Posts Tagged Adverse events

[WEB SITE] Epilepsy Drug With Marijuana-Based Ingredient Could Be Available In The US This Year

 By Allan Adamson Tech Times

A new class of epilepsy drugs based on a marijuana ingredient could be become available in the United States as early as the second half of 2018 pending approval from the Food and Drug Administration.


GW Pharmaceuticals, the maker of the drug called Epidiolex, announced on Wednesday the promising results of a clinical study of the drug.

A group of 171 individuals were randomly assigned to either receive Epidiolex treatment or placebo. The participants were between 2 and 55 years old with a condition called Lennox-Gastaut syndrome. They were also suffering from seizures existing drugs cannot efficiently control.

The participants on average had tried and discontinued use of six anti-seizure treatments and were experiencing 74 “drop” seizures per month. This particular seizure involves the entire body, head and trunk, and often leads to fall and other injuries.

LGS Patients Taking Epidiolex Sees Significant Reduction Seizures

Results of the study, which was reported in the journal Lancet,  showed that over a period of 14 weeks, 44 percent of the patients taking the drug saw significant reduction in seizures. The rate is significantly higher compared with the 22 percent in the placebo group. More of those who were given the experimental drug also experienced a 50 percent or greater reduction in drop seizures.

“LGS is one of the most difficult types of epilepsy to treat and the majority of patients do not have an adequate response to existing therapies,” said Elizabeth Thiele, from Harvard Medical School. “These results show that Epidiolex may provide clinically meaningful benefits for patients with LGS.”

Epidiolex is based on pure marijuana-derived cannabidiol or CBD. The cannabis compound has been known for its medical benefits sans making people feeling “stoned.”

Adverse Events Linked To Use Of Epidiolex

Adverse events associated with use of the drug include diarrhea, decreased appetite, sleepiness, vomiting, and fever. Once given the go-signal to be marketed in the United States, the drug is intended to be used as a prescription drug to be dispensed by doctors.

“Add-on cannabidiol is efficacious for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome and is generally well tolerated. The long-term efficacy and safety of cannabidiol is currently being assessed in the open-label extension of this trial,” investigators wrote in their report.

GW Pharmaceuticals has not yet disclosed the pricing of the drug, but Justin Gover, GW’s chief executive officer, said that the company is already in talks with health insurers about coverage.

via Epilepsy Drug With Marijuana-Based Ingredient Could Be Available In The US This Year : Health : Tech Times

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[Abstract] Brivaracetam in the treatment of patients with epilepsy – clinical experiences

Objectives. To assess first clinical experiences with Brivaracetam (BRV) in the treatment of epilepsies.
Methods. Data on patients treated with BRV from February to December 2016 and with at least one clinical follow-up were collected from electronic patient records. Data on safety and efficacy were evaluated retrospectively.
Results. In total, 93 patients were analysed; 12 (12.9%) received BRV in monotherapy. Mean duration of follow up was 4.85 months (MD=4 months; SD=3.63). Fifty-seven patients had more than one seizure per month at baseline and had a follow-up of more than 4 weeks; the rate of ≥50% responders was 35.1% (n=20) in this group, of which five (8.8%) patients were newly seizure free.
In 50.5% (47/93), patients were switched from Levetiracetam (LEV) to BRV, of which 43 (46.2%) were switched immediately. Adverse events (AE) occurred in 39.8%, with 22.6% being behavioural, and 25.8% non-behavioural. LEV-related AE (LEV-AE) were significantly reduced by switching to BRV.
The discontinuation of BRV was reported in 26/93 patients (28%); 10 of those were switched back to LEV with an observed reduction of AE in70%.
For clinical reasons, 12 patients received BRV in monotherapy, 75% were seizure free and previous LEV-AE improved in 6/9 patients. BRV-related AE occurred in 5/12 cases, five patients discontinued BRV.
Conclusion. BRV seems to be a safe, easy and effective option in the treatment of patients with epilepsy, especially in the treatment of patients that have psychiatric comorbidities and might not be good candidates for LEV-treatment. BRV broadens the therapeutic spectrum and facilitates personalized treatment.


via Frontiers | Brivaracetam in the treatment of patients with epilepsy – clinical experiences | Neurology

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[Abstract] Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review – Epilepsy & Behavior


We reviewed the crude risk of seizures and other adverse events of rTMS in patients with epilepsy.

A crude per-subject risk of 2.9% (95% CI: 1.3–4.5) was estimated for seizures occurring during or shortly after.

The safety of rTMS applied to patients with epilepsy appears to be the same as in other conditions.


Approximately one-third of patients with epilepsy remain with pharmacologically intractable seizures. An emerging therapeutic modality for seizure suppression is repetitive transcranial magnetic stimulation (rTMS). Despite being considered a safe technique, rTMS carries the risk of inducing seizures, among other milder adverse events, and thus, its safety in the population with epilepsy should be continuously assessed.

We performed an updated systematic review on the safety and tolerability of rTMS in patients with epilepsy, similar to a previous report published in 2007 (Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007; 10 (4): 521–8), and estimated the risk of seizures and other adverse events during or shortly after rTMS application.

