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PubMed1995

[Hyperprolactinemic amenorrhea:treatment with cabergoline versus bromocriptine. Results of a national multicenter randomized double-blind study].

OBJECTIVES: Cabergoline is a new, long-acting D2 agonist, highly effective in suppressing prolactin and restoring gonadal function in hyperprolactinaemic amenorrhoea. This study compares its efficacity and safety with that of the reference compound, bromocriptine. METHODS: A prospective study involved 21 French Centres and 120 women, with hyperprolactinaemic amenorrhoea, randomized to either cabergoline (CAB 0.5-1 mg twice weekly) or bromocriptine (BRC 2.5-5 mg twice daily). Treatment is given under double-blind conditions for the first 8 weeks, and subsequently in open conditions in further 16 weeks with dose adjustments according to response. Patients were assessed for biochemical and clinical efficacy and drug safety (adverse symptoms and biology). RESULTS: Normoprolactinaemia was achieved in 56/60 (93.3%) taking CAB and 27/58 (48.2%) taking BRC (p < 0.0001). Ovulatory cycles or pregnancy were recorded in 71.6% and 48.2% of patients (p = 0.001). Prolactin suppression to below 50% of the baseline value was observed in 1.6% and 15.5% (p = 0.007). Adverse symptoms were recorded in 31/60 (51.6%) and 40/58 (69.2%) patients respectively in the double-blind period, and 53.3% versus 65.5% for the full course of the study. There were significantly fewer gastro-intestinal symptoms in the CAB group, 36.6% versus 84.5% (p < 0.0001). CONCLUSION: Cabergoline is a new prolactin-lowering drug, more effective and better tolerated with fewer gastrointestinal symptoms than the reference compound, bromocriptine.

Adolescent↗
PubMed1995

Termination of unwanted pregnancy in dogs with the dopamine agonist, cabergoline, in combination with a synthetic analog of PGF2alpha, either cloprostenol or alphaprostol.

Associations of a dopamine agonist, cabergoline, and a synthetic analog of PGF2alpha, either alphaprostol or cloprostenol, were used to induce pregnancy termination in 15 mature Beagle bitches. Alphaprostol (20 microg/kg/d) was injected subcutaneously (sc) in combination with cabergoline (1.65 microg/kg/d, sc) daily for 5 d from Day 32 after the LH peak in 5 animals. Cloprostenol 2.5 microg/kg/d in one group (n = 5) and 1 microg/kg/d in another group (n = 5) was also used in combination with the same dosage of cabergoline, following the same protocol, but starting from Day 25 after the LH peak. Treatment efficacy, defined by the number of pregnancy terminations, was 100% in all treated groups. Dose-related side effects due to PGF2alpha were observed (excessive salivation, prostration, vomiting, diarrhoea, scratching at the injection site), and were less severe with cloprostenol than with alphaprostol. In the group treated with the lowest dosage of cloprostenol, no adverse reactions were noticed. In all treated groups, interestrus intervals compared with previous cycles and in control animals were reduced after treatment.

Journal Article↗
PubMed1998

Quantitative determination of cabergoline in human plasma using liquid chromatography combined with tandem mass spectrometry.

A liquid chromatography/mass spectrometry (LC/MS) method using electrospray ionization (ESI) is described for the quantitative determination of cabergoline (N-[3-(dimethylamino)propyl]-N-(ethylamino)-carbonyl-6-(2-propenyl)- ergoline-8 beta-carboxamide) in human plasma. The method consists of liquid-liquid extraction after addition of deuterated internal standard, and reverse-phase liquid chromatography with electrospray ionization combined with tandem mass spectrometry (MS/MS). Using selected reaction monitoring, the method provides a quantitation limit of 1.86 pg/mL. Calibration curves acquired on five different days showed good linearity (r > 0.99) in the range 1.86-124 pg/mL and reproducibility of the slope (% relative standard deviation, RSD = 10.0). The intra-day precision, determined by assaying plasma containing four different concentrations of cabergoline processed in replicate, was found to range from 2.4 to 17.0% (RSD). The inter-day precision, evaluated for the same concentrations, ranged from 7.9 to 10.7% (RSD). The accuracy of the method, expressed as the percent ratio between found to added amount, was 99.1 +/- 10.2% (RSD = 10.3%, n = 78).

Cabergoline↗
PubMed2003

High-sensitivity quantitation of cabergoline and pergolide using a triple-quadrupole mass spectrometer with enhanced mass-resolution capabilities.

