The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders: An open, uncontrolled, multicentre study

J. Webster, G. Piscitelli, A. Polli, A. D'Alberton, L. Falsetti, C. Ferrari, P. Fioretti, G. Giordano, M. L'Hermite, E. Ciccarelli, P. G. Crosignani, L. DeCecco, R. Fadini, G. Faglia, C. Flamigni, G. Tamburrano, I. Ismail, M. F. Scanlon

Research output: Contribution to journalArticle

Abstract

Objective: We assessed the efficacy and safety of the new, long-acting dopamine agonist drug cabergoline during long-term therapy of hyperprolactinaemia. Design: Open, prospective, multicentre study. Patients: One hundred and sixty-two females with either a microprolactinoma (n = 100), idiopathic hyperprolactinaemia (n = 54), empty sella syndrome (n = 7) or residual hyperprolactinaemia after surgery for a macroprolactinoma (n = 1). All had previously been treated with cabergoline or placebo for 4 weeks as part of a dose-finding study. Measurements: Menstrual pattern, adverse symptoms, blood pressure and pulse, serum pRL, blood count, liver and renal function were assessed after one month and subsequently at two-monthly intervals. Results: Treatment was started at doses of 0.25 mg (n = 3), 0.5 mg (n = 8), 1 mg (n = 150) or 2 mg (n = 1) per week, given either as a single weekly dose (n = 8) or divided into twice-weekly doses (n = 154), and was continued for at least 49 weeks in 123 patients. Final treatment doses ranged from 0.25 mg fortnightly to 2 mg twice weekly: most patients finished the study taking 0.5 mg once (n = 31) or twice (n = 77) weekly. Stable normalization of pRL levels was achieved in 138 subjects (85% of 114 patients completing 49 weeks of therapy and having dose adjustments according to the protocol, the biochemical success rate was 92%. Fifty-nine of the 65 previously amenorrhoeic women (91%) and 44 of the 49 (90%) who were previously oligomenorrhoeic resumed regular menses and/or became pregnant during the study. Adverse events were reported in 64 patients (39.5%). In 84% of cases with adverse events, the symptoms were of mild or moderate severity and most occurred during the first few weeks of therapy; five patients (3%) discontinued treatment because of poor tolerance. The most frequent symptoms were dizziness (13% of patients), headache (13%), nausea (10%) and weakness and/or fatigue (10%). Of 27 patients who had previously been poorly tolerant of other dopamine agonists, 17 (63%) did not experience any side-effects and only one was intolerant of cabergoline. No adverse haematological or biochemical effects were detected except for a slight downward trend in haemoglobin which may have been related to the resumption of regular menses in previously amenorrhooic or oligomenorrhoeic women. A mild hypotensive effect was observed, mean systolic and diastolic blood pressures falling by 5 and 4 mmHg respectively during treatment. Conclusions: The results provide evidence for the longterm effectiveness and safety of cabergoline in the treatment of hyperprolactinemia. Its ability to normalize PRL and restore gonadal function compares favourably with reported data on reference compounds while its tolerability profile and simple administration schedule offer potential advantages in terms of patient acceptability.

Original languageEnglish
Pages (from-to)323-329
Number of pages7
JournalClinical Endocrinology
Volume39
Issue number3
Publication statusPublished - 1993

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Multicenter Studies
Hyperprolactinemia
Prolactinoma
Therapeutics
Menstruation
Dopamine Agonists
Blood Pressure
Accidental Falls
Empty Sella Syndrome
Safety
cabergoline
Dopamine Agents
Dizziness
Nausea
Fatigue
Headache
Appointments and Schedules
Hemoglobins
Placebos
Prospective Studies

ASJC Scopus subject areas

  • Endocrinology

Cite this

Webster, J., Piscitelli, G., Polli, A., D'Alberton, A., Falsetti, L., Ferrari, C., ... Scanlon, M. F. (1993). The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders: An open, uncontrolled, multicentre study. Clinical Endocrinology, 39(3), 323-329.

