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Painful diabetic peripheral neuropathy (PDPN) impacts nearly 20–25% of people with long-standing diabetes and can substantially impair function and quality of life.
Combining low-dose pregabalin (80 mg) with thioctic acid (400 mg) twice daily provides non-inferior pain relief to high-dose pregabalin (150 mg) twice daily while reducing side effects in painful diabetic peripheral neuropathy.
Painful diabetic peripheral neuropathy (PDPN) impacts nearly 20–25% of people with long-standing diabetes and can substantially impair function and quality of life. Although pregabalin is commonly used for neuropathic pain, dose-related central nervous system adverse effects, including dizziness and somnolence, can restrict treatment adherence and continuation.
Thioctic acid, also referred to as alpha-lipoic acid (ALA), is an antioxidant with neuroprotective, metabolic, and neuromodulatory properties. The study evaluated whether adding thioctic acid could allow a lower pregabalin dose while maintaining analgesic efficacy and improving tolerability.
This multicenter, double-blind, randomized trial was conducted at nine centers in Mexico.
Adult patients with diagnosed PDPN who were partial responders or non-responders (defined as exhibiting <50% reduction in pain intensity) following an initial pregabalin titration phase were enrolled. Out of 645 screened individuals, 439 eligible patients were randomized in a 1:1 ratio into two treatment arms for a 12-week intervention period:
The primary endpoint was pain intensity at week 12 utilizing a 10-point visual analog scale (VAS). The non-inferiority margin was 0.735.
Among 297 patients in the per-protocol population, the adjusted between-group difference in pain scores was 0.04, with an upper 99.17% confidence interval of 0.62, confirming non-inferiority of combination therapy. Pain trajectories and ≥30% and ≥50% responder rates were similar, although non-inferiority was not formally established for secondary outcomes. The combination therapy also reduced key dose-limiting adverse effects, with dizziness reported in 34% vs. 52% and dry mouth in 10% vs. 20% with pregabalin alone. Serious adverse events did not increase.
Fixed-dose low-dose pregabalin + thioctic acid matched the pain control of high-dose pregabalin monotherapy while alleviating side effects, making it a safer treatment option for PDPN.
Brain Communications
Combination therapy with pregabalin and thioctic acid offers safer pain control in diabetic neuropathy: a multicenter, double-blind, non-inferiority trial
Edith Zárate et al.
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