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PubMed1980

[Longterm effect and maintenance therapy with cutaneous isosorbide dinitrate in patients with coronary heart disease (author's transl)].

The aim of this study was to examine the duration of action of a single cutaneous application of a 10% isosorbide dinitrate ointment (ISDN-S) and also to ascertain the possible appearance of nitrate tolerance after 6--8 months' maintenance therapy with ISDN-S. After a single application of the ointment an effect lasting more than 7 hours was confirmed by bicycle ergometry. After longterm therapy an acute test with rapidly acting sublingual ISDN produced an undiminished response thus showing lack of nitrate tolerance.

Coronary Disease↗
PubMed1980

Clinical effects of a sustained-release preparation of isosorbide dinitrate on angina pectoris.

The antianginal action of a sustained-release preparation of isosorbide dinitrate (SUS-ID), administered twice a day, was examined in open trial in 61 patients with angina pectoris. The results obtained were as follows: 1) The frequency of anginal attacks as well as consumption of nitroglycerin tablets began to decrease significantly in the two weeks following the commencement of treatment with SUS-ID; increasing the dose and prolonging the period of administration resulted in further augmentation of its clinical effect. 2) The subjective symptoms improved in 44 of the 61 patients studied (72.1%), and 17 patients (27.9%) showed an improved electrocardiogram. 3) Both the systolic and diastolic blood pressures were significantly lowered, but little change in heart rate was observed. 4) According to the efficacy assessment by the doctors in charge, this drug was judged to be "effective and strongly recommendable" and to be "usable" in 56 of 61 patients (91.8%). Thus SUS-ID was considered to be of clinical usefulness. 5) In terms of side effects, 14 patients (23.0%) complained of headache and three patients (4.9%) of dizziness. These side effects, however, were not serious enough to cause withdrawal of the drug.

Adult↗
PubMed1982

[Absorption of isosorbide dinitrate in guinea-pig intestine and in the colon of sheep (author's transl)].

Segments of the intestine of anaesthetized guinea-pigs and the colon of conscious sheep were perfused with saline containing 0.1--25 mg/l 1,4:3,6-dianhydrosorbitol-2,5-dinitrate (isosorbide dinitrate, ISDN). The increase in ISDN uptake was linearly related to its concentration. Absorption was rapid. In the jejunum and the ileum of guinea-pig, 7% of perfused ISDN was absorbed per 10 cm of intestine in the proximal and 15% in the distal colon, respectively. In the total colon of sheep, 83% disappeared during the perfusion. Per unit of length, surface or dry weight of mucosa the net flux of ISDN in the small intestine was only half that in the colon. Absorption from the colon per unit of wet weight of the gut was only slightly higher compared to the small intestine. 1 h after the infusion of 14C-labelled ISDN into the large intestine of sheep filled with normal contents 14C-activity was detected in the plasma, a maximum was reached after 4 h. Renal excretion of ISDN or its 14C-labelled metabolites was parallel to the ISDN concentration in blood. Microbial degradation of ISDN to CO2 in colon contents was insignificant.

Animals↗
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↗
PubMed1982

[Hemodynamic and coronary effects of isosorbide dinitrate: comparison of intravenous and intracoronary injection].

The hemodynamic and coronary effects of a single dose of 3 mg of isosorbide dinitrate (ISD) were studied in 26 patients after intra-coronary (17 cases) and intravenous injection (9 cases). The study was carried out after opacification of the coronary arteries and a 0,4 mg ergometrine test. The radiological contrast and ergometrine increased left ventricular end diastolic (10,4 +/- 0,89 mm Hg to 22,5 +/- 1,88 mm Hg) and systolic pressures (131,4 +/- 4,8 mm Hg to 158,7 +/- 5,8 mm Hg) without changing V max. After ergometrine, the diameter of the coronary vessels decreased by 8,8%. After ISD, these pressures fell significantly from the 10th second; the lowest pressure after ISD was related to the initial pressure at the end of the ergometrine test (systolic pressure Y = 0,68 X + 6,39, R = 0,89, p less than 0,001) ( end diastolic pressure : Y = 0,36 X + 0,17, R = 0,68 , p less than 0,01). Moderate transient tachycardia was probably a reflex reaction. The increase in V max, maximal after 1 to 2 minutes, seemed to have a different mechanism. The global effect is to decrease myocardial oxygen consumption as reflected by the fall in the tension - time - index (3083 +/- 2,13 to 2330 +/- 184 mm Hg . sec-1 . min . The diameter of the coronary vessels rose by 26% with respect to the smallest diameter observed after ergometrine. The intracoronary and intrafemoral venous injection gave identical hemodynamic and coronary changes from the first minute. The effects were maximal between 2 and 4 minutes and continued after 10 minutes. The only difference was a more rapid decrease in systolic pressure after intrafemoral administration. Dilatation occurred before the hemodynamic effects after intracoronary injection, which is an argument for using intracoronary ISD in the treatment of spasm induced by ergometrine.

