Once-daily sustained-release pregabalin (YHD1119) achieves quality of life outcomes comparable to twice-daily immediate-release pregabalin in patients with peripheral neuropathic pain
In a phase 3 randomized, double-blind, active-controlled trial, 296 Korean patients with peripheral neuropathic pain received either once-daily sustained-release pregabalin (YHD1119) or twice-daily immediate-release pregabalin for 12 weeks. Quality of life measures (SF-12, WSIS, PGIC, CGIC) showed no statistically significant differences between groups, with SF-12 Physical Component Summary changes of +2.50 vs +3.08 (p=0.5243) and WSIS improvements of -2.12 vs -2.19 (p=0.3691). The results support the new SR formulation as a practical alternative with comparable patient-reported benefit and once-daily dosing convenience.
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Once-daily sustained-release pregabalin (YHD1119) achieves quality of life outcomes comparable to twice-daily immediate-release pregabalin in patients with peripheral neuropathic pain The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 48/100 (low).
The Claim
Once-daily sustained-release pregabalin (YHD1119) achieves quality of life outcomes comparable to twice-daily immediate-release pregabalin in patients with peripheral neuropathic pain
This conclusion is most relevant to: Korean adults with peripheral neuropathic pain due to diabetic peripheral neuropathy or postherpetic neuralgia.
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Quality of life outcomes with a new sustained‑release pregabalin in a phase 3 trial of peripheral neuropathic pain. (Current medical research and opinion, 2026) —
How It Works
The proposed biological pathway:
- ▸Sustained-release formulation uses gastroretentive technology to prolong drug release
- ▸Allows once-daily dosing versus twice-daily immediate-release
- ▸Maintains steady pregabalin exposure over 24 hours
- ▸Results in comparable quality of life and sleep outcomes to immediate-release
Who Might Benefit
Evidence fit by population:
- ▸Korean adults with peripheral neuropathic pain due to diabetic peripheral neuropathy or postherpetic neuralgia
Recommended Dose
N/A (dosing not specified in abstract)
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Per-protocol analysis only, not intention-to-treat, may introduce selection bias
- ▸Study conducted in Korean population, limiting generalizability to other ethnic groups
- ▸No placebo control group, so absolute efficacy cannot be assessed
- ▸Duration limited to 12 weeks, long-term outcomes not evaluated
Frequently Asked Questions
What is YHD1119?▼
YHD1119 is a new sustained-release formulation of pregabalin developed using gastroretentive technology to allow once-daily dosing, compared to the standard immediate-release pregabalin taken twice daily.
How does once-daily SR pregabalin compare to IR pregabalin in quality of life?▼
In this phase 3 trial, once-daily SR pregabalin showed comparable improvements in quality of life measures (SF-12, WSIS, PGIC, CGIC) to twice-daily IR pregabalin, with no statistically significant differences between groups.
What was the sample size and duration of this study?▼
The study included 296 participants in the per-protocol analysis and lasted 12 weeks.
Is once-daily SR pregabalin a viable alternative to IR pregabalin?▼
Yes, the findings suggest that once-daily SR pregabalin provides similar patient-reported benefits and sleep improvements, offering the convenience of once-daily dosing, which may improve adherence.
References
- 1.Lee S, An T, Kim S. “Quality of life outcomes with a new sustained‑release pregabalin in a phase 3 trial of peripheral neuropathic pain..” Current medical research and opinion, 2026. PMID: 42622433 DOI: 10.1080/03007995.2026.2719074