Quantitative analysis of pharmaceuticals with low systemic plasma levels requires the utmost in sensitivity and selectivity from the analytical method used. A recently introduced triple-quadrupole mass spectrometer with unique enhanced mass-resolution capability was evaluated in the analysis of two such drugs, cabergoline and pergolide, in plasma. Liquid chromatographic/electrospray ionization selected reaction monitoring determination of cabergoline in plasma at unit mass-resolution demonstrated improved sensitivity (50 fg on-column), coupled with suitable accuracy and precision over a broad linear dynamic range covering five orders of magnitude (50 fg to 5 ng on-column). Liquid chromatographic/atmospheric pressure chemical ionization selective reaction monitoring determination of pergolide in plasma also attained a high level of sensitivity (500 fg on-column) at unit mass-resolution, with accuracy and precision values well within pharmaceutical industry standards. Again, a linear dynamic range covering five orders of magnitude (500 fg to 50 ng on-column) was achieved for the assay. Utility of the enhanced mass-resolution feature of the triple-quadrupole mass spectrometer in the determination of pergolide resulted in an improvement in analyte sensitivity (250 fg on-column) and linear dynamic range (250 fg to 50 ng on-column).

Animals↗
PubMedDate not supplied

Cabergoline modulation of alpha-subunits and FSH secretion in a gonadotroph adenoma.

Most non-functioning pituitary adenomas respond poorly to medical therapy. We describe the case of a 62-year-old man who presented with clinical features of an invasive macroadenoma. Baseline hormonal evaluation revealed increased FSH and alpha-subunit (alpha-SU) levels. Transsphenoidal exeresis followed by radiotherapy (RT) was performed. Almost all neoplastic cells were intensely immunoreactive for alpha-SU. On PCR analysis, specific amplification products were observed for somatostatin 2, 3 and 5 receptors as well as for both short and long isoforms of the dopamine D2 receptor. In vitro, alpha-SU and FSH were released into the medium by adenoma cells and increased after TRH stimulation. After surgery, alpha-SU and FSH levels were still elevated. Short-term slow-release lanreotide treatment did not modify either alpha-SU or FSH levels. Cabergoline was started and a fast and long-lasting decrease in alpha-SU and, to a lesser extent, in FSH was observed. The tumor remnant was unmodified on magnetic resonance imaging 3 years after surgery and RT. This case report shows that the in vitro expression of somatostatin receptors may not be directly associated to the in vivo response of alpha-SU and FSH to lanreotide, probably because of a functional uncoupling of the receptors. Cabergoline should be considered as an effective therapy for hormonal, and perhaps proliferative, control of gonadotroph adenoma remnants before the effects of RT are fully effective.

Adenoma↗
PubMed2000

Use of the dopamine agonists bromocriptine and cabergoline in the management of risperidone-induced hyperprolactinemia in patients with psychotic disorders.

Risperidone is a novel antipsychotic agent that blocks both dopaminergic and serotonergic receptors. In several reports, clinically significant hyperprolactinemia has been reported in patients on this agent. However, the optimal management of risperidone-induced hyperprolactinemia has not been clarified. We reviewed the records of 5 patients with psychotic disorders who were evaluated for risperidone-induced hyperprolactinemia. There were 4 females and 1 male patient, aged 30-45 yr. All patients had significant hyperprolactinemia, with prolactin (PRL) levels ranging from 65.5 to 209 microg/l. All but 1 of these patients had manifestations of hypogonadism. In these 4 patients, risperidone therapy was continued and the dopamine agonists bromocriptine or cabergoline were added. In 3 out of 4 patients, such additional therapy reduced the PRL level and alleviated hypogonadism. None of the patients treated with these agents had a worsening of psychosis. We conclude that risperidone can cause clinically significant hyperprolactinemia in patients treated with this drug. If risperidone therapy must be continued in such patients, addition of the dopamine agonists bromocriptine or cabergoline may successfully alleviate hyperprolactinemia and the associated manifestations without worsening psychotic symptoms.

Adult↗
PubMedDate not supplied

Pregnancy outcome after cabergoline treatment in early weeks of gestation.

We collected information on 61 pregnancies in 50 women treated with cabergoline. These pregnancies resulted in 12 (19.7%) early terminations (five induced abortions, six spontaneous abortions, one hydatidiform mole) and 49 (80.3%) live births. In one case, malformations were suspected by a gynecologist based on ultrasound at 12 gestational weeks and the pregnancy was terminated; additional information was not available. There was one case of trisomy 18. The frequency of spontaneous and induced abortions and major congenital malformations was comparable with rates in the general population. The data did not indicate any potential adverse effect of the drug on pregnancy. The data from this study in combination with previous reports can exclude a congenital malformation risk greater than 10% associated with pregnancy exposure to cabergoline.

