A Prospective, Observational Study Assessing Effectiveness, Safety, and QoL of Greek Patients with Multiple Sclerosis Under Treatment with Fingolimod.

INTRODUCTION: Fingolimod is the first approved oral therapy for relapsing-remitting multiple sclerosis (RRMS). The present study aimed to further characterize fingolimod's safety profile, and to assess the patient-reported treatment satisfaction and impact of fingolimod on the quality of life (QoL) of patients with multiple sclerosis (MS) treated in routine care in Greece. METHODS: This was a multicenter, prospective, observational, 24-month study conducted in Greece by hospital-based and private practice neurologists who specialize in MS. Eligible patients had initiated fingolimod within 15 days in accordance with the locally approved label. Safety outcomes included any adverse event (AE) observed during the study period and efficacy outcomes included both objective (disability progression and 2-year annualized relapse rate) and patient-reported assessments (Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 and the EuroQol (EQ)-5-dimension (5D) 3-level instruments). RESULTS: A total of 489 eligible patients (age 41.2 ± 9.8 years; 63.7% female; 4.2% treatment-naive) were exposed to fingolimod for a median of 23.7 months. During the observation period, 20.5% of the participants experienced 233 AEs. Lymphopenia (8.8%), leukopenia (4.2%), hepatic enzyme increased (3.4%), and infections (3.0%) were the most common. Most patients (89.3%) did not experience disability progression; the 2-year annualized relapse rate decreased by 94.7% compared to baseline. The median EQ-visual analogue scale (VAS) was 74.5 at month 24 vs. 65.0 at enrollment (p < 0.001) and the EQ-5D index score was 0.80 vs. 0.78, respectively. Significant improvements were noted in the TSQM global satisfaction and effectiveness domain scores between 6 and 24 months post enrollment (median scores at month 24, 71.4 and 66.7, respectively) (p < 0.001). Significant increases from enrollment to the 24th month were also noted in the patients' global satisfaction and effectiveness domain scores [mean change of 7.4 ± 17.7 (p = 0.005) and mean increase of 5.4 ± 16.2) (p = 0.043), respectively]. CONCLUSION: In the real-world setting of Greece, fingolimod demonstrates a clinical benefit and a predictable and manageable safety profile, which contribute towards high patient-reported treatment satisfaction and improvements in the QoL of patients with MS.

A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.

Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA). COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to GA 20 mg daily from another DMT. Eligible patients had converted to GA and had received prior DMT for 3-6 months, depending on the reasons for conversion. Patients were assessed at baseline and at 6, 12, 18, and 24 months. In total, 672 patients from 148 centers worldwide were included in the analysis. Change of therapy to GA was prompted primarily by lack of efficacy (53.6 %) or intolerable adverse events (AEs; 44.8 %). Over a 24-month period, 72.7 % of patients were relapse free. Mean annual relapse rate decreased from 0.86 [95 % confidence interval (CI) 0.81-0.91] before the change to 0.32 (95 % CI 0.26-0.40; p < 0.0001) at last observation, while the progression of disability was halted, as the Kurtzke Expanded Disability Status Scale (EDSS) scores remained stable. Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable. The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

An open-label, add-on study of pregabalin in patients with partial seizures: a multicenter trial in Greece.

INTRODUCTION: Pregabalin efficacy and safety as an adjunctive treatment for partial seizures was evaluated using an open-label, flexible-dose. STUDY DESIGN: In 98 adults with refractory partial epilepsy taking 1-3 anti-epileptic drugs with ≥2 seizures during an 8-week baseline period. METHODS: Pregabalin was increased to ≤600 mg/day during a 9-week dose optimization period with dosage maintained for 12 additional weeks. Primary endpoint was the percentage change in partial seizure frequency between the 8-week baseline and 12-week observation period. RESULTS: Pregabalin treatment was associated with a significant reduction in partial seizure frequency: median percent change in partial seizure frequency from baseline to 12 weeks was -33% and -22% in patients with a baseline seizure frequency of ≤3 and >3 per 28 days, respectively. The 50% and 75% responder rates were 41.94% (95% CI: 31.91-51.96) and 30.11% (95% CI: 20.78-39.43), respectively. Nineteen percent of subjects were seizure-free throughout the last 12 weeks. Pregabalin administration resulted in a significant reduction in anxiety (mean reduction in Hospital Anxiety and Depression Scale scores of 1.68 units, 95% CI: -2.60 to -0.76). Most patients were much improved or very much improved on Patient Global Impression of Change (53.8%) and Clinical Global Impression of Change (53.8%). The most frequently self-reported adverse events (AEs) were mild or moderate somnolence (20.4%) and dizziness (5.1%) with a low AE discontinuation rate (5.1%). CONCLUSIONS: The efficacy and side-effect profile of pregabalin were similar to previous pregabalin double-blind, controlled studies. Additionally, pregabalin, as an add-on treatment for partial epilepsy, exhibits significant anti-anxiety properties.

