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PubMed2000

[Comparative evaluation of antianginal efficacy of isosorbide dinitrate in various doses in patients with stable angina].

In a randomized, double-blind, placebo (P) controlled with cross-over design study 38 male patients with stable angina and angiographically proven coronary artery disease, received isosorbide dinitrate (ISDN) in various single doses: 10 mg, 20 mg, 20 mg slow-release (-SR), 40 mg-SR, 80 mg-SR and 120 mg-SR. Evaluation of antianginal efficacy and the effect of ISDN on the simple hemodynamic parameters was performed by analysis of walking times on the treadmill: total, to angina and to ischemia (WTI) as well as: heart rate and systolic blood pressure at rest and during exercise. Exercise stress tests on the treadmill were performed: preceding drug administration, 2 hours and 6 h after. 6 h after taking the drug all doses of ISDN improved significantly all three analysed walking times on the treadmill, for example WTI in comparison to P (p < 0.001): 10 mg by 34.6%, 20 mg by 49.6%, 20 mg-SR by 42.9%, 40 mg-SR by 52.5%, 80 mg-SR by 66.0%, and 120 mg-SR by 58.4%. ISDN 20 mg was more active antianginally than 10 mg, but was connected with more severe orthostatic hypotension and headaches. ISDN 20 mg-SR was weaker in the improvement of coronary reserve than ISDN 20 mg, but it gave less adverse effects. The elevation of ISDN-SR dose was effective in the improvement of coronary reserve up to 80 mg-SR (without further benefits after 120 mg-SR). The antianginal efficacy of doses: 40 mg-SR, 80 mg-SR and 120 mg-SR was not significantly different.

Angina Pectoris↗
PubMed1988

Effects of long-term treatment with 120 mg of sustained-release isosorbide dinitrate and 60 mg of sustained-release nifedipine on myocardial perfusion.

Forty patients with coronary artery disease and scintigraphically proven myocardial ischemia were randomized into 2 groups receiving 4 weeks of treatment with either 120 mg of isosorbide dinitrate (ISDN) release or 60 mg of nifedipine release. Control exercise testing and myocardial scintigraphy were continued until anginal pains occurred, and repeated at identical individual workloads at the end of the 4 weeks of drug therapy. Myocardial scintigrams were evaluated by quantitative recording of counts in 60 segments/frame. Twenty patients in the ISDN group (group I) exhibited 47 significantly ischemic areas. The remaining 20 patients (group II), treated with nifedipine, had 50 ischemic areas before therapy. In the ischemic areas in group I, there was a mean difference of 30.9% between counts at rest and during exercise in the pretreatment period, and a difference of 18.1% after therapy (39.0%). In group II, the pretreatment difference was 28.8%, decreasing to 20.6% after therapy (17.8%). Both groups of patients were subsequently subdivided into 3 subsets: (1) significantly improved perfusion, (2) significant worsening, and (3) unchanged myocardial perfusion. Group I had 59.5% of areas with significant improvement and 10.6% of areas with significant worsening. In 29.7% of the areas, the findings were unchanged. Group II had improvement in 40% of areas, of significantly worsened areas in 6%, and unchanged areas in 54%, in both groups myocardial ischemia was reduced by therapy, but ISDN improved myocardial perfusion to a considerably greater extent than did nifedipine.

Adult↗
PubMed1997

Double-blind randomized multicenter study on the efficacy of trapidil versus isosorbide dinitrate in stable angina pectoris.

BACKGROUND: Trapidil is an inhibitor of phosphodiesterase I-IV with resulting positive lusitropic, vasodilating, and antiplatelet effects. HYPOTHESIS: This study was undertaken to compare the antianginal efficacy of trapidil with that of isosorbide dinitrate (ISDN) in patients with stable angina pectoris. METHODS: We studied 95 patients with stable angina pectoris who were randomized into a double-blind parallel group study with either oral trapidil or ISDN. After a 1-week run-in period and a 2-week wash-out phase, the patients received either trapidil 200 mg t.i.d. (n = 48) or ISDN 20 mg t.i.d. (n = 47) for 12 weeks. All antianginal medication, except sublingual glyceryl trinitrate (GTN), was discontinued during the study. Patients underwent an exercise electrocardiogram on an ergometer bicycle according to a modified Bruce protocol before and at 6 and 12 weeks during treatment. RESULTS: The workload capacity increased from 583 +/- 281 W.min before treatment to 833 +/- 444 W.min after 12 weeks of treatment in the trapidil group (p < 0.01) and from 555 +/- 276 W.min to 827 +/- 361 W.min in the ISDN group (p < 0.01). The anginal attacks per week as well as the use of GTN decreased significantly in both groups. After 12 weeks of therapy, the cumulative ST-segment depression during exercise decreased by 67% in the trapidil patients and by 23% in the ISDN patients. Compared with baseline, the double product at the 75 W level was reduced in both groups after 12 weeks of treatment. Blood pressure and heart rate at rest remained nearly unchanged. Overall, no statistical difference was found between the two study groups. The tolerability was good. CONCLUSION: Oral trapidil therapy is safe and effective in stable angina pectoris and is equivalent to standard therapy with ISDN.