Abnormalities, Drug-Induced↗
PubMed1999

Low dose cabergoline induced interstitial pneumonitis.

Certain dopaminergic anti-Parkinson drugs (ergolines) have repeatedly been identified as a cause of pleuropulmonary disease with a focus on serosal cell damage. Recently, a pathogenetic link between ergolines and prior asbestos exposure was suggested, as regards the development of pleural pathology. This report describes a patient with idiopathic Parkinson's disease, who was on a multiple drug regimen including low dose cabergoline. The patient developed a febrile illness with widespread bilateral lung infiltrations nonresponsive to beta-lactam and macrolide antibiotics. Bronchoalveolar lavage and transbronchial lung biopsy showed a "hypersensitivity-like" interstitial lung disease, which cleared almost completely within 2 months after simple drug withdrawal. Circumstantial evidence suggests a so far undescribed adverse lung reaction to cabergoline, devoid of the more usual pleural changes.

Aged↗
PubMed2006

Drug insight: Cabergoline and bromocriptine in the treatment of hyperprolactinemia in men and women.

Prolactinoma is the most frequent pituitary tumor histotype. Men generally have macroadenomas whereas women generally have microadenomas. The major objectives of treating prolactinomas are to suppress excessive hormone secretion and its clinical consequences, to remove the tumor mass while preserving the residual pituitary function, and possibly to prevent disease recurrence or progression. Primary therapy of prolactinomas is based on use of dopamine-receptor agonists. Bromocriptine induces normalization of prolactin levels in 80-90% of patients with microprolactinomas and approximately 70% of those with macroprolactinomas. Tumor-mass shrinkage and improvement of visual-field defects are found in the majority of treated macroprolactinomas, but bromocriptine often causes side effects. Cabergoline is very effective and well tolerated in more than 90% of patients with either microprolactinomas or macroprolactinomas. Cabergoline treatment also induces tumor shrinkage in the majority of patients with macroprolactinomas. Tumor shrinkage is more evident if patients have not previously been treated with other dopamine agonists. Fewer results are available for men than for women, but there is no evidence that men are less responsive to dopamine agonists than are women.

Adenoma↗
PubMed2000

The effect of quinagolide and cabergoline, two selective dopamine receptor type 2 agonists, in the treatment of prolactinomas.