An observational trial to investigate the efficacy and tolerability of levetiracetam in trigeminal neuralgia.

OBJECTIVE: To explore the efficacy and tolerability of levetiracetam in medical treatment of trigeminal neuralgia. BACKGROUND: Antiepileptic drugs (AEDs) are considered as first-line treatment for trigeminal neuralgia, although their use is often limited due to incomplete efficacy and tolerability. Newer AEDs with improved safety profile may be useful in this disorder. METHODS: Patients suffering from trigeminal neuralgia (either primary or secondary) refractory to previous treatments were recruited to be treated with levetiracetam (3-4 g/day) for 16 weeks as add-on therapy, after a 2-week baseline period. Rescue medication was allowed in both the baseline and treatment phases. The primary efficacy measure was the number of attacks per day. The patients' efficacy evaluation, the patients' global evaluation for both safety and efficacy, changes in the Hamilton Depression Scale, the Hamilton Anxiety Scale, and the Quality of Life Measure Short Form-36 were secondary parameters. RESULTS: Twenty-three patients were included in the analysis. After treatment and compared to the baseline phase, the number of daily attacks decreased by 62.4%. All secondary parameters changed significantly with the exception of the Quality of Life Measure Short Form-36 score. Seven patients withdrew from the study. Five patients (21.7%) reported side effects and 2 withdrew. CONCLUSIONS: Levetiracetam may be effective and safe in trigeminal neuralgia treatment. Confirmation in a randomized controlled study is needed.

Test-retest reliability of p13n23 and n34p44 components of vestibular evoked myogenic potentials in a large healthy population.

OBJECTIVE: The aim of this study is to evaluate the reliability of the VEMP characteristics recorded in a large number of healthy subjects. METHODS: VEMP response was obtained on 75 healthy volunteers. Thirty-nine (39) of them were males and 36 were females. Their age varied between 25 and 63 years (mean value 43). Recording was achieved using monaural acoustic stimulation and ipsilateral muscle contraction. Latencies of p13, n23, n34, p44 peaks, p13n23 and n34p44 amplitudes and the interaural amplitude differences (IAD) were assessed. RESULTS: The stability of latencies, amplitudes of the first p12-n23 and second n34-p44 waveforms was verified. The second complex was present in 76%. No factor indicates statistically significant side difference for both runs. IAD variable was not statistically different from zero in all cases. Results show very good reliability for amplitudes, good for some latencies, poor for some other latencies and IAD34-44 and very poor for IAD13-23. No strong and significant correlations were also found between IAD34-44 and IAD13-23 and between p13n23 and n34p44 amplitudes. CONCLUSION: It is the first time that optimal latencies and amplitudes for early and late components of VEMP are described in a large sample of healthy subjects. The p13, n23, n34 and p44 latencies and p13-n23, and n34-p44 amplitudes were reliable, verifying that the method is reproducible and feasible. The IAD13-23 has the disadvantage of low reliability.

Vestibular evoked myogenic potential eliciting in normal subjects: comparison of four different methods.

OBJECTIVE: Vestibular evoked myogenic potential (VEMP) recording is a new method for testing the otolith receptors and vestibulospinal pathways. The aim of this study was to evaluate the characteristics of VEMP using four different techniques to find reasons to prefer one type of recording over the others. MATERIAL AND METHODS: Twenty healthy persons, 10 males and 10 females with ages ranging from 20 to 57 years (mean age 41 years), were enrolled in this study. Eliciting of VEMPs by using monaural or binaural acoustic stimulation and unilateral or bilateral SCM contraction was evaluated; 105 dB NHL acoustic stimulation consisting of 145 dB rarefaction clicks was applied. Latencies of p13, n23, n34, p44 peaks; amplitudes p13-n23 and n34-p44; and interaural amplitude differences (IADs) were assessed. RESULTS: All four methods elicited constant and evident waveforms. The reliability coefficients of amplitudes were high for all four methods and for both waves. However, the higher scores of reliability appeared for the monaural-ipsilateral recording. The results indicated no statistically significant difference between the right and left sides for all four types of VEMP eliciting. No correlation was found between IAD13-23 and IAD34-44 for all four methods. Statistically significant differences were found only for n23 latency among the four methods. CONCLUSIONS: Although no evidence to reject or strongly favour a specific method was found, the monaural-ipsilateral recording was associated with some advantages.