Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs.

Gadelha M, Bex M, Colao A, Pedroza García EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G

Frontiers in endocrinology3 Feb 2020Cited by 34 (Europe PMC)

PMID32117045PMCIDPMC7008501DOI10.3389/fendo.2019.00931PepBankPUB-32117045

Download PDF PubMedAsk about this study

Jump to 3 results

Summary

Introduction: Acromegaly is a rare, serious endocrine disorder characterized by excess growth hormone (GH) secretion by a pituitary adenoma and overproduction of insulin-like growth factor I (IGF-I). Transsphenoidal surgery is the treatment of choice, although many patients require additional interventions. First-generation somatostatin analogs (SSAs) are the current standard of medical therapy; however, not all patients achieve control of GH and IGF-I. Outcomes from a Phase IIIb open-label study of patients with uncontrolled acromegaly on first-generation SSAs switching to pasireotide are reported. Methods: Adults with uncontrolled acromegaly (mean GH [mGH] ≥1 μg/L from a five-point profile over 2 h, and IGF-I >1.3× upper limit of normal [ULN]) despite ≥3 months' treatment with maximal approved doses of long-acting octreotide/lanreotide received open-label long-acting pasireotide 40 mg/28 days. Pasireotide dose could be increased (maximum: 60 mg/28 days) after week 12 if biochemical control was not achieved, or decreased (minimum: 10 mg/28 days) for tolerability. Patients who completed 36 weeks' treatment could continue receiving pasireotide during an extension (weeks 36-72) when concomitant medication for acromegaly was permitted. Primary endpoint was proportion of patients with mGH and IGF-I Results: One hundred and twenty-three patients were enrolled and received pasireotide; 88 patients continued into the extension. Overall, 18 [14.6% (95% CI: 8.9-22.1)] patients achieved mGH 2.5 μg/L. For patients who entered the extension, 14.8% (95% CI: 8.1-23.9), 12.5% (95% CI: 6.4-21.3), 14.8% (95% CI: 8.1-23.9) and 11.4% (95% CI: 5.6-19.9) had mGH Conclusions: Switching to long-acting pasireotide provided biochemical control in some patients, which was sustained with continued treatment. Long-term safety and tolerability of long-acting pasireotide was consistent with the known safety profile. These data support long-acting pasireotide for some patients with acromegaly who are uncontrolled on first generation SSAs. Clinical Trial Registration: clinicaltrials.gov, identifier: NCT02354508.

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

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanNon-randomized trialEfficacy outcome
In uncontrolled acromegaly, 18 patients (14.6%, 95% CI 8.9-22.1) achieved mean GH <1 μg/L and IGF-I <ULN at week 36 with pasireotide.
In plain wordsIn uncontrolled acromegaly, 14.6% achieved the specified hormone targets at week 36 with pasireotide.
Peptide
Pasireotide
Outcome
Not applicableBiochemical control overall
Study
n = 123
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 mg/28 days, adjustable to 10-60 mg/28 days · 36 weeksAs given in this study (human).
Measurements
patients achieving mGH <1 ug/L and IGF-I <ULN
18 patients
week 36, overall
proportion achieving mGH <1 ug/L and IGF-I <ULN
14.6%
week 36, overall; 95% CI 8.9-22.1
95% CI of proportion
8.9 to 22.1%
week 36, overall
Source sentences
Summary
Overall, 18 [14.6% (95% CI: 8.9-22.1)] patients achieved mGH 2.5 μg/L.
3 context sentences(design, population, supporting numbers)
Summary · context
Outcomes from a Phase IIIb open-label study of patients with uncontrolled acromegaly on first-generation SSAs switching to pasireotide are reported.
Summary · context
Adults with uncontrolled acromegaly (mean GH [mGH] ≥1 μg/L from a five-point profile over 2 h, and IGF-I >1.3× upper limit of normal [ULN]) despite ≥3 months' treatment with maximal approved doses of long-acting octreotide/lanreotide received open-label long-acting pasireotide 40 mg/28 days.
Summary · context
Pasireotide dose could be increased (maximum: 60 mg/28 days) after week 12 if biochemical control was not achieved, or decreased (minimum: 10 mg/28 days) for tolerability.
Show in the study text Report a problemFND-3211704501
02HumanNon-randomized trialEfficacy outcome
In uncontrolled acromegaly with screening mean GH 1.0-2.5 μg/L, forty-two point nine percent achieved mean GH <1 μg/L and IGF-I <ULN at week 36 with pasireotide.
In plain wordsIn acromegaly with screening growth hormone 1.0-2.5 μg/L, forty-two point nine percent reached the hormone targets at week 36 with pasireotide.
Peptide
Pasireotide
Outcome
Not applicableBiochemical control, screening GH 1.0-2.5 μg/L
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 mg/28 days, adjustable to 10-60 mg/28 days · 36 weeksAs given in this study (human).
Source sentences
Summary
Overall, 18 [14.6% (95% CI: 8.9-22.1)] patients achieved mGH 2.5 μg/L.
3 context sentences(design, population, supporting numbers)
Summary · context
Outcomes from a Phase IIIb open-label study of patients with uncontrolled acromegaly on first-generation SSAs switching to pasireotide are reported.
Summary · context
Adults with uncontrolled acromegaly (mean GH [mGH] ≥1 μg/L from a five-point profile over 2 h, and IGF-I >1.3× upper limit of normal [ULN]) despite ≥3 months' treatment with maximal approved doses of long-acting octreotide/lanreotide received open-label long-acting pasireotide 40 mg/28 days.
Summary · context
Pasireotide dose could be increased (maximum: 60 mg/28 days) after week 12 if biochemical control was not achieved, or decreased (minimum: 10 mg/28 days) for tolerability.
Show in the study text Report a problemFND-3211704502
03HumanNon-randomized trialEfficacy outcome
In uncontrolled acromegaly with screening mean GH >2.5 μg/L, 6.4% achieved mean GH <1 μg/L and IGF-I <ULN at week 36 with pasireotide.
In plain wordsIn uncontrolled acromegaly with higher screening growth hormone, 6.4% achieved biochemical control at week 36 with pasireotide.
Peptide
Pasireotide
Outcome
Not applicableBiochemical control, screening GH above 2.5 μg/L
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 mg/28 days, adjustable to 10-60 mg/28 days · 36 weeksAs given in this study (human).
Measurements
biochemical control (mGH <1 ug/L and IGF-I <ULN)
6.4%
week 36; screening mGH >2.5 ug/L
Source sentences
Summary
Overall, 18 [14.6% (95% CI: 8.9-22.1)] patients achieved mGH 2.5 μg/L.
3 context sentences(design, population, supporting numbers)
Summary · context
Outcomes from a Phase IIIb open-label study of patients with uncontrolled acromegaly on first-generation SSAs switching to pasireotide are reported.
Summary · context
Adults with uncontrolled acromegaly (mean GH [mGH] ≥1 μg/L from a five-point profile over 2 h, and IGF-I >1.3× upper limit of normal [ULN]) despite ≥3 months' treatment with maximal approved doses of long-acting octreotide/lanreotide received open-label long-acting pasireotide 40 mg/28 days.
Summary · context
Pasireotide dose could be increased (maximum: 60 mg/28 days) after week 12 if biochemical control was not achieved, or decreased (minimum: 10 mg/28 days) for tolerability.
Show in the study text Report a problemFND-3211704503

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 postedNCT02354508

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

Novartis Pharmaceuticalsn = 12331 Mar 2015 to 27 Sept 2018

Acromegaly

Trial page ClinicalTrials.govUpdated 10 Dec 2019

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 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC