Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial
Bibliographic record
Abstract
UNLABELLED: Aims/Introduction: Diabetic peripheral neuropathy (DPN) is often associated with pain, and thus a new treatment option is anticipated. We recently showed the efficacy of pregabalin in a randomized, double-blind, placebo-controlled, 14-week trial in Japanese patients with painful DPN. In the present study, we evaluated the long-term efficacy and safety of pregabalin for the relief of painful DPN. MATERIALS AND METHODS: A total of 123 patients were enrolled in a 52-week open-label study, from among those who participated in the preceding double-blind trial. The subjects received pregabalin 150-600 mg/day. Pain intensity was measured using the short-form McGill pain questionnaire (SF-MPQ: total score, visual analog scale and present pain intensity). RESULTS: The efficacy parameter SF-MPQ showed a decrease over the treatment period. The changes in visual analog scale and present pain intensity at the final evaluation were -25.4 mm and -0.7, respectively, suggesting an analgesic effect of pregabalin. Commonly reported adverse events were somnolence, weight gain, dizziness and peripheral edema, but most of them were mild to moderate in intensity. No new concerns about safety as a result of long-term administration of pregabalin were identified. CONCLUSIONS: The findings from this trial suggest that long-term treatment with pregabalin is beneficial for pain relief in patients with DPN. This trial was registered with ClinicalTrials.gov (no. NCT00553280). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00122.x, 2011).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".