Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial

S L Fougner; J Bollerslev; J Svartberg; M Øksnes; J Cooper; S M Carlsen

doi:10.1530/EJE-14-0249

Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial

Eur J Endocrinol. 2014 Aug;171(2):229-35. doi: 10.1530/EJE-14-0249. Epub 2014 May 27.

Authors

S L Fougner¹, J Bollerslev², J Svartberg², M Øksnes³, J Cooper³, S M Carlsen²

Affiliations

¹ Department of EndocrinologyMedical Clinic, St Olavs University Hospital, 7006 Trondheim, NorwaySection of Specialized EndocrinologyDepartment of Endocrinology, Oslo University Hospital, Rikshospitalet, Oslo, NorwayFaculty of MedicineUniversity of Oslo, Oslo, NorwayDivision of Internal MedicineUniversity Hospital of North Norway, Tromsø, NorwayTromsø Endocrine Research GroupInstitute of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, NorwayDepartment of MedicineCentre for Clinical Research, Haukeland University Hospital, Bergen, NorwayDepartment of EndocrinologyStavanger University Hospital, Stavanger, NorwayUnit for Applied Clinical ResearchNorwegian University of Science and Technology (NTNU), Trondheim, Norway stine.fougner@ntnu.no.
² Department of EndocrinologyMedical Clinic, St Olavs University Hospital, 7006 Trondheim, NorwaySection of Specialized EndocrinologyDepartment of Endocrinology, Oslo University Hospital, Rikshospitalet, Oslo, NorwayFaculty of MedicineUniversity of Oslo, Oslo, NorwayDivision of Internal MedicineUniversity Hospital of North Norway, Tromsø, NorwayTromsø Endocrine Research GroupInstitute of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, NorwayDepartment of MedicineCentre for Clinical Research, Haukeland University Hospital, Bergen, NorwayDepartment of EndocrinologyStavanger University Hospital, Stavanger, NorwayUnit for Applied Clinical ResearchNorwegian University of Science and Technology (NTNU), Trondheim, NorwayDepartment of EndocrinologyMedical Clinic, St Olavs University Hospital, 7006 Trondheim, NorwaySection of Specialized EndocrinologyDepartment of Endocrinology, Oslo University Hospital, Rikshospitalet, Oslo, NorwayFaculty of MedicineUniversity of Oslo, Oslo, NorwayDivision of Internal MedicineUniversity Hospital of North Norway, Tromsø, NorwayTromsø Endocrine Research GroupInstitute of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, NorwayDepartment of MedicineCentre for Clinical Research, Haukeland University Hospital, Bergen, NorwayDepartment of EndocrinologyStavanger University Hospital, Stavanger, NorwayUnit for Applied Clinical ResearchNorwegian University of Science and Technology (NTNU), Trondheim, Norway.
³ Department of EndocrinologyMedical Clinic, St Olavs University Hospital, 7006 Trondheim, NorwaySection of Specialized EndocrinologyDepartment of Endocrinology, Oslo University Hospital, Rikshospitalet, Oslo, NorwayFaculty of MedicineUniversity of Oslo, Oslo, NorwayDivision of Internal MedicineUniversity Hospital of North Norway, Tromsø, NorwayTromsø Endocrine Research GroupInstitute of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, NorwayDepartment of MedicineCentre for Clinical Research, Haukeland University Hospital, Bergen, NorwayDepartment of EndocrinologyStavanger University Hospital, Stavanger, NorwayUnit for Applied Clinical ResearchNorwegian University of Science and Technology (NTNU), Trondheim, Norway.

PMID: 24866574
DOI: 10.1530/EJE-14-0249

Abstract

Objective: Randomised studies have demonstrated a beneficial effect of pre-surgical treatment with somatostatin analogues (SSA) in acromegaly when evaluated early postoperatively. The objective of this study was to evaluate the long-term surgical cure rates.

Methods: Newly diagnosed patients were randomised to direct surgery (n=30) or 6-month pretreatment with octreotide LAR (n=32). The patients were evaluated 1 and 5 years postoperatively. Cure was defined as normal IGF1 levels and by normal IGF1 level combined with nadir GH <2 mU/l in an oral glucose tolerance test, all without additional post-operative treatment. A meta-analysis using the other published randomised study with long-term analyses on preoperative SSA treatment was performed.

Results: The proportion of patients receiving post-operative acromegaly treatment was equal in the two groups. When using the combined criteria for cure, 10/26 (38%) macroadenomas were cured in the pretreatment group compared with 6/25 (24%) in the direct surgery group 1 year postoperatively (P=0.27), and 9/22 (41%) vs 6/22 (27%) macroadenomas, respectively, 5 years postoperatively (P=0.34). In the meta-analysis, 16/45 (36%) macroadenomas were cured using combined criteria in the pretreatment group vs 8/45 (18%) in the direct surgery group after 6-12 months (P=0.06), and 15/41 (37%) vs 8/42 (19%), respectively, in the long-term (P=0.08).

Conclusion: This study does not prove a beneficial effect of SSA pre-surgical treatment, but in the meta-analysis a trend towards significance can be claimed. A potential favourable, clinically relevant response cannot be excluded.

Trial registration: ClinicalTrials.gov NCT00521300.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Acromegaly / drug therapy*
Acromegaly / surgery
Delayed-Action Preparations / administration & dosage
Humans
Octreotide / administration & dosage*
Octreotide / therapeutic use
Somatostatin / analogs & derivatives
Treatment Outcome

Substances

Delayed-Action Preparations
Somatostatin
Octreotide

Associated data

ClinicalTrials.gov/NCT00521300