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LX9211 demonstrates significant potential for reducing diabetic peripheral neuropathic pain, especially at lower doses.
LX9211, particularly at 10 mg, provided a clinically meaningful reduction in diabetic nerve pain, offering substantial relief to patients, as deciphered from a new study issued in “Diabetes Care”. Investigators explored LX9211 (orally administered, selective, potent inhibitor of adapter protein-2–associated kinase 1) as a treatment for diabetic peripheral neuropathic pain (DPNP), aiming to alleviate the discomfort associated with this challenging condition.
Researchers conducted a double-blind, multicenter trial with 319 DPNP patients. The enrolled volunteers were randomly assigned to receive either 10 mg LX9211, 20 mg LX9211, or a placebo daily for 6 weeks. Pain was assessed daily via an 11-point scale. The key endpoint measured was the alteration in average daily pain scores from baseline to week 6. Using mixed-model repeated-measures, the difference between LX9211 groups and placebo was analyzed.
The 10 mg LX9211 group achieved pivotal pain relief compared to placebo (-1.39 vs. -0.72 points), with the least squares mean difference of -0.67, and a p-value of 0.007. The 20 mg LX9211 group also showed improvement (-1.27 vs. -0.72 points), but the difference did not reach statistical significance. Benefits were observed from the first week and continued throughout the trial. LX9211 also improved various secondary outcomes.
Common side effects like headache, dizziness, and nausea were witnessed. More participants treated with LX9211 (20 mg, n = 28 [26.4%]; 10 mg, n = 17 [16.0%]) suspended the study drug early due to adverse events compared to placebo (n = 3 [2.8%]). Serious adverse events were rare (2 [1.9%], 0, and 1 [0.9%], respectively). Thus, LX9211 shows encouraging results in attenuating diabetic nerve pain and warrants further research in larger studies to confirm its effectiveness and safety.
Diabetes Care
Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of a Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study
Rodica Pop-Busui et al.
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