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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Cardiovascular Diabetology
Published in: Cardiovascular Diabetology 1/2017

Open Access 01-12-2017 | Correction

Correction to: Updates on cardiovascular outcome trials in diabetes

Authors: Oliver Schnell, Lars Rydén, Eberhard Standl, Antonio Ceriello, on behalf of the D&CVD EASD Study Group

Published in: Cardiovascular Diabetology | Issue 1/2017

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Excerpt

Following publication of the original article [1], the authors submitted a corrected version of Table 4 (see below), as the original version contained a mistake.
Table 4
Comparison of outcome results from terminated CVOTs in comparison to placebo
 
SAVOR-TIMI53 [1, 2]
EXAMINE [3, 4]
TECOS [5]
ELIXA [6]
EMPA-REG OUTCOME [7]
LEADER [8]
Class
HR (95% CI)
Class
HR (95% CI)
Class
HR (95% CI)
Class
HR (95% CI)
Class
HR (95% CI)
Class
HR (95% CI)
p value
p value
p value
p value
p value
p value
Cardiovascular endpoints
 Primary composite MACE
CV death, MI, or stroke
1.00 (0.89–1.12)
0.99
CV death, MI, or stroke
0.96 (≤ 1.16)
0.32
CV death, MI, UA, or stroke
0.98 (0.89–1.08)
0.65
CV death, MI, UA, or stroke
1.02 (0.89–1.17)
0.81
CV death, MI, or stroke
0.86 (0.74–0.99)
0.04a
CV death, MI, or stroke
0.87 (0.78–0.97)
0.01
 Cardiovascular death
Primary endpoint
1.03 (0.87–1.22)
0.72
Primary endpoint
0.79 (0.60–1.04)
0.10
Secondary endpoint
1.03 (0.89–1.19)
0.71
Primary endpoint
0.98 (0.78–1.22)
0.85
Primary endpoint
0.62 (0.49–0.77)
< 0.001
Primary endpoint
0.78 (0.66–0.93)
0.007
 Myocardial infarction
Primary endpoint
0.95 (0.80–1.12)
0.52
Primary endpoint
1.08 (0.88–1.33)
0.47
Secondary endpoint
0.95 (0.81–1.11)
0.49
Primary endpoint
1.03 (0.87–1.22)
0.71
Primary endpoint
0.87 (0.70–1.09)
0.23
Primary endpoint
0.86 (0.73–1.00)
0.046
 Stroke
Primary endpoint
1.11 (0.88–1.39)
0.38
Primary endpoint
0.91 (0.55–1.50)
0.71
Secondary endpoint
0.97 (0.79–1.19)
0.76
Primary endpoint
1.12 (0.79–1.58)
0.54
Primary endpoint
1.18 (0.89–1.56)
0.26
Primary endpoint
0.86 (0.71–1.06)
0.16
 Hospitalization for unstable angina
Secondary endpoint
1.19 (0.89–1.60)
0.24
Secondary endpoint
0.90 (0.60–1.37)
0.632
Secondary endpoint
0.90 (0.70–1.16)
0.42
Primary endpoint
1.11 (0.47–2.62)
0.81
Secondary endpoint
0.99 (0.74–1.34)
0.97
Extended
primary endpoint
0.98 (0.76–1.26)
0.87
 Hospitalization for heart failure
Secondary endpoint
1.27 (1.07–1.51)
0.007
Extended primary endpoint
1.19 (0.90–1.58)
0.220
Secondary endpoint
1.00 (0.83–1.20)
0.98
Secondary endpoint
0.96 (0.75–1.23)
0.75
Secondary endpoint
0.65 (0.50–0.85)
0.002
Extended
primary endpoint
0.87 (0.73–1.05)
0.14
 