OBJECTIVE: To compare effectiveness and tolerability of quinagolide (CV 205-502) and cabergoline (CAB) treatments in 39 patients with prolactinoma. STUDY DESIGN: All 39 patients were treated first with quinagolide for 12 months and then with cabergoline for 12 months. A wash-out period was performed in all patients after 12 months of both treatments in order to evaluate recurrence of hyperprolactinaemia. PATIENTS: Twenty-three patients with microprolactinoma (basal serum PRL levels 1620-18750 mU/l) and 16 patients with macroprolactinoma (basal serum PRL levels 4110-111000 mU/l), previously shown to be intolerant of bromocriptine. All patients had gonadal failure and 11 patients with macroprolactinoma had visual field defects. Five patients with macro- and one with microprolactinoma had previously undergone surgery. STUDY PROTOCOL: The starting doses of quinagolide and CAB were 0.075 mg/day and 0.5 mg/week, respectively, subsequently increased up to 0.6 mg once daily and 1.5 mg twice weekly, respectively. Serum PRL levels were measured monthly for the first 3 months and then quarterly for 12 months. PRL levels were assayed weekly for the first month and then monthly during the wash-out period. Tumour shrinkage was evaluated by serial magnetic resonance imaging (MRI) studies of the hypothalamus-pituitary region at study entry and after 6 and 12 months of both treatments in micro- and macroprolactinomas. RESULTS: After 12 months of quinagolide treatment, serum PRL levels normalized in all 23 patients with microprolactinoma (100%) and in 14 out of 16 with macroprolactinoma (87.5%). A tumour volume reduction of greater than 80% was documented by MRI studies in five of 23 (21.7%) patients with microprolactinoma and in four of 16 (25%) with macroprolactinoma. All patients had recurrence of hyperprolactinaemia after 15-60 days withdrawal of quinagolide treatment. However, before starting CAB treatment basal PRL levels were significantly lower than before quinagolide treatment both in microprolactinomas (4667.4 +/- 714.7 vs. 2636.1 +/- 262.3 mU/l, P = 0.006) and in macroprolactinomas (24853.1 +/- 7566.7 vs. 3576.6 +/- 413.0 mU/l, P = 0.013). After 12 months of CAB treatment, serum PRL levels normalized in 22 out of 23 patients with microprolactinoma (95.6%) and in 14 out of 16 with macroprolactinoma (87.5%). No difference in PRL nadir was found after quinagolide and CAB treatments both in micro 174.6 +/- 30.6 vs. 169.8 +/- 37.9 mU/l, P = 0.5) and in macroprolactinomas (277.5 +/- 68.4 vs. 341.8 +/- 95.2 mU/l, P = 0.6). A tumour volume reduction of greater than 80% was documented by MRI studies in seven other patients with microprolactinoma (30.4%) and in five other patients with macroprolactinoma (31.2%). After CAB treatment, further tumour shrinkage ranging 4-40% and 2-70% was observed in 12 micro- and seven macroprolactinomas, respectively. The percentage of tumour shrinkage after CAB was significantly higher than that observed after quinagolide in microprolactinomas (48.6 +/- 9.5 vs. 26.7 +/- 4. 5%, P = 0.046) but not in macroprolactinomas (47.0 +/- 10.6 vs. 26.8 +/- 8.4%, P = 0.2). The withdrawal from CAB treatment, induced an increase in serum PRL levels in all macroprolactinomas between 15 and 30 days, in 15 out of 23 microprolactinoma after 30 days, and in four patients after 2-4 months. In the remaining four patients serum PRL levels remained normal after 12 months of CAB withdrawal. Both compounds were tolerated satisfactorily by all patients. In the first week of quinagolide treatment, 12 patients reported nausea and postural hypotension, which spontaneously disappeared during the second-third week of treatment. None of the 39 patients reported side-effects during CAB treatment. CONCLUSIONS: Both quinagolide and CAB treatments, induced the normalization of serum PRL levels in the great majority of patients with prolactinoma. Tumour shrinkage was recorded in 22-25% of patients after quinagolide and in 30-31% after CAB treatment

Adult↗
PubMed2002

Control of fertility in the red fox (Vulpes vulpes): effect of a single oral dose of cabergoline in early pregnancy.

Single oral doses of 100 microg kg(-1) cabergoline (CAB) were previously found to affect the reproductive success of silver fox (Vulpes vulpes) vixens from Day 28 post insemination (PI) onwards by causing abortions and postnatal mortality. The present trial investigated the effect of a single oral dose of 100 microg kg(-1) CAB given to farmed silver fox vixens at 7, 14, 21 or 28 days PI. Six vixens were dosed with CAB at each day PI and abortions, total post-partum litter loss and the combined effects of both were compared with a group of vixens that received a placebo and a control group of vixens that received no treatment. No significant difference existed between the placebo and control groups in the incidence of abortion, postnatal litter loss and litter size at 3 weeks post partum. Overall, a significantly higher frequency of abortions were detected in vixens dosed with CAB (6/24) compared with the combined placebo and control (0/41) groups (P<0.01). Cabergoline administration was significantly associated with complete litter loss (P<0.01) and the combined effects of abortion and litter loss (P<0.001). Oral CAB significantly reduced the reproductive success of vixens when given at Day 21 and Day 28 PI, but not at Day 7 and Day 14 PI.

Abortion, Induced↗
PubMed2004

Resolution of macroprolactinoma-induced symptomatic hydrocephalus following cabergoline therapy.

A 71-year-old man was referred because of memory loss. Magnetic resonance imaging showed a pituitary macroadenoma associated with hydrocephalus. Marked hyperprolactinaemia was present. After 2 months of cabergoline therapy, magnetic resonance imaging showed tumour shrinkage with resolution of the hydrocephalus. We report, for the first time, the adequate and rapid clinical response of a macroprolactinoma-induced symptomatic hydrocephalus in an elderly man to a low and once-a-week dose of cabergoline therapy. Medical therapy with this dopamine agonist in this particular patient was so effective that ventriculo-peritoneal shunting could be avoided.

Adenoma↗
PubMed2004

Constrictive pericarditis and pleuropulmonary fibrosis secondary to cabergoline treatment for Parkinson's disease.

A 63 year old man with a six year history of Parkinson's disease presented with signs of right heart failure following a knee replacement. Constrictive pericarditis was diagnosed and a radical pericardectomy performed. Six months later, the patient remained unwell with raised inflammatory markers. An inflammatory fibrotic reaction caused by cabergoline was diagnosed. He improved after cessation of cabergoline.

