Efficacy evaluation on flexible dozes of Pregabalin for treatment of peripheral neuropathy in refrac- tory painful diabetics / 上海预防医学

ABSTRACT

Objective ] To evaluate the efficacy and tolerability of a flexible-dose pregabalin regimen in patients with refractory painful diabetic peripheral neuropathy . [ Methods] A prospective, open, non-randomized design was adopted .A series of 48 patients with refractory painful diabetic peripheral neuropathy received pregabalin 150 to 300 mg/d for 4 weeks.Pain intensity and sleep interference score were measured using numerical rating scale at baseline and at 2 and 4 weeks after therapy.Secondary meas-ures for assessment of mood and overall efficacy included 17-item Hamilton depression scale ( HAMD -17), Hamilton anxiety scale ( HAMA) and patient global impression of change ( PGIC).Adverse events were recorded . [ Results] The 46 patients completed the 4 weeks study .The mean dose of pregabalin was (262.5 ±57.9)mg/d at endpoint.The mean pain score decreased from 6.2 ±1.0 at baseline to 4.3 ± 1.4 at 2 weeks and 3.0 ±1.6 at 4 weeks ( P all <0.01).The mean sleep interference score was 5.1 ±1.4, 3.3 ±1.4, 2.1 ±1.5 respectively (P all <0.01).Also, significant improvements were noted in the HAMD and HAMA score (P<0.01).And among them, 26 patients (56.5%) reported“very much improved” or“much improved” in PGIC.Pregabalin was generally well tolerated without severe side effects reported and only 2 patients ( 4 .2%) discontinued the study because of their dizziness , somnolence . [ Conclusion] Pregabalin 150 to 300 mg/d can effectively improve pain , sleep, anxiety/depression in patients with refractory painful diabetic peripheral neuropathy , and it was well-tolerated.