title: Antihypertensive efficacy and tolerability of lercanidipine in daily clinical practice. The ELYPSE Study. Eficacia de Lercanidipino y su Perfil de Seguridad.
abstract: OBJECTIVE
  Lercanidipine, a long-acting dihydropyridine with a good antihypertensive efficacy and tolerability in clinical use. With the aim to determine the efficacy and tolerability of this drug in usual clinical practice we performed the ELYPSE trial.
  
  
  METHODS
  Grade 1 or 2 essential hypertensive patients in whom their physicians considered to prescribe a dihydropyridine were conferred to Lercanidipine 10 mg once daily with a 3-month follow-up; 9059 patients were included (age: 63 +/- 11 years; 58% women, 60% over 60 years, 56% grade 2 hypertensives and 69% previously treated with other antihypertensive drugs). A subgroup of 1267 patients (14%) who were included in the study had experienced adverse reactions with other drugs. Electronic case-report forms and a central database (Internet) were used in this trial.
  
  
  RESULTS
  At baseline, blood pressure (BP) was 160.1 +/- 10.2/95.6 +/- 6.6 mmHg; and heart rate (HR) 77.3 +/- 9.3 beats/min. Significant reductions in both systolic and diastolic BP were attained at 1 month with slight additional decreases 2 months later. At 3 months, BP was 141.4 +/- 11.3/ 83.1 +/- 6.9 mmHg, and HR 75.2 +/- 8.2 beats/min (p < 0.001 versus baseline). At the study end. 64% of the patients achieved a diastolic BP < 90 mmHg, BP control (< 140/90 mmHg) was attained in 32%. In the subgroup of diabetics (n = 1269) an adequate BP control (< 130/85) was attained in only 16.4%. The overall incidence of adverse events was 6.5%, of which the most frequent were headache (2.9%), ankle oedema (1.2%), flushing (1.1%) and palpitations (0.6%). Withdrawal rate was < 1%. The efficacy and tolerability in the subgroup of patients included in the study due to adverse events with other drugs were similar to the whole study group.
  
  
  CONCLUSIONS
  In this study Lercanidipine has shown a good efficacy and tolerability in daily clinical practice. These findings are concordant with those reported in randomized controlled trials.
authors.affiliation: Servicio de Cardiología, Hospital Ramón y Cajal, Madrid, Spain. vbarriosa@meditex.es
authors.forename: Vivencio
authors.initials: V
authors.lastname: Barrios
authors.forename: Angel
authors.initials: A
authors.lastname: Navarro
authors.forename: Antonio
authors.initials: A
authors.lastname: Esteras
authors.forename: Manuel
authors.initials: M
authors.lastname: Luque
authors.forename: Joaquima
authors.initials: J
authors.lastname: Romero
authors.forename: Juan
authors.initials: J
authors.lastname: Tamargo
authors.forename: Luis
authors.initials: L
authors.lastname: Prieto
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Carrasco
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Herranz
authors.forename: Josefa
authors.initials: J
authors.lastname: Navarro-Cid
authors.forename: Luis M
authors.initials: LM
authors.lastname: Ruilope
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004095:Dihydropyridines / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010352:Patient Dropouts; D011446:Prospective Studies
chemical_list: D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; C060343:lercanidipine