We searched the literature for reports of rTMS being applied on patients with epilepsy, with no time or language restrictions, and obtained studies published from January 1990 to August 2015. A total of 46 publications were identified, of which 16 were new studies published after the previous safety review of 2007.

We noted the total number of subjects with epilepsy undergoing rTMS, medication usage, incidence of adverse events, and rTMS protocol parameters: frequency, intensity, total number of stimuli, train duration, intertrain intervals, coil type, and stimulation site.

Our main data analysis included separate calculations for crude per subject risk of seizure and other adverse events, as well as risk per 1000 stimuli. We also performed an exploratory, secondary analysis on the risk of seizure and other adverse events according to the type of coil used (figure-of-8 or circular), stimulation frequency (≤1 Hz or >1 Hz), pulse intensity in terms of motor threshold (<100% or ≥100%), and number of stimuli per session (<500 or ≥ 500).

Presence or absence of adverse events was reported in 40 studies (n = 426 subjects). A total of 78 (18.3%) subjects reported adverse events, of which 85% were mild. Headache or dizziness was the most common one, occurring in 8.9%. We found a crude per subject seizure risk of 2.9% (95% CI: 1.3–4.5), given that 12 subjects reported seizures out of 410 subjects included in the analysis after data of patients with epilepsia partialis continua or status epilepticus were excluded from the estimate.

Only one of the reported seizures was considered atypical in terms of the clinical characteristics of the patients’ baseline seizures. The atypical seizure happened during high-frequency rTMS with maximum stimulator output for speech arrest, clinically arising from the region of stimulation. Although we estimated a larger crude per subject seizure risk compared with the previous safety review, the corresponding confidence intervals contained both risks. Furthermore, the exclusive case of atypical seizure was the same as reported in the previous report. We conclude that the risk of seizure induction in patients with epilepsy undergoing rTMS is small and that the risk of other adverse events is similar to that of rTMS applied to other conditions and to healthy subjects.

Our results should be interpreted with caution, given the need for adjusted analysis controlling for potential confounders, such as baseline seizure frequency. The similarity between the safety profiles of rTMS applied to the population with epilepsy and to individuals without epilepsy supports further investigation of rTMS as a therapy for seizure suppression.

Source: Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review – Epilepsy & Behavior

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[ARTICLE] The adverse event profile of levetiracetam: A meta-analysis on children and adults – Full Text HTML/PDF

Article Outline

  1. 1. Introduction
  2. 2. Methods
    1. 2.1. Criteria for considering studies in this review
      1. 2.1.1. Types of studies
      2. 2.1.2. Types of participants
      3. 2.1.3. Search methods for identification of studies
    2. 2.2. Analysis of adverse events
      1. 2.2.1. Selection of adverse events
      2. 2.2.2. Statistical analysis
  3. 3. Results
    1. 3.1. Included studies
    2. 3.2. General tolerability
    3. 3.3. Treatment withdrawals
    4. 3.4. Adverse effects
    5. 3.5. Dose–effect correlations of statistically significant levetiracetam adverse effects
  4. 4. Discussion
  5. 5. Conclusions
  6. Conflict of interest statement
  7. Appendix A. Supplementary data
  8. References


  • We analyzed the adverse events (AEs) profile of levetiracetam with a meta-analysis.
  • A combined analysis of children and adults with any disease was performed.
  • The risk of withdrawals was higher for patients taking levetiracetam than placebo.
  • A general good tolerability profile of levetiracetam has been evidenced.
  • We did not find a clear dose–response relationship for the significant AEs.


Purpose: To analyze the adverse events (AEs) significantly associated with levetiracetam (LEV) therapy through a meta-analysis of all available double-blind, randomized placebo-controlled trials (RCTs), performed in any age, gender, ethnic background and disease. General tolerability and study withdrawals due to AEs associated with LEV treatment were also investigated. In addition, a dose–effect responses relationship for all variables was assessed.

Methods: RCTs were identified searching Medline (PubMed), Embase and Cochrane CENTRAL for the words “Levetiracetam” and “randomized controlled trial”, with different search strategies, setting the limits “humans” and “English”. Very common and common AEs according to the summary of product characteristics were investigated. RevMan version 5.2 was used for the statistical analyses. Risk difference with 95% confidence intervals was used to investigate the association of any AEs and withdrawal with LEV.

Results: Twenty-six studies with 2832 patients were included in the RCTs analysis. Nasopharyngitis, somnolence, dizziness, nervousness/irritability and asthenia/fatigue were statistically significant associated with LEV. In addition, LEV was significantly associated with an increased risk of AEs-related withdrawals. No dose–response relationship was found for any of the assessed variables.

Conclusions: This first large meta-analysis suggests that participants were more likely to discontinue LEV than placebo.The AE profile confirmed that LEV is associated with few unfavorable sedative, vestibulocerebellar and behavioral effects, such as nervousness and irritability. However, there does not seem to be a clear dose–response relationship.

Continue —> The adverse event profile of levetiracetam: A meta-analysis on children and adults – Seizure – European Journal of Epilepsy

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