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PubMedDate not supplied

[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↗
PubMed1989

[Isosorbide dinitrate treatment of silent myocardial ischemia in patients after myocardial infarction].

In a group of 17 men and women aged 38-65 years (means = 51.1) three months after the first myocardial infarction we studied changes in silent ischemic ST segment depression by using Holter monitoring and exercise stress testing before and after 120 mg/daily of oral isosorbide dinitrate (Isoket). Repeated ECG monitoring and exercise stress test were performed after two weeks. It was found that before isosorbide dinitrate therapy 16 out of 17 patients had 56 episodes of ST segment depression of 1-5 mm including 6 (37.5%) symptomatic episodes and 10 (62.5%) asymptomatic episodes. The number of asymptomatic episodes after isosorbide dinitrate therapy decreased more than five times (p less than 0.001), their duration was three times shorter (p less than 0.01). ST segment depressions were also significantly smaller. During isosorbide dinitrate therapy the duration of stress test was almost doubled and the achievable heart rate increased (p less than 0.02; p less than 0.05). The magnitude of ST segment depression during exercise testing also decreased significantly (p less than 0.01) and at heart rate below 100 beats/min ischemic ST segment depression were not observed, in contrast to pre-treatment period. Thus it may be concluded that silent myocardial ischemia is a frequent event in patients after the first myocardial infarction and isosorbide dinitrate significantly decreases the number of symptomatic and asymptomatic episodes detected by Holter monitoring.

Adult↗
PubMed1987

The use of isosorbide in the treatment of severe, uncontrolled hypertension.

Isosorbide dinitrate was administered sublingually and compared with placebo in a double-blind, randomized fashion to determine its effectiveness and safety in the rapid control of severe arterial hypertension. In 11 patients who received 10 mg of isosorbide dinitrate, blood pressure (BP) dropped from 205 +/- 8/131 +/- 3 to 166 +/- 9/106 +/- 5 mm Hg at 120 minutes. In eight patients who received placebo, BP dropped from 203 +/- 8/130 +/- 3 to 193 +/- 11/122 +/- 5 mm Hg at 120 minutes. When 10 mg of isosorbide dinitrate was administered sublingually after 120 minutes to placebo-pretreated patients, their BP dropped to 161 +/- 7/105 +/- 6 mm Hg at 240 minutes. Our study group (19 patients) was compared with a "control" group (six patients) whose BP (203 +/- 12/132 +/- 8 mm Hg) was treated only with conventional antihypertensive medications and bed rest; five (83%) of the six controls achieved steady BP control at 24 hours vs nine (47%) of the 19 study patients pretreated with isosorbide. There were no side effects, including hypotension, orthostatic effect, and reflex tachycardia. Sublingual isosorbide safely and effectively lowers systolic and diastolic BP in patients with severe, uncontrolled arterial hypertension.

Administration, Oral↗
PubMedDate not supplied

Patient self-reporting of compliance does not correspond with electronic monitoring: an evaluation using isosorbide dinitrate as a model drug.

STUDY OBJECTIVE: To assess the accuracy of patient-kept diaries relative to electronic monitoring of compliance with isosorbide dinitrate prescribed 3 times/day for ischemic heart disease. DESIGN: Unblinded, prospective, three-phase study. METHODS: Patients with coronary artery disease prescribed isosorbide dinitrate 3 times/day were asked to record the time of administration of each dose in a pocket diary while being monitored for compliance with a computerized Medication-Event Monitoring System (MEMS-4) vial that electronically recorded the date and time the vial was opened. RESULTS: Sixty-eight stable outpatients with documented coronary artery disease who were prescribed isosorbide dinitrate 3 times/day were evaluated. Based on a prospectively chosen definition including a nitrate-free period, the mean (+/-SD) overall compliance rates were 71% (+/-30) versus 55% (+/-32) for the patient-kept diaries and the MEMS vials respectively (p = 0.001). The concordance between patient-kept diaries and MEMS data indicate that 67% of patients overestimate their compliance when using a self-recording tool. An average of 30% of diary entries were in error compared with the MEMS vial recordings. CONCLUSIONS: Patient-kept diaries statistically overestimate actual compliance relative to that determined by MEMS devices. Given the prevalence of the use of diaries as the predominant tool on which researchers depend to document compliance with study drugs, our findings suggest that this practice should be reevaluated specifically when the time of the dose and documentation of administration are critical to qualifying the outcome of drug therapy. Such is the case with isosorbide dinitrate use in patients with ischemic heart disease. Furthermore, the overall poor compliance documented in this study suggests that the utility of isosorbide dinitrate prescribed 3 times/day be reevaluated as a clinically effective antianginal drug.

