Pregabalin (Page 5 of 16)
Controlled Studies of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients
Adverse Reactions Leading to Discontinuation
Approximately 15% of patients receiving pregabalin and 6% of patients receiving placebo in trials of adjunctive therapy for partial-onset seizures discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the pregabalin group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).
Most Common Adverse Reactions
Table 6 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received pregabalin and 294 patients received placebo for up to 12 weeks. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.
Body System | 150 mg/d | 300 mg/d | 600 mg/d | All PGB * | Placebo |
---|---|---|---|---|---|
Preferred Term | [N = 185] | [N = 90] | [N = 395] | [N = 670]† | [N = 294] |
% | % | % | % | % | |
| |||||
Body as a Whole | |||||
Accidental Injury | 7 | 11 | 10 | 9 | 5 |
Pain | 3 | 2 | 5 | 4 | 3 |
Digestive System | |||||
Increased Appetite | 2 | 3 | 6 | 5 | 1 |
Dry Mouth | 1 | 2 | 6 | 4 | 1 |
Constipation | 1 | 1 | 7 | 4 | 2 |
Metabolic and Nutritional Disorders | |||||
Weight Gain | 5 | 7 | 16 | 12 | 1 |
Peripheral Edema | 3 | 3 | 6 | 5 | 2 |
Nervous System | |||||
Dizziness | 18 | 31 | 38 | 32 | 11 |
Somnolence | 11 | 18 | 28 | 22 | 11 |
Ataxia | 6 | 10 | 20 | 15 | 4 |
Tremor | 3 | 7 | 11 | 8 | 4 |
Thinking Abnormal ‡ | 4 | 8 | 9 | 8 | 2 |
Amnesia | 3 | 2 | 6 | 5 | 2 |
Speech Disorder | 1 | 2 | 7 | 5 | 1 |
Incoordination | 1 | 3 | 6 | 4 | 1 |
Abnormal Gait | 1 | 3 | 5 | 4 | 0 |
Twitching | 0 | 4 | 5 | 4 | 1 |
Confusion | 1 | 2 | 5 | 4 | 2 |
Myoclonus | 1 | 0 | 4 | 2 | 0 |
Special Senses | |||||
Blurred Vision § | 5 | 8 | 12 | 10 | 4 |
Diplopia | 5 | 7 | 12 | 9 | 4 |
Abnormal Vision | 3 | 1 | 5 | 4 | 1 |
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