Effectiveness and Tolerability of Fixed-Dose Combination Enalapril plus Nitrendipine in Hypertensive Patients Results of the 3-Month Observational, Post-Marketing, Multicentre, Prospective CENIT Study Alejandro de la Sierra, 1 Alejandro Roca-Cusachs, 2 Josep Redo ´n, 3 Rafael Marı ´n, 4 Manuel Luque, 5 Mariano de la Figuera, 6 Margarida Garcia-Garcia 7 and Liliana Falkon, 8 on behalf of the CENIT Study Working Group 1 Hypertension Unit, Hospital Clinic Barcelona, Barcelona, Spain 2 Hypertension Unit, Hospital De la Santa Creu i Sant Pau, Barcelona, Spain 3 Internal Medicine Department, Hospital Clı ´nico Valencia, University of Valencia, Valencia, Spain 4 Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain 5 Hypertension Unit, Hospital Clı ´nico San Carlos, Madrid, Spain 6 La Mina Primary Health Care Centre, Barcelona, Spain 7 Operations Department, Biometria Clinica CRO, Barcelona, Spain 8 Medical Department, Ferrer Internacional, Barcelona, Spain Abstract Background and objective: Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg adminis- tered as a single daily dose in hypertensive patients. Methods: This was a post-authorization, multicentre, prospective, observa- tional study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (‡140/90 mmHg for pa- tients without diabetes mellitus, or ‡130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: ‘controlled’ meant controlled BP (<140/90 mmHg for nondiabetic patients, or <130/85 mmHg for diabetic patients); ‘response’ meant controlled BP, or a decrease in SBP of ‡20 mmHg and in DBP of ‡10 mmHg. The main laboratory test parameters ORIGINAL RESEARCH ARTICLE Clin Drug Invest 2009; 29 (7): 459-469 1173-2563/09/0007-0459/$49.95/0 ª 2009 Adis Data Information BV. All rights reserved.