Treatment of Acromegaly with the Growth Hormone-Receptor Antagonist Pegvisomant

doi:10.1056/NEJM200004203421604

Volume 342:1171-1177		April 20, 2000		Number 16

Treatment of Acromegaly with the Growth Hormone–Receptor Antagonist Pegvisomant

Peter J. Trainer, M.D., William M. Drake, M.B., Laurence Katznelson, M.D., Pamela U. Freda, M.D., Vivien Herman-Bonert, M.D., A.J. van der Lely, M.D., Eleni V. Dimaraki, M.D., Paul M. Stewart, M.D., Keith E. Friend, M.D., Mary Lee Vance, M.D., G. Michael Besser, M.D., D.Sc., and John A. Scarlett, M.D.

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by Utiger, R. D.

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ABSTRACT

Background Patients with acromegaly are treated with surgery,radiation therapy, and drugs to reduce hypersecretion of growthhormone, but the treatments may be ineffective and have adverseeffects. Pegvisomant is a genetically engineered growth hormone–receptorantagonist that blocks the action of growth hormone.

Methods We conducted a 12-week, randomized, double-blind studyof three different daily doses of pegvisomant (10 mg, 15 mg,and 20 mg) and placebo, given subcutaneously, in 112 patientswith acromegaly.

Results The mean (±SD) serum concentration of insulin-likegrowth factor I (IGF-I) decreased from base line by 4.0±16.8percent in the placebo group, 26.7± 27.9 percent in thegroup that received 10 mg of pegvisomant per day, 50.1±26.7percent in the group that received 15 mg of pegvisomant perday, and 62.5±21.3 percent in the group that received20 mg of pegvisomant per day (P<0.001 for the comparisonof each pegvisomant group with placebo), and the concentrationsbecame normal in 10 percent, 54 percent, 81 percent, and 89percent of patients, respectively (P<0.001 for each comparisonwith placebo). Among patients treated with 15 mg or 20 mg ofpegvisomant per day, there were significant decreases in ringsize, soft-tissue swelling, the degree of excessive perspiration,and fatigue. The score for total symptoms and signs of acromegalydecreased significantly in all groups receiving pegvisomant(P $<=$ 0.05). The incidence of adverse effects was similar in allgroups.

Conclusions On the basis of these preliminary results, treatmentof patients who have acromegaly with a growth hormone–receptorantagonist results in a reduction in serum IGF-I concentrationsand in clinical improvement.

Source Information

From the Christie and South Manchester University Hospitals, Manchester, United Kingdom (P.J.T.); St. Bartholomew's Hospital, London (W.M.D., G.M.B.); Massachusetts General Hospital, Boston (L.K.); Columbia College of Physicians and Surgeons, New York (P.U.F.); Cedars–Sinai Medical Center, Los Angeles (V.H.-B.); Academic Hospital Dijkzigt, Rotterdam, the Netherlands (A.J.L.); the University of Michigan Medical Center, Ann Arbor (E.V.D.); the University of Birmingham, Birmingham, United Kingdom (P.M.S.); the University of Texas M.D. Anderson Cancer Center, Houston (K.E.F.); the University of Virginia Health Sciences Center, Charlottesville (M.L.V.); and Sensus Drug Development, Austin, Tex. (J.A.S.). Other authors were Michael O. Thorner, M.B., D.Sc., University of Virginia Health Sciences Center, Charlottesville; Craig Parkinson, M.B., the Christie and South Manchester University Hospitals, Manchester, United Kingdom; Anne Klibanski, M.D., Massachusetts General Hospital, Boston; Jeffrey S. Powell, M.D., Columbia College of Physicians and Surgeons, New York; Ariel L. Barkan, M.D., University of Michigan Medical Center, Ann Arbor; Michael C. Sheppard, M.D., Ph.D., University of Birmingham, Birmingham, United Kingdom; Mario Maldonado, M.D., University of Texas M.D. Anderson Cancer Center, Houston; D. Roderick Rose, M.D., and David R. Clemmons, M.D., University of North Carolina School of Medicine, Chapel Hill; Gudmundur Johannsson, M.D., Ph.D., and Bengt-Åke Bengtsson, M.D., Sahlgrenska University Hospital, Göteborg, Sweden; Stavros Stavrou, M.D., and David L. Kleinberg, M.D., New York University Medical Center, New York; David M. Cook, M.D., Oregon Health Sciences University, Portland; Lawrence S. Phillips, M.D., Emory University School of Medicine, Atlanta; Martin Bidlingmaier, M.D., and Christian J. Strasburger, M.D., Klinikam Innenstadt, Ludwig-Maximilians-Universität, Munich, Germany; Suzanne Hackett, M.S., and Kenneth Zib, B.S., StatWorks, Chapel Hill, N.C.; and William F. Bennett, Ph.D., and Robert J. Davis, Pharm.D., Sensus Drug Development, Austin, Tex.

Address reprint requests to Dr. Scarlett at Sensus Drug Development, 98 San Jacinto Blvd., Suite 430, Austin, TX 78701, or at chip{at}sensuscorp.com.

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