Effects of sibutramine plus verapamil sustained release/trandolapril combination on blood pressure and metabolic variables in obese hypertensive patients.
OBJECTIVE
The management of obese hypertensive subjects may require the administration of anti-obesity and antihypertensive drugs. Sibutramine use has raised concerns regarding a potential increase in subjects' blood pressure and heart rate. The primary end-points of this study were an evaluation of the effect of sibutramine together with a verapamil sustained release/trandolapril combination tablet versus verapamil sustained release/trandolapril alone on the blood pressure and heart rate in obese hypertensive patients.


METHODS
Patients received a low-fat low-calorie diet and were randomly allocated to open-label verapamil sustained release/trandolapril 180/2 mg (n = 26) or sibutramine 10 mg together with verapamil sustained release/trandolapril 180/2 mg (n = 28) daily for 6 months.


RESULTS
Significant reductions in the subjects' systolic blood pressure and diastolic blood pressure were observed in both groups (p < 0.01 versus baseline). At 6 months a greater fall in blood pressure was observed in the sibutramine/verapamil sustained release/trandolapril group compared with the verapamil sustained release/trandolapril group (systolic blood pressure 21.9 +/- 8.1 versus 15.9 +/- 12.3 mmHg and diastolic blood pressure 15.7 +/- 8.1 versus 9.1 +/- 9.9 mmHg) but this was only significant (p = 0.03) for diastolic blood pressure. The subjects' heart rate did not change significantly in any group. No significant sibutramine-associated attenuation of blood pressure reduction was observed during the study. The sibutramine/verapamil sustained release/trandolapril treatment resulted in significantly greater improvement in the subjects' anthropometric variables, homeostasis model assessment and lipid profiles compared with verapamil sustained release/trandolapril administration. The subjects' small dense low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and visfatin plasma levels were only measured in the sibutramine/verapamil sustained release/trandolapril group (all decreased by p < 0.05 versus baseline).


CONCLUSIONS
The sibutramine/verapamil sustained release/trandolapril combination in obese hypertensive patients significantly reduced their blood pressure and improved their anthropometric and metabolic variables without affecting the heart rate.
University of Ioannina, Department of Internal Medicine, School of Medicine, 45 110 Ioannina, Greece. egepi@cc.uoi.gr
E
E
Nakou
T D
TD
Filippatos
E N
EN
Liberopoulos
A D
AD
Tselepis
D N
DN
Kiortsis
D P
DP
Mikhailidis
M S
MS
Elisaf
D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001067:Appetite Depressants / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001837:Body Weights and Measures; D002097:C-Reactive Protein / Q000032:analysis; D003503:Cyclobutanes / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004032:Diet; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D054409:Nicotinamide Phosphoribosyltransferase / Q000187:drug effects; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D014700:Verapamil / Q000008:administration & dosage / Q000627:therapeutic use*
D000959:Antihypertensive Agents; D001067:Appetite Depressants; D003503:Cyclobutanes; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D007211:Indoles; D008055:Lipids; C052035:trandolapril; D002097:C-Reactive Protein; D014700:Verapamil; D054409:Nicotinamide Phosphoribosyltransferase; C058254:sibutramine