Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study.

Pivonello R, Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Trovato A, Hughes G, Salgado LR, Lacroix A, Schopohl J, Biller BM

Clinical endocrinology27 Mar 2014Cited by 80 (Europe PMC)

PMID24533697DOI10.1111/cen.12431PepBankPUB-24533697

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Summary

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialEfficacy outcome
In Cushing's disease, blood pressure decreased during pasireotide treatment even without full UFC control, most in patients without antihypertensive medication.
In plain wordsIn Cushing's disease, blood pressure decreased during pasireotide treatment even without full urinary cortisol control.
Peptide
Pasireotide
Outcome
DecreaseBlood pressure
Study
n: not reported in source
Outcome group
Blood pressure · Cardiovascular
Studied dose
600 or 900 μg bid randomized; 300 μg bid uptitration; up to 1200 μg bid in open-label phase · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
Reductions in blood pressure were observed even without full UFC control and were greatest in patients who did not receive antihypertensive medications during the study.
4 context sentences(design, population, supporting numbers)
Summary · context
Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid).
Summary · context
At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration.
Summary · context
At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid.
Summary · context
Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control.
Report a problemFND-2453369701
02HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients achieving UFC control, total cholesterol significantly decreased during pasireotide treatment.
In plain wordsIn Cushing's disease patients achieving urinary cortisol control, total cholesterol decreased during pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseTotal cholesterol
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
600 or 900 μg bid randomized; 300 μg bid uptitration; up to 1200 μg bid in open-label phase · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
Significant reductions in total cholesterol and low-density lipoprotein (LDL)-cholesterol were observed in patients who achieved UFC control.
4 context sentences(design, population, supporting numbers)
Summary · context
Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid).
Summary · context
At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration.
Summary · context
At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid.
Summary · context
Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control.
Report a problemFND-2453369702
03HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients achieving UFC control, LDL cholesterol significantly decreased during pasireotide treatment.
In plain wordsIn Cushing's disease patients achieving urinary cortisol control, LDL cholesterol decreased during pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseLDL cholesterol
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
600 or 900 μg bid randomized; 300 μg bid uptitration; up to 1200 μg bid in open-label phase · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
Significant reductions in total cholesterol and low-density lipoprotein (LDL)-cholesterol were observed in patients who achieved UFC control.
4 context sentences(design, population, supporting numbers)
Summary · context
Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid).
Summary · context
At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration.
Summary · context
At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid.
Summary · context
Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control.
Report a problemFND-2453369703
04HumanNon-randomized trialEfficacy outcome
In Cushing's disease, BMI, weight and waist circumference decreased during pasireotide treatment even without full UFC control.
In plain wordsIn Cushing's disease, BMI, weight and waist size decreased during pasireotide treatment even without full urinary cortisol control.
Peptide
Pasireotide
Outcome
DecreaseBMI, weight and waist circumference
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
600 or 900 μg bid randomized; 300 μg bid uptitration; up to 1200 μg bid in open-label phase · subcutaneous · 12 monthsAs given in this study (human).
Source sentences
Summary
Reductions in BMI, weight and waist circumference occurred during the study even without full UFC control.
4 context sentences(design, population, supporting numbers)
Summary · context
Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid).
Summary · context
At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration.
Summary · context
At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid.
Summary · context
Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control.
Report a problemFND-2453369704
05HumanNon-randomized trialSafety outcome
In Cushing's disease, hyperglycaemia-related events occurred in 72·8% of patients during pasireotide treatment.
In plain wordsIn Cushing's disease, events related to high blood glucose occurred in 72·8% during pasireotide treatment.
Peptide
Pasireotide
Outcome
Not applicableHyperglycaemia-related events
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
600 or 900 μg bid randomized; 300 μg bid uptitration; up to 1200 μg bid in open-label phase · subcutaneous · 12 monthsAs given in this study (human).
Measurements
Patients with hyperglycaemia-related events
72.8%
during the study
Source sentences
Summary
Adverse effects were typical of somatostatin analogues except for hyperglycaemia-related events, which were experienced by 72·8% of patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid).
Summary · context
At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration.
Summary · context
At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid.
Summary · context
Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control.
Report a problemFND-2453369705

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Version history

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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

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