Comparison of antianginal efficacy of sustained release isosorbide dinitrate with short-acting isosorbide dinitrate.
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Angina Pectoris↗
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Comparison of the time to onset of action on myocardial ischaemia following intravenous administration of isosorbide dinitrate and 5-isosorbide mononitrate in Chinese patients.
OBJECTIVE: The onset of action of intravenous isosorbide dinitrate (CAS 87-33-2, ISDN) and intravenous 5-isosorbide mononitrate (CAS 16051-77-7, 5-ISMN) were compared by measurement of the indicators of perfusion to ischaemic myocardium. METHODS: Twenty-five patients with coronary heart disease were randomly allocated to receive intravenous ISDN or 5-ISMN. The extent of myocardial ischaemia before infusion and at 3, 15 and 45 min after commencement of infusion was evaluated using 99mTc-MIBI myocardium tomography imaging and electrocardiograms. RESULTS: The perfusion defects were significantly reduced or resolved in 11 patients (84.1%) receiving ISDN and 2 patients (15.38%) receiving 5-ISMN at 3 min. At 15 min the improvement was significantly greater in the ISDN group than in the 5-ISMN group. The improvements of 99mTc-MIBI myocardial uptake ratio and electrocardiograms were statistically significant in the ISDN group at 3 min and 15 min compared to pre-infusion. Although a significant improvement appeared at 15 min in the 5-ISMN group, it was significantly less than that observed in the ISDN group (p < 0.05). After 45 min, there were improvements in ischaemia in both groups with the difference compared to pre-infusion being significant, and there was no statistically significant difference between the ISDN and 5-ISMN group. CONCLUSION: In patients with coronary heart disease with ischaemic episodes the onset of therapeutic activity was more rapid with intravenous ISDN compared to 5-ISMN. ISDN should be the preferred intravenous nitrate for acute ischaemic episodes where a rapid onset of therapeutic action is desired.
Acute Disease↗
[The effect of isosorbide dinitrate on esophageal emptying in chagasic megaesophagus].
The effect of 5 mg of sublingual dinitrate isosorbide (DNI) on the esophageal emptying of a semi-solid test meal labeled with 99mTc-sulfur colloid was studied by a scintigraphic technique in 18 chagasic patients with megaesophagus. DNI significantly reduced the esophageal retention measured at 0, 5, 10, 15, and 20 minutes after the end of the test meal ingestion. Five minutes after the meal not preceded by DNI the esophageal retention was always higher than 10% whilst 5 minutes after the meal preceded by DNI the retention was lower than 10% in 10 patients. These results indicate that DNI may be useful to reduce esophageal retention in chagasic megaesophagus.
Adult↗
Effects of isosorbide dinitrate spray on central hemodynamics. Comparison with sublingual glyceryl trinitrate and isosorbide dinitrate.
Effects of isosorbide dinitrate (ISDN) spray (Iso Mack Spray) on central hemodynamics were determined in comparison to sublingual glyceryl trinitrate (nitroglycerin) and ISDN, paying particular attention to their onset and duration of action. In nine patients with uncomplicated acute myocardial infarction, ISDN spray (2 sprays, 2.5 mg) glyceryl trinitrate (TNG, 0.3 mg) and ordinary ISDN tablet (5 mg) were administered by the single-blind crossover method under hemodynamic monitoring with a Swan-Ganz catheter. Systolic pulmonary artery pressure (s-PA), systolic pressure (s-BP) and heart rate were measured every minute for 10 min, every 5 min for the subsequent 20 min and thereafter every 15 to 30 min up to 120 min. Using s-PA as a measure of nitrate action, the onset and duration of action as well as the magnitude of change was compared among the three drugs. ISDN spray had a quick onset of action (2.67 +/- 2.4 min, mean +/- SD) comparable to that of TNG (2.67 +/- 1.00 min), while ISDN spray had a long duration of action (57.4 +/- 42.1 min), which was comparable to that of sublingual ISDN (85.6 +/- 39.5 min, ns) and was significantly longer than that of TNG (11.4 +/- 6.4 min, p less than 0.05). ISDN spray (2.5 mg) showed the same hemodynamic changes as were induced by 0.3 mg TNG or 5 mg ISDN. The results of this study led us to conclude that ISDN spray is a useful agent which induces the abortion of anginal attacks by its quick onset and long duration of action.
Administration, Topical↗
[Comparative pharmacokinetics and bioavailability of isosorbide dinitrate and its metabolites isosorbide 5- and 2-mononitrate from delayed-release preparations].
