The safety and efficacy of efonidipine, an L- and T-Type dual calcium channel blocker, on heart rate and blood pressure in indian patients with mild-to-moderate essential hypertension

Type of funding sources: None.

Efonidipine hydrochloride, an L- and T-type dual calcium channel blocker, have a heart rate (HR)-slowing action in addition to a blood pressure (BP)-lowering effect. Many younger Indian hypertensive patients has sinus tachycardia. Beta blockers are not first line of antihypertensive agents. The aim of this study was to determine the effect of efonidipine on HR and BP in Indian patients with mild-to-moderate hypertension.

In a single center, prospective, open-labeled, single-armed study, we enrolled 335 patients who had mild-to-moderate hypertension [Systolic blood pressure ≥ 140 mm Hg and ≤ 160 mm Hg; Diastolic blood pressure ≥ 90 and ≤ 110 mm Hg]. After a 2-week washout, eligible patients were treated with efonidipine (40 mg once daily for 12 weeks). The primary end point was the change in HR from baseline to week 12. The secondary endpoint included the change in trough sitting office BP between baseline and week 12. Laboratory and clinical adverse events were monitored at each study visit (4, 8, and 12 weeks). A dedicated nurse using mercury sphygmomanometer recorded blood pressure thrice spacing 15 minutes apart. The initial two readings were discarded, and third reading was accepted as final reading of actual blood pressure.

335 patients were included in the intention-to-treat analysis. After 12 weeks of treatment with efonidipine, the resting HR decreased significantly from baseline to week 12 {from 96.5 ± 15.3 to 71.8 ± 9.9 beats/minute, p < 0.0001}. The trough BP {sitting systolic blood pressure (SiSBP) and SiDBP} also decreased significantly (SiSBP: from 158.6 ± 10.2 to 122.9± 5.5 mmHg, p < 0.0001; SiDBP: from 99.6 ± 8.4 to 87.3 ± 7.6 mmHg, p < 0.0001) The incidence of pedal oedema was seen in 0.5% of patients. The symptomatic hypotension was not seen any patients. The adherance to the therapy was 98.9%. 18% patients required second antihypertensive medication to achieve the BP target of ≤ 130/80 mm Hg.

Efonidipine was effective in controlling both HR and BP in patients with mild-to-moderate hypertension in Indian patients. Its safe drug as a mono therapy with good adherence and minimal side effects.