Efficacy and safety of fampridine for walking disability in multiple sclerosis

2020 ◽  
Vol 10 (5) ◽  
pp. 277-287
Author(s):  
Eva Costa Arpín
Keyword(s):  
Multiple Sclerosis ◽  
Back Pain ◽  
Walking Speed ◽  
Development Phase ◽  
Concomitant Treatment ◽  
Efficacy And Safety ◽  
Real World Setting ◽  
Number Of Patients ◽  
History Of ◽  
Clinically Significant

Fampridine is the only drug approved for the treatment of walking impairment in multiple sclerosis. Around a third of the patients on treatment obtained an improvement in walking speed during the development phase. The effects are clinically significant, appear soon after the start of the treatment and are long-lasting, but disappear soon after the drug is withdrawn. In the real-world setting, the number of patients with a significant response to the treatment seems to be higher (around 70%). The tolerance is good, with mild to moderate, and transient adverse events. The most commonly reported are insomnia, headache, fatigue, back pain, dizziness, nausea and balance disorders. The main contraindications are a history of seizures, renal impairment and concomitant treatment with OCT2 inhibitors.

Development of cladribine treatment in multiple sclerosis

1996 ◽  
Vol 1 (6) ◽  
pp. 343-347 ◽  
Author(s):  
JC Sipe ◽  
JS Romine ◽  
JA Koziol ◽  
R McMillan ◽  
J Zyroff ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Course ◽  
Progressive Multiple Sclerosis ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Relapsing Remitting ◽  
History Of ◽  
New Type ◽  
Cns Demyelination

Cladribine is a new type of drug with properties of selective lymphocyte suppression that appear to favorably alter the clinical course of progressive multiple sclerosis (MS). The history of the development of cladribine treatment in chronic progressive MS is discussed, and the application of cladribine treatment to progressive multiple sclerosis in a double-blind, placebo crossover study is reviewed. Cladribine selectively targets both resting and dividing lymphocytes and may be able to destroy the activated lymphocytes that induce CNS demyelination, thus producing stabilization or improvement in chronic MS. Although the role of cladribine has not yet been fully defined, additional studies are underway to evaluate the efficacy and safety of cladribine in both progressive MS and relapsing-remitting MS.

scholarly journals Efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with multiple sclerosis: Interim analysis of the randomized placebo-controlled study

2019 ◽  
Vol 5 (2) ◽  
pp. 205521731985272 ◽  
Author(s):  
Masahiro Mori ◽  
Takashi Ohashi ◽  
Yasuhiro Onizuka ◽  
Katsutoshi Hiramatsu ◽  
Masakazu Hase ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Japanese Patients ◽  
Dimethyl Fumarate ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Number Of Patients ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background The use of dimethyl fumarate has not been reported in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Objectives The purpose of this study was to evaluate the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Methods APEX was a phase 3, multinational trial, which consisted of a 24-week, randomized (1:1), double-blind study where patients received dimethyl fumarate 240 mg or placebo twice daily, followed by an open-label extension where all patients received dimethyl fumarate 240 mg. The primary endpoints were the total number of new gadolinium-enhancing (Gd+) lesions in Weeks 12–24 (Part I) and long-term safety (Part II). This post-hoc subgroup analysis evaluated the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis ( n=52) up to Week 72 (24 weeks Part I and 48 weeks Part II). Results Dimethyl fumarate reduced the mean total number of new gadolinium-enhancing lesions at Weeks 12–24 by 94% versus placebo; the number of patients who had a relapse over 24 weeks was reduced by 72%. Adverse events leading to discontinuation of the study drug were reported in 9% of patients receiving placebo/dimethyl fumarate and 4% of patients in dimethyl fumarate/dimethyl fumarate. Conclusions Dimethyl fumarate demonstrated sustained efficacy and acceptable tolerability in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis for 72 weeks.

scholarly journals RISK FACTORS FOR MULTIPLE SCLEROSIS IN VOLYN REGION (UKRAINE)

2016 ◽  
Vol 6 ◽  
pp. 45-51
Author(s):  
Nataliia Bobryk ◽  
Larysa Sokolova
Keyword(s):  
Risk Factors ◽  
Multiple Sclerosis ◽  
Paternal Age ◽  
Control Group ◽  
Number Of Patients ◽  
History Of ◽  
One Year ◽  
Associated Risk Factors ◽  
Simplex Virus

The prevalence rate of multiple sclerosis (MS) in Volyn Region (101.0 per 100000) is the highest in Ukraine. To study MS risk factors in Volyn Region, special questionnaires were distributed among all MS patients residing in Volyn region. Results were obtained from 227 respondents including 154 women and 73 men of mean age 43±10.6 years. The control group included 105 healthy respondents inhabiting Volyn region. We found associated risk factors for MS to be: mother of Volyn origin, maternal age after 27 years old and paternal age after 29 years old at birth of respondent, subject's born as a third child, brestfeeding for less than one year, living in the zone of industrial pollution, near mobile, TV- and radio re-translators, full traffic automobile roads, time spending outdoors less than one hour in winter and less than eight hours in summer, consumption of fruit and vegetables less than 5 times a week, of beef less than 3 times a week, poultry meet less than 3, berries less than 3, cereals less than 4 times a week, chronic stressful situations in life. Patients with MS more frequently reported AVRI, hepatitis and herpes simplex virus. Among patients with MS there were fewer respondents with history of chickenpox, rubella and DPT (diphtheria, pertussis, tetanus), BCG immunizations. Here, we introduced a novel study of MS risk factors within Volyn Region. The Registry established in 2012 is being constantly updated and can be a database for a long-term retrospective study involving a large number of patients.