The present comparative pharmacokinetic study performed to establish the relative bioavailability for an isosorbide dinitrate (ISDN) retard preparation (Sorbidilat-retard) included 6 healthy, male and female volunteers. In a randomised cross-over scheme the volunteers received a capsule Sorbidilat retard forte and a tablet of a standard preparation which contained as well 40 mg isosorbide dinitrate as retard formulation. Blood samples were taken over a period of 24 h and isosorbide dinitrate, 5-isosorbide mononitrate and 2-isosorbide mononitrate measured in the serum by means of gas chromatography with electron-capture detection. The resorption rate for all three substances revealed only minor differences between Sorbidilat and the standard preparation. However, the slightly retarded absorption for the compound from Sorbidilat with a longer period of invasion led to a higher maximal concentration and to higher serum levels of ISDN and the mononitrates over the whole period of observation. The relative bioavailability for all three substances ISDN, 5-isosorbide mononitrate and 2-isosorbide mononitrate, was estimated from the areas under the plasma concentration-time curves and was 2 to 2.5 fold higher for the Sorbidilat preparation than for the standard preparation.
Adult↗
Randomised trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary oedema.
BACKGROUND: Nitrates and furosemide, commonly administered in the treatment of pulmonary oedema, have not been compared in a prospective clinical trial. We compared the efficacy and safety of these drugs in a randomised trial of patients with severe pulmonary oedema and oxygen saturation below 90%. METHODS: Patients presenting to mobile emergency units with signs of congestive heart failure were treated with oxygen 10 L/min, intravenous furosemide 40 mg, and morphine 3 mg bolus. 110 patients were randomly assigned either to group A, who received isosorbide dinitrate (3 mg bolus administered intravenously every 5 min; n=56) or to group B, who received furosemide (80 mg bolus administered intravenously every 15 min, as well as isosorbide dinitrate 1 mg/h, increased every 10 min by 1 mg/h; n=54). Six patients were withdrawn on the basis of chest radiography results. Treatment was continued until oxygen saturation was above 96% or mean arterial blood pressure had decreased by 30% or to below 90 mm Hg. The main endpoints were death, need for mechanical ventilation, and myocardial infarction. The analyses were by intention to treat. FINDINGS: Mechanical ventilation was required in seven (13%) of 52 group-A patients and 21 (40%) of 52 group-B patients (p=0.0041). Myocardial infarction occurred in nine (17%) and 19 (37%) patients, respectively (p=0.047). One patient in group A and three in group B died (p=0.61). One or more of these endpoints occurred in 13 (25%) and 24 (46%) patients, respectively (p=0.041). INTERPRETATION: High-dose isosorbide dinitrate, given as repeated intravenous boluses after low-dose intravenous furosemide, is safe and effective in controlling severe pulmonary oedema. This treatment regimen is more effective than high-dose furosemide with low-dose isosorbide nitrate in terms of need for mechanical ventilation and frequency of myocardial infarction.
Acute Disease↗
Improvement of walking distance in patients with intermittent claudication by chronic local therapy with isosorbide dinitrate ointment.
Isosorbide dinitrate ointment (100 mg tid) was directly applied to 30 male patients with stable, documented intermittent claudication on the areas where ischemic pain was experienced. The symptom-free distance walked (DWA) and the maximum distance reached (MDR) basally, after one, three, six, and twelve months were evaluated by means of treadmill stress tests (TSTs) (angle 0 degree-velocity constant/patient). After the basal TST, patients were randomly divided into two groups: placebo group and therapy group (double blind), and a further TST was administered one month later. DWA results were 74 +/- 8 m vs 297 +/- 83 m and MDR results were 163 +/- 22 m vs 506 +/- 86 m in the therapy group (basal vs one month TST: p less than .01) and 94 +/- 24 m vs 96 +/- 15 m and 232 +/- 53 m vs 183 +/- 26 m in the placebo group, respectively (basal vs one month TST: NS). Being confident that a significant placebo effect was absent, the authors opened the trial and treated all patients, repeating further TSTs at three, six, and twelve months. The following results were obtained: DWA was 84 +/- 13 m, 316 +/- 63 m, 374 +/- 55 m, and 452 +/- 61 m; and MDR was 197 +/- 29 m, 431 +/- 59 m, 514 +/- 57 m, and 547 +/- 59 m, respectively, in basal conditions and after three, six, and twelve months of treatment (p less than .01 for all the values for both DWA and MDR vs basal values).(ABSTRACT TRUNCATED AT 250 WORDS)
Administration, Topical↗
[Plasma levels of isosorbide dinitrate and its metabolites during intravenous infusion in surgical patients--effect of preoperative administration of isosorbide dinitrate].
Nineteen patients with ischemic heart disease were studied to determine plasma levels of isosorbide dinitrate (ISDN) and its metabolites, isosorbide-2-mononitrate (2-ISMN) and isosorbide-5-mononitrate (5-ISMN) for 6 hrs during intravenous administration of ISDN, using gas chromatography. Differences in plasma levels of these substances were also evaluated in patients with or without preanesthetic medication of ISDN. These patients ranging in ages from 42 to 80 years were administered ISDN intravenously at a rate of 1 micrograms.kg-1 x min-1 during anesthesia and surgery. Preanesthetic administration of ISDN consisted of transdermal application of 40 mg dose. Surgery included gastrectomy, pneumonectomy, extended cholecystectomy, radical mastectomy and so on under either enflurane anesthesia or neuroleptanesthesia. Plasma ISDN levels increased and reached a plateau 3 hrs after the start of intravenous infusion of ISDN in patients of both groups. Plasma 2-ISMN levels increased gradually and reached a plateau 5 hrs after the commencement of intravenous administration of ISDN in patients of both groups. Plasma 5-ISMN levels increased gradually reaching the peak 6 hrs after the start of intravenous infusion of ISDN in both groups. Plasma ISDN, 2-ISMN and 5-ISMN levels were slightly higher in patients who received preanesthetic ISDN than in those who did not receive preanesthetic ISDN. However, there were no statistical differences in plasma ISDN or 2-ISMN levels between the groups except prior to the infusion. On the contrary, plasma 5-ISMN levels were significantly higher in patients who received preanesthetic ISDN than in those who did not receive preanesthetic ISDN for 3 hrs after the start of the infusion.
Adult↗
[Selection of therapy with nitrates in patients with stable effort angina: results of comparative study of common isosorbide dinitrate and long acting preparation of isosorbide-5-mononitrate].
AIM: To assess efficacy and tolerability of a novel drug form of isosorbide-5-mononitrate in patients with ischemic heart disease and stable effort angina as compared with common isosorbide dinitrate pills. MATERIAL AND METHODS: Patients with stable class II-III effort angina (n=30) were included into a randomized crossover study in which they received isosorbide dinitrate (nitrosorbide, 10-20 mg t.i.d.) and long acting isosorbide-5-mononitrate (ephox-long, 50-100 mg o.d.) for 3 weeks each. Efficacy of treatment was assessed by clinical data and treadmill exercise tests. Questionnaires were used for registration of frequency and intensity of attacks of headache. RESULTS: The use of both isosorbide dinitrate and 5-mononitrate was associated with significant improvements of exercise tolerance however effect of mononitrate lasted longer. Nitroglycerine requirement diminished during first week of use of both drugs and remained on this level by the end of 3-rd week of treatment with mononitrate but substantially rose by the end of treatment with dinitrate. Number of attacks of headache increased during first week of treatment with both drugs, became even higher by the end of use of dinitrate and decreased by the end of use of mononitrate. CONCLUSION: Long acting form of isosorbide-5-mononitrate ephox-long taken once daily provides sufficient antianginal effect throughout a day and is better tolerated than nitrosorbide preparation of isosorbide dinitrate with moderately prolonged activity.
Aged↗
Peripheral resistances in acute myocardial infarction: the use of prazosine versus isosorbide dinitrate.
Prazosine and isosorbide dinitrate have been studied in 15 patients with acute myocardial infarction complicated by heart failure. Prazosine at the first hour had a reduction of 39% of pulmonary capillary wedge pressure (PCWP), of 23% of systemic vascular resistences index (SVRI), of 20% of mean arterial pressure (AP). Isosorbide dinitrate at the first hour in a group of 7 patients had a decrease of SVRI by 19%, the cardiac index (CI) augmented by 23%, the PCWP fell by 15%, while in a group of 5 patients the drug had an increase of SVRI by 15%, a fall of 40% of PCWP and a slight decrease of CI.
Cardiac Output↗
[The effects of isosorbide dinitrate spray on the coronary artery and its modification by the preceding chronic oral therapy with long acting isosorbide dinitrate].
