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Comparison · NCT02642159-deaths

Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: deaths from any cause. Trial comparisons, record NCT02642159-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02642159-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.003640.0006420.0203wilson
Risk in group 200.000000000000000001730.0273wilson
Risk difference, group 1 minus group 20.00364-0.02380.0203newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harm, for one more death from any cause on Alirocumab 75 mg Q2W/Up to 150 mg Q2W than on Usual Care275from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: usual care.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \>=100 mg/dL (2.59 mmol/L) at Week 8.
1275EG000
Group 2Usual Care
Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
0137EG001

Harm

What it counts
Total, all-cause mortality
Time frame
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
NCT number
NCT02642159
Phases
PHASE4
Conditions
Dyslipidemia
Interventions
Alirocumab, Statins, Ezetimibe, Fenofibrate, Nicotinic acid, Omega-3 fatty acids, Antihyperglycemic Drug
Lead sponsor
Sanofi
Results first posted
2018-05-01

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
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

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.

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