Event rate (%) active group
 
Event rate (%) active group
 
Event rate (%) active group
 
Event rate (%) active group
 
Event rate (%) active group
 
Event rate (%) active group
 
 Primary composite MACE
7.3
 
11.3
 
9.6
 
13.4
 
10.5
 
13.0
 
 
No. (%)
p value
 
No. (%)
p value
 
No. (%)
p value
 
No. (%)
p value
 
No. (%)
p value
 
No. (%)
p value
 
Non-cardiovascular endpoints
 Renal event
5.8
0.04
 
0.9
0.88
 
1.4
–
 
1.6
–
 
5.2
–
 
5.7
0.003
 
 Acute pancreatitis
0.3
0.77
 
0.4
0.5
 
0.3
0.07
 
0.2
–
 
0.3b
–
 
0.4
0.44
 
 Hypoglycemia events
15.3
< 0.001
 
6.7
0.74
 
2.2
0.33
 
16.6
0.14
 
2.8
 
2.4
0.02
 
 
SUSTAIN 6 [9]
EXSCEL [10]
DEVOTE [11]
CANVAS program [12]
ACE [13]
Class
HR (95% CI)
p value
Class
HR (95% CI)
p value
Class
HR (95% CI)
p value
Class
HR (95% CI)
p value
Class
HR (95% CI)
p value
Cardiovascular endpoints
 Primary composite MACE
CV death, MI, or stroke
0.74 (0.58–0.95)
0.02a
CV death, MI or stroke
0.91 (0.83–1.00)
0.06a
CV death, MI or stroke
0.91 (0.78–1.06)
< 0.001
CV death, MI or stroke
0.86 (0.75–0.97)
0.02a
CV death, MI, stroke, UA and HF
0.98 (0.86–1.11)
0.73
 Cardiovascular death
Primary endpoint
0.98 (0.65–1.48)
0.92
Secondary endpoint
0.88 (0.76–1.02)
Primary endpoint
0.96 (0.76–1.21)
0.71
Primary endpoint
0.87 (0.72–1.06)
Secondary endpoint
0.89 (0.71–1.11)
0.29
 Myocardial infarction
Primary endpoint
0.74 (0.51–1.08)
0.12
Secondary endpoint
0.97 (0.85–1.10)
Primary endpoint
0.85 (0.68–1.06)
0.15
Primary endpoint
0.89 (0.73–1.09)
Secondary endpoint
1.12 (0.87–1.46)
0.38
 Stroke
Primary endpoint
0.61 (0.38–0.99)
0.04
Secondary endpoint
0.85 (0.70–1.03)
Primary endpoint
0.90 (0.65–1.23)
0.50
Primary endpoint
0.87 (0.69–1.09)
Secondary endpoint
0.97 (0.70–1.33)
0.83
 Hospitalization for unstable angina
Extended primary endpoint
0.82 (0.47–1.44)
0.49
–
–
Primary endpoint
0.95 (0.68–1.31)
0.74
–
–
Secondary endpoint
1.02 (0.82–1.26)
0.87
 Hospitalization for heart failure
Extended primary endpoint
1.11 (0.77–1.61)
0.57
Secondary endpoint
0.94 (0.78–1.13)
–
–
Secondary endpoint
0.67 (0.52–0.87)
Secondary endpoint
0.89 (0.63–1.24)
0.48
 
Event rate (%) active group
Event rate (%) active group
Event rate (%) active group
Event rate (%) active group
Event rate (%) active group
 Primary composite MACE
6.6
11.4
8.5
26.9d
14.4
 
No. (%)
p value
No. (%)
p value
No. (%)
p value
No. (%)
p value
No. (%)
p value
Non-cardiovascular endpoints
 Renal event
3.9
–
55 (0.7)
3.8
–
19.7d
0.32
–
 Acute pancreatitis
0.55
–
26 (0.4)
–
–
0.5d
0.63
–
 Hypoglycemia events
22.4c
–
247 (3.4)
4.9
< 0.001a
56.0d
0.20
54 (2)
0.95
aSuperiority test
bAverage across all age ranges
cSevere hypoglycaemia as defined by ADA
dNumber of participants per 1000 patient-years
…
Literature
1.
Metadata
Title
Correction to: Updates on cardiovascular outcome trials in diabetes
Authors
Oliver Schnell
Lars Rydén
Eberhard Standl
Antonio Ceriello
on behalf of the D&CVD EASD Study Group
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Cardiovascular Diabetology / Issue 1/2017
Electronic ISSN: 1475-2840
DOI
https://doi.org/10.1186/s12933-017-0633-4

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