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PubMed1990

Effect of isosorbide dinitrate on enzymatically estimated infarction size and on clinical condition of the patients of acute myocardial infarction.

With the aim of reducing myocardial infarction size, isosorbide dinitrate (ISDN) was tried in 27 patients of acute myocardial infarction (AMI). There was 11% reduction of infarction size, in the ISDN treated group, in comparison to that of non treated group, though the result was not statistically significant. But, many of the in-hospital complications were significantly less in the treated group. After a critical analysis of the result it was concluded that a statistically insignificant result, as regard reduction of infarction size in AMI, cannot always exclude the utility of a drug therapy in AMI.

Creatine Kinase↗
PubMed1987

Nitrate tolerance: comparison of nicorandil, isosorbide dinitrate, and nitroglycerin in anesthetized dogs.

Development of tolerance to nicorandil (NCR), N-(2-hydroxyethyl)nicotinamide nitrate (ester), was compared with that to nitroglycerin (NTG) or isosorbide dinitrate (ISDN) in dogs. An intracoronary arterial (i.a.) injection of NCR (20 micrograms), ISDN (30 micrograms), or NTG (1 microgram) caused coronary vasodilation. Development of tolerance (including cross-tolerance) was determined by examining whether the coronary vasodilating effect of i.a. injection of these drugs was attenuated by a 2-h infusion of NCR, ISDN, or NTG. The effect of i.a. injection of NCR was not affected by i.v. infusion of either NCR (10 micrograms/kg/min), ISDN (10 or 30 micrograms/kg/min), or NTG (1 or 3 micrograms/kg/min). The effects of i.a. injection of NTG and ISDN, however, were attenuated by the NTG or ISDN infusion, whereas they were unaffected by the NCR infusion. Additionally, the coronary vasodilating effect of NCR infusion (30 micrograms/kg/min) or ISDN (30 micrograms/kg/min). These results suggest that NCR does not produce tolerance, whereas NTG and ISDN do, and that there is no cross-tolerance between NCR and NTG, or ISDN in terms of the coronary vasodilating effect.

Anesthesia↗
PubMed1989

Isosorbide dinitrate ameliorates myocardial ischemia after development of collateral function in a canine model.

The effects of i.v. administered isosorbide dinitrate (ISDN) on the reduced level of regional myocardial function during coronary occlusion were studied in conscious dogs before and after collateral development and in the absence of persistent coronary stenosis. The animals were instrumented during sterile surgery with a miniature pressure gauge for measuring left ventricular pressure and a cannula for aortic pressure. Two pairs of piezoelectric crystals were placed in normal and ischemic areas to determine regional circumferential length. A hydraulic cuff occluder and a Doppler flow probe were placed around the left circumflex coronary artery. Collaterals were induced to develop by 2 min of coronary occlusion applied repetitively at an interval of 32 min for 2 to 9 days, until the regional dysfunction produced by coronary occlusion had disappeared. Collateral development was estimated according to percentage of systolic shortening and endsystolic length area (ESL area) during the occlusion. Before collateral development, ISDN in a dose of 100 micrograms/kg did not affect the level of regional dysfunction. The ESL area was 250 +/- 54 and 248 +/- 52 mm.sec before and after ISDN, respectively. After collateral development, the ESL area was 51 +/- 13 mm.sec and it decreased by 35% after the i.v. administration of ISDN. The improvement by ISDN of transient myocardial dysfunction was achieved even during electrical tachypacing. Accordingly, the beneficial effects of ISDN on regional wall motion rendered ischemic during transient coronary occlusion were appreciable after coronary collateral development.

Animals↗
PubMed1989

[Lack of tolerance development in interval therapy with 50 mg isosorbide-5-nitrate retard (Elantan long)].

