Safety of long-term treatment with cabergoline on cardiac valve disease in patients with prolactinomas

Eur J Endocrinol. 2013 Aug 28;169(3):359-66. doi: 10.1530/EJE-13-0231. Print 2013 Sep.

Abstract

Objective: Cabergoline (CAB) has been found to be associated with increased risk of cardiac valve regurgitation in Parkinson's disease, whereas several retrospective analyses failed to detect a similar relation in hyperprolactinemic patients. The current study aimed at investigating cardiac valve disease before and after 24 and 60 months of continuous treatment with CAB only in patients with hyperprolactinemia.

Subjects and methods: Forty patients (11 men and 29 women, aged 38.7 ± 12.5 years) newly diagnosed with hyperprolactinemia entered the study. Cumulative CAB dose ranged from 12 to 588 mg (median 48 mg) at 24 months and 48-1260 mg (median 149 mg) at 60 months. All patients underwent a complete trans-thoracic echocardiographic examination. Valve regurgitation was assessed according to the American Society of Echocardiography.

Results: At baseline, the prevalence of trace mitral, aortic, pulmonic, and tricuspid regurgitations was 20, 2.5, 10, and 40% respectively, with no patient showing clinically relevant valvulopathy. After 24 months, no change in the prevalence of trace mitral (P=0.78) and pulmonic (P=0.89) regurgitations and of mild aortic (P=0.89) and tricuspid (P=0.89) regurgitations was found when compared with baseline. After 60 months, the prevalence of trace tricuspid regurgitation was only slightly increased when compared with that after 24 months (37.5%; P=0.82), but none of the patients developed significant valvulopathy. No correlation was found between cumulative dose and prevalence or grade of valve regurgitation at both evaluations. Prolactin levels normalized in all patients but one.

Conclusion: CAB does not increase the risk of significant cardiac valve regurgitation in prolactinomas after the first 5 years of treatment.

Trial registration: ClinicalTrials.gov NCT00460616.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Cabergoline
  • Cohort Studies
  • Dopamine Agonists / administration & dosage
  • Dopamine Agonists / adverse effects*
  • Dopamine Agonists / therapeutic use
  • Drug Monitoring
  • Early Diagnosis
  • Ergolines / administration & dosage
  • Ergolines / adverse effects*
  • Ergolines / therapeutic use
  • Female
  • Follow-Up Studies
  • Heart Valve Diseases / chemically induced*
  • Heart Valve Diseases / diagnostic imaging
  • Heart Valve Diseases / epidemiology
  • Heart Valve Diseases / physiopathology
  • Heart Valves / diagnostic imaging
  • Heart Valves / drug effects*
  • Humans
  • Italy / epidemiology
  • Male
  • Middle Aged
  • Pituitary Neoplasms / drug therapy*
  • Prevalence
  • Prolactinoma / drug therapy*
  • Severity of Illness Index
  • Time Factors
  • Ultrasonography

Substances

  • Antineoplastic Agents
  • Dopamine Agonists
  • Ergolines
  • Cabergoline

Associated data

  • ClinicalTrials.gov/NCT00460616