Administration, Oral↗
PubMed1982

Benefits from adding nifedipine to the treatment of unstable angina when beta-blockade and isosorbide dinitrate have proved inadequate.

Nifedipine (10 mg orally six times daily) was given to patients with unstable angina persisting despite adequate beta-blockade (group I, 35 patients) or despite the association of adequate beta-blockade and sublingual isosorbide dinitrate (group II, 47 patients). Stabilization of anginal symptoms was achieved in 31/35 patients of group I and in 39/47 patients of group II. Aorto-coronary bypass grafting was carried out in 19 patients because of persisting unstable angina (five patients) or because of the severity of residual angina (14 patients). Tolerance to these drug combinations was excellent, with side-effects consisting mainly of transient headache (eight patients) and noncardiac ankle edema (eight patients). Nifedipine was found to be valuable in stabilizing unstable angina persisting despite beta-blockade and nitrates.

Aged↗
PubMed1981

Treatment of acute myocardial infarction with sodium nitroprusside during 24 hours, followed by isosorbide dinitrate.

In a controlled randomized study of 328 consecutive patients admitted within 24 hours after the onset of acute myocardial infarction, 163 patients received a sodium nitroprusside infusion during 24 hours, followed by six times a day 5 mg isosorbide dinitrate for seven days and 165 patients received a glucose 5% infusion. Excluded from the study were patients with either pulmonary edema and/or cardiogenic shock, two or more previous myocardial infarctions or a systolic blood pressure of less than 95 mmHg just before entering the study. Sodium nitroprusside was titrated in such a way that systolic blood pressure was kept between 95 and 105 mmHg. Standard medical treatment for both groups was the same. CK-MB was sampled every four hours until peak value was reached. Endpoint of the study was a significant reduction in mortality within a week after starting treatment.

Clinical Trials as Topic↗
PubMed1985

Arteriographic demonstration of the release of coronary artery spasm by isosorbide dinitrate: a twenty-five-year retrospective.

It has been 25 years since my colleagues and I were first approached to apply the then newly emerging technique of coronary arteriography to the study of the effects of the new vasodilator isosorbide dinitrate (ISDN) on coronary arteries in vivo. Through a combination of careful patient assessment and serendipity, we were able to visualize the prompt release of coronary artery spasm by ISDN. Ensuing years have seen dramatic advances both in angiographic techniques and in the knowledge of ISDN efficacy. This review will briefly summarize the early work with ISDN and detail how the improvements in cineangiography have fostered better understanding of the actions of ISDN.

Cineangiography↗
PubMed1984

Transdermal isosorbide dinitrate in angina pectoris: effect of acute and sustained therapy.

Twelve patients with chronic, stable angina pectoris underwent hemodynamic investigations and treadmill exercise testing before and during a 24-hour period after the application of 100 mg of transdermal isosorbide dinitrate (ISDN) and matching placebo. Compared with placebo, there were no changes in systolic blood pressure or heart rate at rest or during exercise; but treadmill walking time to the onset of angina and to the development of moderate angina was significantly prolonged at 2, 4 and 8 hours, but not at 24 hours, after drug application. Patients subsequently received these same treatment regimens for 7 to 10 days and underwent repeat exercise testing. During this sustained phase of the investigation, treadmill walking time to the onset of angina and to the development of moderate angina was similar 4, 8 and 24 hours after application of ISDN and placebo. Thus, transdermal ISDN in a dose of 100 mg is effective for 8 hours during acute therapy, but during sustained therapy tolerance developed and no antianginal effects of ISDN persisted.

Administration, Topical↗
PubMed1989

Blood volume and right heart haemodynamics in abrupt hypotension following sublingual isosorbide dinitrate in acute myocardial infarction.

