Clinical and Hormonal Criteria of the Effectiveness of Suppressive Cabergoline Therapy in Patients with Organic Hyperprolactinemia
Background. In modern international guidelines, there are not distinguished criteria for the evaluation of clinical symptoms, including somatic, neurological status, although almost all neuroendocrinologists acknowledge the presence exactly of heterospecific complaints and symptoms in patients with organic hyperprolactinemia. Treatment of organic hyperprolactinemia is aimed at achieving recovery of normal levels of the biologically active prolactin (PRL) and a reduction in adenoma volume. The objective of the study — to investigate the clinical and hormonal effectiveness of different modes of suppressive cabergoline therapy in patients with prolactinoma during 12 months. Materials and methods of the study. 61 patients with prolactinoma (PROL) (52 women and 9 men) aged 16–66 years were examined and underwent 12-month course of treatment by selective dopamine agonist cabergoline (CAB). The total duration of the disease ranged from 1 to 60 months, average one — 12.3 ± 10.1 months. 40 women treated with CAB had microPROL, 12 — macro- and giant PROL. 2 men had microadenoma, 7 — macroadenoma. PROL was verified using magnetic resonance imaging. PRL blood levels (ng/mL) were determined by enzyme-linked immunosorbent assay on automated analyzer StatFax 2100 (Awareness Technology, USA) by means of commercial ELISA reagent kit (DRG Diagnostics, USA). We have used two modes of therapy: first one — the mode of gradual increase of CAB dose, starting from 0.5 mg a week, with subsequent control of the PRL blood level every 4 weeks and titration of the dose if necessary (increase in a week dose by 0.25–0.5 mg). Second one — the mode of high starting doses on the basis of the following: the quantity of CAB tablets (0.5 mg) corresponded to the rate of increased PRL blood levels in relation to the upper limit of age norm, but no more than 4 mg (8 tablets) a week. The statistical data analysis was carried out using program package Statgraphics Plus for Windows 3.0 (Manugistic Inc. USA). Results. We have proposed an integrated scoring system to assess the clinical and hormonal effectiveness of CAB suppressive therapy in patients with organic hyperprolactinemia, which enables at all stages of follow-up to correct treatment, to assess the possible risks from the use of high doses of the drug and to optimize the selection of an adequate dose. The optimal mode of therapy with cabergoline in patients with microprolactinoma is the regimen of gradually increasing doses, the positive clinical and hormonal effect of which is observed in 80 % of patients 3 months after initiation of treatment. Conclusions. Administration of high starting doses of cabergoline in patients with macro- and giant prolactinomas enables in a short span of time (in 1 month) to achieve reliable positive dynamics of the indicators of neurological, performance and hormonal status compared with the group of patients receiving therapy in the mode of gradually increasing doses of the drug.
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