Antiparkinson Agents↗
PubMed1997

Effects of cabergoline in a pituitary adenoma secreting follicle-stimulating hormone.

A patient with a pituitary adenoma secreting follicle-stimulating hormone with co-existent primary hyperaldosteronism is described. After his second transsphenoidal surgery, the patient developed a Staphylococcus aureus pituitary abscess. Symptoms improved after abscess drainage. Subsequent cabergoline therapy arrested the deterioration of symptoms. and decreased serum follicle-stimulating hormone concentrations. Cabergoline may be a useful treatment for aggressively growing non-prolactin-secreting pituitary adenomas.

Adenoma↗
PubMed1999

A study of the aetiology of pseudopregnancy in the bitch and the effect of cabergoline therapy.

Thirty-two permanently pseudopregnant bitches were treated with the anti-prolactin drug cabergoline. They had all been ovariohysterectomised up to five months after their last season, in some cases over two years previously, when most were reported as showing no signs of the condition. The clinical signs were mainly behavioural, the majority being aggressive, and a small number were lactating. The efficiency of the cabergoline therapy was classified by the owners as 'excellent' or 'good' in 50 per cent of the cases, and fair in 36 per cent. The rate of success was markedly better than in similar cases treated with reproductive steroids. In all but one of the bitches, the plasma prolactin concentrations were basal.

Aggression↗
PubMed2002

The novel use of very high doses of cabergoline and a combination of testosterone and an aromatase inhibitor in the treatment of a giant prolactinoma.

Most prolactinomas respond rapidly to low doses of dopamine agonists. Occasionally, stepwise increases in doses of these agents are needed to achieve gradual prolactin (PRL) reductions. Approximately 50% of treated men remain hypogonadal, yet testosterone replacement may stimulate hyperprolactinemia. A 34-yr-old male with a pituitary macroadenoma was found to have a PRL level of 10,362 micro g/liter and testosterone level of 3.5 nmol/liter. Eleven months of dopamine agonist therapy at standard doses lowered PRL levels to 299 micro g/liter. Subsequent stepwise increases in cabergoline (3 mg daily) further lowered PRL levels to 71 micro g/liter, but hypogonadism persisted. Initiation of testosterone replacement resulted in a rise and discontinuation in a fall of PRL levels. Aromatization of exogenous testosterone to estradiol and subsequent estrogen-stimulated PRL release was suspected. Concomitant use of cabergoline with the aromatase inhibitor anastrozole after resuming testosterone replacement resulted in the maintenance of testosterone levels and restoration of normal sexual function, without increasing PRL. Ultimately, further reduction in PRL on this therapy permitted endogenous testosterone production. Thus, novel pharmacological maneuvers may permit successful medical treatment of some patients with invasive macroprolactinomas.

Adult↗
PubMed1997

Metastatic prolactinoma: effect of octreotide, cabergoline, carboplatin and etoposide; immunocytochemical analysis of proto-oncogene expression.

A 49-yr-old woman presented with an extensive prolactinoma (serum PRL > 10,000 mU/L, normal range < 450 mU/L). Over a 5-yr period following transsphenoidal surgery and pituitary irradiation, she became increasingly resistant to high doses of bromocriptine and underwent transfrontal surgery followed by stereotactic radiotherapy. In spite of these treatments, serum prolactin estimations rose progressively to > 100,000 mU/L. Magnetic resonance imaging scanning demonstrated a massive cystic tumor invading the temporal lobes, extending into the cervical and thoracic spine, with metastases to cervical lymph nodes. High-dose cabergoline administration resulted in a 30% decrease in serum PRL. Octreotide was administered as a continuous sc infusion with a profound analgesic effect on facial pain but with no effect on tumor progression. She was treated with a course of chemotherapy consisting of carboplatin and etoposide without any noticeable effect. The patient died 6 months following chemotherapy. Immunocytochemical analysis demonstrated positive nuclear staining for WAF-1, Rb protein, c-myc, and p53 both in the original and metastatic tumors. The metastases but not the primary tumor stained for c-jun. Metastatic prolactinoma remains a therapeutic challenge. It is associated with a variable proto-oncogene expression, which may be coincidental or causal. Cabergoline had no advantage over bromocriptine. Octreotide relieved facial pain but did not alter tumor progression. An effective therapy for metastatic prolactinoma remains to be identified.

Antineoplastic Agents, Hormonal↗