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  1. Article
  2. Source: Campus Sanofi
  3. May 8, 2025

Odyssey outcomes - elderly patients results

Author: Sanofi

Editorial Team

  

Odyssey Outcomes: Addition of PCSK9i to background Statin therapy further reduces MACE.

View the study background

Elderly patients sub-analysis overview

Study outcomes

Primary outcome: composite of death from CHD, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization
Key secondary outcome: all-cause death
All outcomes were adjudicated by physicians who were unaware of the trial-group assignments

*Pre-specified analysis: Age <65 years (n=13,840), age≥65 years (n=5,084). The Cox regression model with age as a continuous variable, randomized treatment and the interaction was used to estimate the event rate at 3 years and HRs comparing alirocumab versus placebo at specific ages to test the interaction between age and treatment with alirocumab

Baseline characteristics by age group

Characteristic

<65 years (n=13,840)

≥65 years (n=5084)

P-value

Age (years), mean ± SD

54.2 ± 6.3

70.5 ± 4.7

 

Women, n (%)

2948 (21.3)

1814 (35.7)

<0.0001

Medical history before index ACS, n (%)

 

 

 

Hypertension

8390 (60.6)

3859 (75.9)

<0.0001

Diabetes mellitus

3787 (27.4)

1657 (32.6)

<0.0001

Myocardial infarction

2499 (18.1)

1134 (22.3)

<0.0001

Percutaneous coronary intervention

2212 (16.0)

1029 (20.2)

<0.0001

Coronary artery bypass graft

582 (4.2)

465 (9.1)

<0.0001

Stroke

337 (2.4)

274 (5.4)

<0.0001

Peripheral artery disease

428 (3.1)

331 (6.5)

<0.0001

Congestive heart failure

1800 (13.0)

1014 (19.9)

<0.0001

Index, ACS, n (%)

n=13,818

n=5075

<0.0001

STEMI

5039 (36.4)

1497 (29.4)

 

Non-STEMI

6422 (46.4)

2753 (54.2)

 

Unstable angina

2357 (17.0)

825 (16.2)

 

PCI or CABG for index ACS, n (%)

10,201 (73.7)

3475 (68.4)

<0.0001

SD, Standard deviation

Characteristic

<65 years (n=13,840)

≥65 years (n=5084)

P-value

The from index ACS to randomization
(months), mean ± SD

3.6 ± 2.8

3.8 ± 2.8

0.0003

Body mass index (kg/m2), mean ± SD

28.8 ± 4.9

27.8 ± 4.6

<0.0001

Renal function

 

 

 

eGFR (mL/min), mean ± SD

83.1 ± 18.5

70.2 ± 18.2

<0.0001

eGFR <60 mL/min, n (%)

1,163 (8.4)

1,377 (27.1)

<0.0001

Lipid-lowering drugs at randomization, n (%)

 

 

<0.0001

High-intensity
atorvastatin/rosuvastatin

12,565 (90.8)

4,246 (83.5)

 

Low- or moderate-intensity atorvastatin/rosuvastatin

1,027 (7.4)

580 (11.4)

 

No statin

222 (1.6)

238 (4.7)

 

Ezetibime

408 (2.9)

142 (2.8)

0.57

Treatment effect by age group: Primary composite outcome

Relative Risk Reduction Hazard Ratio (Alirocumab vs Placebo)
≥65 years: 0.78, 95% CI 0.68-0.91
<65 years: 0.89, 95% CI 0.80-1.00
Interaction p-value: 0.19
Absolute Risk Reduction At 3 years (Placebo - Alirocumab)
≥65 years: 3.88%, 95% Cl 1.74-6.02
<65 years: 0.91%, 95% Cl -0.13 to 1.95
Interaction p-value: 0.015

Treatment effect by age group: All cause death

Relative Risk Reduction Hazard Ratio (Alirocumab vs Placebo)
≥65 years: 0.77, 95% CI 0.62-0.95
<65 years: 0.94, 95% CI 0.77-1.15
Interaction p-value: 0.46
Absolute Risk Reduction At 3 years (Placebo - Alirocumab)
≥65 years: 2.08%, 95% Cl 0.48-3.67
<65 years: 0.11%, 95% Cl -0.50 to 1.72
Interaction p-value: 0.024

Safety: Adverse events by age group

Adverse Event

Randomized Treatment

Relative Risk (95%CI) Alirocumab vs Placebo

 

Alirocumab, N (%)

Placebo, N (%)

 

Any adverse event

 

 

 

≥65 years

1,974 (79.0)

2,042 (79.3)

1.00 (0.97 -1.02)

<65 years

5,191 (74.7)

5,240 (76.3)

0.98 (0.96 -1.00)

Serious adverse event

 

 

 

≥65 years

703 (28.1)

781 (30.3)

0.93 (0.85 -1.01)

<65 years

1,499 (21.6)

1,569 (22.8)

0.94 (0.89 -1.00)

Adverse event leading to discontinuation of treatment

 

 

 

≥65 years

121 (4.8)

128 (5.0)

0.97 (0.76 -1.24)

<65 years

222 (3.2)

196 (2.9)

1.12 (0.93 -1.35)

Neurocognitive disorder

 

 

 

≥65 years

52 (2.1)

65 (2.5)

0.82 (0.57 -1.18)

<65 years

91 (1.3)

102 (1.5)

0.88 (0.67 -1.17)

New-onset diabetes in patients w/o diabetes at baseline

 

 

 

≥65 years

156 (9.2)

167 (9.7)

0.95 (0.77 -1.17)

<65 years

492 (9.7)

509 (10.2)

0.95 (0.84 -1.07)

Hemorrhagic stroke - adjudicated

 

 

 

≥65 years

1 (0.0)

6 (0.2)

0.17 (0.02 -1.42)

<65 years

8 (0.1)

10 (0.1)

0.79 (0.31 -2.00)

Alanine aminotransferase> 3 x upper limit of normal

 

 

 

≥65 years

64 (2.6)

70 (2.8)

0.94 (0.67 -1.31)

<65 years

148 (2.1)

158 (2.3)

0.92 (0.74 -1.15)

Aspartate

 

 

 

≥65 years

52 (2.1)

48 (1.9)

1.11 (0.75 -1.64)

<65 years

108 (1.6)

118 (1.7)

0.90 (0.70 -1.17)

Elderly Patients’ sub-analysis conclusions¹

  • Alirocumab demonstrated an effective RRR for primary MACE outcome, and was associated with an effective reduction of all-cause death across age categories
  • There was a highly significant interaction of treatment effect and age on the absolute reduction of all-cause death, and although adverse events generally were more frequent in older patients, there was no increase occurrence in any of the safety endpoints
View Published Article

MAT-BH-2100544/v2/Jun 2023  

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