CV 205-502 treatment in therapy-resistant acromegalic patients

Abstract

Lombardi G, Colao A, Ferone D, Sarnacchiaro F, Marzullo P, Di Sarno A, Rossi E, Merola B. CV 205-502 treatment in therapy-resistant acromegalic patients. Eur J Endocrinol 1995;132:559–64. ISSN 0804–4643 The growth hormone (GH) inhibitory effect of CV 205-502 was evaluated during acute and 3-month administration, alone or in combination with octreotide, in 12 therapy-resistant acromegalic patients. Although these patients previously had undergone surgery and received chronic therapy with octreotide at 0.3–0.6 mg/day, they still had high GH and insulin-like growth factor I (IGF-I) levels. CV 205-502 (0.15 mg), octreotide (0.1 mg) and placebo were tested acutely. CV 205-502 at the dose of 0.15 mg caused a decrease of GH level (from 34.9 ± 15.1 to 2.7 ± 0.3 μg/l) in 4/12 (33.3%) and completely inhibited prolactin (PRL) secretion in all the patients. Octreotide caused a decrease of GH level (from 37 ± 6.7 to 15.9 ± 3.0 μg/l) without any change of PRL level. The GH and PRL levels were not changed during placebo administration. CV 205-502 at the dose of 0.3 mg/day (chronic test) normalized GH and IGF-I levels in five patients (41.6%: the four responders to the acute test and an additional patient who was a poor responder to acute CV 205-502 administration). The remaining seven patients were subjected to CV 205-502 (0.6 mg/day) and octreotide (0.6 mg/day) in combination for 3 months. In 2/7 patients the combined therapy induced a greater inhibition of GH and IGF-I levels than did each drug when administered alone. The drug was well-tolerated by the 12 patients. In conclusion, CV 205-502 is able to normalize GH and IGF-I levels and to improve clinical symptoms in certain acromegalic patients resistant to other therapeutic approaches. CV 205-502 can, therefore, be considered an effective alternative in the medical management of acromegaly when the first choices, surgery and octreotide, fail to resolve GH hypersecretion. Gaetano Lombardi, via G. Santacroce 40/a, 80129 Napoli, Italy