Disproportionality Analysis of Hypotension-Related Adverse Drug Reactions Associated With Type 1a Selective Alpha-Blockers in VigiBase
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Bibliographic record
Abstract
INTRODUCTION: Some evidence suggests no association between type 1a (T1a) selective alpha-blockers and hypotension-related adverse drug reactions (HR-ADRs), although safety concerns still exist. We sought to investigate the association of HR-ADRs with selective T1a blockers and identify at-risk groups. METHODS: We used disproportionality analysis to detect signals of HR-ADRs (dizziness, fainting, falls, and fractures) reported with selective T1a blocker use (tamsulosin and silodosin) in VigiBase, a global database of individual case safety reports. Excluding duplicates, all reports were included (1967-2022). Significance was determined using lower bound 95% empiric Bayes estimator > 1; only then were reporting odds ratios (RORs) and 95% CIs reported. Subgroup analyses were stratified by sex, age (<65 and ≥65 years), and indication for men only (urinary stone disease [USD] and benign prostatic hyperplasia [BPH]). RESULTS: We identified 5963 reports of HR-ADRs with selective T1a blockers. Selective T1a blockers were significantly associated with HR-ADRs (ROR 1.46; 95% CI 1.42-1.49). In men, selective T1a blockers for USD were associated with increased risk of HR-ADRs (ROR 1.60; 95% CI 1.56-1.65), which only remained significant in the older subgroup (ROR 6.70; 95% CI 3.20-14.01). No association was found for BPH. In women, selective T1a blockers were associated with an increased risk of HR-ADRs (ROR 1.09; 95% CI 0.99-1.09). This was only significant in the younger subgroup (ROR 1.17; 95% CI 1.03-1.32). CONCLUSIONS: In older men with USD and younger women, selective T1a blockers were associated with higher risk of HR-ADRs, suggesting the need for continued monitoring in these populations. No signal was observed for men with BPH.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.005 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.002 |
| 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 it