Studie
Efficacy and Säkerhet 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 Studie).
In 151 people with painful diabetic neuropathy, adding alpha-lipoic acid did not beat pregabalin alone for pain at 12 weeks.
Denna 12 veckor långa multicenterstudie i fas IV omfattade 151 personer med typ 2-diabetes och smärtsam diabetisk perifer neuropati. Deltagarna fördelades 1:1:1 till alfaliponsyra (ALA) 480 mg/dag, pregabalin 150 mg/dag eller kombinationen av dem. Det primära utfallsmåttet var förändringen från baslinjen i smärtpoäng på visuell analog skala. Pregabalin alone reduced pain by 19.73 ± 18.94 mm at week 12, versus 23.28 ± 18.15 mm with the combination. The least-squares mean difference was 3.46 mm (95% CI -4.94 to 11.87), meeting the trial's non-inferiority criterion for pregabalin alone. Säkerhet did not differ significantly among the groups. A cluster with relatively shorter neuropathy duration had a 14.79 mm difference between pregabalin alone and combination treatment (95% CI 4.59 to 24.99; p=0.0055), but this was a subgroup analysis. The reported comparison does not show that adding ALA improved pain overall. This is a treatment study in people with diabetic neuropathic pain, not a study of healthy ageing or longevity.
Pregabalin monotherapy was non-inferior to the combination therapy in alleviating diabetic peripheral neuropathy pain.
The trial was open-label and lasted only 12 weeks. Its endpoint was a pain score in a type 2 diabetes population; the potentially favourable result came from a cluster analysis that requires confirmation.
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