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Treatment of Prolactin-Secreting Pituitary Macroadenomas with the Long-acting Non-Ergot Dopamine Agonist CV 205-502

Mary Lee Vance, MD; Maurice Lipper, MD; Anne Klibanski, MD; Beverly M. K. Biller, MD; Naguib A. Samaan, MD, PhD; and Mark E. Molitch, MD
[+] Article, Author, and Disclosure Information

Grant Support: By the Sandoz Research Institute and in part by General Clinical Research Center USPHS Grant RR-00847 to the University of Virginia.

Requests for Reprints: Mary Lee Vance, MD, Box 511, University of Virginia Health Sciences Center, Charlottesville, VA 22908.

Current Author Addresses: Dr. Vance: Department of Internal Medicine, Box 511, University of Virginia Health Sciences Center, Charlottesville, VA 22908.

Dr. Lipper: Department of Radiology, Box 170, University of Virginia Health Sciences Center, Charlottesville, VA 22908. Drs. Klibanski and Biller: Department of Internal Medicine, Massachusetts General Hospital, Boston, MA 02114.

Dr. Samaan: Department of Internal Medicine, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030. Dr. Molitch: Department of Internal Medicine, Northwestern University Medical School, Chicago, IL 60611.

© 1990 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1990;112(9):668-673. doi:10.7326/0003-4819-112-9-668
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Study Objective: Evaluation of the effects of an experimental long-acting non-ergot dopamine agonist, CV 205-502, on serum prolactin, tumor size, gonadal function, visual abnormalities, and tolerability in patients with macroprolactinomas. Design: Prospective, unblinded, dose escalation as needed. Setting: Four university medical centers; patients referred for treatment.

Patients: Twenty-six hyperprolactinemic patients (prolactin > 150 µg/L) with a pituitary macroadenoma were treated for 24 weeks with CV 205-502 given once daily.

Measurements and Main Results: Serum prolactin was measured at regular intervals. Prolactin levels decreased in all patients during treatment (mean pretreatment level, 2051.7 ±1077 µg/L [± SE]; 24 weeks, 39.0 ±11.3 µg/L; P = 0.0001); normal prolactin levels were achieved in 15 (58%). Tumor size decreased in 21 of 26 patients and ranged from 6% to 67% (mean, 19.2% ± 3.4%). Onset or return of regular menses occurred in 11 of 15 premenopausal women, accompanied by an increase in estradiol concentrations (pretreatment, 186.5 ± 25.0 pmol/L; on treatment, 690.9 ± 104.3 pmol/L; P = 0.0003). Serum testosterone increased in 6 of 8 men; sexual function improved in 5 of 7 with pretreatment abnormalities. Two patients with reversible visual abnormalities improved within 2 weeks of starting treatment. Side effects occurred in 11 patients and abated over 1 to 2 weeks or after the dose was reduced. There was no evidence of toxicity as indicated by serial serum chemistries, liver function tests, hematologic profiles, thyroxine levels, and electrocardiogram studies.

Conclusions: CV 205-502 reverses hyperprolactinemia and promotes reduction in tumor size with reversal of visual abnormalities and restoration of gonadal function in most patients. This compound will probably be useful in treating prolactinomas.





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