0473 Alendronate is Associated With a Significantly Higher Odds of Obstructive Sleep Apnea (OSA): Results from the US FDA Adverse Events Reporting System (FAERS)
Bibliographic record
Abstract
OSA is recognized as a heterogeneous disorder. The literature on the role of medications in OSA pathogenesis has tended to focus on central nervous depressants. We examined the association of Alendronate (a commonly used bisphosphonate that is FDA-approved for osteoporosis and Paget’s disease of the bone) and OSA. Alendronate was among one of the 5 most frequent medications documented as primary suspect (PS) for the adverse effect (AE) of OSA in the FAERS post-marketing individual safety reports (ISR). To our knowledge the association of Alendronate and OSA has not been previously reported. We examined the FAERS database from January 1, 2004-June 30, 2017 (total ISR =9,553,117) and examined ISRs where Alendronate was documented as PS for the AE of OSA. Medical Dictionary for Regulatory Activities (MedDRA) preferred term of ‘Sleep apnoea syndrome’ (MedDRA code 10040979) was used to select ISRs designating OSA as AE. Reporting odds ratios (ROR) with 95% confidence intervals (CI) were calculated to assess disproportionality signals for OSA both when Alendronate (i) was used for FDA-approved indications, and (ii) when used for any indication. Results: Overall there were 626,321 ISR for Alendronate (mean+/-SD age: 61.20+/-11.06 years, age data on 437,493 ISR; 94.3% female, 5.7% male, gender data on 538,566 ISR). When used for FDA-approved indications (OSA-related ISR=625) versus all other medications for the same indications (OSA-related ISR=129), the disproportionality signal for OSA was 6.20 (95% 5.13-7.49), z=18.86, p<0.0001. For Alendronate used for any indication (OSA-related ISR=917) versus all other medications for any indication (OSA-related ISR=10,998) the disproportionality signal for OSA was 3.74 (95% CI 3.50-4.00), z=38.36, p<0.0001. Alendronate was associated with a previously unreported higher odds of OSA both (i) when used for FDA-approved indications, and (ii) when used for any indication. Factors other than the primary FDA indications (that could theoretically affect chest wall function), such as possible direct irritation of portions of the upper airway by Alendronate and its pro-inflammatory actions, may be important. None
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".