scholarly journals Comparing the Safety and Efficacy of Ziferon and Betaferon in Patients With Remitting- Relapsing Multiple Sclerosis

2020 ◽  
Author(s):  
Mohammad Reza Gheini ◽  
Mohammad Ali Sahraian ◽  
Amir Reza Azimi ◽  
Naser Mmoghadasi ◽  
Mahmud Abdoli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Relapse Rate ◽  
Safety Profile ◽  
Lesion Volume ◽  
Cumulative Number ◽  
Efficacy And Safety ◽  
T2 Lesions ◽  
Number Of Patients ◽  
Significant Difference ◽  
Magnetic Resonance Imaging Mri

Background: The present study aimed to compare the clinical efficacy and safety profile of Ziferon and Betaferon. Objectives: In total, 41 consecutive patients with relapsing forms of Multiple Sclerosis (MS) were selected from the MS outpatient clinic affiliated to Tehran University of Medical Sciences. The patients were randomly assigned into two groups. Methods: Each group either received Ziferon 250 mcg Subcutaneously (SC) in alternate days or Betaferon 250 mcg SC on alternate days. Clinical and para-clinical outcomes, such as mean relapse rate/year score, mean Expanded Disability Status Scale (EDSS)/year score, the cumulative number, and the volume of gadolinium-enhancing lesions, in addition to the cumulative number of new T2 lesions and safety profile were evaluated for each group during the years of treatment. Results: There were no significant differences in Magnetic Resonance Imaging (MRI) outcomes (change in total lesion volume, new lesion per T2-weighted scan, and gadoliniumenhancing lesions per T1-weighted scan from baseline; P=0.236, P=0.56, & P=0.496, respectively was observed). There was no significant difference in the relapse rate between Ziferon and Betaferon treated groups (P=0.56). There were no unexpected safety events. The number of patients who discontinued the study due to adverse events occurrence was similar between the two groups. Conclusion: Evidence demonstrates the non-inferiority and bio-similarity of Ziferon (interferon beta-1b) to Betaferon in terms of efficacy and safety profile.

scholarly journals Therapeutic possibilities of topical corticosteroids in modern clinical practice

2020 ◽  
pp. 36-45
Author(s):  
T. A. Belousova ◽  
M. V. Kail
Keyword(s):  
Clinical Practice ◽  
Subcutaneous Tissue ◽  
Import Substitution ◽  
New Drugs ◽  
Advanced Technology ◽  
Efficacy And Safety ◽  
Topical Corticosteroids ◽  
Number Of Patients ◽  
History Of ◽  
History Of Use

Over the past decade, dermatological practice has seen an increase in the number of patients suffering from skin and subcutaneous tissue diseases. Annually, 6.4-6.9 million new cases of this group of diseases are registered, which encourages the constant search for new drugs and the continuous improvement of methods and schemes of application of proven drugs. Topical corticosteroids, despite more than 65 years of history of use in the treatment of patients with steroid-sensitive dermatoses, have not lost their relevance. At present, they have no therapeutic alternative in terms of speed of onset and anti-inflammatory activity, so they are essential in the treatment of many skin pathologies. One of the trends in modern pharmacology is not so much the production of new active molecules of TCS or their modifications, as the creation of new pharmacological forms of known molecules - micronized, nanonized, which give the drug the most important property -increased bioavailability. This advanced technology is actively used in the production of domestic topical drugs of Akriderm lines, which make a major contribution to the program of import substitution and drug availability for the population. The optimal combination of ingredients of the foundation of these drugs complements and potentiates the therapeutic effect of steroid. For more than 30 years in clinical practice, a combination of 0.05% betamethasone dipropionate, 0.1% gentamicin sulfate and 1% clotrimazole (Triderm, Akriderm GK) is used. Many years of positive clinical experience of dermatologists using this fixed combination proves the validity of its use in many clinical situations when bacterial and fungal infection is involved. An open randomized comparative study conducted by Russian dermatologists on the efficacy and safety of Akriderm GK (cream) and Triderm (cream) in the complex treatment of eczema showed similar profiles of high clinical efficacy and safety of both drugs.

Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker
Keyword(s):  
Scientific Evidence ◽  
Daily Practice ◽  
Severe Adverse Effect ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Foam Sclerotherapy ◽  
History Of ◽  
One Year ◽  
Additional Therapy

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

An unusual presentation of epigastric pain due to thrombophlebitis of a recanalised umbilical vein – case report

2019 ◽  
Vol 98 (8) ◽  
pp. 326-327 ◽  
Keyword(s):  
Liver Cirrhosis ◽  
Abdominal Pain ◽  
Case Report ◽  
Portal Hypertension ◽  
Liver Disease ◽  
Epigastric Pain ◽  
Umbilical Vein ◽  
History Of ◽  
Clinically Significant ◽  
Inflammatory Changes

Introduction: The umbilical vein can become recanalised due to portal hypertension in patients with liver cirrhosis but the condition is rarely clinically significant. Although bleeding from this enlarged vein is a known complication, the finding of thrombophlebitis has not been previously described. Case report: We report the case of a 62-year-old male with a history of liver cirrhosis due to alcoholic liver disease presenting to hospital with epigastric pain. A CT scan of the patient’s abdomen revealed a thrombus with surrounding inflammatory changes in a recanalised umbilical vein. The patient was managed conservatively and was discharged home the following day. Conclusion: Thrombophlebitis of a recanalised umbilical vein is a rare cause of abdominal pain in patients with liver cirrhosis.

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