The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders : An open, uncontrolled, multicentre study. / Webster, J.; Piscitelli, G.; Polli, A.; D'Alberton, A.; Falsetti, L.; Ferrari, C.; Fioretti, P.; Giordano, G.; L'Hermite, M.; Ciccarelli, E.; Crosignani, P. G.; DeCecco, L.; Fadini, R.; Faglia, G.; Flamigni, C.; Tamburrano, G.; Ismail, I.; Scanlon, M. F.

In: Clinical Endocrinology, Vol. 39, No. 3, 1993, p. 323-329.

Research output: Contribution to journalArticle

Webster, J, Piscitelli, G, Polli, A, D'Alberton, A, Falsetti, L, Ferrari, C, Fioretti, P, Giordano, G, L'Hermite, M, Ciccarelli, E, Crosignani, PG, DeCecco, L, Fadini, R, Faglia, G, Flamigni, C, Tamburrano, G, Ismail, I & Scanlon, MF 1993, 'The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders: An open, uncontrolled, multicentre study', Clinical Endocrinology, vol. 39, no. 3, pp. 323-329.
Webster, J. ; Piscitelli, G. ; Polli, A. ; D'Alberton, A. ; Falsetti, L. ; Ferrari, C. ; Fioretti, P. ; Giordano, G. ; L'Hermite, M. ; Ciccarelli, E. ; Crosignani, P. G. ; DeCecco, L. ; Fadini, R. ; Faglia, G. ; Flamigni, C. ; Tamburrano, G. ; Ismail, I. ; Scanlon, M. F. / The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders : An open, uncontrolled, multicentre study. In: Clinical Endocrinology. 1993 ; Vol. 39, No. 3. pp. 323-329.
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TY - JOUR

T1 - The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinaemic disorders

T2 - An open, uncontrolled, multicentre study

AU - Webster, J.

AU - Piscitelli, G.

AU - Polli, A.

AU - D'Alberton, A.

AU - Falsetti, L.

AU - Ferrari, C.

AU - Fioretti, P.

AU - Giordano, G.

AU - L'Hermite, M.

AU - Ciccarelli, E.

AU - Crosignani, P. G.

AU - DeCecco, L.

AU - Fadini, R.

AU - Faglia, G.

AU - Flamigni, C.

AU - Tamburrano, G.

AU - Ismail, I.

AU - Scanlon, M. F.

PY - 1993

Y1 - 1993

N2 - Objective: We assessed the efficacy and safety of the new, long-acting dopamine agonist drug cabergoline during long-term therapy of hyperprolactinaemia. Design: Open, prospective, multicentre study. Patients: One hundred and sixty-two females with either a microprolactinoma (n = 100), idiopathic hyperprolactinaemia (n = 54), empty sella syndrome (n = 7) or residual hyperprolactinaemia after surgery for a macroprolactinoma (n = 1). All had previously been treated with cabergoline or placebo for 4 weeks as part of a dose-finding study. Measurements: Menstrual pattern, adverse symptoms, blood pressure and pulse, serum pRL, blood count, liver and renal function were assessed after one month and subsequently at two-monthly intervals. Results: Treatment was started at doses of 0.25 mg (n = 3), 0.5 mg (n = 8), 1 mg (n = 150) or 2 mg (n = 1) per week, given either as a single weekly dose (n = 8) or divided into twice-weekly doses (n = 154), and was continued for at least 49 weeks in 123 patients. Final treatment doses ranged from 0.25 mg fortnightly to 2 mg twice weekly: most patients finished the study taking 0.5 mg once (n = 31) or twice (n = 77) weekly. Stable normalization of pRL levels was achieved in 138 subjects (85% of 114 patients completing 49 weeks of therapy and having dose adjustments according to the protocol, the biochemical success rate was 92%. Fifty-nine of the 65 previously amenorrhoeic women (91%) and 44 of the 49 (90%) who were previously oligomenorrhoeic resumed regular menses and/or became pregnant during the study. Adverse events were reported in 64 patients (39.5%). In 84% of cases with adverse events, the symptoms were of mild or moderate severity and most occurred during the first few weeks of therapy; five patients (3%) discontinued treatment because of poor tolerance. The most frequent symptoms were dizziness (13% of patients), headache (13%), nausea (10%) and weakness and/or fatigue (10%). Of 27 patients who had previously been poorly tolerant of other dopamine agonists, 17 (63%) did not experience any side-effects and only one was intolerant of cabergoline. No adverse haematological or biochemical effects were detected except for a slight downward trend in haemoglobin which may have been related to the resumption of regular menses in previously amenorrhooic or oligomenorrhoeic women. A mild hypotensive effect was observed, mean systolic and diastolic blood pressures falling by 5 and 4 mmHg respectively during treatment. Conclusions: The results provide evidence for the longterm effectiveness and safety of cabergoline in the treatment of hyperprolactinemia. Its ability to normalize PRL and restore gonadal function compares favourably with reported data on reference compounds while its tolerability profile and simple administration schedule offer potential advantages in terms of patient acceptability.