Fluctuating mononitrate plasma levels in the course of 24 h are a prerequisite for prevention of nitrate tolerance in patients with angina pectoris undergoing longterm treatment. In 12 patients with angiographically proven coronary artery disease (54 +/- 7 years) effects of 50 mg Isosorbide-5-mononitrate (IS-5-MN) in a slow-release (SR) formulation on hemodynamics and exercise tolerance were evaluated after a first dose and at the end of a 1-week treatment period with 50 mg given once-daily. 1 and 2 h after medication mean pulmonary artery pressure (PAP) at rest was reduced by 30% (p less than 0.001) and 25% (p less than 0.01 respectively. During submaximal bicycle exercise (50 W, 3 min) PAP was significantly reduced by IS-5-MN by 35% (1 and 2 h after medication). At the end of exercise (discontinuation), drug-induced reductions of PAP were 19% (1 h) and 21% (2 h) (p less than 0.05), respectively. IS-5-MN led to a marked increase of exercise capacity (base-line: 396 +/- 119 W x min); 1 h: 646 +/- 153 W x min (p less than 0.01). At stress testing 2, 4 and 10 h post medication improvements were 67% (p less than 0.01), 49% (p less than 0.01) and 28% (p less than 0.01), respectively. 24 h after medication baseline values were reached again. After a 1-week treatment with 50 mg IS-5-MN SR daily, beneficial effects of the drug on hemodynamics and working capacity could be demonstrated. Again, significant effects could be shown up to 10 h after drug administration. Thus, IS-5-MN SR administered once daily proved effective in intermediate-term treatment of patients with coronary artery disease with regard to hemodynamics and exercise capacity.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

[Combination therapy with isosorbide dinitrate and verapamil in patients with coronary heart disease and hypertension: effect on blood pressure, ischemia and left ventricular function].

In the treatment of myocardial ischemia in hypertensive patients, nitrates as the basic compound have to be combined with another substance in order to achieve a maximum effect and a 24-h-protection. As these patients often show an impaired left ventricular function because of arterial hypertension or previous myocardial infarction, a further deterioration of the left ventricular ejection fraction (EF) has to be avoided. We therefore investigated in a pilot study. EF, blood pressure, and ST-segment depression under isosorbide dinitrate 120 mg s.r. alone, and in combination with verapamil 120 mg s.r. in 14 male patients with angiographically proven coronary artery disease and arterial hypertension. EF at rest ranged from 29% to 76%. Radionuclide ventriculography was performed at rest and simultaneously with the ECG during exercise before medication, 2 h after ISDN and 4 h after the additional intake of verapamil. The systolic blood pressure at rest fell from 159 +/- 14 to 132 +/- 10 (p less than 0.001) after 2 h and to 132 +/- 16 mmHg after 6 h (p less than 0.01). During exercise there was a decrease from 196 +/- 21 to 174 +/- 21 (p less than 0.01) and to 178 +/- 22 mmHg (p less than 0.001), respectively. The ST-segment depression was reduced from 2.2 +/- 1.1 to 0.8 +/- 0.6 (p less than 0.01) and to 0.9 +/- 0.5 mm (p less than 0.001). EF at rest improved from 53 +/- 14% to 57 +/- 14% after ISDN alone and to 58 +/- 15% after ISDN + verapamil (p less than 0.01), and during exercise from 57 +/- 20% to 62 +/- 19% (p less than 0.05) and to 61 +/- 17% (n.s.). Even in the subgroup of patients with impaired LV-EF (8 at rest and 7 pts during exercise) there was a significant improvement (p less than 0.05) as well after ISDN alone, as there was with combination therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

[Assay of plasma isosorbide dinitrate and its metabolites after oral administration of immediate and delayed-action forms].

This paper describes a kinetic comparative study of plasma concentrations of isosorbide dinitrate (ISDN) and its mononitrate derivatives (2-ISMN or 5-ISMN) after oral administration of a sustained release form of ISDN or a (non) sustained release form of 5-ISMN. The blood extracts determinations were performed by electron capture gas chromatography which is an accurate and sensitive method suitable for the quantitation of concentrations in the nanogram per ml range. The results are in good agreement with those of the literature. The standard form of 5-ISMN is rapidly absorbed. The Tmax value is approximately 1H with a corresponding Cmax value close to 400 ng/ml. For the sustained release drugs, the Tmax increases to 6H and Cmax is nearly half the 5-ISMN standard form value. Considering the administered dose, it seems better to use 5-ISMN than ISDN. For a long lasting treatment of angina pectoris and ischaemic cardiac diseases, both forms can be used.

Administration, Oral↗
PubMed1989

[Efficacy and length of action of a slow-release formulation of isosorbide-5-mononitrate in stable effort angina].

