Efficacy and Safety of Pregabalin and Alpha‐Lipoic Acid Combination in Patients With Painful Diabetic Peripheral Neuropathy: A Randomized, Open‐Label, Non‐Inferiority, Phase IV Clinical Trial and Subgroup Analysis ( OPTIMUM Study )
Primary result · VAS pain score change from baselineResult — go to the resultLSM difference 3.46 mm 95% CI −4.94 to 11.87Authors' conclusion
The pregabalin monotherapy demonstrated non-inferiority compared to the combination therapy in alleviating DPN pain.
Study context
- Population
- Patients with T2D and painful diabetic peripheral neuropathy (DPN)randomized 1:1:1
- Participants
- 151 patients
- Comparison
- Pregabalin monotherapy vs alpha-lipoic acid (ALA) + pregabalin combination therapy
- Primary endpoint
- Change in visual analogue scale (VAS) pain score from baseline
- Follow-up
- 12 weeks
Methodological detailsphase 4, active-controlled, open-label, multicentre, non-inferiority
- Phase 4
- Active-controlled
- Open-label
- Multicentre
- Non-inferiority
Primary result
VAS pain score change from baseline · Week 12
Least square mean (LSM) difference
3.46 mm
95% CI −4.94 to 11.87
Change by group
Pregabalin
−19.73
SD 18.94 · mm
Combination
−23.28
SD 18.15 · mm
Pregabalinvs Combination
LSM difference 3.46 mm (95% CI −4.94 to 11.87)
As reported in the abstract
Further findings
| Outcome | LSM difference (mm) (CI) | P value | |
|---|---|---|---|
| VAS score, cluster 1 (relatively shorter DPN duration) · 12 weeksPregabalinvs CombinationCluster analysis | 14.79 (4.59–24.99) | P = 0.0055 | |
| −100102030Difference, mm (linear scale) |
Safety
- No significant differences across treatment groups
Original publication
Efficacy and Safety of Pregabalin and Alpha‐Lipoic Acid Combination in Patients With Painful Diabetic Peripheral Neuropathy: A Randomized, Open‐Label, Non‐Inferiority, Phase IV Clinical Trial and Subgroup Analysis ( OPTIMUM Study ). Diabetes Obes Metab. Published 29 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →