title: Effects on office and home blood pressure of the lercanidipine-enalapril combination in patients with Stage 2 hypertension: a European randomized, controlled clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: aIRCSS, Istituto Auxologico Italiano and University Milano-Bicocca, Milan, Italy bHospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain cInstitute of Clinical Cardiology, Department of Systemic Hypertension, Moscow, Russia dCardiovascular Prevention Unit, Hôpital de la Pitié Salpétrière, Paris, France eHannover Medical School, Department of Nephrology and Hypertension, Hannover, Germany fDepartment of Internal Medicine, University Hospital of Treviso & University of Padova, Padova, Italy gDepartment of Biochemistry and Molecular Biology, Karol Marcinkowski University of Medical Sciences, Poznan, Poland hStrazhesko Institute of Cardiology, Kiev, Ukraine.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mancia
authors.forename: Antonio
authors.initials: A
authors.lastname: Coca
authors.forename: Irina
authors.initials: I
authors.lastname: Chazova
authors.forename: Xavier
authors.initials: X
authors.lastname: Girerd
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.forename: Paolo
authors.initials: P
authors.lastname: Pauletto
authors.forename: Danuta
authors.initials: D
authors.lastname: Pupek-Musialik
authors.forename: Yevgeniya
authors.initials: Y
authors.lastname: Svyshchenko
mesh_terms: D000328:Adult; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D004095:Dihydropyridines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004656:Enalapril / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D004338:Drug Combinations; D004656:Enalapril; C060343:lercanidipine