Coronary Circulation↗
PubMed1981

[Comparison between the hemodynamic effects of nitroglycerine ointment and oral isosorbide dinitrate in the treatment of left ventricular failure (author's transl)].

The hemodynamic effects of standard dose of Nitroglycerin (NTG) ointment (23 +/- 4 mg) and oral Isosorbide Dinitrate (ISDN) 10 mg were compared in the treatment of left ventricular failure. Ten patients, 8 males and 2 females (mean age 59 +/- 9 years), affected by acute myocardial infarction (7 cases). Ischemic cardiomyopathy (2 cases) and hypertensive cardiomyopathy (1 case) were submitted to right heart catheterization by triple lumen Swan-Ganz catheter. Heart Rate (HR), mean Arterial Pressure (AP), Right Atrial Pressure (RAP), mean Pulmonary Artery Pressure (PAP), Pulmonary Wedge Pressure (PWP), Stroke volume (SV), Cardiac Index (CI), Stroke Work Index (SWI), Systemic Vascular Resistances (SVR), Pulmonary Total Resistances (PTR) were controlled every 30 minutes until the disappearance of the hemodynamic effects. ISDN did not produce any statistically significant changes; on the contrary NTG ointment caused significant changes in: (formula: see text). Decrease of RAP, PAP, PWP, PTR and increase of SV, CI, SWI were statistically significant from 30 until 180 minutes after NTG ointment administration. These changes were statistically different from those produced by ISDN (p less than 0,05). Thus NTG ointment, at this dose, improved cardiac performance, while oral ISDN 10 mg did not. It is concluded that the hemodynamic effects of NTG ointment are prompt and sustained.

Administration, Oral↗
PubMed1980

[Pulmonary artery pressure measurement for assessment of bioavailability of isosorbide dinitrate and pentaerythritol tetranitrate (author's transl)].

In a double-blind cross-over study with 9 patients suffering from ischemic cardiomyopathy with cardiac failure, the effect of 3 different drug preparations on pulmonary artery pressure (PA-pressure) was studied. Iso-Ameritrat is a new drug-combination consisting of a sweet-tasting wrap containing 2.5 mg Isosorbide Dinitrate (ISDN) and of a bitter-tasting core containing 10 mg Pentaerythritol Tetranitrate (PETN) and 200 mg Meprobamate. A statistically significant decrease of PA-pressure values could be observed already 3 minutes after administration of Iso-Ameritrat. Within the next minutes this decrease even augmented and lasted over the whole period of measurement (30 minutes). After administration of the second drug preparation (Ameritrat), containing 10 mg PETN and 200 mg Meprobamate in the core, but not any nitrate in the wrap a slight but also statistically significant decrease of PA-pressure values could be documented. Therefore a sublingual resorption of PETN can be assumed. The precise beginning of the effect of PETN couldn't be assured, but it must be within 5 minutes. A thir preparation, containing only 200 mg Meprobamate in the bitter tasting core caused no significant decrease of PA-pressure values.

Adult↗
PubMed1982

[Effects of isosorbide dinitrate on systemic haemodynamics, regional coronary blood flow and ST-segment. A study on normal and/or ischaemic dog heart (author's transl)].

In dogs, isosorbide dinitrate (ISDN) reduced venous return, and in spite of mild tachycardia the cardiac output fell by reduction of stroke volume. Depending on modalities of administration, the drug had little or no influence on systemic arterial pressure. Cardiac inotropism remained unchanged. Heart work was consistently reduced. During temporary occlusion of the left coronary artery, ISDN had little effect on regional blood flow in normal myocardial areas but increased transmural blood flow and the endocardium/epicardium perfusion ratio in ischaemic areas. The redistribution of coronary blood flow produced by ISDN to the benefit of ischaemic areas was accompanied by a simultaneous decrease in the intensity of electric ischaemia.

Animals↗
PubMed1982

[Value of isosorbide dinitrate injection in the acute phase of myocardial infarction. Clinical and haemodynamic study (author's transl)].

