ER Niacin/Laropiprant vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.556 | 0.547 | 0.565 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.527 | 0.518 | 0.535 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0291 | 0.0169 | 0.0413 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.06 | 1.03 | 1.08 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.12 | 1.07 | 1.18 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on ER Niacin/Laropiprant than on Placebo | 34.4 | 24.2 | 59.2 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | ER Niacin/Laropiprant | I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily | 7,137 | 12,838 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily | 6,762 | 12,835 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Mean 3.6 year follow-up | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE | ClinicalTrials.gov |
| NCT number | NCT00461630 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Cardiovascular Disease, Peripheral Arterial Disease, Diabetes Mellitus, Coronary Heart Disease | ClinicalTrials.gov |
| Interventions | ER niacin/laropiprant, simvastatin, ezetimibe/simvastatin | ClinicalTrials.gov |
| Lead sponsor | University of Oxford | ClinicalTrials.gov |
| Results first posted | 2014-01-28 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00461630?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.