| PICO | Description |
|---|---|
| Population | Patients with diabetic peripheral neuropathy experiencing moderate to severe pain. |
| Intervention | Once-daily prolonged-release pregabalin (150–600 mg/day). |
| Comparison | Placebo and immediate-release pregabalin (thrice-daily doses of 150–600 mg/day). |
| Outcome | Pregabalin PR had comparable efficacy to pregabalin IR in managing pain and significantly improved outcomes compared to placebo. Common side effects included dizziness and somnolence. |
RCT
Pain Pract · 2025
Once-daily PR pregabalin for diabetic neuropathy pain
RCT · diabetic peripheral neuropathy · 13 weeks
Trial design
Change from baseline — both arms
Pain score change, PR
-3.43
LSM, FAS
Pain score change, placebo
-3.04
LSM, FAS
PR vs placebo
p=0.0158
superior
PR vs IR difference
0.06
95% CI -0.28, 0.41
⬡ Bottom Line
Once-daily prolonged-release pregabalin cut weekly pain scores more than placebo and was non-inferior to thrice-daily immediate-release pregabalin in diabetic peripheral neuropathy. Dizziness and somnolence were the common adverse effects.
P
Population
Patients with diabetic peripheral neuropathy and moderate to severe pain
I
Intervention
Once-daily prolonged-release pregabalin 150-600 mg/day
C
Comparator
Placebo and thrice-daily immediate-release pregabalin 150-600 mg/day
O
Outcome
Change in mean weekly pain score from baseline to end of treatment