The vasodilatory effect of a new formula of isosorbide dinitrite (ISDN) spray on the left coronary artery was studied by comparing its effects in 46 consecutive patients who subsequently received intracoronary injection with ISDN (2.5 mg). In addition, the influence long acting and ISDN for chronic cases on the vasodilatory effects of ISDN spray and on subsequent intracoronary injection of ISDN was investigated. The patients were divided into two groups, those who had had chronic oral ISDN (Group N; 29 patients) and those who had not (Group O; 17 patients). The vasodilatory effect of ISDN spray was evaluated in segments; 5, 6, 8, 11 and 12 by AHA classification and it dilated those segments by 9.9%, 13.2%, 21.5%, 15.6% and 23.5% respectively. Subsequent intracoronary injection of ISDN dilated those segments by 10.4%, 14.0%, 27.2%, 17.9% and 29.1% respectively. The differences in the degree of vasodilation caused by ISDN spray and that caused by injection in segments 8, 11, 12 were statistically significant. However, the per cent dilation of ISDN spray in segments 5 in group N was 5.9%, and 18.4% in group O, revealing a significant difference depending on previous chronic administration of long acting ISDN. We conclude that ISDN spray did dilate the coronary artery, and subsequent intracoronary administration of ISDN dilated it further in the distal portions of the left coronary artery. Long acting oral ISDN for chronic cases seemed to attenuate the vasodilatory action of ISDN.
Administration, Oral↗
[Dependence of a drop in blood pressure in pulmonary circulation and in the right heart on dosage of isosorbide dinitrate].
An effect of isosorbide dinitrate on blood pressure values in the pulmonary circulation and the right heart has been investigated in 25 patients with a history of the first transmural myocardial infarction. Group I including 12 patients has been given 5 mg isosorbide nitrate in a 60-minute intravenous infusion while group II of 13 patients has been given 10 mg of the drug in the same way. Both groups have been matched in clinical data and blood pressure value in the pulmonary circulation which has been normal. Pulmonary blood pressure has been measured with Swan-Ganz catheter prior to the administration of drug, and 15, 30, 45 and 60 minutes following an infusion. Isosorbide dinitrate in a dose of 5 mg did not decrease blood pressure in the pulmonary circulation statistically significantly. The differences in blood pressure falls did exceed 9%. Filling pressure in the right ventricle did not change either while systolic blood pressure decrease by 16.6%. A double dose of isosorbide dinitrate reduced blood pressure in the pulmonary artery by about 1/3 of the baseline value, and blood pressure in the right ventricle (mean right atrial pressure) by 57.2%. Both systolic and diastolic arterial pressures were reduced. Isosorbide dinitrate reduced blood pressure in the pulmonary circulation in patients who underwent myocardial infarction, and hypotensive effect has been dose-related. A reduction in the right ventricular filling pressure has been a one of important mechanisms decreasing pulmonary pressures.
Adult↗
The daylong pattern of the antianginal effect of long-term three times daily administered isosorbide dinitrate.
Three times daily administration of isosorbide dinitrate may avoid much of the tolerance seen with more frequent dosing. To determine the daylong pattern of the antianginal effect of three times daily isosorbide dinitrate, eight men with stable exertional angina and a positive exercise test were studied. The subjects had demonstrated increased exercise duration in response to oral isosorbide dinitrate therapy and absence of complete tolerance to long-term three times daily isosorbide dinitrate. Treadmill exercise to onset of angina was performed over 2 days at 8 AM, 9 AM, 11 AM, 1 PM, 2 PM, 4 PM, 6 PM and 7 PM. On one day each patient received isosorbide dinitrate at 8 AM, 1 PM and 6 PM in a previously titrated dose (mean 27.5 mg), which had been taken three times daily for at least 2 weeks. On the other day at the same hours each patient received double blind a placebo identical in appearance to isosorbide dinitrate. One hour after the 8 AM dose of isosorbide dinitrate, mean systolic blood pressure at rest had fallen by 19 mm Hg and mean exercise time to angina increased by 200 s. However, by 11 AM exercise time had returned to control level. One hour after the 1 PM dose of isosorbide dinitrate, exercise time increased by a mean of 150 s but was again at control level 2 h later.(ABSTRACT TRUNCATED AT 250 WORDS)
Aged↗
[Treatment of infantile hydrocephalus with isosorbide dinitrate (author's transl)].
Eighteen of infantile hydrocephalus have been treated with isosorbide dinitrate. Pharmacology of this compound is considered. It appears that completely dinitrated isosorbide is the major metabolite. Isosorbide may be effective in a variable proportion of various types of infantile hydrocephalus. Results of isosorbide dinitrate therapy in children with "communicating" and "noncommunicating" hydrocephalus are reported. Treatment was monitored by simple measurements, and it's toxicity proved to be scanty.
