TY - JOUR
T1 - Effects on office and home blood pressure of the lercanidipine-enalapril combination in patients with Stage 2 hypertension
T2 - A European randomized, controlled clinical trial
AU - Mancia, Giuseppe
AU - Coca, Antonio
AU - Chazova, Irina
AU - Girerd, Xavier
AU - Haller, Hermann
AU - Pauletto, Paolo
AU - Pupek-Musialik, Danuta
AU - Svyshchenko, Yevgeniya
PY - 2014
Y1 - 2014
N2 - OBJECTIVES:: The aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine (L) and enalapril (E) at different doses on office and home blood pressure (BP) in patients with Stage 2 hypertension. STUDY DESIGN:: This was a randomized, double-blind, placebo-controlled, factorial study conducted in 100 centres from seven countries. Patients with office DBP 100-109 mmHg and home DBP at least 85 mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo, L (10 or 20 mg), E (10 or 20 mg) or the four L-E combinations. The efficacy parameters were office DBP at trough (primary), SBP at trough and home SBP and DBP. Office BP was measured at each visit in both the sitting and the standing position, while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end. Safety parameters included adverse events, laboratory tests and 12-lead ECG. RESULTS:: A total of 1039 patients were randomized (48% men, mean age 54 years, mean BMI 30 kg/m, 40% obese patients). Baseline BP was similar in all groups and lower for home than for office values (149/95 and 159/103 mmHg, respectively). A marked placebo effect was observed on office but not on home BP. Combination therapy was superior to placebo at all doses for both office and home BP. The greatest effect was observed in the L20/E20 group, in which the SBP/DBP fall amounted to -19.2/-15.2 and -13.2/-7.5 mmHg for sitting office and home BP, respectively. Similar reductions were observed on standing office BP. The L20/E20 combination was associated with less cough, palpitations and leg oedema than monotherapies, with no increased rate of dizziness or hypotension. CONCLUSION:: In Stage 2 hypertension, a fixed-dose combination of L and E ensures a control of both office and out-of-office BP, with a favourable tolerability profile.
AB - OBJECTIVES:: The aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine (L) and enalapril (E) at different doses on office and home blood pressure (BP) in patients with Stage 2 hypertension. STUDY DESIGN:: This was a randomized, double-blind, placebo-controlled, factorial study conducted in 100 centres from seven countries. Patients with office DBP 100-109 mmHg and home DBP at least 85 mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo, L (10 or 20 mg), E (10 or 20 mg) or the four L-E combinations. The efficacy parameters were office DBP at trough (primary), SBP at trough and home SBP and DBP. Office BP was measured at each visit in both the sitting and the standing position, while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end. Safety parameters included adverse events, laboratory tests and 12-lead ECG. RESULTS:: A total of 1039 patients were randomized (48% men, mean age 54 years, mean BMI 30 kg/m, 40% obese patients). Baseline BP was similar in all groups and lower for home than for office values (149/95 and 159/103 mmHg, respectively). A marked placebo effect was observed on office but not on home BP. Combination therapy was superior to placebo at all doses for both office and home BP. The greatest effect was observed in the L20/E20 group, in which the SBP/DBP fall amounted to -19.2/-15.2 and -13.2/-7.5 mmHg for sitting office and home BP, respectively. Similar reductions were observed on standing office BP. The L20/E20 combination was associated with less cough, palpitations and leg oedema than monotherapies, with no increased rate of dizziness or hypotension. CONCLUSION:: In Stage 2 hypertension, a fixed-dose combination of L and E ensures a control of both office and out-of-office BP, with a favourable tolerability profile.
KW - combination therapy
KW - enalapril
KW - essential hypertension (Stage 2)
KW - factorial study design
KW - home blood pressure
KW - lercanidipine
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U2 - 10.1097/HJH.0000000000000239
DO - 10.1097/HJH.0000000000000239
M3 - Article
C2 - 24906174
AN - SCOPUS:84904036094
VL - 32
SP - 1700
EP - 1707
JO - Journal of Hypertension
JF - Journal of Hypertension
SN - 0263-6352
IS - 8
ER -