Arterial blood pressure and heart rate were measured in 43 patients with acute myocardial infarction and a systolic blood pressure greater than or equal to 120 mmHg during sublingual administration of 5 mg of isosorbide dinitrate. In 25 of them right heart haemodynamics were also measured. Severe (greater than or equal to 25%) hypotension developed in 12 patients (Group 1, systolic blood pressure 158 +/- 28 to 78 +/- 17 mmHg, mean +/- SD) but not in the remaining 31 (Group 2) and was accompanied by a fall in heart rate (82 +/- 20 to 70 +/- 22 beats min-1, P less than 0.05), in cardiac output (4.3 +/- 0.3 to 3.2 +/- 0.41 min-1, P less than 0.02, n = 5) and in systemic vascular resistances (2326 +/- 463 to 1532 +/- 442 dynes sec-1 cm.5, P less than 0.02) not present in Group 2. The reduction in right (Group 1, 8 +/- 3 to 3 +/- 1, vs. Group 2, 10 +/- 3 to 6 +/- 3 mmHg, P less than 0.005) and in left ventricular filling pressures (Group 1, 15 +/- 4 to 8 +/- 2, vs. Group 2, 18 +/- 6 to 13 +/- 5 mmHg, P less than 0.001) was more remarkable in Group 1. In this group there was also a high incidence of anterior infarction (9/12, 75%).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Sublingual↗
PubMed1977

Hemodynamics and antianginal effects of high dose oral isosorbide dinitrate after chronic use.

In a randomized, double-blind, crossover study, 19 patients with angina were exercised 2 min after 0.4 mg sublingual nitroglycerin and after sublingual placebo and before and 1, 3, and 5 hours after oral isosorbide dinitrate (ISDN) and oral placebo. After initial testing, patients took the dose of ISDN they had had during the study (mean dose 29 mg) for a mean period of 5.6 months before retesting using the same protocol. Compared to placebo, exercise time after sublingual nitroglycerin increased 56% (P less than 0.001) initially and 51% (P less than 0.001) at retest. Compared to placebo, exercise time increased 58% (P less than 0.05) initially and 58% (P less than 0.005) at retest 1 hour after ISDN, 38% (P less than 0.05) initially and 27% (P less than 0.005) at retest 3 hours after ISDN, and 13% (NS) initially and 21% (P less than 0.02) at retest five hours after ISDN. The mean exericse times initially and at retest were not significantly different. Hemodynamic changes (decrease in systolic blood pressure and increase in heart rate) at 15 min persisted through 300 min after ISDN during both initial testing and during retesting. However, these changes were significantly less during retesting. We conclude that a partial tolerance to the hemodynamic effects of the drug develops after chronic use of high dose oral ISDN but that the antianginal efficacy of both sublingual nitroglycerin and oral ISDN is unimpaired.

Adult↗
PubMed1984

Controlled comparison of the pharmacodynamic effects of nicorandil (SG-75) and isosorbide dinitrate in man.

Nicorandil (SG-75) is a long acting mononitrate. A randomized, double-blind, crossover study in 10 healthy subjects has compared the haemodynamic actions of single sublingual doses of nicorandil 15, 30 and 60 mg with Isosorbide dinitrate (ISDN) 5 mg and placebo. Heart rate, blood pressure, systolic time intervals (STI) and left ventricular echocardiograms were used to assess haemodynamics over a 6 h period. Within 15 min of nicorandil administration, heart rate increased and peripheral resistance decreased (dose-dependent); the preejection period (corrected; PEPc) and the ratio of PEP to left ventricular ejection time (LVET) - PEP/LVET - were shortened by the 60 mg dose; the heart rate corrected electromechanical systole (QS2c) was almost unchanged; left ventricular end diastolic and systolic diameters (EDD and ESD) were diminished. The effects on certain parameters had not completely disappeared after 6 h. ISDN produced a similar pattern with somewhat less intense effects; although PEPc and PEP/LVET were prolonged. The effects of both drugs can be attributed to vasodilatation on both the arteriolar and venous sides. The predominant action of ISDN was to reduce preload and thereby to lengthen PEPc and PEP/LVET; in addition, it lessened afterload. Although nicorandil caused a distinct reduction in preload, as shown by the smaller EDD, the effects of afterload reduction were predominant at the high dose induced shortening of PEPc and PEP/LVET. The profile of action of nicorandil should encourage clinical testing to evaluate its ability to induce ventricular unloading.

Adult↗
PubMed1983

Chronic treatment and tolerance with high doses of isosorbide dinitrate in a slow release form in patients with angina pectoris.