Left ventricular failure is one of the most common complications of acute myocardial infarction and may have very serious haemodynamic consequences. Isosorbide dinitrate administered by intravenous infusion in doses of 3 to 7 mg/hour had highly beneficial effects on pre-load and frequently improved cardiac output. The results obtained in this series of 10 consecutive patients demonstrate that the drug has very favourable effects on the immediate prognosis of myocardial infarction.

Adult↗
PubMed1982

[Use of isosorbide dinitrate (Risordan) injection in left ventricular failure following acute myocardial infarction (author's transl)].

Haemodynamic and echocardiographic studies of isosorbide dinitrate were conducted in 12 patients (8 men and 4 women) with left ventricular failure consecutive to recent myocardial infarction. The groups: group I received 5 mg/h and group II 10 mg/h Risordan intravenously. After one hour treatment, group I patients showed a significant fall in both PAP (from 32.3 +/- 5.3 to 26.7 +/- 6.9 mmHg; p less than 0.01) and PCP (from 21.8 +/- 4.7 to 17.3 +/- 7.7 mmHg; p less than 0.05). These haemodynamic changes were amplified after a second hour of treatment: PAP fell to 24 +/- 7.9 mmHg (p less than 0.01) and PCP to 14.2 +/- 4.4 mmHg (p less than 0.001). RAP decreased from 7.2 +/- 5.1 to 3.5 +/- 5 (p less than 0.05). There were no changes in heart rate, systemic arterial pressure, peripheral resistance, cardiac index, forward stroke work nor, on echocardiography, in ventricular diameters, shortening fraction and VCF. After one hour treatment, group II patients showed a fall in PAP (from 30.5 +/- 4.7 to 21.7 +/- 3.5 mmHg; p less than 0.01), PCP (from 21.7 +/- 4.8 to 14.8 +/- 4.9 mmHg: p less than 0.001) and RAP (from 10.3 +/- 2.9 to 7.2 +/- 2; p less than 0.01). The systolic diameter of the left ventricle was reduced from 66.3 +/- 10.6 to 64.3 +/- 11.3 (p less than 0.01). After 4 hours, improvement in PAP and PCP was maintained; the other values remained stable. The effectiveness of Risordan i.v. in left ventricular failure consecutive to acute myocardial infarction is due to reduction of filling pressures in the left ventricule. With the 10 mg/h dose, as opposed to the 5 mg/h dose, the systemic arterial pressure and the double and triple products tend to be reduced, which suggests greater effectiveness.

Aged↗
PubMed1982

[Intravenous isosorbide dinitrate in acute cardiac failure (author's transl)].

Isosorbide dinitrate (ISDN) was used by intravenous infusion in 7 patients with acute cardiac failure consecutive to acute (5) or chronic (1) myocardial infarction or to non-obstructive cardiomyopathy (1). Pulmonary artery pressure (PAP), pulmonary capillary pressure (PCP), right atrial pressure (RAP) and cardiac output were measured (PCP), right atrial pressure (RAP) and cardiac output were measured by intracardiac catheterization. The initial dosage of 2.5 mg/hour was increased until PCP was reduced to 15 mmHg or less or until troublesome side-effects developed. Control was achieved in 3 patients with doses of 2.5 to 7 mg/hour and, to a lesser extent, in one patient with up to 20 mg/hour. Three patients failed to respond even to higher doses and needed furosemide i.v. or furosemide + dobutamine. One patient died of cardiogenic shock. No changes in cardiac output, heart rate and blood pressure and no clinical side-effects were recorded. Thus, in acute cardiac failure ISDN may be effective in doses slightly superior to those of nitroglycerin, but increasing the dosage above 7 or 8 mg/hour does not bring additional benefits. The drug is remarkably well tolerated.

Acute Disease↗
PubMed1982

[Effects of isosorbide dinitrate injection on acute myocardial infarction. A haemodynamic and gamma-angiographic study (author's transl)].

