Table 1.
Summary of published material showing common side effects of gabapentin enacarbil at varying doses
| Adverse event | Placebo | 600 mg/day | 1,200 mg/day | 2,400 mg/day | 3,600 mg/day | 4,800 mg/day | 6,000 mg/day | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Evidence source | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C |
| n | 245 | 95 | 31 | 163 | – | – | 269 | 107 | – | – | 82 | 8 | – | 87 | 8 | – | – | 8 | – | – | 8 |
| CNS | |||||||||||||||||||||
| Somnolence/sedation | 6% | 8% | 0% | 20% | – | – | 27% | 10% | – | – | 11% | 0% | – | 14% | 0% | – | – | 13% | – | – | 50% |
| Dizziness | 4% | 15% | 3% | 13% | – | – | 22% | 17% | – | – | 26% | 50% | – | 20% | 38% | – | – | 75% | – | – | 38% |
| Headache | 11% | 9% | 3% | 12% | – | – | 15% | 10% | – | – | 10% | 13% | – | 7% | 0% | – | – | 25% | – | – | 0% |
| Fatigue | 4% | 1% | 0% | 6% | – | – | 7% | 6% | – | – | 4% | 0% | – | 10% | 0% | – | – | 0% | – | – | 25% |
| GI | |||||||||||||||||||||
| Nausea | 5% | 5% | 6% | 6% | – | – | 7% | 8% | – | – | 4% | 13% | – | 9% | 50% | – | – | 13% | – | – | 25% |
| Metabolism | |||||||||||||||||||||
| Weight gain | 2% | 1% | – | 2% | – | – | 3% | 3% | – | – | 5% | – | – | 5% | – | – | – | – | – | – | – |
Notes: A = amalgamated data from three double-blind, placebo controlled 12 week trials in patients with RLS.17 B = randomized, double-blind, placebo controlled trial assessing efficacy and safety in patients with PHN.20 C = randomized, double-blind, placebo controlled, cross over study in healthy volunteers.24– indicates data unavailable. Data from17; data taken with permission from Zhang L, Rainka M, Freeman R, et al. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN I 10748). J Pain. 2013; l4(6):590–603;20 and data taken with permission from Clinical Therapy, 31, Lal R, Sukbuntherng J, Luo W, et al, 1776–1786, copyright Elsevier (2009).24
Abbreviations: CNS, central nervous system; GI, gastrointestinal; PHN, postherpetic neuralgia; n, number of patients; RLS, restless leg syndrome.