scholarly journals The Safety and Efficacy of Pregabalin Add-on Therapy in Restless Legs Syndrome Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Hyoeun Bae ◽  
Yong Won Cho ◽  
Keun Tae Kim ◽  
Richard P. Allen ◽  
Christopher J. Earley
Keyword(s):  
Side Effects ◽  
Restless Legs Syndrome ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Restless Legs ◽  
Persistent Symptoms ◽  
Before And After ◽  
Severity Index Score ◽  
Irls Score ◽  
Symptomatic Control

Pregabalin is increasingly being used as a first-line treatment for symptomatic control of restless legs syndrome (RLS). This study aimed to evaluate the efficacy and safety of pregabalin as add-on therapy in RLS patients already taking dopamine agonists (DA) but still in need of further management. Patients with idiopathic RLS were enrolled, and all had already been prescribed DA for at least 3 months but still had either persistent symptoms, side effects, or comorbid insomnia. An initial dose of 75 mg pregabalin was begun, adjusted as needed, and maintained at a stable dose for 4 weeks, followed by observation for a total of 8 weeks. RLS symptoms and insomnia scores were evaluated before and after add-on pregabalin treatment. Patients were monitored for side effects that could be attributed to pregabalin. A total of 32 RLS patients were enrolled, and 20 subjects remained until the endpoint. After the pregabalin add-on, the mean IRLS score showed significant improvement compared to the baseline (p < 0.001). The insomnia severity index score also improved (p = 0.036), and no serious adverse effects were observed. Our preliminary data suggests the potential for pregabalin as an add-on therapy to DA with regards to both efficacy and safety in patients who have inadequate RLS improvement.

584 Response to Intravenous Ferric Carboxymaltose in the Treatment of Childhood Restless Legs Syndrome/Periodic Limb Movement Disorder

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A230-A230
Author(s):  
Wendy Edlund ◽  
Suresh Kotagal
Keyword(s):  
Side Effects ◽  
Movement Disorder ◽  
Serum Ferritin ◽  
Restless Legs Syndrome ◽  
Ferric Carboxymaltose ◽  
Periodic Limb Movement ◽  
Periodic Limb Movement Disorder ◽  
Restless Legs ◽  
Before And After

Abstract Introduction Pediatric Restless Legs Syndrome (RLS)/Periodic Limb Movement Disorder (PLMD) are treatable disorders affecting quality of life. The first line therapy is oral iron, which may have gastrointestinal side effects or suboptimal absorption. Consequently, parenteral iron preparations are needed, but have been insufficiently studied in children. This study evaluates the response to intravenous ferric carboxymaltose (FCM) in pediatric RLS/PLMD. Methods We performed a retrospective chart review of children who received FCM between May 2018 and January 2019 for treating RLS/PLMD. Serum ferritin before and after the infusion were compared. Where possible, the Clinical Global Impressions of Improvement (CGI-I) was evaluated. Side effects documented in the charts were extracted. The median administered dose of FCM was 10.1 mg/kg (range 9.6–20.8) over 0.6 to2 hours. Results There were 27 patients, with mean age of 10.0 +/-4.2 years. 52% were female. 24 had RLS and 3 had PLMD. 20/27 (69.7%) had prior oral iron therapy; 4/20 (26.0%) experienced side effects. Adverse events from FCM infusion included procedure-related anxiety in 4/27, nausea in 1/27, infusion site pain in 2/27, and tachycardia in 1/27. One patient developed subcutaneous extravasation of iron with brownish skin discoloration and a resulting adjustment disorder. Three patients had phosphorus checked following infusion; all were normal. Serum ferritin was available both before and after the infusion for 17 patients. Mean serum ferritin prior to infusion was 27.2 +/-15.7 µg/L (range 6–58) and after the infusion it was 109.8 +/-49.34 µg/L (range 27–192). Mean ferritin increase was 82.6 +/-41.5 µg/L (range 14–160; p=0.0001). Post-infusion ferritin was over 50 µg/L for all but 2 of the subjects, with follow up ranging from 31–266 days (mean 120 days). A larger increase was seen at higher doses (p=0.01). Ferritin increase was not impacted by age, gender, symptom severity, PLMI or prior ferritin level. CGI-I was applied to 15 patients with sufficient follow-up documentation and showed improvement in 86%, with 79% much or very much improved. Conclusion The administration of FCM in children with RLS/PLMD is associated with a satisfactory rise in serum ferritin and modest symptomatic improvement. Support (if any):

scholarly journals The effect of electroacupuncture on hemodialysis patients with restless legs syndrome (RLS): study protocol for a randomized crossover trial

