Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly · Source last updated 2018-04-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Participants
Interval / dispersion
95% Confidence Interval
Time frame
Extension baseline up to approximately week 268
What was measured
The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set
Groups in this outcome
Pasireotide LAR 40 mg Extension
If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
Pasireotide LAR 60 mg Extension
If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
Cross Over to Pasireotide Extension
Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Pasireotide LAR 40 mg Extension
57
Pasireotide LAR 60 mg Extension
54
Cross Over to Pasireotide Extension
62
Reported measurements
Week 16
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
16.7
Not reported
7.92
29.29
Not reported
Cross Over to Pasireotide Extension
6.5
Not reported
1.79
15.70
Not reported
Week 28
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
14.8
Not reported
6.62
27.12
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 40
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
9.3
Not reported
3.08
20.30
Not reported
Cross Over to Pasireotide Extension
4.8
Not reported
1.01
13.50
Not reported
Week 52
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
4.8
Not reported
1.01
13.50
Not reported
Week 64
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
9.7
Not reported
3.63
19.88
Not reported
Week 76
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
6.5
Not reported
1.79
15.70
Not reported
Week 88
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
7.0
Not reported
1.95
17.00
Not reported
Pasireotide LAR 60 mg Extension
20.4
Not reported
10.63
33.53
Not reported
Cross Over to Pasireotide Extension
4.8
Not reported
1.01
13.50
Not reported
Week 100
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
12.3
Not reported
5.08
23.68
Not reported
Pasireotide LAR 60 mg Extension
14.8
Not reported
6.62
27.12
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 112
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
14.0
Not reported
6.26
25.79
Not reported
Pasireotide LAR 60 mg Extension
20.4
Not reported
10.63
33.53
Not reported
Cross Over to Pasireotide Extension
9.7
Not reported
3.63
19.88
Not reported
Week 124
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
7.0
Not reported
1.95
17.00
Not reported
Pasireotide LAR 60 mg Extension
14.8
Not reported
6.62
27.12
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 136
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
3.5
Not reported
0.43
12.11
Not reported
Pasireotide LAR 60 mg Extension
18.5
Not reported
9.25
31.43
Not reported
Cross Over to Pasireotide Extension
11.3
Not reported
4.66
21.89
Not reported
Week 148
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
14.8
Not reported
6.62
27.12
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 160
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
14.8
Not reported
6.62
27.12
Not reported
Cross Over to Pasireotide Extension
9.7
Not reported
3.63
19.88
Not reported
Week 172
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
14.0
Not reported
6.26
25.79
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 184
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
7.0
Not reported
1.95
17.00
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
3.2
Not reported
0.39
11.17
Not reported
Week 196
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
13.0
Not reported
5.37
24.90
Not reported
Cross Over to Pasireotide Extension
8.1
Not reported
2.67
17.83
Not reported
Week 208
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
9.3
Not reported
3.08
20.30
Not reported
Cross Over to Pasireotide Extension
6.5
Not reported
1.79
15.70
Not reported
Week 220
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
7.4
Not reported
2.06
17.89
Not reported
Cross Over to Pasireotide Extension
6.5
Not reported
1.79
15.70
Not reported
Week 232
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
10.5
Not reported
3.96
21.52
Not reported
Pasireotide LAR 60 mg Extension
3.7
Not reported
0.45
12.75
Not reported
