The treatment with pasireotide in Cushing's disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center.

Simeoli C, Ferrigno R, De Martino MC, Iacuaniello D, Papa F, Angellotti D, Pivonello C, Patalano R, Negri M, Colao A, Pivonello R

Journal of endocrinological investigation16 Jul 2019Cited by 19 (Europe PMC)

PMID31313243PMCIDPMC6952330DOI10.1007/s40618-019-01077-8PepBankPUB-31313243

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Summary

PurposesPasireotide is the first medical therapy officially approved for adult patients with Cushing's disease (CD) experiencing failure of pituitary surgery or not candidates for surgery. The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center. In addition, the current study focused on safety issues encountered during the study, detailing the management of the different adverse events associated with the treatment with pasireotide in Naples center.MethodsFourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.ResultsFull or partial disease control was obtained in 85.7% of patients, according to a "per-protocol" methodology analysis, and in 42.9% of patients, according to an "intention-to-treat" methodology analysis, after 12 months of treatment. A relevant improvement in clinical signs and symptoms, mainly in facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength was observed; body weight, body mass index, and waist circumference significantly reduced, and a slight non-significant reduction was observed in the prevalence of visceral obesity, hypercholesterolemia, and hypertriglyceridemia. Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step; no patients discontinued treatment for hyperglycaemia. Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment. Millimetric gallstones and biliary sludge (7.1%) were managed with ursodeoxycholic acid, inducing lithiasis and biliary sludge resolution, whereas hypocortisolism-related adverse events (7.1%) were resolved with a reduction in the pasireotide dose.ConclusionsThe current study on a limited series of patients contributes to confirm that pasireotide may be considered a valid option for treatment of patients with CD, although it requires an appropriate management of adverse events, especially hyperglycaemia.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanNon-randomized trialEfficacy outcome
In Cushing's disease, pasireotide produced full or partial disease control in 42.9% by intention-to-treat analysis after 12 months.
In plain wordsIn Cushing's disease, 42.9% achieved full or partial control after 12 months of pasireotide by intention-to-treat analysis.
Peptide
Pasireotide
Outcome
Not applicableDisease control intention to treat
Study
n = 14
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Measurements
Full or partial disease control, intention-to-treat
42.9%
after 12 months of treatment
Source sentences
Summary
Full or partial disease control was obtained in 85.7% of patients, according to a "per-protocol" methodology analysis, and in 42.9% of patients, according to an "intention-to-treat" methodology analysis, after 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324302
02HumanNon-randomized trialSafety outcome
In Cushing's disease, glucose metabolism deterioration occurred in 71.4% during pasireotide treatment, requiring staged dietary and antihyperglycemic management.
In plain wordsIn Cushing's disease, 71.4% experienced worsening blood sugar control during pasireotide treatment.
Peptide
Pasireotide
Outcome
Not applicableGlucose metabolism deterioration
Study
n = 14
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Measurements
Deterioration of glucose metabolism
71.4%
safety cohort of 14 patients
Source sentences
Summary
Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step;
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324306
03HumanNon-randomized trialSafety outcome
In Cushing's disease, no patients discontinued pasireotide for hyperglycaemia.
In plain wordsIn Cushing's disease, no patients stopped pasireotide because of high blood sugar.
Peptide
Pasireotide
Outcome
Not applicableDiscontinuation for hyperglycaemia
Study
n = 14
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated
Source sentences
Summary
no patients discontinued treatment for hyperglycaemia.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324307
04HumanNon-randomized trialSafety outcome
In Cushing's disease, nausea occurred in 21.4% during pasireotide treatment.
In plain wordsIn Cushing's disease, 21.4% experienced nausea during pasireotide treatment.
Peptide
Pasireotide
Outcome
Not applicableNausea
Study
n = 14
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
Nausea
21.4%
safety cohort of 14 patients
Source sentences
Summary
Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324308
05HumanNon-randomized trialSafety outcome
In Cushing's disease, vomiting occurred in 14.3% during pasireotide treatment; nausea/vomiting generally resolved, except in one patient despite antiemetic treatment.
In plain wordsIn Cushing's disease, 14.3% experienced vomiting during pasireotide treatment, with persistent nausea or vomiting in one patient despite treatment.
Peptide
Pasireotide
Outcome
Not applicableVomiting
Study
n = 14
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
Vomiting
14.3%
safety cohort of 14 patients
Source sentences
Summary
Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324309
06HumanNon-randomized trialSafety outcome
In Cushing's disease, diarrhoea occurred in 14.3% during pasireotide treatment and improved with loperamide.
In plain wordsIn Cushing's disease, 14.3% experienced diarrhoea during pasireotide treatment, which improved with loperamide.