This double-blind randomized placebo-controlled study was designed to evaluate the acute effects of orally administered slow-release isosorbide-5-mononitrate (SR IS-5-MN) in 12 patients with chronic stable angina. After a prestudy screening to assess the reproducibility of exercise response, the patients entered the study lasting 5 days. On the first and fourth day of the trial, each patient underwent a bicycle exercise test 4, 8 and 24 hours after acute administration of SR IS-5-MN 50 mg or placebo. Statistic analysis of the results was performed using a 2-way analysis of variance for cross-over design. Compared to placebo, 4 hours after administration, SR IS-5-MN prolonged the exercise time from 525 +/- 162 s to 685 +/- 207 s (p less than 0.05; 30%) and - 1mm time from 437 +/- 147 s to 562 +/- 219 (p less than 0.05; 29%). After 8 hours SR IS-5-MN prolonged the exercise time from 510 +/- 145 s to 615 +/- 189 s (p:ns; 21%), and - 1mm time from 415 +/- 128 s to 522 +/- 205 s (p less than 0.05; 26%). No significant changes were observed 24 hours after SR IS-5-MN administration. The maximal rate-pressure product was significantly increased by SR IS-5-MN 4 hours after administration.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

[Extent of therapeutic effect and duration of 1 capsule of 120 mg isosorbide dinitrate in a slow release form].

In this randomised, double-blind placebo-controlled crossover study we investigated the efficacy of 120 mg isosorbide dinitrate s.r. 12 h after application in comparison to 2 and 6 h in 18 patients with angiographically proven coronary artery disease, stable exercise-induced angina and reproducible ST-segment depression. Bicycle ergometry was performed before, 2, 6 and 12 h after medication and nitrate plasma levels were drawn before each exercise test. After 2 h, the exercise-induced ST-segment depression in comparison to placebo was reduced from 2.3 mm +/- 0.8 to 0.7 +/- 0.5, after 6 h to 1.0 mm +/- 0.8) and after 12 h to 1.9 mm +/- 0.8 (p less than 0.01). 82% of the patients suffering from angina on the control exercise test before medication were free of symptoms 2 and 6 h after ISDN 120 mg s. r., but showed angina again after 12 h. In comparison to the plasma levels 2 h after ingestion, the concentrations in plasma after 12 h were much lower for ISDN, equal for IS-2-MN, and more than double for IS-5-MN. Thus, 12 h after ingestion of 120 mg ISDN s.r. there is still a significant reduction of ST-segment depression. This 12-h benefit is 40% od the maximum effect.

Aged↗
PubMed1989

[Effects of slow-release isosorbide-5-mononitrate on ergometric parameters and cardiac output in stable effort angina pectoris: a double-blind randomized placebo study].

The effects of a single oral dose of 60 mg of sustained release (R) isosorbide-5-mononitrate (ISM) administered in 9 male patients (mean age: 53 +/- 7 years) with stable exercise-induced angina pectoris were studied in a randomized, double blind, cross-over study. The effectiveness of the drug was evaluated by concomitant ergometer exercise stress test and cardiac output determination (bioimpedance method, Bomed Med-Ltd) performed 1 hour before and 1, 4, 10 and 24 hours after acute administration of placebo (P) and ISM-R. After P, all patients showed a positive exercise test, whereas 3 patients during ISM-R treatment had a negative exercise stress test 1 and 4 hours after ISM-R administration. Compared with P, ISM-R produced a statistically significant improvement of exercise stress test parameters at peak exercise (maximum work load, heart rate, systolic and diastolic blood pressures and double product) up to 10 hours after drug administration. On the other hand, cardiac output did not significantly differ at any time after ISM-R compared with both control conditions and P treatment. Moreover, no side effect was detected in any patient during the study. In conclusion, a single oral dose of 60 mg of sustained-release ISM-R seems to be an effective drug in the treatment of effort angina, its effectiveness lasting more than 10 hours without side effects.

Adult↗
PubMed1989

[The anti-ischemic effect of isosorbide dinitrate alone and in combination with gallopamil and propranolol].