Nine men with angiographically proven coronary sclerosis and a reproducible ischemic response on the exercise ECG were treated for 9 weeks with a dose of 180-240 mg isosorbide dinitrate slow release (ISDN sr) daily. In the week before the beginning of the treatment (week 1) and in the week after its conclusion (week 10), exercise tests were carried out before and 1 and 3 h after administration of 60 mg ISDN sr or placebo. This part of the investigation was double-blind, cross-over and randomized. In an open study carried out during the 2nd-9th weeks, exercise tests were carried out weekly before and 1 and 3 h after the usual morning dose of 60 mg ISDN sr. The interval between the morning exercise and the last evening dose was 8-10 h. Exercise duration and required level of exertion remained constant during the entire study. The sum of ischemic ST-segment depression during and after exercise, heart rate (ECG) and blood pressure (RR) were all measured. Both before and after the period of treatment 60 mg ISDN sr produced a significant reduction in ST-segment depression after 1 and 3 h. During the treatment phase no significant improvement in comparison to controls could be observed from the 7th week onward. However, even in controls the ST-segment depression was less in the 8th and 9th weeks than during the first few weeks.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1990

A prospective, randomized, double-blind, crossover study to compare the efficacy and safety of chronic nifedipine therapy with that of isosorbide dinitrate and their combination in the treatment of chronic congestive heart failure.

We performed a prospective, randomized, double-blind, crossover study to compare the efficacy and safety of vasodilation with the calcium entry blocker nifedipine with that of isosorbide dinitrate (ISDN) and their combination as treatment for heart failure. Twenty-eight patients with New York Heart Association Functional class II or III chronic heart failure due to left ventricular systolic dysfunction were studied. All patients were maintained on a constant dose of digitalis and diuretics throughout the study. Eight weeks of therapy with nifedipine alone or in combination with ISDN resulted in a significantly higher incidence of heart failure deterioration necessitating hospitalizations and/or additional diuretics. Twenty-four percent of patients required hospitalization during nifedipine therapy and 26% required hospitalization during nifedipine-ISDN combination therapy in comparison to 0% requiring hospitalization during ISDN therapy alone. The total number of heart failure-worsening episodes was nine among patients on nifedipine, three among patients on ISDN (p less than 0.09 versus nifedipine), and 21 among patients on nifedipine-ISDN combination (p less than 0.001 versus nifedipine, p less than 0.0001 versus ISDN). Premature discontinuation of drug administration due to clinical deterioration or other side effects occurred in 29% of patients during nifedipine therapy, 5% of patients during ISDN therapy (p = 0.05 versus nifedipine), and 19% of patients during the combination therapy. A comparison of eight patients who demonstrated clinical deterioration on nifedipine with the remainder of the patients demonstrated no significant difference in left ventricular ejection fraction (0.24 +/- 0.06 versus 0.23 +/- 0.07) or maximal oxygen uptake during exercise (13 +/- 3 versus 14 +/- 2 ml/kg/min).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

In vitro-in vivo correlation of percutaneous absorption: isosorbide dinitrate and morphine hydrochloride.

The potential of an in vitro skin preparation as a model for predicting in vivo percutaneous absorption of drugs was examined. In vitro and in vivo skin permeation data for two model drugs with different lipophilicity, isosorbide dinitrate (ISDN) and morphine hydrochloride (MPH), were compared using pharmacokinetic techniques. In vitro permeation data published previously were analyzed based on a single pathway model, and permeation parameters were obtained. The disposition parameters were estimated from the plasma concentration profiles after i.v. administration. The plasma concentrations after topical application were then simulated using the obtained permeation and disposition parameters, and the values were compared with the corresponding observed ones. Although the simulated plasma concentration curves were not greatly different from those observed, there were some differences in the time course-pattern. Causes for these in vitro-in vivo differences were discussed.

Animals↗
PubMedDate not supplied

Comparative effects of captopril and isosorbide dinitrate on the arterial wall of hypertensive human brachial arteries.

Blood pressure, diameter, volume distensibility, and compliance of brachial artery were measured noninvasively in patients with sustained essential hypertension before and after Captopril in 11 patients and before and after isosorbide dinitrate (ISDN) in 11 other patients. Both drugs caused a similar significant decrease in mean arterial pressure (MAP) (p less than 0.001) and increase in arterial compliance (p less than 0.001), defined as the product of arterial volume by distensibility. ISDN increased arterial compliance through a dominant increase in arterial diameter (0.524 +/- 0.029 vs. 0.455 +/- 0.022 cm; p less than 0.001) and hence volume, whereas Captopril increased compliance through an increase in volume distensibility (0.20 +/- 0.02 vs. 0.12 +/- 0.02% change volume/mm Hg; p less than 0.001) with minimal changes in arterial diameter. The study provided evidence that of the two vasodilating drugs, ISDN and Captopril, only Captopril caused a predominant pharmacological relaxing effect on the wall of hypertensive human brachial arteries studied in situ.

