Gabapentin Use and Adverse Effects among Hemodialysis Patients Diagnosed with Pruritus or Neuropathic Pain in US Claims Data
Bibliographic record
Abstract
Background: Chronic kidney disease-associated pruritus (CKD-aP) is linked with numerous clinical and patient-reported outcomes. Gabapentin (Gaba) is indicated for neuropathic pain (NP), and also used off-label to reduce pruritus symptoms. There are, however, concerns about adverse events (AEs), namely altered mental status and risk of falls. We explored real-world Gaba utilization patterns and relevant AEs in US hemodialysis (HD) patients, and how they may differ by diagnosis of CKD-aP vs. NP. Methods: We used claims data from 533,232 adult HD patients in the USRDS database between 2016-2020 with Fee-For-Service Medicare Part D coverage. Gaba use, dose, and time to discontinuation were stratified by time-updated diagnosis of CKD-aP or NP. The associations between time-varying Gaba dose – defined as current prescription updated continuously – and six AEs were analysed by recurrent event Andersen-Gill model and adjusted for potential confounders, separately by time-updated diagnosis of CKD-aP or NP. Results: Point-prevalence of Gaba prescription was 13.9% overall, and was higher among patients with NP (21.1%) than with CKD-aP (11.0%). Median [IQR] time to discontinuation was 5.2 [2.0, 13.0] months in the NP group and 4.2 [1.5, 11.6] months in the CKD-aP group. Mean Gaba dose was higher (503 vs. 433 mg/day) in the NP vs. CKD-aP group, and increased during the first year of use from 410 to 494 mg/day. AE rates ranged from 9.3 (fracture) to 37.8 (altered mental status) per 100 patient-years. We observed a strong dose-response association between Gaba dose and AEs, particularly among patients with CKD-aP (Table). Conclusion: Use of Gaba in HD patients was associated with a higher risk of AEs (including altered mental status, dizziness, falls, and fracture), even at doses as low as 100 mg/day. The increase was greater when Gaba was used off-label in CKD-aP patients. Prescribers should consider the clinically relevant side effects of Gaba when providing treatment options to their patients with CKD-aP. Funding: Commercial Support - Commercial support by Vifor Fresenius Medical Care Renal Pharma
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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 | 0.002 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".