Peptide
Pasireotide
Outcome
Not applicableDiarrhoea
Study
n = 14
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
Diarrhoea
14.3%
safety cohort of 14 patients
Source sentences
Summary
Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324310
07HumanNon-randomized trialSafety outcome
In Cushing's disease, millimetric gallstones and biliary sludge were reported together at 7.1% during pasireotide treatment and resolved with ursodeoxycholic acid.
In plain wordsIn Cushing's disease, small gallstones and biliary sludge (7.1%) occurred during pasireotide treatment and resolved with ursodeoxycholic acid.
Peptide
Pasireotide
Outcome
Not applicableMillimetric gallstones and biliary sludge
Study
n = 14
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
Millimetric gallstones and biliary sludge
7.1%
safety cohort of 14 patients, reported together
Source sentences
Summary
Millimetric gallstones and biliary sludge (7.1%) were managed with ursodeoxycholic acid, inducing lithiasis and biliary sludge resolution, whereas hypocortisolism-related adverse events (7.1%) were resolved with a reduction in the pasireotide dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324311
08HumanNon-randomized trialSafety outcome
In Cushing's disease, hypocortisolism-related adverse events occurred in 7.1% and resolved after pasireotide dose reduction.
In plain wordsIn Cushing's disease, low-cortisol adverse events occurred in 7.1% and resolved after the pasireotide dose decreased.
Peptide
Pasireotide
Outcome
Not applicableHypocortisolism-related adverse events
Study
n = 14
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Hypocortisolism-related adverse events
7.1%
safety cohort of 14 patients
Source sentences
Summary
Millimetric gallstones and biliary sludge (7.1%) were managed with ursodeoxycholic acid, inducing lithiasis and biliary sludge resolution, whereas hypocortisolism-related adverse events (7.1%) were resolved with a reduction in the pasireotide dose.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324313
09HumanNon-randomized trialEfficacy outcome
In Cushing's disease, pasireotide improved clinical signs and symptoms, mainly facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength.
In plain wordsIn Cushing's disease, clinical signs and symptoms improved during pasireotide treatment.
Peptide
Pasireotide
Outcome
Direction not reportedClinical signs and symptoms
Study
n = 8
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated
Source sentences
Summary
A relevant improvement in clinical signs and symptoms, mainly in facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength was observed;
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324303
10HumanNon-randomized trialEfficacy outcome
In Cushing's disease, body weight, body mass index and waist circumference significantly decreased during pasireotide treatment.
In plain wordsIn Cushing's disease, weight, body mass index and waist circumference significantly decreased during pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseBody weight, body mass index and waist circumference
Study
n = 8
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
body weight, body mass index, and waist circumference significantly reduced, and a slight non-significant reduction was observed in the prevalence of visceral obesity, hypercholesterolemia, and hypertriglyceridemia.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324304
11HumanNon-randomized trialEfficacy outcome
In Cushing's disease, visceral obesity, hypercholesterolemia and hypertriglyceridemia prevalence decreased slightly during pasireotide treatment without statistical significance.
In plain wordsIn Cushing's disease, visceral obesity, high cholesterol and high triglyceride prevalence decreased slightly during pasireotide treatment without statistical significance.
Peptide
Pasireotide
Outcome
DecreaseVisceral obesity, hypercholesterolemia and hypertriglyceridemia prevalence
Study
n = 8
Outcome group
Metabolic pathways and metabolomics · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
and a slight non-significant reduction was observed in the prevalence of visceral obesity, hypercholesterolemia, and hypertriglyceridemia.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324305
12HumanNon-randomized trialEfficacy outcome
In Cushing's disease, pasireotide produced full or partial disease control in 85.7% by per-protocol analysis after 12 months.
In plain wordsIn Cushing's disease, 85.7% achieved full or partial control after 12 months of pasireotide by per-protocol analysis.
Peptide
Pasireotide
Outcome
Not applicableDisease control per protocol
Study
n: not reported in source
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Measurements
Full or partial disease control, per-protocol
85.7%
after 12 months of treatment
Source sentences
Summary
Full or partial disease control was obtained in 85.7% of patients, according to a "per-protocol" methodology analysis, and in 42.9% of patients, according to an "intention-to-treat" methodology analysis, after 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center.
Summary · context
Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
Show in the study text Report a problemFND-3131324301

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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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The treatment with pasireotide in Cushing's disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center.

Summary

Results from this study12

Version history

Subjects

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Keywords