Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients - Full Text View

Purpose

In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

Condition	Intervention	Phase
Acromegaly	Drug: cabergoline	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

Resource links provided by NLM:

Drug Information available for: Dopamine Octreotide acetate Cabergoline Octreotide Cabergoline diphosphate

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Control of IGF-I levels [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

control IGI-I levels [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

serum for IGI-I, GH and prolactin measures

Enrollment:	19
Study Start Date:	May 2005
Study Completion Date:	December 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Responders to cabergoline patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week)	Drug: cabergoline cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal Other Name: cabergoline-Dostinex

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled

Criteria

Inclusion Criteria:

Active disease, under octreotide treatment at least 9 months

Exclusion Criteria:

Cabergoline allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014793

Locations

Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04039030

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Study Director:

Julio Abucham, PhD

Federal University of São Paulo

More Information

Publications:

Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004 Aug;61(2):209-15.

Selvarajah D, Webster J, Ross R, Newell-Price J. Effectiveness of adding dopamine agonist therapy to long-acting somatostatin analogues in the management of acromegaly. Eur J Endocrinol. 2005 Apr;152(4):569-74.

Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8.

Rocheville M, Lange DC, Kumar U, Patel SC, Patel RC, Patel YC. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science. 2000 Apr 7;288(5463):154-7.

Jallad RS, Bronstein MD. Optimizing medical therapy of acromegaly: beneficial effects of cabergoline in patients uncontrolled with long-acting release octreotide. Neuroendocrinology. 2009;90(1):82-92. Epub 2009 May 8.

Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin Endocrinol (Oxf). 2005 Oct;63(4):477-8. No abstract available.

Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9.

Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74.

Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. Epub 2009 Feb 10. Review.

Responsible Party:	Priscilla Olim de Andrade MAttar, Federal University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01014793 History of Changes
Other Study ID Numbers:	Mattapr1
Study First Received:	November 16, 2009
Last Updated:	November 16, 2009
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:

Acromegaly resistant
combined-treatment
dopamine agonist

Additional relevant MeSH terms:

Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Cabergoline

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013