Nicardipine Hydrochloride (Page 2 of 6)

Electrophysiologic Effects

In general, no detrimental effects on the cardiac conduction system were seen with the use of nicardipine hydrochloride capsules.

Nicardipine hydrochloride increased the heart rate when given intravenously during acute electrophysiologic studies and prolonged the corrected QT interval to a minor degree. The sinus node recovery times and SA conduction times were not affected by the drug. The PA, AH, and HV intervals 1 and the functional and effective refractory periods of the atrium were not prolonged by nicardipine hydrochloride capsules and the relative and effective refractory periods of the His-Purkinje system were slightly shortened after intravenous nicardipine hydrochloride.

1 PA = conduction time from high to low right atrium, AH = conduction time from low right atrium to His bundle deflection or AV nodal conduction time, HV = conduction time through the His bundle and the bundle branch-Purkinje system.

Renal Function

There is a transient increase in electrolyte excretion, including sodium. Nicardipine hydrochloride capsules do not cause generalized fluid retention, as measured by weight changes, although 7% to 8% of the patients experience pedal edema.

Effects in Angina Pectoris

In controlled clinical trials of up to 12 weeks’ duration in patients with chronic stable angina, nicardipine hydrochloride capsules increased exercise tolerance and reduced nitroglycerin consumption and the frequency of anginal attacks. The antianginal efficacy of nicardipine hydrochloride capsules (20 to 40 mg) have been demonstrated in four placebo-controlled studies involving 258 patients with chronic stable angina. In exercise tolerance testing, nicardipine hydrochloride capsules significantly increased time to angina, total exercise duration and time to 1 mm ST segment depression. Included among these four studies was a dose-definition study in which dose-related improvements in exercise tolerance at 1 and 4 hours postdosing and reduced frequency of anginal attacks were seen at doses of 10, 20 and 30 mg tid. Effectiveness at 10 mg tid was, however, marginal. In a fifth placebo-controlled study, the antianginal efficacy of nicardipine hydrochloride capsules were demonstrated at 8 hours postdose (trough). The sustained efficacy of nicardipine hydrochloride capsules have been demonstrated over long-term dosing. Blood pressure fell in patients with angina by about 10/8 mm Hg at peak blood levels and was little different from placebo at trough blood levels.

Effects in Hypertension

Nicardipine hydrochloride capsules produced dose-related decreases in both systolic and diastolic blood pressure in clinical trials. The antihypertensive efficacy of nicardipine hydrochloride capsules administered three times daily has been demonstrated in three placebo-controlled studies involving 517 patients with mild to moderate hypertension. The blood pressure responses in the three studies were statistically significant from placebo at peak (1 hour postdosing) and trough (8 hours postdosing) although it is apparent that well over half of the antihypertensive effect is lost by the end of the dosing interval. The results from placebo controlled studies of nicardipine hydrochloride capsules given three times daily are shown in the following table:

Table 1

SYSTOLIC BP (mm Hg)

DIASTOLIC BP (mm Hg)

Dose

Number of Patients

Mean

Peak Response

Mean

Trough Response

Trough/

Peak

Dose

Number

of

Patients

Mean

Peak Response

Mean Trough Response

Trough/ Peak

20 mg

50

-10.3

-4.9

48%

20 mg

50

-10.6

-4.6

43%

52

-17.6

-7.9

45%

52

-9.0

-2.9

32%

30 mg

45

-14.5

-7.2

50%

30 mg

45

-12.8

-4.9

38%

44

-14.6

-7.5

51%

44

-14.2

-4.3

30%

40 mg

50

-16.3

-9.5

58%

40 mg

50

-15.4

-5.9

38%

38

-15.9

-6.0

38%

38

-14.8

-3.7

25%

The responses are shown as differences from the concurrent placebo control group. The large changes between peak and trough effects were not accompanied by observed side effects at peak response times. In a study using 24-hour intra-arterial blood pressure monitoring, the circadian variation in blood pressure remained unaltered, but the systolic and diastolic blood pressures were reduced throughout the whole 24 hours.

When added to beta-blocker therapy, nicardipine hydrochloride capsules further lower both systolic and diastolic blood pressure.

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