In 18 patients (17 male and 1 female, 40 to 63 years old) with coronary heart disease, a randomized double-blind study was carried out to investigate in comparison to placebo, the antiischemic effects of 5, 10 and 20 mg isosorbide dinitrate (ISDN) alone and in combination with gallopamil (G: 25 and 50 mg) or 80 mg propranolol (P: 80 mg) on the ischemic ST-segment-depression in standardized exercise ECGs. ST-depression following administration of ISDN alone was reduced significantly and dose-dependently: following 5 mg from 1.32 +/- 1.14 to 1.0 +/- 0.85 mm (-25.2%; p less than 0.05), 10 mg from 1.17 +/- 0.85 to 0.91 +/- 0.69 mm (-21.7% n.s.) and 20 mg from 1.19 +/- 0.5 to 0.52 +/- 0.57 mm (-53.6%; p less than 0.001). In combination with gallopamil (G: 25 and 50 mg) or propranolol (P) reduction of ST-depression was more pronounced: by 5 mg ISDN with 25 mg G from 1.32 +/- 1.14 to 0.7 +/- 0.71 mm (-46.4%; p less than 0.05), with 50 mg G from 1.32 +/- 1.14 to 0.8 +/- 0.83 mm (-38.8%; p less than 0.01), with 80 mg P from 1.32 +/- 1.14 to 0.28 +/- 0.35 mm (-79.5% p less than 0.01), by 10 mg ISDN combined with 25 mg G from 1.17 +/- 0.85 to 0.69 +/- 0.6 mm (-40.7%; p less than 0.05), with 50 mg G from 1.17 +/- 0.85 to 0.66 +/- 0.62 mm (-43.5%; p less than 0.05), with 80 mg P from 1.17 +/- 0.85 to 0.64 +/- 0.78 mm (-46.4%; p less than 0.01), and by 20 mg ISDN with 25 mg G from 1.19 +/- 0.5 to 0.42 +/- 0.43 mm (-62.6%; p less than 0.001), with 50 mg G from 1.19 +/- 0.5 to 0.39 +/- 0.45 mm (-65.2%; p less than 0.001) and with 80 mg P from 1.19 +/- 0.5 to 0.05 +/- 0.16 mm (-95.8%; p less than 0.001).

Adult↗
PubMed1989

Determination of isosorbide-5-mononitrate in tablets by differential pulse polarography.

A differential pulse polarographic method requiring little sample separation was developed for the determination of isosorbide-5-mononitrate in tablet dosage form with the standard addition technique and without interference from common excipients. Britton-Welford buffer (pH 3.0) was used as the supporting electrolyte, the single peak occurring at -0.36 V vs. a reference Ag/AgCl electrode. The irreversible, diffusion controlled, two-electron reduction process at the dropping mercury electrode permits a precise and accurate determination of the active ingredient in the 0.4-20 microgram/ml concentration range.

Indicators and Reagents↗
PubMed1989

[Moniside (isosorbide-5-mononitrate)--the effect on some changes in a hyperlipoproteinemia mode in rats].

The influence of the preparation moniside (isosorbide-5-mononitrate on some functional, lipid and enzymic changes in a model of hyperproteinemia of rats was investigated. Studies were carried out on 45 male rats, divided into 3 groups: I group-control, nontreated; II group--control treated with cholesterol diet; III group--experimental treated with cholesterol diet and monoside in a dose of 20 mg/kg of body weight orally 6 days a week. The experiment continued 3 months. Changes in general state, body mass, static physical endurance, stability to electric current were described as well as the following lipid parameters: cholesterol (mmol/l), cholesterol in lipoproteins with high density (LHD), cholesterol in lipoproteins with low and very low density (LLD, LVLD), tryglycerols (Tr), free fatty acids (FFA). Changes in enzymic activity of aspartataminotransferase (ASAT), alaninamidotransferase (AlAt), hydroxybutiratdehydrogenase (HBDH) and creatinphosphokinase (CPK). Morphological examinations of heart, aorta, liver, kidneys and adrenal were made as well. The results from the experiments showed that in a model with hyperlipoproteinemia general state of experimental animals was impaired, body mass was reduced, physical endurance and stability to electric current reduced, while cholesterol and LVLD/were increased, AlAt increased mult many times, but HBDH and CPK diminished their activity. Functional possibilities of the organism increased at a slight degree under the influence of monoside. Lipid changes, established after cholesterol diet, did not change substantially, while deviations in enzymic activity were normalized.

Animals↗
PubMed1989

Performance of a slow-release formulation of isosorbide-5-mononitrate (ISMO retard).

From the in vitro release-rate constant of a new sustained-release (SR) preparation of 40 mg isosorbide-5-mononitrate, the concentration-time profile in healthy subjects could be excellently predicted. Therapeutically, effective concentrations of 100 ng/ml were achieved within 20 min and lasted up to a maximum of 15.6 h. The decline of concentrations below this value thereafter, guarantees the absence of tolerance development in chronic therapy. In a three-period change-over study, two other commercial SR preparations exhibited only 79% and 53% of the bioavailability of the new formulation, which was significant in both cases. Compared with literature data, the absolute bioavailability of the new form should lie in the order of at least 85%.