Administration, Oral↗
PubMed1997

[Study of the bioequivalence of a new isosorbide dinitrate tablet formulation compared with the standard preparation].

An investigation in the bioequivalence of a new tablet formulation with 5 mg isosorbide dinitrate (CAS 87-33-2, ISDN 5 von ct) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to isosorbide dinitrate was 107.5% and for Cmax 112.5%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to isosorbide dinitrate and the metabolites isosorbide-2-nitrate and isosorbide-5-nitrate, respectively. The difference in tmax showed no clinical relevance. The new formulation was bioequivalent to the reference.

Adult↗
PubMed1990

Enhancement of portal pressure reduction by the association of isosorbide-5-mononitrate to propranolol administration in patients with cirrhosis.

This study investigated whether oral doses of isosorbide-5-mononitrate, a preferential venous dilator that decreases portal pressure, could enhance the effects of propranolol on portal hypertension. Taking part in the study were 28 patients with cirrhosis and portal hypertension. Twenty patients (group 1) had hemodynamic measurements in baseline conditions after beta-blockade by intravenous administration of propranolol and after receiving oral doses of isosorbide-5-mononitrate. The remaining eight patients (group 2) were given oral isosorbide-5-mononitrate while receiving chronic propranolol therapy. In group 1, propranolol significantly reduced portal pressure (estimated as the gradient between wedged and free hepatic venous pressures) from 21.5 +/- 3.9 to 18.6 +/- 4.2 mm Hg (-13.7%, p less than 0.001), azygos blood flow (-38%, p less than 0.001), hepatic blood flow (-12.8%, p less than 0.05), cardiac output (-24.5%, p less than 0.001) and heart rate (-18.4%, p less than 0.001) without significant changes in mean arterial pressure. Addition of oral isosorbide-5-mononitrate caused a further and marked fall in portal pressure (to 15.7 +/- 3.1 mm Hg, p less than 0.001), without additional changes in azygos blood flow but with significant additional reductions in hepatic blood flow (-15.5%, p less than 0.05), cardiac output (-11.5%, p less than 0.001) and mean arterial pressure (-22%, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMedDate not supplied

Plasma concentrations of isosorbide dinitrate after cutaneous and sublingual doses to human subjects.

After application of 100 mg (nominal dose) isosorbide dinitrate as an ointment to the skin of human subjects, mean drug concentrations were 1 to 2 ng/ml for 1.5 hour and reached a peak of 6.2 ng/ml at 6 hours. Thereafter, mean concentrations declined slowly to 2.9 ng/ml at 12 hours and 1.2 ng/ml at 24 hours. After a sublingual dose of 5 mg isosorbide dinitrate, mean drug concentrations reached a peak of 15.9 ng/ml at 0.5 hour and declined with a half-life of about 50 minutes. The mean bioavailability of isosorbide dinitrate from the ointment was estimated as 30 per cent of that from the sublingual tablet when corrected for differences in dose/body weight ratio. The results demonstrate that concentrations of isosorbide dinitrate in plasma can be maintained for relatively long periods when the drug is applied to the skin.

Administration, Topical↗
PubMed1990

Altered hemodynamic response to isosorbide dinitrate in essential hypertension.

Relaxation produced by nitrates on venous, arteriolar, and large arterial vessels is well known but has never been studied in human hypertensive aortas studied in vivo. In this investigation, the effects of acute oral administration of 20 mg of isosorbide dinitrate were evaluated in 12 patients with sustained essential hypertension and nine normotensives of the same age. Noninvasive measurements of systolic, diastolic, and mean arterial pressure, carotid-femoral pulse wave velocity and aortic-arch diastolic diameter using suprasternal echocardiography were determined before and 3 hours after drug administration. In normal subjects, isosorbid dinitrate significantly decreased systolic blood pressure and pulse pressure but did not affect diastolic and mean arterial pressure. In contrast, in hypertensives, the same dosage of isosorbid dinitrate decreased together systolic, diastolic mean, and pulse pressure. In both populations, pulse wave velocity decreased significantly whereas aortic arch diastolic diameter increased markedly. The increase was observed mainly in normal subjects. The study provided evidence that (1) both in normal subjects and hypertensives, isosorbide dinitrate caused an increase in aortic diameter together with an increase in arterial distensibility; and (2) the changes in mean arterial pressure were significant only in hypertensives, indicating that the altered vasodilator response in essential hypertension is not endothelium-mediated.

