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Marleen BW.Indd Prolactinomas : clinical studies Kars, M. Citation Kars, M. (2008, September 10). Prolactinomas : clinical studies. Retrieved from https://hdl.handle.net/1887/13092 Version: Corrected Publisher’s Version Licence agreement concerning inclusion of doctoral thesis in the License: Institutional Repository of the University of Leiden Downloaded from: https://hdl.handle.net/1887/13092 Note: To cite this publication please use the final published version (if applicable). ?d]lpanÿ =KNPE?R=HRA?=H?EBE?=PEKJ=J@IEH@ PNE?QOLE@NACQNCEP=PEKJ(>QPJK?HEJE?=H DA=NP@EOA=OA=BPANĄUA=NOKB@KL=IEJA =CKJEOPPDAN=LUBKNLNKH=?PEJKI= I]nhaajG]noý(Re_pkne]@ahc]`kþ(A`q]n`N*Dkhi]jþ(Ne_d]n`=*Baah`anoÿ(Fkd]jjaoS*=*Oiepý( Fkd]jjao=*Nkiefjý(FankajF*>]tþ(=h^anpkI*Lanaen]ý ý@al]npiajpokbAj`k_nejkhkcu]j`Iap]^khe_@eoa]oao]j`kbþ?]n`ekhkcu(Hae`ajQjeranoepu Ia`e_]h?ajpan(Hae`aj(PdaJapdanh]j`o(ÿ@al]npiajpkbEjpanj]hIa`e_eja(Oa_pekjkb Aj`k_nejkhkcu(An]oiqoIa`e_]h?ajpan(Nkppan`]i(PdaJapdanh]j`o F?hejAj`k_nejkhIap]^(ejlnaoo ÿ HoofdstukMarleen BW.indd paginas.indd 43 3 11-Jun-0815-05-2008 15:16:23 09:14:25 PM ABSTRACT Objective. Treatment with ergot-derived dopamine agonists, pergolide and cabergoline, has been associated with an increased frequency of valvular heart disease in Parkinson’s disease. The aim of the present study was to assess the prevalence of valvular heart disease in patients treated with dopamine agonists for prolactinomas. Design. Cross-sectional study. Patients. We performed two-dimensional and Doppler echocardiography in 78 consecutive patients with prolactinoma (mean age 47 ± 1.4 yr, 26% male, 31% macroprolactinoma) treated with dopamine agonists for at least 1 year (mean 8 ± 0.6 yr) and 78 control subjects. Patients were classifi ed according to treatment: patients treated with cabergoline (group 1: n=47), and patients not treated with cabergoline (group 2: n=31). Results. Clinically relevant valvular heart disease was present in 12% (9 of 78) of patients vs. 17% (13 of 78) of controls (P=0.141), and in 17% (8 of 47) of patients treated with cabergoline vs. 3% (1 of 31) of patients not treated with cabergoline (P=0.062). Mild tricuspid regurgita- tion was present in 41% of patients vs. 26% of controls (P=0.042), and aortic valve calcifi cation was present in 40% of patients compared to 18% of controls (P=0.003). There was no relation between the cumulative dose of cabergoline and the presence of mild, moderate or severe valve regurgitation. Conclusion. Several years of dopamine agonist treatment in patients with prolactinomas is Chapter 3 Chapter associated with increased prevalence of aortic valve calcifi cation and mild tricuspid regurgita- 44 tion, but not with clinically relevant valvular heart disease. Therefore, additional studies on the adverse cardiac eff ects of dopaminergic drugs in prolactinoma are warranted, especially in patients with much longer use of these drugs. Marleen BW.indd 44 11-Jun-08 15:16:24 PM Dopamine agonists and valvular heart disease in prolactinoma 45 INTRODUCTION Long-term therapy with dopamine agonists is the treatment of choice for patients with prolactinomas, because of the high effi cacy of these drugs in controlling hyperprolactinemia and tumor size. However, dopamine agonist therapy has been associated with valvular heart disease in patients with Parkinson’s disease. Since 2002, several studies reported an association between treatment with pergolide, bromocriptine, or cabergoline and valvular heart disease (1-8). Recently, large population-based studies demonstrated an increased incidence and rela- tive risk of developing cardiac valve disease in patients treated with pergolide or cabergoline for Parkinson’s disease (9;10). The cardiac abnormalities in these patients are manifested by fi brotic changes that cause thickening, retraction, and stiff ening of valves. This may result in clinically signifi cant regurgita- tion requiring valve replacement. However, these data from patients with Parkinson’s disease can not be simply extrapolated to patients treated with dopamine agonists for prolactinomas, since gender and age of these patients, as well as duration and dosage of dopamine agonists, diff er considerably from those used in patients with prolactinomas. Furthermore, it can not be excluded that disease-specifi c aspects are also involved. Hence, it is presently unclear whether the treatment of prolactinomas with dopamine agonists is also associated with valvular heart disease. Therefore, the aim of the present study was to assess the prevalence of valvular abnor- malities in consecutive patients treated with dopamine agonists for prolactinomas. PATIENTS AND METHODS Patients and controls In a cross-sectional study design, we included 78 consecutive patients with prolactinomas treated with dopamine agonists