6 months on GAA, serum UA (normal, 173-359 mmol/ml for women, 258-491 mmol/ml for men) increased in nine and marginally decreased (302 to 300 mmol/ml) in a single patient. Mean UA significantly increased from 240 to 303 mol/ml (P=0.0014). At 12 months, UA remained significantly higher than at start (P=0.006) decreasing in only one patient. In contrast, we found no significant UA changes after 6 and 12 months of treatment in 21 MS patients treated with interferon b1-a (Avonex®), or in 11 treated with interferon b1-a (Rebif®), or in five placebo-treated controls. Increasing UA, a natural inhibitor of free radicals, may represent a mechanism of action of glatiramer acetate in MS.

scholarly journals Effects of intermittent negative pressure and active recovery therapies in the post-match period in elite soccer players: A randomized, parallel arm, comparative study

2020 ◽  
Vol 12 (1) ◽  
pp. 59-68
Author(s):  
Alex Souto Maior ◽  
Marcio Tannure ◽  
Fábio Eiras ◽  
Arthur de Sá Ferreira
Keyword(s):  
Comparative Study ◽  
Skin Temperature ◽  
Negative Pressure ◽  
Lower Limbs ◽  
Soccer Players ◽  
Active Recovery ◽  
Open Label ◽  
Pressure Therapy ◽  
Professional Soccer ◽  
Ergometer Exercise

SummaryStudy aim: This study compared the effects of intermittent negative pressure therapy (INPT) vs. active recovery therapy (ART) on post-match physiological parameters such as serum CK level and skin temperature of the lower limbs in elite soccer players.Material and methods: Twenty healthy male professional soccer players from a Brazilian first division soccer club were enrolled in this randomized, parallel arm, open label, comparative study. After participating in 2 soccer matches, they were randomly assigned to two groups (n = 10) to receive a 30-min session of INPT (intermittent exchange of hypobaric pressure range 33 to 51 mmHg) or ART (self-myofascial release, mobility and stability exercises, and cycle ergometer exercise). The intervention was conducted after a match with assessments immediately before and after the intervention and again 24 h after the intervention.Results: A significant interaction effect (F2,36 = 4.503, p = 0.018, η2 = 0.130) was observed, indicating that the decrease of CK from pre-intervention to 24 h post-intervention was greater in the INPT than in the ART group. Lower limb skin temperature was significantly lower after INPT than after ART (p < 0.003).Conclusions: Serum CK level and skin temperature of lower limbs showed better recovery up to 24 h after the intervention with INPT in elite soccer players.

scholarly journals TO COMPARE THE EFFECT OF CHITOSAN, LIFESTYLE MODIFICATION, AND COMBINATION OF CHITOSAN AND LIFESTYLE MODIFICATION ON BODY MASS INDEX IN OBESE PATIENTS

2019 ◽  
pp. 230-233
Author(s):  
VASUNDHARA BHOPLE ◽  
DEEPAK BHOSLE
Keyword(s):  
Body Mass Index ◽  
Comparative Study ◽  
Body Mass ◽  
Lifestyle Modification ◽  
T Test ◽  
Pronounced Effect ◽  
Obese Patients ◽  
Open Label ◽  
Study Population ◽  
Pronounced Reduction

Objective: The objective of this study was to compare the effect of chitosan, lifestyle modification, and combination of chitosan and lifestyle modification on body mass index (BMI) in obese patients. Methods: A prospective, randomized, open-label comparative study conducted for the period of 24 weeks. The study population was enrolled in three groups (chitosan 500 mg BD, lifestyle modification, and chitosan 500 mg BD and lifestyle modification). Data were analyzed using “t”-test and ANOVA. Results: There is a reduction in BMI in all the three groups. However, when we combined chitosan and lifestyle modification, there is pronounced reduction in BMI, which is statistically significant (p<0.0001). Conclusions: Chitosan and lifestyle modification have more pronounced effect on reduction on BMI as compared to monotherapy alone.

scholarly journals Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study

2021 ◽  
Vol 7 (4) ◽  
pp. 205521732110615
Author(s):  
Peter Rieckmann ◽  
Robert Zivadinov ◽  
Alexey Boyko ◽  
Krzysztof Selmaj ◽  
Jessica K. Alexander ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Low Frequency ◽  
Exposure Period ◽  
Similar Efficacy ◽  
Open Label ◽  
Open Label Extension ◽  
Multiple Sclerosis Patients ◽  
Relapsing Multiple Sclerosis

Objective Describe the long-term outcomes of early-start (ES) and delayed-start (DS) glatiramer acetate 40 mg/mL treatment three times weekly (GA40) for up to seven years in the Glatiramer Acetate Low-frequency Administration (GALA) study in patients with relapsing multiple sclerosis (RMS). Methods Patients were evaluated every three to six months. The primary efficacy endpoint was annualized relapse rate (ARR); additional endpoints were exploratory or post hoc. For efficacy, data from the entire exposure period were used for the ES and DS cohorts. For safety, exposure only under GA40 was considered. Results Of the patients who continued into the open-label extension (OLE), 580/834 (70%) ES and 261/419 (62%) DS completed the OLE. For the entire placebo-controlled and OLE study period, ARR was 0.26 for ES and 0.31 for DS patients (risk ratio = 0.83; 95% confidence interval [CI]: 0.70–0.99). ES prolonged median time to first relapse versus DS (4.9 versus 4.3 years; hazard ratio = 0.82; 95% CI: 0.6–0.96). OLE-only results showed DS patients experienced similar efficacy for relapse and disability outcomes as ES patients. Adverse events were consistent with the well-established GA safety profile. Conclusions GA40 treatment conferred clinical benefit up to seven years, resulting in sustained efficacy and was generally well tolerated in RMS patients.

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