2020 ◽  
Author(s):  
Jia-Ming Chen ◽  
Ping-Fang Chiu ◽  
Yu-Jun Chang ◽  
Po-Chi Hsu ◽  
Chia-Chu Chang ◽  
...  
Keyword(s):  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Severity Index ◽  
Hemodialysis Patients ◽  
Restless Legs ◽  
The Subject ◽  
Group 2 ◽  
And Control ◽  
The Relationship ◽  
Registration Date

Abstract Background The aim of the present study was to evaluate the effects of electroacupuncture (EA) in hemodialysis patients with restless leg syndrome (RLS) by heart rate variability (HRV) monitor. Methods112 subjects who were hemodialysis patients with RLS will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 2 times a week for 4 weeks. After 4 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include HRV recordings, International Restless Legs Syndrome Rating Scale (IRLSRS) and Insomnia Severity Index (ISI). DiscussionThis study is the first investigation to analyze the relationship between EA and the change of HRV by an objective monitor. If the findings of the current trial are positive, this study will also help support an effective, safe and cheap approach to clinical treatment of this challenging disorder, help foster improved understanding the relationship between RLS and HRV, and ultimately contribute to elucidate the mechanisms of EA. Trial registrationClinicalTrials.gov Identifier: NCT04356794; registration date: April 22, 2020.

scholarly journals Evaluation of Efficacy and Safety Profile of Intense Pulsed Light Treatment in Melasma in Darker Skin Type

2020 ◽  
Vol 12 (1) ◽  
pp. 3-8
Author(s):  
Nishant Choudhary ◽  
Abhishek De ◽  
Amrita Sil ◽  
Gobinda Chatterjee
Keyword(s):  
Safety Profile ◽  
Severity Index ◽  
Skin Type ◽  
Intense Pulsed Light ◽  
P Value ◽  
Efficacy And Safety ◽  
Pulsed Light ◽  
First Line Therapy ◽  
Type Iv ◽  
Before And After

AbstractIntroduction. We undertook a prospective, interventional study to evaluate the efficacy and safety profile of Intense Pulsed light (IPL) treatment of melasma in dark skin phenotypes.Material and Methods. The study was conducted in 32 patients of skin type IV and V. IPL with 640 nm and 690 nm filters was used. The patients were called once a month to undergo 6 sessions. Melasma area and severity index (MASI) and Clinician Global Impression Scores were used for evaluation. We followed “per protocol” analysis.Results. Out of 26 patients who completed the treatment, 12 patients showed improvement, MASI remained unchanged in 10 patients and 4 patients showed deterioration. MASI scores before and after treatment were 6.70 ± 3.53 and 6.32 ± 3.90 (p value=0.6891). Erythema and pain were the common side effects noted. Seventeen out of 32 patients had thyroid disorders.Conclusion. IPL should be avoided as a first line therapy in darker skin type. However, it can be used as an adjuvant therapy in some cases after careful deliberations.

scholarly journals Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome

2015 ◽  
Vol 16 (11) ◽  
pp. 1342-1347 ◽  
Author(s):  
Juliane Schneider ◽  
Alexander Krafft ◽  
Mauro Manconi ◽  
Astrid Hübner ◽  
Christian Baumann ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Restless Legs Syndrome ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Restless Legs

scholarly journals Fexofenadine Treatment of Atopic Dogs: Preliminary Clinical Results

2006 ◽  
Vol 75 (4) ◽  
pp. 549-555 ◽  
Author(s):  
A. Plevnik ◽  
T. Kotnik ◽  
S. Kobal
Keyword(s):  
Atopic Dermatitis ◽  
Severity Index ◽  
Clinical Results ◽  
Efficacy And Safety ◽  
Time Points ◽  
The Third ◽  
Study Results ◽  
Significant Difference ◽  
Severity Index Score ◽  
The Mean