for at least one year. Diagnostic criteria for prolactinoma were serum prolactin levels at least two times above the upper limit of normal, and evidence of a pituitary tumor on computerized tomography scan or magnetic resonance imaging. A macro- prolactinoma was defi ned by a diameter > 10 mm. Patients with macroprolactinemia, prolactin levels above the normal range secondary to primary hypothyroidism, or pituitary stalk com- pression, as well as subjects using drugs known to increase prolactin levels, were excluded. In addition, patients with concomitant growth hormone excess or -defi ciency, or Parkinson’s dis- ease were excluded. None of the patients had myocardial infarction in the preceding fi ve years, thyreotoxicosis, rheumatic fever, endocarditis, connective tissue disease, carcinoid syndrome, or used anorectic drugs. One female patient appeared to be pregnant (gestation duration of 14 weeks) at the moment of evaluation, and, as a consequence, was excluded. Patients were divided into two study groups, according to dopamine agonist treatment. Group 1 consisted of patients treated with cabergoline (n=47). Group 2 consisted of patients Marleen BW.indd 45 11-Jun-08 15:16:25 PM treated with bromocriptine, terguride, or quinagolide, or of patients who received other treatment modalities, such as surgery, without any dopamine agonists (n=31). All patients underwent a complete clinical and echocardiographic assessment. We evaluated 78 control subjects matched for age, gender, body surface, and left ventricular systolic function, recruited from an echocardiographic database, as previously described (11). Exclusion criteria for these control subjects were the same as for the patients with prolacti- noma. We controlled for left ventricular systolic function to avoid inclusion of patients with mitral regurgitation caused by left ventricular enlargement, with subsequent incomplete mitral leafl et closure. Those controls who were referred for echocardiographic evaluation of known valvular heart disease, murmur, congestive heart failure, or cardiac transplantation were also excluded. As a consequence, the control group comprised of subjects, who were referred for either atypical chest pain, palpitations or syncope without murmurs. The study was performed because of the publications on the association between treat- ment with dopamine agonists and valvular disease. The Medical Ethics Committee of Leiden University Medical Center judged that this study was therefore part of regular patient care. Anthropometric parameters Height, weight, waist circumference, and blood pressure were measured at the outpatient clinic. Waist circumference was measured at the height of the umbilicus, using the same measuring- tape for all subjects. Normal values are < 102 cm for men, and < 88 cm for women. Blood pres- Chapter 3 Chapter sure was measured automatically (Dinamap) six times during 20 minutes recording session. The 46 lowest systolic and diastolic blood pressures were noted. Hypertension was defi ned as systolic pressure > 140 mmHg, or diastolic pressure > 90 mmHg, or the use of antihypertensive medica- tion. All anthropometric parameters were measured by the same investigator. Prolactin assay and normal values Prolactin was measured using an electrochemiluminescence immunoassay (“ECLIA”) using Roche Elecsys 1010/2010 and Modular Analytics E170 (Elecsys module), the inter-assay varia- tion coeffi cient was 2.4-2.6%, the intra-assay variation coeffi cient was 1.8-1.9%. The detection limit was 0.047 μg/L (Roche, Basel, Switzerland). Normal values for basal PRL were < 15 μg/L in men, and < 23 μg/L in women. Echocardiography, data acquisition Echocardiography was performed with the subjects in the left lateral decubitus position using a commercially available system (Vingmed system Vivid-7; General Electric-Vingmed, Milwaukee, WI, USA). Standard 2-dimensional and color Doppler data, triggered to the QRS complex, were obtained using a 3.5 MHz transducer, at a depth of 16 cm in the parasternal (long- and short- axis) and apical (2- and 4-chamber, long-axis) views. The images were stored for off -line analysis (EchoPac 6.0.1, General Electric Vingmed Ultrasound, Milwaukee, WI, USA). Left ventricular (LV) Marleen BW.indd 46 11-Jun-08 15:16:25 PM Dopamine agonists and valvular heart disease in prolactinoma 47 dimensions were measured from M-mode images acquired from the parasternal long-axis view: inter-ventricular septum thickness (IVST), posterior wall thickness (PWT), LV end-diastolic diameter (LVEDD), LV end-systolic diameter (LVESD), fractional shortening (FS), and LV ejection fraction (LVEF). Left ventricular mass (LVM) was calculated by the cube formula, and using the correction formula proposed by Devereux et al.: 0.8 × (1.04{[LVEDD + PWT + IVST]³
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