Administration, Oral↗
Dose-response curve of angiographically smooth human epicardial vessel segments to intracoronary injections of isosorbide dinitrate.
The coronary vasodilator properties of isosorbide dinitrate are well established but the doses generally used (1,000-2,000 micrograms) are still empirical. We studied, with the use of quantitative coronary arteriography (CAESAR System), the response of smooth vessel segments (greater than 1.85 mm diameter), preconstricted with methylergometrine (400 micrograms i.v.), to intracoronary injections of graded doses (5-100 micrograms) of isosorbide dinitrate and the effects of these injections on systemic hemodynamic parameters in 10 patients undergoing diagnostic coronary angiography. Six further patients, in whom the injections of isosorbide dinitrate were replaced by equivalent volumes of normal saline, served as controls. Relative to the diameter 5 min after injection of methylergometrine, the diameter increased by a mean +/- SD of 9 +/- 7, 26 +/- 12, 33 +/- 15, 38 +/- 14, and 39 +/- 16% after injections of 5, 15, 60, 240, and 1,000 micrograms, respectively, of isosorbide dinitrate. After a cumulative dose of 80 micrograms, subsequent doses did not cause further significant increases in diameter. Injection of saline in the control group did not alter the coronary diameter. A significant fall in systolic arterial pressure, compared to the control group, occurred at a cumulative dose of 320 micrograms. The mean arterial pressure and heart rate were unchanged. Significant coronary vasodilation occurs with intracoronary doses of isosorbide much smaller than those currently employed. Cumulative doses of 320 micrograms or more cause systemic hemodynamic changes without producing additional coronary vasodilation. During interventional cardiac procedures, where systemic hypotension is undesirable, the use of smaller doses of intracoronary isosorbide dinitrate than currently employed may be feasible and should be investigated further.
Adult↗
[Studies on isosorbide dinitrate. II. Determination of isosorbide 5-mononitrate in human plasma and pharmacokinetics].
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Adult↗
Use of isosorbide dinitrate saliva concentrations for biopharmaceutical investigations.
The concentration of isosorbide dinitrate in paired samples of plasma and mixed saliva was monitored for up to 24 hr after oral administration of 60 mg of sustained-release isosorbide dinitrate to eight healthy volunteers. Measured isosorbide dinitrate plasma concentrations were mainly in the range of 0.1-10 ng/ml. Isosorbide dinitrate was excreted into saliva resulting in a mean (+/- SD) saliva-plasma concentration ratio of 0.68 +/- 0.37. A significant correlation between concentrations of isosorbide dinitrate in saliva and plasma was found (p less than 0.01). The sustained-release properties of the administered formulation were confirmed from the concentrations of isosorbide dinitrate found in both saliva and plasma. Saliva-plasma ratios were independent of the absolute concentrations of isosorbide dinitrate but showed a slight tendency to decrease with time. The principal factor relating saliva and plasma isosorbide dinitrate concentrations appeared to be the degree of plasma protein binding of the drug.
Adolescent↗
Hemodynamic evaluation of isosorbide dinitrate in alcoholic cirrhosis. Pharmacokinetic-hemodynamic interactions.
Isosorbide dinitrate, a long-acting organic nitrate, has been shown to decrease portal pressure in the experimental animal and humans. We conducted a double-blind randomized hemodynamic evaluation of the effects of placebo and 10 mg and 20 mg isosorbide dinitrate in stable individuals with alcoholic cirrhosis. Baseline values for all three groups were similar. Isosorbide dinitrate resulted in a peak reduction of the hepatic venous gradient of 24.7% +/- 3.0%, with significantly decreased values 4 h after the administration of the 20-mg dose. A reduction of arterial pressure and cardiac index (peak decrease of 25.7% +/- 1.5%) was well tolerated by 13 of 15 patients. Changes in mean arterial pressure were not predictive of modifications in the hepatic vein wedge pressure. There was no relation between the area under the plasma isosorbide dinitrate concentration curve and hemodynamic changes. Levels of isosorbide-5-mononitrate, a vasoactive metabolite, were detectable for an 8-h period. Isosorbide dinitrate significantly reduced portal pressure in stable cirrhotics, in association with systemic hemodynamic changes. Thus, titration of isosorbide dinitrate is required to maximize hemodynamic benefits in individual patients. As the decrease in portal pressure is more predictable than the effect of previously tested pharmacologic agents, isosorbide dinitrate should be evaluated for its efficacy in the management of portal hypertension.
Blood Pressure↗