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      Pegvisomant Normalizes Insulin-like Growth Factor-I in Acromegaly: Presented at AACE

      By Paula Moyer

      SAN DIEGO, CA -- May 21, 2003 -- Patients with acromegaly will respond to pegvisomant (Somavert) even if they have not responded optimally to octreotide (Sandostatin), according to findings presented here on May 16th at the American Association of Clinical Endocrinologists 12th Annual Meeting and Clinical Congress.

      "Pegvisomant is useful in the treatment of acromegaly regardless of a patient's prior outcome with octreotide," said Mary Lee Vance, MD, professor of internal medicine, division of endocrinology, University of Virginia, Charlottesville, Va. "It normalized insulin-like growth factor-I [IGF-I] in more than 90% of patients who had been receiving octreotide."

      Previous studies have shown that the IGF-I receptor inhibitor pegvisomant, normalizes insulin-like IGF-I levels in up to 97% of patients (Eur J Endocrinol 2003; Apr. 148[Suppl 2]:S027-32), an effect seen in 20% to 68% of patients treated with octreotide, which reduces growth hormone (GH) and IGF-I levels.

      The researchers reviewed the records of 109 patients who had received pegvisomant in a long-term extension trial. Of these, 44 had received octreotide subcutaneously up to the time of enrollment.

      They compared IGF-I concentrations at several time points to determine each patient's response to octreotide, their treatment-free baseline IGF-I concentrations, and response to pegvisomant.

      Ninety-three percent of patients had IGF-I concentrations within the normal range for their age after undergoing pegvisomant treatment. By contrast, 39% had normal concentrations while receiving octreotide treatment.

      Mean difference in IGF-I concentrations from baseline to screening was 29%, reflecting the treatment effect of octreotide. The mean difference in those concentrations from baseline to the final study visit was 50%, a reflection of the treatment effect seen with pegvisomant.

      On the basis of these findings, Dr. Vance and her co-investigators concluded that pegvisomant's mechanism of action results in effective biochemical control of acromegaly. For most patients in whom octreotide did not result in optimal control, pegvisomant lowered and normalized IGF-I concentrations, she reported.

      The study was sponsored by Pfizer, Inc.,New York, NY.


      [Study title: Normalization of Insulin-Like Growth Factor-I With Pegvisomant in a Subset of Patients With Acromegaly Previously Treated With Octreotide. Abstract 41]



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