NEWS HIGHLIGHTS
Published Studies Related to Afeditab (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...
Clinical Trials Related to Afeditab (Nifedipine)
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.
A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension [Not yet recruiting]
Objective:
- To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients
with hypertension.
- To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in
patients with hypertension.
- To study flow-mediated dilatation and oxidative stress in nonsmoker with essential
hypertension but without diabetes mellitus or dyslipidemia.
Study Design:
- Head-to-head, randomized and parallel design.
- A total of 60 patients with a clinically confirmed diagnosis of hypertension will
provide 30 available patients in each treatment group.
- The drugs and dosage will be as follows:
Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once
daily (Adalat OROS, Bayer)
Method:
After washout period, the eligible patients will randomly be allocated to receive two brands
of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood
pressure measurement (ABPM) at both entrance and final stages of the study. The patients
will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of
nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than
140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4
weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood
pressure measurement will be set to take reading at 1-hour intervals during the 24 hours
assessment.
Physical examination included the measurement of heart rate and blood pressure. The value
will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory
test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood
chemistry test will be measured immediately before the start of treatment and after 8 weeks’
treatment or at time of discontinuation. Thiobarbituric acid–reactive substances (TBARS) in
patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated
vasodilation will also be evaluated. Possible concomitant medication will remain constant
throughout the study. The physician will question the patients as to their compliance at
each visit. If compliance dose not reach 80%, the subject will be dropped out.
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.
Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis [Completed]
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis [Recruiting]
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor.
This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral
indomethacin for preterm labor tocolysis in an effort to identify which drug is most
effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy
to receive oral nifedipine or oral indomethacin. Both the patient and primary medical
provider will be blinded to the identity of the study drug. An abdominal ultrasound will be
performed in the labor and delivery unit prior to the administration of the tocolytic in
order to assess fetal position and fluid level, and to document fetal cardiac activity and
movement, and will be repeated at 48 hours post-randomization. Following randomization, the
patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills
each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive
either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine
every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
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