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Once-daily use of sustained-release Pregabalin relieves diabetic peripheral neuropathic pain without the need for repeated dosing throughout the day.
New sustained-release (SR) Pregabalin formulation recommended as once-per-day provides pain relief for diabetic peripheral neuropathy (DPN) on par with the traditional twice-daily immediate-release (IR) version, as per a phase 4 randomized clinical study published in the “Journal of Diabetes and Its Complications”. Kyong Hye Joung and researchers aimed to explore whether SR Pregabalin exhibits non-inferiority to IR Pregabalin in alleviating DPN pain along with patient contentment and adherence.
Conducted over 8 weeks, this open-label study compared 75 mg of IR Pregabalin to 150 mg of SR Pregabalin in a total of 130 type 2 diabetic patients with peripheral neuropathic pain. The variation in the visual analogue scale (VAS) scores after the use of IR and SR formulations of Pregabalin from the start was included in the primary efficacy endpoint. For the alteration in VAS pain score, the least squares (LS) means were found to be -17.95 for SR pregabalin and -18.74 for IR pregabalin.
The inter-group LS mean difference was 0.79, with the upper limit of the 95% CI [-5.99, 7.58] falling under the pre-specified non-inferiority margin of about 9.2 mm. To sum up, both formulations equally reduced pain, with a minimal difference in efficacy and comparable safety profiles, indicating SR Pregabalin’s prospect as a suitable and effective treatment option.
Journal of Diabetes and Its Complications
A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release Pregabalin with immediate-release Pregabalin in type 2 diabetic patients with peripheral neuropathic pain
Kyong Hye Joung et al.
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