Key Points Question Is HSK16149, a selective ligand of the a2δ subunit of voltage-gated calcium channels, effective and safe for Chinese patients with diabetic peripheral neuropathic pain (DPNP)? Findings In… Click to show full abstract
Key Points Question Is HSK16149, a selective ligand of the a2δ subunit of voltage-gated calcium channels, effective and safe for Chinese patients with diabetic peripheral neuropathic pain (DPNP)? Findings In this randomized, adaptive phase 2 to 3 clinical trial of 725 patients who were randomly assigned to receive HSK16149 in doses of 40 mg/d, 80 mg/d, 120 mg/d, or 160 mg/d, pregabalin in a dose of 300 mg, or placebo, the efficacy of HSK16149 (40 and 80 mg/d) was superior to placebo in all groups for relieving DPNP and appeared well tolerated. Meaning These findings suggest that 40- and 80-mg/d HSK16149 can be considered as new interventional therapies for Chinese patients with DPNP.
Journal Title: JAMA Network Open
Year Published: 2024
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