Administration, Oral↗
PubMed1988

Utilization of diethyl-beta-cyclodextrin as a sustained-release carrier for isosorbide dinitrate.

Heptakis(2,6-di-O-ethyl)-beta-cyclodextrin (2) was prepared and its physicochemical properties, such as aqueous solubility and surface activity, were compared with those of beta-cyclodextrin (1) and heptakis(2,6-di-O-methyl)-beta-cyclodextrin (3). A possible utility of 2 as a sustained-release drug carrier was examined using a water-soluble drug, isosorbide dinitrate. The dissolution and release rates of isosorbide dinitrate from capsule and tablet forms were significantly retarded by the complexation with 2. The sustained-release pattern of isosorbide dinitrate was produced for a long period after the oral administration of a single dose of capsule or tablet containing the 2 complex to rats. The results indicated that 2 may serve as a hydrophobic drug carrier for sustained-release of isosorbide dinitrate.

Animals↗
PubMed1982

[Menière's disease and isosorbide as an oral hyperosmotic agent (author's transl)].

According to a nationwide survey in 1977 and average of 54.7% of Menière's disease patients were unable to function normally in their daily lives. These patients mostly complained of repeated attacks of vertigo (male 40.3%, female 29.2%) (Watanabe et al. 1980). For the purpose of improving the repeated attacks of vertigo, Isosorbide as an oral hyperosmotic diuretic was first administered orally to 21 patients with Menière's disease from November 1979 to January 1981 for reducing the endolymphatic hydrops that can be presumed to be of pathogenetic importance. The electrocochleographic examinations were carried out on these patients at the same time. Usually, the SP/AP wave form in the electrocochleographic examinations appears to be more abnormal in patients with a fluctuating hearing loss or a flat hearing loss. The average of negative SP/AP in 24 patients with Meniére's disease was 0.54. The indication of Isosorbide administration was determined by this particular SP/AP wave abnormality, and clinical of Isosorbide for the patients with Menière's disease were evaluated. In 18 patients who experienced relief, attack of vertigo did not occur in 12 (63%) and vertigo was relieved in six (31%). In two patients with long administration, hearing improvement could already be observed during the period of treatment. The electrocochleographic examinations showed a decrease in the SP/AP wave form. In two patients with short administration, hearing loss was temporarily observed in middle and low frequencies; the hearing loss later improved more than before treatment in these patients. In only one patient, aggravation of hearing was observed after administration, but whether it was a side effect or not, remains to be understood. The period of observation of these results was a mean value of 4 months and 12 days. The Isosorbide therapy in patients with Menière's disease in expected to replace saccus surgery.

Adult↗
PubMed1988

Intratympanic gentamycin therapy for Menière's disease placed by tubal catheter with systemic isosorbide.

In 1974, six patients with incapacitating unilateral Menière's disease were given an empiric treatment with intratympanic gentamycin sulfate via the eustachian tube using a tubal catheter with a small side-branch. These patients then showed excellent results with relief from vertigo over a 13-year period. Since 1980, we have treated patients suffering from Menière's disease with isosorbide. When patients could not be controlled with this therapy, isosorbide was given in addition to intratympanic gentamycin therapy using a tubal catheter. Of 75 patients with Menière's disease who received gentamycin and isosorbide therapy, 41 patients could be evaluated by the classification for Menière's disease proposed by the American Academy of Ophthalmology and Otolaryngology (AAOO). Subsequent results showed that vertigo improved in 73% of the patients. According to the AAOO classification, 11 patients (27%) were group A, 16 patients (39%) were group B, and 4 patients (10%) were group C. Eleven patients were group D (27%) and experienced persistent vertigo despite treatment. Our experiences show that patients with severe Menière's disease can be readily treated with intratympanic gentamycin therapy using a tubal catheter, even on an outpatient basis. This treatment is also a most effective treatment, as it allows the effects of isosorbide to be obtained with smaller doses of gentamycin sulfate.

Adult↗
PubMed1991

Pharmacokinetics of oral isosorbide-5-mononitrate in patients with ischemic heart failure.