Adult↗
PubMed1994

Effects of continuous intravenous infusion of isosorbide dinitrate on development of tolerance to vasodilating action in human epicardial coronary arteries.

This study was performed to determine the effects of long-term intravenous infusion on the coronary vasodilating actions of continuous intravenous and bolus intracoronary administration of isosorbide dinitrate (ISDN). With quantitative coronary angiography, the coronary diameter and the vasodilating response to intracoronary ISDN (1 mg) at angiographically normal segments were studied before and after intravenous administration of ISDN, 10 to 60 micrograms/min for 1 hour, 2 days, or 5 days. The vasodilating effects of intravenous ISDN were 72% +/- 13%, 65% +/- 21%, and 6% +/- 11% of the response to intracoronary ISDN in the baseline study in each group. Irrespective of the duration of intravenous infusion, subsequent intracoronary ISDN dilated coronary arteries to extent similar to that observed in each baseline study. In conclusion, significant coronary vasodilating effects of intravenous ISDN were observed after a 2-day infusion, whereas tolerance to the vasodilating effects apparently developed within 5 days of infusion. The vasodilating response to bolus intracoronary ISDN was preserved even when the vasodilating effects of intravenous ISDN were no longer present.

Angina Pectoris↗
PubMed1994

Influence of glyceryl trinitrate on venous and arterial effects of chronic, asymmetric isosorbide dinitrate treatment in patients with ischemic heart disease.

Asymmetric dosage regimes have been introduced to circumvent development of nitrate tolerance. This study assessed invasively the hemodynamics during supine rest and exercise before and after 4 weeks treatment with 30 mg isosorbide dinitrate (ISDN) or placebo asymmetrically b.i.d. in 14 randomized patients with stable ischemic heart disease in a double-blinded study. An intravenous infusion of glyceryl trinitrate (GTN) was used to assess possible nitrate tolerance. During the initial, medication-free exercise all patients had increased pulmonary arterial wedge pressure (PAWP) 31.4 +/- 5.56 mmHg (mean +/- SD), showing impaired left ventricular function, while mean arterial pressures (MAP) rose from 112 +/- 16.3 mmHg at rest to 141 +/- 15.9 mmHg during exercise. After 4 weeks ISDN treatment, mean exercise PAWP and MAP, 3 h after morning dose, were reduced to 22.4 +/- 7.09 mmHg and 127 +/- 18.2 mmHg, respectively. Before the ISDN treatment, GTN reduced exercise PAWP to 13.9 +/- 5.27 mmHg and MAP to 119 +/- 11.2 mmHg, whereas after 4 weeks ISDN treatment, the addition of GTN did not reduce exercise PAWP and MAP to the same low levels. Thus, the applied ISDN regimen improved the hemodynamics, but induced a definite, partial nitrate tolerance.

Aged↗
PubMedDate not supplied

Comparison of vasoactive response of left and right internal thoracic arteries to isosorbide-dinitrate and nitroglycerin: an in vitro study.

OBJECTIVE: The internal thoracic artery (ITA) is the most important graft in coronary artery bypass grafting. Its distal region is, however, prone to vasospasm. We studied the effects of nitroglycerin (NTG) and isosorbide-dinitrate (DSDN) on distal segments of left versus right ITA. METHODS: Rings of distal segments (6 to 9 mm proximal to bifurcation) of the human left and right ITA were studied. After baseline contraction of the rings, achieved using 60 mmol/L of KCl, they were exposed to increasing doses of ISDN and NTG (10 to 100 microg/ml), and dose-response curves were recorded. RESULTS: The contractile response of left ITA rings to KCl were significantly lower than those of right ITA rings (1.87 +/- 0.25 g versus 3.5 +/- 0.61 g, p < 0.005). Both nitrates inhibited the contractile response in a concentration-dependent manner, with relaxing effects of ISDN higher than those of NTG (p < 0.01) in both left and right ITA rings. CONCLUSIONS: The distal segment of the left ITA is less prone to vasospasm than that of the right. ISDN has a considerably higher relaxant effect on this segment than NTG. We therefore recommend favoring high doses of ISDN over NTG as an antispastic measure.

Coronary Artery Bypass↗