The haemodynamic and gamma-angiographic effects of isosorbide dinitrate (ISDN) injection were evaluated in 18 patients with recent myocardial infarction by measuring diastolic (DPAP) and systolic (SPAP) pulmonary artery pressures, diastolic (DAP) and systolic (SAP) systemic arterial pressures, cardiac index (CI) and heart rate (HR). Total ejection fraction (EF) was measured by radionuclide angiography. Within the first hour of treatment, there was a significant fall in DPAP (from 25.11 +/- 6.5 to 18.3 +/- 6 mmHg), SPAP (from 47 +/- 11.5 to 36.6 +/- 10 mmHg) and SAP (from 140 +/- 27.8 to 123 +/- 20 mmHg). Changes in DAP, CI and HR were not significant. The drug produced a significant increase in EF (from 32.6 +/- 15 to 35.3 +/- 15 p. cent). On the basis of these results the patients could be divided into three categories: -- Group I patients (n = 5) with EF greater than 45, in whom the haemodynamic effects (fall in DRAP from 20.8 +/- 4.2 to 16.3 +/- 3 mmHg) and the gamma-angiographic effects (increase in EF from 53.8 +/- 6 to 58.6 +/- 3 p. cent) were favourable. -- Group II patients (n = 5) with EF less than 40, in whom the haemodynamic effects (fall in DRAP from 29 +/- 8.5 to 17.8 +/- 6 mmHg) and the gamma-angiographic effects (increase in EF from 23 +/- 9 to 34 +/- 7 p. cent) were still favourable. -- Group III patients (n = 8) with low EF, in whom there were no significant changes in haemodynamic effects (DPAP from 25.3 +/- 3 to 23.4 +/- 5 mmHg) and gamma-angiographic effects (EF from 26 +/- 6 to 25 +/- 5 p. cent). This group corresponds to cases with very extensive necrosis of unfavourable outcome (4 deaths). One may therefore consider that the lack of effectiveness of ISDN in subjects with left ventricular failure and low EF is of poor prognosis and requires more aggressive therapy.

Adult↗
PubMed1982

Isosorbide dinitrate alone and in association with intra-aortic balloon counterpulsation in acute myocardial infarction. A clinical study by precordial ECG mapping.

The effects of the association of Isosorbide Dinitrate (ISDN) and Intra-Aortic Balloon Counterpulsation (IABCP) on ECGphic signs (in 24-lead precordial maps) of myocardial damage were studied in 7 patients (pts) with anterior acute myocardial infarction (AMI) without cardiogenic shock and/or pulmonary congestion, admitted to the CCU within 6 hours (hrs) since the chest pain. Matched control group consisted of 7 pts treated with ISDN alone. Analysis of variance showed that the association of IABCP and ISDN influenced favourably (p less than 0.01) the trend of the sigma ST (in all leads and in those with ST segment elevation greater than 0.2 mV), of the ST and of NST. The trend of sigma R was similar in the two groups. sigma Q was influenced either by time and by therapy; NQ was significantly lower (p less than 0.01) in pts treated with ISDN and IABCP. These findings seem to give evidence that the association of ISDN and IABCP may really be effective in reducing and stabilizing the ECG extent of ischemic myocardial injury in pts with transmural AMI without left ventricular failure; however this aggressive therapy cannot have a widespread indication until more reliable criteria for evaluating infarct size are available and larger randomized clinical trials performed.

Assisted Circulation↗
PubMed1981

Plasma levels of isosorbide dinitrate and its main metabolites following oral administration of two sustained release formulations in normal man.

The plasma levels of isosorbide dinitrate (ISDN) and the two pharmacologically active metabolites were measured following administration of two oral sustained release formulations containing 40 mg ISDN in nine healthy male volunteers. The new galenic formulation (pellets in a hard gelatin capsule) resulted in generally higher plasma levels for all three assayed substances over the time period of 24 h. The pharmacokinetic interpretation of the plasma levels following administration of the sustained release capsule assuming a one-compartment body model with zero-order invasion and first-order elimination showed a constant liberation over approximately 5 h. The elimination of all three substances was not altered by the new formulation. The plasma levels after administration of the tablet formulaation showed great variations within and between individuals. These data could therefore not be interpreted by the same model.

Administration, Oral↗
PubMed1981

Finger pulse plethysmographic effects of two oral sustained-release formulations of isosorbide dinitrate in normal man.

Two sustained release formulations of 40 mg isosorbide dinitrate, encapsulated pellets and a tablet, were compared double blind following oral administration of single doses in terms of response on finger pulse plethysmography in nine healthy male volunteers. Following both formulations there was a distinct effect on the depth of b-wave in the first derivative of the finger pulse up to 9 h after administration. This change of the parameter of nitrate action was significantly different from placebo for both formulations. The onset of action was more rapid and the peak response greater for the capsule than for the tablet. The overall effects in terms of area under the effect-time curves was also greater for the capsule than for the tablet, however, not statistically significant. Furthermore, the results show that the method of finger pulse plethysmography can be used to determine onset and duration of action nitrate compounds, after single dose administrations.

