Long-term dual blockade with candesartan and lisinopril in hypertensive patients with diabetes: the CALM II study.
OBJECTIVE
To assess and compare the long-term effects of the combination of candesartan and lisinopril with high-dose lisinopril on systolic blood pressure in patients with hypertension and diabetes.


METHODS
This was a prospective, randomized, parallel-group, double-blind, double-dummy study with a 12-month follow-up. Drug therapy was either lisinopril 40 mg once daily or dual-blockade treatment with candesartan 16 mg once daily and lisinopril 20 mg once daily. The study comprised 75 type 1 and type 2 diabetic patients aged 35-74 years. The main outcome measures were seated and 24-h ambulatory systolic blood pressure.


RESULTS
Reduction in systolic blood pressure (24-h systolic blood pressure) reduction was obtained in both treatment arms (mean reduction at final follow-up: dual blockade 6 mmHg vs. lisinopril 2 mmHg), but no significant difference was found between dual-blockade and lisinopril 40 mg once daily (P = 0.10). Both treatments were generally well tolerated, and similar low rates of side effects were found in the two groups.


CONCLUSIONS
There was no statistically significant difference between lisinopril 40 mg once daily and lisinopril 20 mg in combination with candesartan 16 mg once daily in reducing systolic blood pressure in hypertensive patients with diabetes.
Andersen
Niels H
NH
Department of Internal Medicine, Diabetes & Endocrinology, Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark. holmark@ki.au.dk
Poulsen
Per L
PL
Knudsen
Søren T
ST
Poulsen
Steen H
SH
Eiskjaer
Hans
H
Hansen
Klavs W
KW
Helleberg
Kjeld
K
Mogensen
Carl E
CE
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D001713:Biphenyl Compounds; D001794:Blood Pressure / Q000187:drug effects; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D017706:Lisinopril / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects
D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; D017706:Lisinopril; C081643:candesartan