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A phase 3, randomized, double-blind, active-controlled study was carried out to compare the efficacy and safety of novel sustained-release vs. immediate-release pregabalin for management of peripheral neuropathic pain.
For reduction of peripheral neuropathic pain, the novel once-daily sustained-release pregabalin formulation (in daily doses of 150–600 mg/day) was well-tolerated and showed non-inferiority to twice-daily immediate-release pregabalin.
A phase 3, randomized, double-blind, active-controlled study was carried out to compare the efficacy and safety of novel sustained-release vs. immediate-release pregabalin for management of peripheral neuropathic pain.
The study recruited people suffering from diabetic peripheral neuropathy or postherpetic neuralgia. Participants were randomly assigned to get once-daily sustained-release pregabalin or twice-daily immediate-release pregabalin (150–600 mg/day) in a double-dummy manner for twelve weeks as per a stratified permuted block randomization scheme. The daily pain rating scale score at the end of therapy, averaged from the last seven available scores was the major outcome ascertained.
Overall, 86.0% (319/371) randomized people finished the twelve-week treatment (immediate-release pregabalin: n=165; sustained-release pregabalin: n=154; per-protocol set: n=296). For the primary outcome, the least square mean difference between both the groups was 0.06 (standard error 0.19), with the lower limit of confidence interval above the pre-specified margin.
Drug-associated treatment-emergent adverse events were similar between both groups. The occurrence of drug-related treatment-emergent adverse events leading to treatment discontinuation was low (immediate-release pregabalin: 1.1%; sustained-release pregabalin: 2.7%). There were no severe drug-associated treatment-emergent adverse events or deaths.
The novel sustained-release pregabalin formulation appears to be a promising treatment for the alleviation of peripheral neuropathic pain. Following twelve weeks of treatment, the new formulation showed good tolerability in people diagnosed with diabetic peripheral neuropathy or postherpetic neuralgia.
The Clinical Journal of Pain
Efficacy and Safety of a New Sustained-released Pregabalin Formulation Compared with Immediate-release Pregabalin in Patients with Peripheral Neuropathic Pain A Randomized Non-inferiority Phase 3 Trial
Han, Kyung Ah et al.
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