Trial Outcomes & Findings for Acromegaly Combination Treatment Study (NCT NCT01538966)

Last Updated: 2023-01-04

Results Overview

We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.

Recruitment status

TERMINATED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

24 weeks

Results posted on

2023-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose SRL + Weekly Pegvisomant High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)	Low Dose SRL + Daily Pegvisomant Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)	Low Dose SRL + Weekly Pegvisomant Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Overall Study STARTED	23	26	27
Overall Study COMPLETED	15	14	23
Overall Study NOT COMPLETED	8	12	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acromegaly Combination Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose SRL + Weekly Pegvisomant n=15 Participants High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)	Low Dose SRL + Daily Pegvisomant n=14 Participants Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)	Low Dose SRL + Weekly Pegvisomant n=23 Participants Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)	Total n=52 Participants Total of all reporting groups
Age, Continuous	48.6 Years STANDARD_DEVIATION 17.6 • n=5 Participants	52.9 Years STANDARD_DEVIATION 12.1 • n=7 Participants	48.0 Years STANDARD_DEVIATION 13.3 • n=5 Participants	49.5 Years STANDARD_DEVIATION 14.3 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	High Dose SRL + Weekly Pegvisomant n=15 Participants High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)	Low Dose SRL + Daily Pegvisomant n=14 Participants Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)	Low Dose SRL + Weekly Pegvisomant n=23 Participants Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Cost Effectiveness	14,261.33 US dollars/month Standard Deviation 1,645.49	22,542.86 US dollars/month Standard Deviation 11,158.49	9,836.52 US dollars/month Standard Deviation 1,374.99

Adverse Events

High Dose SRL + Weekly Pegvisomant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Low Dose SRL + Daily Pegvisomant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Low Dose SRL + Weekly Pegvisomant

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Dose SRL + Weekly Pegvisomant n=15 participants at risk High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)	Low Dose SRL + Daily Pegvisomant n=14 participants at risk Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)	Low Dose SRL + Weekly Pegvisomant n=23 participants at risk Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Respiratory, thoracic and mediastinal disorders Tuberculosis	0.00% 0/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	4.3% 1/23 • Number of events 1 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	4.3% 1/23 • Number of events 1 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.

Other adverse events

Other adverse events
Measure	High Dose SRL + Weekly Pegvisomant n=15 participants at risk High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)	Low Dose SRL + Daily Pegvisomant n=14 participants at risk Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)	Low Dose SRL + Weekly Pegvisomant n=23 participants at risk Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	7.1% 1/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	13.0% 3/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	4.3% 1/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
General disorders Fatigue	0.00% 0/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	7.1% 1/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	26.1% 6/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
Nervous system disorders Headache	26.7% 4/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	8.7% 2/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
Musculoskeletal and connective tissue disorders Joint pain	13.3% 2/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	17.4% 4/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
Gastrointestinal disorders Nausea	6.7% 1/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	4.3% 1/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.
General disorders Swelling	13.3% 2/15 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	0.00% 0/14 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.	4.3% 1/23 • 6 months Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.

Additional Information

Vivian Hwe

Cedars-Sinai Medical Center

Phone: 424-315-4489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place