title: Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database.
abstract: OBJECTIVE
  To compare a combination of a dihydropyridine calcium-channel blocker with an angiotensin converting enzyme inhibitor vs. monotherapy with one or the other drug and placebo for their effects on home blood pressure (HBP).
  
  
  METHODS
  After a 2-week placebo wash-out, patients with an elevated office blood pressure (BP) (diastolic 100-109 and systolic <180 mmHg) and HBP (diastolic ≥85 mmHg) were randomized double-blind to a 10-week treatment with placebo, lercanidipine, 10 or 20 mg daily, enalapril, 10 or 20 mg daily, or the four possible combinations. In addition to office BP, HBP was self-measured via a validated semiautomatic device twice in the morning and twice in the evening during the 7 days before randomization and at the end of treatment. Baseline and treatment HBP values were separately averaged for each day, morning, evening or the whole monitoring period, excluding the first day. Day-by-day HBP variability was defined as the SD or the variation coefficient of the daily BP averages.
  
  
  RESULTS
  Eight hundred and fifty-four patients with valid HBP recordings at baseline and at the end of treatment were analyzed (intention-to-treat population). From the baseline value (147.0±11.6 mmHg) systolic/diastolic HBP showed a small reduction (average baseline-adjusted change: -1.8/-1.6 mmHg) with placebo, a more marked significant fall with monotherapies (-8.8/-5.9 mmHg, P < 0.001/<0.001 vs. placebo) and even more with combination treatment (11.6/-7.6 mmHg, P < 0.001/ < 0.001 vs. placebo and P < 0.01/ < 0.05 vs. monotherapy). A similar pattern was observed for each of the days of the BP self-monitoring period as well as for either morning or evening values, although the difference between mono and combination treatment appeared to be consistently significant for the morning values only. Day-by-day systolic BP-SD was unaffected by placebo and slightly reduced by drug treatments, with no, however, significant changes in SBP-variation coefficient. Baseline and end of treatment HBP values showed a limited correlation with office BP values, this being particularly the case for treatment-induced changes (correlation coefficients: 0.37 for systolic and 0.45 for diastolic BP).
  
  
  CONCLUSIONS
  This large HBP database shows that the lercanidipine-enalapril combination lowers HBP more effectively than the corresponding monotherapies and placebo, and that this greater effect is consistent between days.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01093807.
authors.affiliation: aUniversity of Milano-Bicocca and IRCCS, Istituto Auxologico Italiano, Milano bClinical Research Unit, Italian Institute of Telemedicine, Varese, Italy cDepartment of Systemic Hypertension, Institute of Clinical Cardiology, Moscow, Russia dHospital Clínic (IDIBAPS), University of Barcelona, Barcelona, Spain eCardiovascular Prevention Unit, Hôpital de la Pitié-Salpêtrière and Assistance Publique-Hôpitaux de Paris, Paris, France fDepartment of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany gDepartment of Cardiology, IRCCS Ospedale San Luca, Istituto Auxologico Italiano and Department of Health Sciences, University of Milano Bicocca, Milano hDepartment of Internal Medicine, University Hospital of Treviso and University of Padova, Padova, Italy iDepartment of Biochemistry and Molecular Biology, Karol Marcinkowski University of Medical Sciences, Poznan, Poland.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mancia
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Irina
authors.initials: I
authors.lastname: Chazova
authors.forename: Antonio
authors.initials: A
authors.lastname: Coca
authors.forename: Xavier
authors.initials: X
authors.lastname: Girerd
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Parati
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 / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D001795:Blood Pressure Determination; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D016208:Databases, Factual; D004095:Dihydropyridines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004656:Enalapril / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009819:Office Visits; D012648:Self Care
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D004656:Enalapril; C060343:lercanidipine