Cross Over to Pasireotide Extension
4.8
Not reported
1.01
13.50
Not reported
Week 244
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
3.7
Not reported
0.45
12.75
Not reported
Cross Over to Pasireotide Extension
6.5
Not reported
1.79
15.70
Not reported
Week 256
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
8.8
Not reported
2.91
19.30
Not reported
Pasireotide LAR 60 mg Extension
3.7
Not reported
0.45
12.75
Not reported
Cross Over to Pasireotide Extension
3.2
Not reported
0.39
11.17
Not reported
Week 268
Values in Participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 40 mg Extension
1.8
Not reported
0.04
9.39
Not reported
Pasireotide LAR 60 mg Extension
3.7
Not reported
0.45
12.75
Not reported
Cross Over to Pasireotide Extension
1.6
Not reported
0.04
8.66
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
3.96
upper Limit
21.52
value
10.5
group Id
OG001
lower Limit
7.92
upper Limit
29.29
value
16.7
group Id
OG002
lower Limit
1.79
upper Limit
15.70
value
6.5
title
Week 16
categories
measurements
group Id
OG000
lower Limit
2.91
upper Limit
19.30
value
8.8
group Id
OG001
lower Limit
6.62
upper Limit
27.12
value
14.8
group Id
OG002
lower Limit
2.67
upper Limit
17.83
value
8.1
title
Week 28
categories
measurements
group Id
OG000
lower Limit
3.96
upper Limit
21.52
value
10.5
group Id
OG001
lower Limit
3.08
upper Limit
20.30
value
9.3
group Id
OG002
lower Limit
1.01
upper Limit
13.50
value
4.8
title
Week 40
categories
measurements
group Id
OG000
lower Limit
2.91
upper Limit
19.30
value
8.8
group Id
OG001
lower Limit
5.37
upper Limit
24.90
value
13.0
group Id
OG002
lower Limit
1.01
upper Limit
13.50
value
4.8
title
Week 52
categories
measurements
group Id
OG000
lower Limit
2.91
upper Limit
19.30
value
8.8
group Id
OG001
lower Limit
5.37
upper Limit
24.90
value
13.0
group Id
OG002
lower Limit
3.63
upper Limit
19.88
value
9.7
title
Week 64
categories
measurements
group Id
OG000
lower Limit
3.96
upper Limit
21.52
value
10.5
group Id
OG001
lower Limit
5.37
upper Limit
24.90
value
13.0
group Id
OG002
lower Limit
1.79
upper Limit
15.70
value
6.5
title
Week 76
categories
measurements
group Id
OG000
lower Limit
1.95
upper Limit
17.00
value
7.0
group Id
OG001
lower Limit
10.63
upper Limit
33.53
value
20.4
group Id
OG002
lower Limit
1.01
upper Limit
13.50
value
4.8
title
Week 88
categories
measurements
group Id
OG000
lower Limit
5.08
upper Limit
23.68
value
12.3
group Id
OG001
lower Limit
6.62
upper Limit
27.12
value
14.8
group Id
OG002
lower Limit
2.67
upper Limit
17.83
value
8.1
title
Week 100
categories
measurements
group Id
OG000
lower Limit
6.26
upper Limit
25.79
value
14.0
group Id
OG001
lower Limit
10.63
upper Limit
33.53
value
20.4
group Id
OG002
lower Limit
3.63
upper Limit
19.88
value
9.7
title
Week 112
categories
measurements
group Id
OG000
lower Limit
1.95
upper Limit
17.00
value
7.0
group Id
OG001
lower Limit
6.62
upper Limit
27.12
value
14.8
group Id
OG002
lower Limit
2.67
upper Limit
17.83
value
8.1
title
Week 124
categories
measurements
group Id
OG000
lower Limit
0.43
upper Limit
12.11
value
3.5
group Id
OG001
lower Limit
9.25
upper Limit
31.43
value
18.5
group Id
OG002
lower Limit
4.66
upper Limit
21.89
value
11.3
title
Week 136
categories
measurements
group Id
OG000
lower Limit
3.96
upper Limit
21.52
value
10.5
group Id
OG001
lower Limit
6.62
upper Limit
27.12
value
14.8
group Id
OG002
lower Limit
2.67
upper Limit
17.83
value
8.1
title
Week 148
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
54
group Id
OG002
value
62
units
Participants
description
The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set
dispersion Type
95% Confidence Interval
groups
description
If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
id
OG000
title
Pasireotide LAR 40 mg Extension
description
If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
id
OG001
title
Pasireotide LAR 60 mg Extension
description
Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
id
OG002
title
Cross Over to Pasireotide Extension
param Type
NUMBER
reporting Status
POSTED
time Frame
Extension baseline up to approximately week 268
title
Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
Triangle