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.
Nakou
E
E
University of Ioannina, Department of Internal Medicine, School of Medicine, 45 110 Ioannina, Greece. egepi@cc.uoi.gr
Filippatos
T D
TD
Liberopoulos
E N
EN
Tselepis
A D
AD
Kiortsis
D N
DN
Mikhailidis
D P
DP
Elisaf
M S
MS
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