Adolescent↗
PubMed1987

[Ischemia tolerance of the heart in percutaneous transluminal coronary angioplasty. Controlled study of the effect of isosorbide dinitrate and nifedipine].

In a randomized controlled study, influence of sublingual isosorbide dinitrate (ISDN) and nifedipine on ischemic tolerance of the heart during percutaneous transluminal coronary angioplasty (PTCA) was examined. After dilations without premedication except heparin ten patients received 10 mg ISDN sublingually and dilations after one, five, and ten minutes were repeated, then 20 mg nifedipine sublingually was administered followed by dilations at one, five, ten, and 15 minutes intervals (group A). First 20 mg nifedipine and then 10 mg ISDN were given sublingually with the same repeated dilations in ten patients forming group B. Mean arterial pressure decreased from 111 +/- 11 to 97 +/- 14 mmHg after ISDN (p less than 0.001) in group A and to 86 +/- 12 mmHg after nifedipine (p less than 0.001). In group B arterial pressure remained constant after nifedipine and decreased to 84 +/- 15 mmHg after ISDN (p less than 0.05). Coronary perfusion pressure in group A remained constant at about 27 +/- 11 mmHg and increased in group B from 27 +/- 14 to 31 +/- 20 mmHg after nifedipine and decreased to 20 +/- 16 mmHg after ISDN (n.s.). Dilation period increased in group A from 33 +/- 15 s to 69 +/- 25 s after ISDN (p less than 0.001) and remained constant after nifedipine 67 +/- 23 s. Dilation time in group B increased from 31 +/- 8 s to 49 +/- 17 s after nifedipine (p less than 0.001) and to 81 +/- 46 s after ISDN (p less than 0.001). Time until ST segment depression of greater than 0.1 mV increased from 14 +/- 5 s to 37 +/- 19 s by ISDN in group A and to 33 +/- 16 s after nifedipine (p less than 0.001). Times in group B measured 16 +/- 5 s and 24 +/- 8 s after nifedipine and 39 +/- 24 s after ISDN (p less than 0.05). In groups A and B arrhythmias could be suppressed despite prolonged dilation times only by application of both drugs.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Sublingual↗
PubMed1988

[Isosorbide dinitrate: correlations between its anti-anginal effect, dosage form and administration schedule].

The action of various dosage forms of isosorbide dinitrate (ID) was studied with the help of repeated treadmill run in 28 CHD patients with stable angina of effort. The mean duration of the antianginal effect of ID standard tablets (nitrosorbide-NS) at a dose of 10 mg per os was 3.0 +/- 0.4 h. The effect of sublingual NS administration was more marked and the duration slightly less than in NS administration per os. ID of prolonged action isomac-retard containing 40 mg of ID produced an effect, insignificantly exceeding in duration the NS effect. Dinitrosorbilong (DNL) for gingival application produced and effect as marked as that of sublingual NS. The duration of the DNL effect significantly exceeded that of the effect of all ID dosage form under study (over 8 h). An increase in a NS dose per os did not result in an effect of the same degree and duration as that of DNL.

Administration, Buccal↗
PubMed1986

[Hemodynamic and anti-angina effects of transdermal nitroglycerin after acute and chronic administration. Additive effect of sublingual isosorbide dinitrate].

To evaluate the acute and chronic anti-anginal efficacy of a Transdermal Therapeutic System, releasing 10 mg of nitroglycerin over 24 hours (TTS 10), and possible additional effects of isosorbide dinitrate 5 mg (ISDN) sublingually (s.l.), ten patients with stable exercise-induced angina pectoris and pathological coronary angiography were studied. The protocol of the trial consisted of an initial acute study, carried out in double-blind conditions and following a cross-over design, to compare TTS 10 and placebo. Cycloergometric exercise tests were performed on the first and second day, 3 hours after dosing. After a 30 minute rest period, a sublingual 5 mg dose of ISDN was given and 15 minutes later a further exercise test was carried out. Subsequently, patients received TTS 10 in single-blind conditions for 16 days. On the 15th and 16th day, stress test was repeated, 3 hours after the application of active plasters and, 30 minutes later, a further exercise test was performed, 15 minutes after a sublingual dose of ISDN 5 mg or placebo, given in double-blind conditions and in randomized sequence. After acute and chronic administration, TTS 10 significantly improved exercise tolerance in comparison with placebo. During the first acute study, ISDN 5 mg s.l., led to a significant reduction in systolic BP, a reflex increase in heart rate and a further improvement in exercise tolerance, whether patients were on placebo or TTS.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