Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study.

Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R

Journal of endocrinological investigation8 May 2020Cited by 17 (Europe PMC)

PMID32385851DOI10.1007/s40618-020-01246-0PepBankPUB-32385851

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients with controlled mUFC at month 12, systolic pressure decreased from baseline by 8.4 mmHg (95% CI -13.9, -2.9).
In plain wordsIn patients with controlled cortisol, systolic blood pressure decreased from baseline during pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseSystolic blood pressure in controlled mUFC subgroup
Study
n = 45
Outcome group
Blood pressure · Cardiovascular
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Measurements
Change from baseline in mean systolic blood pressure
−8.4 mmHg
controlled mUFC at month 12
95% CI of change in systolic blood pressure
−13.9 to −2.9 mmHg
controlled mUFC at month 12
Source sentences
Summary
Patients with controlled mUFC at month 12 (n = 45) had the greatest improvements from baseline in mean systolic (- 8.4 mmHg [95% CI - 13.9, - 2.9]) and diastolic blood pressure (- 6.0 mmHg [- 10.0, - 2.0]).
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585101
02HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients with controlled mUFC at month 12, diastolic pressure decreased from baseline by 6.0 mmHg (95% CI -10.0, -2.0).
In plain wordsIn patients with controlled cortisol, diastolic blood pressure decreased from baseline during pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseDiastolic blood pressure in controlled mUFC subgroup
Study
n = 45
Outcome group
Blood pressure · Cardiovascular
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Measurements
Change from baseline in mean diastolic blood pressure
−6 mmHg
controlled mUFC at month 12
95% CI of change in diastolic blood pressure
−10 to −2 mmHg
controlled mUFC at month 12
Source sentences
Summary
Patients with controlled mUFC at month 12 (n = 45) had the greatest improvements from baseline in mean systolic (- 8.4 mmHg [95% CI - 13.9, - 2.9]) and diastolic blood pressure (- 6.0 mmHg [- 10.0, - 2.0]).
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585102
03HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients receiving pasireotide, mean BMI, weight and waist circumference improved irrespective of mUFC control.
In plain wordsIn Cushing's disease patients, body measurements improved during pasireotide treatment regardless of cortisol control.
Peptide
Pasireotide
Outcome
Direction not reportedBMI, weight and waist circumference
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Source sentences
Summary
Mean BMI, weight, and waist circumference improved irrespective of mUFC control.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585103
04HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients receiving pasireotide, CushingQoL total score improved significantly by 5.9-8.3 points at month 12 versus baseline, irrespective of mUFC control.
In plain wordsIn Cushing's disease patients, quality of life improved from baseline during pasireotide treatment.
Peptide
Pasireotide
Outcome
Direction not reportedCushingQoL total score
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Measurements
Improvement in CushingQoL total score versus baseline
5.9 to 8.3 points
month 12, range across mUFC control groups
Source sentences
Summary
Significant improvements in CushingQoL total score of 5.9-8.3 points were found at month 12 compared with baseline, irrespective of mUFC control
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585104
05HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients receiving pasireotide, physical problem scores improved and drove total quality-of-life improvement.
In plain wordsIn Cushing's disease patients, physical problem scores improved during pasireotide treatment.
Peptide
Pasireotide
Outcome
Direction not reportedPhysical problem score
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Source sentences
Summary
changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585105
06HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients receiving pasireotide, psychosocial scores showed smaller improvements than physical problem scores.
In plain wordsIn Cushing's disease patients, psychosocial scores improved less than physical problem scores during pasireotide treatment.
Peptide
Pasireotide
Outcome
Direction not reportedPsychosocial score
Study
n: not reported in source
Outcome group
Quality of life · Mental health and mood
Studied dose
Initially 10 or 30 mg every 28 days, adjusted within 5-40 mg · 12 monthsAs given in this study (human).
Source sentences
Summary
changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels…
Summary · context
Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.
Report a problemFND-3238585106

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01374906

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Novartis Pharmaceuticalsn = 1504 Nov 2011 to 21 Dec 2016

Cushing's Disease

Trial page ClinicalTrials.govUpdated 22 May 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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