CV 205-502 treatment in therapy-resistant acromegalic patients.
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 micrograms/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 micrograms/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.(ABSTRACT TRUNCATED AT 250 WORDS)
Lombardi
G
G
Department of Molecular and Clinical Endocrinology and Oncology, Federico II University, Naples, Italy.
Colao
A
A
Ferone
D
D
Sarnacchiaro
F
F
Marzullo
P
P
Di Sarno
A
A
Rossi
E
E
Merola
B
B
D000172:Acromegaly / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D013006:Growth Hormone / Q000037:antagonists & inhibitors / Q000097:blood; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011388:Prolactin / Q000378:metabolism
D000634:Aminoquinolines; D018491:Dopamine Agonists; D007334:Insulin-Like Growth Factor I; C046650:quinagolide; D011388:Prolactin; D013006:Growth Hormone