Administration, Oral↗
PubMed1980

[Pharmacodynamic effects of the sustained-release tablet of isosorbide dinitrate and its bioavailability in conscious dogs (author's transl)].

Oral administration of isosorbide dinitrate (ISDN), 1 approximately 2 mg/kg, resulted in a dose-dependent decrease in the pulse pressure by reducing the systolic pressure and slightly elevating the diastolic pressure in conscious dogs. Therefore, this system was employed to evaluate the effectiveness of the sustained-release ISDN tablet as compared with that of the standard tablet. Four standard tablets (20 mg of ISDN) given in a single dose significantly decreased the pulse pressure, which became lowest at 2 hr after administration and returned to the near original level at 6 hr. On the other hand, with four sustained-release tablets (80 mg of ISDN) 4 hr was required to produce a maximum decrease, and at 10 hr, the pulse pressure was still much lower than the original level. The plasma concentration of ISDN was measured by a gas chromatographic method. The time course of the plasma concentration of ISDN after administration of each preparation was correlated with that of the decrease in the pulse pressure. This suggests that the system employed is useful in evaluating the bioavailability of various preparations of organic nitrates (ISDN). In addition, these data demonstrate that the sustained-release formulation of ISDN possesses a prolonged pharmacological effect.

Animals↗
PubMed1980

Reduction of myocardial ischemic injury with sublingual isosorbide dinitrate.

Twenty-one patients with acute anterior myocardial infarction had precordial ST segment mapping, using a system of 42 leads, at 0, 2, 4, 8, 24, and 48 hours (control group). Eleven patients (treatment group) had maps on admission and after 30-45 minutes; then serial maps were performed at similar intervals after 5-10 mg of isosorbide dinitrate (ISD). There were no significant differences in age, sex, functional class, mean time elapsed between onset of chest pain and admission, and inhospital mortality between the groups. Controls had a higher incidence of recurrent MI (6 patients vs 2) compared with the ISD group (P less than 0.05).The sum of ST segment elevations in all leads (ΣST) was similar in both groups on admission and remained at the same level in controls for 48 hours. One hour after ISD the blood pressure decreased significantly; ΣST and the number of leads with more than 1 mm ST elevation (NST) decreased significantly (62±10 to 31±4 / 26±1 to 19±2) (P less than 0.01). In the ISD group serial ST maps showed significant decreases (52±5 vs 28±4; 44±4 vs 26±2; 45±4 vs 29±3; 51±5 vs 28±3, 52±8 vs 28±2, respectively at 2, 4, 8, 24 and 48 hours), suggesting reduction of ischemic injury by ISD.Estimation of infarct size (in units from R wave height and Q and S wave depths in leads I, AVL and V(1)-V(6)) indicated a reduction in the ISD group on days one, two and seven. Total CPK, SGOT and LDH levels were similar on admission; at 24 and 48 hours after admission CPK values were not significantly different but SGOT and LDH were lower in the treated group.

Aged↗
PubMed1980

[Influence of isosorbide dinitrate on haemodynamics and gas exchange in acute respiratory distress syndrome (author's transl)].

The effects of intravenous isosorbide dinitrate (ISDN: 3, 6, 9, and 12 mg/h) on systemic and pulmonary vasculature, gas exchange, and dynamic lung compliance were investigated in 7 controlled ventilated patients suffering from ARDS after trauma or in sepsis. Parameters were recorded before and after 20 min. ISDN infusion with 30 min interruption between the different dosage steps. Systemic circulation, heart rate, cardiac index, and stroke index remained grossly unchanged. MPAP was significantly decreased at 6, 9, and 12 mg/h ISDN to 61,7%, 61%, and 69,3% of initial value, as well as PCWP to 49,6% 45,5% and 41,5% of initial value. The drop of RVSWI at 6 and 9 mg/h ISDN to 59,1% and 63,2% also was statistically significant. There was an increase in Qs/Qt, AaDO2, and dynClung, though the increases were not statistically significant. O2availability remained unchanged. Administration of ISDN in ARDS causes an improvement in right ventricular function due to a reduction of pre- and afterload as well as intrapulmonary blood volume. In a similar manner increasing lung compliance may be explained by volume shif. The slight alterations of ventilation-perfusion-ratio as seen by increases in Qs/Qt and AaDO2 can be tolerated because of the unchanged O2availability.

Hemodynamics↗