DILATRATE-SR SUMMARY
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5 dinitrate, an organic nitrate. The organic nitrates are vasodilators, active on both arteries and veins. Each dilatrate®-SR sustained release capsule contains 40 mg of isosorbide dinitrate, in a micro-dialysis delivery system that causes the active drug to be released over an extended period.
dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
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NEWS HIGHLIGHTS
Published Studies Related to Dilatrate-SR (Isosorbide)
Randomized controlled trial of the efficacy of isosorbide-SR addition to current treatment in medical expulsive therapy for ureteral calculi. [2011.10] It has been suggested that nitrates are potent smooth muscle relaxants that may reduce pain and facilitate ureteral stone passage; therefore it may be an option for medical expulsive therapy in ureteral stones. In a prospective randomized controlled clinical trial, we evaluated the efficacy of medical expulsive therapy with isosorbide-SR 40 mg in patients with ureteral stones (</=10 mm)...
Intravaginal administration of isosorbide mononitrate and misoprostol for cervical ripening and induction of labour: a randomized controlled trial. [2011.07] BACKGROUND: Labor induction in the presence of unfavorable cervix is a common indication for the use of prostaglandins. However, in the last years, there has been a considerable interest in the use of nitrous oxide donors for cervical ripening and labor induction. OBJECTIVE: To evaluate the efficacy and safety of intravaginal administration of NOD isosorbide mononitrate (IMN) plus misoprostol versus misoprostol alone for cervical ripening and induction of labor. SETTING: Department of Obstetrics and Gynecology, Woman's Health Center, Assiut University... CONCLUSIONS: Using a combination of IMN and misoprostol is more efficient than misoprostol alone in terms of fast cervical ripening and shortening of induction-labour interval.
Comparison of isosorbide mononitrate and misoprostol for cervical ripening in termination of pregnancy between 8 and 12 weeks: a randomized controlled trial. [2011.06] AIM: The present study was undertaken to compare the efficacy of isosorbide mononitrate (IMN) and misoprostol for cervical ripening in termination of pregnancy between 8 and 12 weeks... CONCLUSION: The results show that IMN has a definite role and better safety profile than misoprostol in first trimester cervical ripening, although misoprostol is more effective and causes less blood loss.
[Comparison of isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy]. [2011.05] CONCLUSIONS: the isosorbide dinitrate is associated with lower duration of labor compared with dinoprostone. There was no difference in the maternal-fetal outcome by using whatever drug.
Improvement of hypertension and LVH in maintenance hemodialysis patients treated with sustained-release isosorbide mononitrate. [2011.03] BACKGROUND: Hypertension and left ventricular hypertrophy (LVH) are independent predictors of morbidity and mortality in maintenance hemodialysis (MHD) patients. The level of serum asymmetric dimethylarginine (ADMA) is increased in MHD patients, which is a kind of uremic toxin. It can competitively inhibit nitric oxide production from L-arginine, which can increase vascular resistance, then lead to endothelium dysfunction, hypertension, LVH and decrease of ejection fraction. A sustained-release preparation of isosorbide mononitrate can lead to vasodilatation by releasing nitrogen monoxide. But it remains unclear whether oral isosorbide mononitrate in MHD patients can control blood pressure (BP) and reverse LVH. The aim of the present study was to evaluate the safety and efficacy of oral sustained-release isosorbide mononitrate on hypertension and LVH in MHD patients... CONCLUSIONS: Sustained-release isosorbide mononitrate, which is safe and well tolerated, can effectively control BP, decrease the category and quantity of hypotensive drugs, improve left ventricular hypertrophy and reduce the incidence of acute left heart failure in MHD patients.
Clinical Trials Related to Dilatrate-SR (Isosorbide)
A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis [Recruiting]
This study investigates the effective power of angina pectoris after Quick-Acting Heart
Reliever and isosorbide dinitrate interventing respectively the patients with moderate
coronary stenosis for six months. At the same time, the studying will assess the plaque,
myocardial blood-supplying,quality of life and observe the end point of the heart (including
the myocardial revascularization, death and myocardial infarction). The purpose is to study
the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever
for moderate coronary stenosis lesions.
Effect of Vasodilators on Cardiac Function in Diastolic Heart Failure [Recruiting]
The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide
dinitrate ± hydralazine on arterial wave reflections, exercise capacity, left ventricular
(LV) mass/fibrosis and diastolic function in patients with Heart Failure and Preserved
Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial
wave reflections induced by vasoactive therapy will correlate with the improvement in
exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess
whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can
predict the sustained changes in the reflected wave and other hemodynamic parameters in
response to chronic vasodilator therapy.
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 [Recruiting]
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU
200 and IBU and ISO combinations (200 +20) given in single dose.
This study is being conducted to support the submission for new indication in treatment of
the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular
dystrophy.
Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy [Not yet recruiting]
This study is dedicated to determination of the long term effectiveness of coronary heart
disease (CHD) treatments - cardiac shock wave therapy (CSWT) in comparison with other kinds
of medical and surgical treatment. For that purpose the investigators will observe the
patients with CHD who enrolled in this study in their routine course of treatment. But the
investigators will not interfere with the patient treatment. Each participant will be
followed-up for five years. The collected data will allow to determine if the particular
method, CSWT, could really make any additional contribution to the more traditional methods
of CHD treatment and if the CSWT is only temporarily effective or could exert the long term
effect as well.
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients [Recruiting]
This is a randomized, double blind, placebo-controlled study, clinical trail designed to
evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate
for the relief of acute anginal pain episodes in acute coronary syndrome patients in
comparison with the usual manner of S/L isosorbide dinitrate .
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