抽象的

Antihypertensive effectiveness of lercanidipine administered using an electronic pillbox compared with usual care in a cohort of mild to-moderately hypertensive patients:the ELECTRA study

Vivencio Barrios, Carlos Escobar, Angel Navarro, Alberto Calderon and Luis M Ruilope

Objective: It has been suggested that poor blood pressure (BP) control in the community is related to poor treatment tolerability and compliance. In the ELECTRA study we assessed whether the use of an electronic pillbox device (medical event monitoring system [MEMS]) could improve antihypertensive effectiveness of lercanidipine in a large group of hypertensive patients treated for 12 weeks.

Methods: A total of 1523 outpatients with mild-to-moderate essential hypertension participated in this multicenter, randomized, open-label study. All patients received lercanidipine 10 mg once daily for 12 weeks. They were randomly allocated in a 1:2 design to use MEMS (n = 485) or usual care (actively monitored pill counts; n = 1038). If BP control was not achieved, additional therapy was allowed. Compliance was considered to be good if over 80% of tablets were taken by the patient.

Results: Good compliance was observed in 92% of the MEMS group versus 91% of the usual-care group (p = not significant). At the study end, no differences were observed in BP reductions between the two arms. Systolic BP was reduced 21.6 ± 14.8 mmHg in the MEMS group versus 22.2 ± 13 mmHg in the usual-care group, and diastolic BP 12.8 ± 9.2 versus 13.8 ± 7.8 mmHg, respectively (p = not significant). Pulse pressure was also similarly reduced in both groups (8.8 ± 4.1 vs 8.4 ± 3.9 mmHg; p = not significant). At the study end, 24.2% of patients required add-on therapy to achieve BP goal (24% in the MEMS vs 24.3% in the usual-care group; p = not significant). A low incidence of adverse events (5.4%) was detected, edema being the most frequently reported (2.7%). As expected, in patients with poorer compliance, the antihypertensive effectiveness was worse.

Conclusion: Lercanidipine produced effective and similar BP-lowering effects in the MEMS and usual-care groups over a 12-week period. Treatment compliance was high (>90%) with both regimens, which is most likely related to the good tolerability profile of lercanidipine, and also to active monitoring of compliance by physicians in the usual-care group. Further studies are warranted to confirm these data during longer follow-up.