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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In all controlled and uncontrolled trials in patients with partial-onset seizures, 1327 patients have received VIMPAT of whom 1000 have been treated for longer than 6 months and 852 for longer than 12 months.
Clinical Trials Experience
Adverse Reactions Leading To Discontinuation
In controlled clinical trials, the rate of discontinuation as a result of an adverse event was 8% and 17% in patients randomized to receive VIMPAT at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day, and 5% in patients randomized to receive placebo. The adverse events most commonly ( > 1% in the VIMPAT total group and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.
Most Common Adverse Reactions
Table 2 gives the incidence of treatment-emergent adverse events that occurred in ≥ 2% of adult patients with partial-onset seizures in the total VIMPAT group and for which the incidence was greater than placebo. The majority of adverse events in the VIMPAT patients were reported with a maximum intensity of 'mild' or 'moderate'.
Table 2: Treatment-Emergent
Adverse Event Incidence in Double-Blind, Placebo-Controlled Partial-Onset
Seizure Trials (Events ≥ 2% of Patients in VIMPAT Total and More Frequent
Than in the Placebo Group)
|System Organ Class/Preferred Term||Placebo
|VIMPAT 200 mg/day
|VIMPAT 400 mg/day
|VIMPAT 600 mg/day
|Ear and labyrinth disorder|
|General disorders and administration site conditions|
|Gait disturbance||< 1||< 1||2||4||2|
|Injury, poisoning and procedural complications|
|Nervous system disorders|
|Skin and subcutaneous disorders|
Abnormalities in liver function tests have been observed in controlled trials with VIMPAT in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs. Elevations of ALT to ≥ 3× ULN occurred in 0.7% (7/935) of VIMPAT patients and 0% (0/356) of placebo patients. One case of hepatitis with transaminases > 20x ULN was observed in one healthy subject 10 days after VIMPAT treatment completion, along with nephritis (proteinuria and urine casts). Serologic studies were negative for viral hepatitis. Transaminases returned to normal within one month without specific treatment. At the time of this event, bilirubin was normal. The hepatitis/nephritis was interpreted as a delayed hypersensitivity reaction to VIMPAT.
Other Adverse Reactions in Patients with Partial-Onset Seizures
The following is a list of treatment-emergent adverse events reported by patients treated with VIMPAT in all clinical trials in patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Events addressed in other tables or sections are not listed here. Events included in this list from the controlled trials occurred more frequently on drug than on placebo and were based on consideration of VIMPAT pharmacology, frequency above that expected in the population, seriousness, and likelihood of a relationship to VIMPAT. Events are further classified within system organ class.
Cardiac disorders: palpitations
Ear and labyrinth disorders: tinnitus
Injury, poisoning, and procedural complications: fall
Musculoskeletal and connective tissue disorders: muscle spasms
Psychiatric disorders: confusional state, mood altered, depressed mood
Intravenous Adverse Reactions
Adverse reactions with intravenous administration generally appeared similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). One case of profound bradycardia (26 bpm: BP 100/60 mmHg) was observed in a patient during a 15 minute infusion of 150mg VIMPAT. This patient was on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.
Comparison of Gender and Race
The overall adverse event rate was similar in male and female patients. Although there were few non-Caucasian patients, no differences in the incidences of adverse events compared to Caucasian patients were observed.
The following adverse reactions have been identified during post-approval use of VIMPAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Agranulocytosis
Cardiac disorders: Bradycardia
Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder
Read the Vimpat (lacosamide tablet and injection) Side Effects Center for a complete guide to possible side effects
Drug-drug interaction studies in healthy subjects showed no pharmacokinetic interactions between VIMPAT and carbamazepine, valproate, digoxin, metformin, omeprazole, midazolam, or an oral contraceptive containing ethinylestradiol and levonorgestrel. There was no evidence for any relevant drug-drug interaction of VIMPAT with common AEDs in the placebo-controlled clinical trials in patients with partial-onset seizures [see CLINICAL PHARMACOLOGY].
The lack of pharmacokinetic interaction does not rule out the possibility of pharmacodynamic interactions, particularly among drugs that affect the heart conduction system.
Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients.
Drug Abuse And Dependence
VIMPAT is a Schedule V controlled substance.
In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). However, the rate of euphoria reported as an adverse event in the VIMPAT development program at therapeutic doses was less than 1%.
Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.
Read the Vimpat Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/10/2013
This monograph has been modified to include the generic and brand name in many instances.
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