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Submitted on February 15, 2005
Accepted on July 22, 2005
Department of Internal Medicine and Department of Neurosurgery (A.L.B.), University of Michigan Medical Center, Ann Arbor, Michigan 48109-0354; Pfizer Inc (P.H., P.B.), New York, New York 10017-5755; Division of Endocrinology/Metabolism (D.R.C.), University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599; Departments of Endocrinology (W.M.D.), St. Bartholomew's Hospital, London EC1A 7BE, and Christie Hospital, Manchester M20 4BX, United Kingdom; Division of Internal Medicine (R.F.G), University of Texas MD Anderson Medical Center, Houston, Texas 77030; Department of Endocrinology (P.J.T.), Christie Hospital, Manchester M20 4BX, United Kingdom; Erasmus Medical Centre Rotterdam (A.J.VDL.), Rotterdam, The Netherlands; Department of Internal Medicine (M.L.V.), University of Virginia Health Sciences Center, Charlottesville, Virginia 22908
* To whom correspondence should be addressed. E-mail: abarkan{at}med.umich.edu.
Context: In clinical practice, patients with acromegaly may be switched from therapy with long-acting somatostatin analogs to pegvisomant. The effect of changing therapies on glucose homeostasis and safety has not been reported.
Objectives: to monitor changes in IGF-I levels, glycemic control, and safety, particularly liver function and tumor size.
Design: Multicenter, open-label, 32-week trial.
Setting: Outpatient clinics.
Patients: 53 patients with acromegaly previously treated with octreotide LAR.
Intervention: Pegvisomant 10 mg/d was initiated 4 weeks after the last dose of octreotide LAR and was adjusted based on serum IGF-I concentrations at weeks 12, 20, and 28.
Main Outcome Measures: Changes in IGF-I, HbA1c, FPG, and safety during the first 12 weeks following conversion.
Results: At the end of pegvisomant treatment, IGF-I was normalized in 78% of patients. At week 32, median fasting glucose concentration and HbA1c were reduced (-1.4 mmol/L and -0.4%, respectively; both P 
0.0001) in the study population. Improvements in glycemic control occurred also in patients with normal IGF-I concentrations at week 4 (n = 15, fasting glucose -1.7 mmol/L, P 0.0001; HbA1c -0.2%, P = 0.03). Decreases in fasting glucose and HbA1c levels were observed in patients with and without diabetes. HbA1c was reduced by >1.0% in patients with diabetes. Median pituitary tumor volume did not change, although tumor volume increased in two patients with macroadenomas.
Conclusions: Conversion from octreotide LAR to pegvisomant was safe and well tolerated. Improved glycemic control indicates that pegvisomant should be considered in patients with acromegaly and diabetes.
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