Nifedipine (Nifedipine) - Summary

NIFEDIPINE SUMMARY

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers.

Vasospastic Angina

Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.

Chronic Stable Angina (Classical Effort-Associated Angina)

Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.

In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.

Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.)

Hypertension

Nifedipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.

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NEWS HIGHLIGHTS

Published Studies Related to Nifedipine

Two dose regimens of nifedipine for management of preterm labor: a randomized controlled trial. [2009.09]
We compared two dose regimens of tocolytic oral nifedipine. Women with singleton pregnancies admitted in preterm labor (24 to 34 weeks) were randomized to high-dose (HD) nifedipine ( N = 49; 20 mg loading dose, repeated in 30 minutes, daily 120 to 160 mg slow-release nifedipine for 48 hours followed by 80 to 120 mg daily until 36 weeks) or low-dose (LD) nifedipine ( N = 53; 10 mg, up to four doses every 15 minutes, daily 60 to 80 mg slow-release nifedipine for 48 hours followed by 60 mg daily until 36 weeks)...

A randomized placebo-controlled study on the effect of nifedipine on coronary endothelial function and plaque formation in patients with coronary artery disease: the ENCORE II study. [2009.07]
CONCLUSION: The ENCORE II trial demonstrates in a multi-centre setting that calcium channel blockade with nifedipine for up to 2 years improves coronary endothelial function on top of statin treatment, but did not show an effect of nifedipine on plaque volume.

Effects of enalapril or nifedipine on muscle strength or functional capacity in elderly subjects. A double blind trial. [2009.06]
INTRODUCTION: The inhibition of angiotensin-converting enzyme could be useful to avoid sarcopenia in the elderly... CONCLUSION: In this group of elderly subjects, enalapril was not superior to nifedipine with regard to the age-related decline of muscle performance.

The effects of the tocolytics atosiban and nifedipine on fetal movements, heart rate and blood flow. [2009.06]
CONCLUSION: This study demonstrates for the first time the direct effects of atosiban on fetal movement, heart rate and blood flow. Tocolysis with either atosiban or nifedipine combined with betamethasone administration appears to have no direct fetal adverse effects.

To compare the efficacy and safety of nifedipine sustained release with Ginkgo biloba extract to treat patients with primary Raynaud's phenomenon in South Korea; Korean Raynaud study (KOARA study). [2009.05]
This study examined the efficacy and safety of nifedipine sustained release (nifedipine SR) compared with Ginkgo biloba extract as treatment for primary Raynaud's phenomenon (RP) in Korea. Primary RP were screened and assigned to either the nifedipine SR group (Group N) or the Ginkgo biloba extract group (Group G) in the ratio of 2:1...

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Clinical Trials Related to Nifedipine

Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension [Completed]
This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.

Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis [Completed]

Losartan Therapy in Pulmonary Hypertension [Completed]
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels. Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.

Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery [Completed]
To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery and the following 24 hours or placebo (0. 9% saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in renal function.

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery [Not yet recruiting]
To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group.

The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.

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