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

	Full Text PDF Editorial by Utiger, R. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

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

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

Results The mean (±SD) serum concentration of insulin-like growth factor I (IGF-I) decreased from base line by 4.0±16.8 percent in the placebo group, 26.7± 27.9 percent in the group that received 10 mg of pegvisomant per day, 50.1±26.7 percent in the group that received 15 mg of pegvisomant per day, and 62.5±21.3 percent in the group that received 20 mg of pegvisomant per day (P<0.001 for the comparison of each pegvisomant group with placebo), and the concentrations became normal in 10 percent, 54 percent, 81 percent, and 89 percent of patients, respectively (P<0.001 for each comparison with placebo). Among patients treated with 15 mg or 20 mg of pegvisomant per day, there were significant decreases in ring size, soft-tissue swelling, the degree of excessive perspiration, and fatigue. The score for total symptoms and signs of acromegaly decreased significantly in all groups receiving pegvisomant (P0.05). The incidence of adverse effects was similar in all groups.

Conclusions On the basis of these preliminary results, treatment of patients who have acromegaly with a growth hormone–receptor antagonist results in a reduction in serum IGF-I concentrations and 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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