AB - Objective: We assessed the efficacy and safety of the new, long-acting dopamine agonist drug cabergoline during long-term therapy of hyperprolactinaemia. Design: Open, prospective, multicentre study. Patients: One hundred and sixty-two females with either a microprolactinoma (n = 100), idiopathic hyperprolactinaemia (n = 54), empty sella syndrome (n = 7) or residual hyperprolactinaemia after surgery for a macroprolactinoma (n = 1). All had previously been treated with cabergoline or placebo for 4 weeks as part of a dose-finding study. Measurements: Menstrual pattern, adverse symptoms, blood pressure and pulse, serum pRL, blood count, liver and renal function were assessed after one month and subsequently at two-monthly intervals. Results: Treatment was started at doses of 0.25 mg (n = 3), 0.5 mg (n = 8), 1 mg (n = 150) or 2 mg (n = 1) per week, given either as a single weekly dose (n = 8) or divided into twice-weekly doses (n = 154), and was continued for at least 49 weeks in 123 patients. Final treatment doses ranged from 0.25 mg fortnightly to 2 mg twice weekly: most patients finished the study taking 0.5 mg once (n = 31) or twice (n = 77) weekly. Stable normalization of pRL levels was achieved in 138 subjects (85% of 114 patients completing 49 weeks of therapy and having dose adjustments according to the protocol, the biochemical success rate was 92%. Fifty-nine of the 65 previously amenorrhoeic women (91%) and 44 of the 49 (90%) who were previously oligomenorrhoeic resumed regular menses and/or became pregnant during the study. Adverse events were reported in 64 patients (39.5%). In 84% of cases with adverse events, the symptoms were of mild or moderate severity and most occurred during the first few weeks of therapy; five patients (3%) discontinued treatment because of poor tolerance. The most frequent symptoms were dizziness (13% of patients), headache (13%), nausea (10%) and weakness and/or fatigue (10%). Of 27 patients who had previously been poorly tolerant of other dopamine agonists, 17 (63%) did not experience any side-effects and only one was intolerant of cabergoline. No adverse haematological or biochemical effects were detected except for a slight downward trend in haemoglobin which may have been related to the resumption of regular menses in previously amenorrhooic or oligomenorrhoeic women. A mild hypotensive effect was observed, mean systolic and diastolic blood pressures falling by 5 and 4 mmHg respectively during treatment. Conclusions: The results provide evidence for the longterm effectiveness and safety of cabergoline in the treatment of hyperprolactinemia. Its ability to normalize PRL and restore gonadal function compares favourably with reported data on reference compounds while its tolerability profile and simple administration schedule offer potential advantages in terms of patient acceptability.

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