The purpose of our study was to investigate the efficacy and safety of the antihistamine fexofenadine versus methylprednisolone in dogs with atopic dermatitis. Eight dogs were included in the study and randomly allocated to two groups of four animals. The first group (F) received oral fexofenadine and the second group (M) received methylprednisolone. Over a period of 6 weeks, we evaluated the CADESI (Canine Atopic Dermatitis Extent Severity Index) score and the pruritus score and made measurements of biochemical blood indicators (AP, ALT, AST, urea, creatinine) on three occasions. The study results did not reveal any statistically significant differences compared to baseline in AST, ALT, AP, urea and creatinine values in any of the treated groups and at any of the time points during the treatment (p > 0.112). The mean CADESI values and the severity of pruritus were reduced by more than 50% in both groups during the treatment course. There were no statistically significant differences between group M and group F. A statistically significant difference compared to the baseline was found in the reduction of the CADESI score in group F in the sixth week of treatment (p = 0.011). There was also a significant reduction compared to the baseline in the severity of pruritus ingroup M in the third (p = 0.004) and sixth week of treatment (p = 0.022). Our results indicate the possible use of fexofenadine in the treatment of atopic dermatitis in dogs, as it was demonstrated safe and effective in comparison with methylprednisolone.

1001 Intravenous Ferric Carboxymaltose For Restless Legs Syndrome In Children And Adolescents

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A380-A380
Author(s):  
L M DelRosso ◽  
R Ferri ◽  
R P Allen ◽  
M L Chen ◽  
S Kotagal ◽  
...  
Keyword(s):  
Side Effects ◽  
Children And Adolescents ◽  
Serum Ferritin ◽  
Restless Legs Syndrome ◽  
Iron Supplementation ◽  
Oral Iron ◽  
Ferric Carboxymaltose ◽  
Chi Square ◽  
Restless Legs ◽  
Post Infusion

Abstract Introduction Substantial scientific evidence implicates brain iron deficiency in the pathophysiology of restless legs syndrome (RLS). Current clinical guidelines recommend oral and intravenous iron (IV) in the treatment of both adult and pediatric RLS but studies using ferric carboxymaltose (FCM) are lacking in children and adolescents. Methods Retrospective case series of children and adolescents with RLS treated with IV FCM who had serum ferritin levels <50 μg/L. Patients were offered a single dose of IV FCM, 15 mg/kg if weighting <50 kg or 750 mg if weighting >50 kg. Iron profile, serum ferritin, and severity assessment by the International Restless Legs Study Group severity scale (IRLS) were collected pre- and post-infusion. Clinical Global Impression Scale (CGI) was used instead of the IRLS for children. Phosphorus level and adverse effects were assessed post-infusion in all patients. Age and sex-matched children with RLS treated with oral iron supplementation (mean dosage 1.5±0.62 mg/kg/day) were included as a comparison group. Results Twenty-eight subjects (15 females, mean age 11.5 years, SD 4.23) and 24 controls were included. Baseline ferritin levels were not significantly different from those of controls but increased significantly from 13.9±7.02 to 112.9±12.00 μg/L after 8 weeks from infusion (p<0.000001), when they were also significantly higher than control values (34.2±21.64 μg/mL, p<0.000001). Transferrin saturation increased from 22.8±9.77% to 31.7±6.81% (p<0.0001), total iron binding capacity decreased from 366.7±51.32 to 302.0±37.83 μg/dL (p<0.0000035). RLS was reported to be resolved or improved in all children treated with IV iron (vs. 62.5% of controls) while none of them reported no change (vs. 37.5% of controls; Chi-square test 9.84, p<0.002). IRLS Score decreased in adolescents from 30.7±22.68 to 3.2±4.21 (p<0.000008) while CGI-I was “very much improved” in six children and “much improved” in four. Side effects were reported in 17.8% of patients treated IV and 20.8% controls (Chi-square 0.0169, p=0.897). FCM side effects included lightheadedness and gastrointestinal discomfort. Post IV phosphorus levels were normal in all participants. Conclusion This open-label, observational and retrospective study indicates that FCM IV infusion is an effective treatment for pediatric RLS with higher efficacy than oral iron supplementation. Support  

Long-term efficacy and safety of gabapentin enacarbil in Japanese restless legs syndrome patients

2012 ◽  
Vol 36 (2) ◽  
pp. 251-257 ◽  
Author(s):  
Yuichi Inoue ◽  
Naohisa Uchimura ◽  
Kenji Kuroda ◽  
Koichi Hirata ◽  
Nobutaka Hattori
Keyword(s):  
Restless Legs Syndrome ◽  
Efficacy And Safety ◽  
Gabapentin Enacarbil ◽  
Restless Legs ◽  
Term Efficacy
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