This study compared the pharmacokinetics of orally administered isosorbide-5-mononitrate (20 mg) in patients with and without signs of ischemic heart failure after acute myocardial infarction. The central venous pressure was used as a parameter of global myocardial function and to separate 17 patients into two groups with normal (group I: CVP less than 6 cmH2O; Killip class I; n = 9) and elevated (group II: CVP greater than or equal to 6 cmH2O; Killip class II-III; n = 8) pressure. As compared to subjects with normal CVP patients with hemodynamic impairment showed a markedly lower peak concentration of isosorbide-5-mononitrate levels (475 +/- 32 vs 663 +/- 38 ngml-1; p less than 0.01; mean +/- SEM) which occurred delayed (32 +/- 6 vs 55 +/- 9 s; p less than 0.05). Reduced cardiac function also resulted in a prolonged elimination of isosorbide-5-mononitrate as was suggested by the diminished elimination rate constant (0.14 +/- 0.01 vs 0.18 +/- 0.01 h-1; p less than 0.05). Thus, in patients with ischemic heart failure cardiac performance influences both the absorption and apparent elimination phase of oral isosorbide-5-mononitrate.

Absorption↗
PubMed1983

The effects of glyceryl trinitrate, isosorbide dinitrate and sodium nitroprusside on haemodynamics, coronary blood flow and myocardial oxygen consumption - an experimental study.

The influences of glyceryl trinitrate, isosorbide dinitrate and sodium nitroprusside intravenously on haemodynamics, coronary circulation and myocardial oxygen consumption were investigated in closed chest dogs (n = 8). In an attempt to simulate heart failure the dogs received blood transfusion (15 ml/kg) in the presence of halothane-induced myocardial depression. All three nitrates reduced the loads for the left ventricle. With isosorbide dinitrate and sodium nitroprusside the preload and pulmonary pressure decreased to a greater extent than with glyceryl trinitrate. The haemodynamic results suggest that sodium nitroprusside is the favourable nitrate in left ventricular failure because it produces a balanced reduction in the ratio of pre- and afterload. Four micrograms/kg X min sodium nitroprusside induced marked coronary dilatation; glyceryl trinitrate had only a slight coronary vasodilating effect. With isosorbide dinitrate the myocardial blood flow remained well adapted to oxygen demand, the coronary vascular resistance did not change. Sodium nitroprusside produced a significant change of the transmural myocardial blood distribution-expressed as the epi/endocardial blood flow ratio. The ratio was increased by sodium nitroprusside, much more than by glyceryl trinitrate or isosorbide dinitrate.

Animals↗
PubMed1979

Effect of isosorbide dinitrate on response to submaximal and maximal exercise in patients with congestive heart failure.

Isosorbide dinitrate is an effective vasodilator that improves resting left ventricular performance in patients with congestive heart failure, but little is known of the effect of the drug on the response to exercise. Bicycle exercise to symptomatic maximum was performed by 18 patients with class II to IV congestive heart failure before and 90 minutes after administration of isosorbide dinitrate, 40 mg orally. Although resting pulmonary wedge pressure and systemic vascular resistance were significantly reduced after isosorbide dinitrate, exercise duration was not altered and maximal oxygen consumption was not significantly changed (13.6 +/- 1.3 [SEM] standard error of the mean versus 13.8 +/- 1.2 ml/kg per min). At peak exercise pulmonary wedge pressure of 37.1 +/- 1.7 mm Hg, cardiac index of 4.19 +/- 0.35 liters/min per m2, and systemic vascular resistance of 14.7 +/- 1.3 units were not significantly different after nitrate administration. However, at submaximal loads, pulmonary wedge pressure was reduced from 33.6 +/- 1.7 to 27.9 +/- 1.8 mm Hg (P less than 0.01), and systemic resistance from 16.5 +/- 1.5 to 13.7 +/- 1.0 units (P less than 0.01) after administration of isosorbide dinitrate. Thus, short-term administration of nitrates does not improve maximal exercise capacity or left ventricular performance at maximal exercise in patients with congestive heart failure, but it does appear to improve pump function at submaximal work loads and may therefore enable patients to perform limited exercise more comfortably.

Administration, Oral↗
PubMed1988

Effect of intravenous isosorbide dinitrate versus nitroglycerin on elevated pulmonary arterial wedge pressure during acute myocardial infarction.

To compare the acute and sustained effect of intravenous isosorbide dinitrate to intravenous nitroglycerin in patients with acute myocardial infarction and elevated pulmonary artery wedge pressure, 111 patients were randomized and studied within 96 hours of admission to the coronary care unit. All patients had a pulmonary artery wedge pressure greater than or equal to 10 mm Hg and received either isosorbide dinitrate (74 patients) or nitroglycerin (37 patients) for 24 to 48 hours. Blood pressure, heart rate, pulmonary artery wedge pressure, cardiac output, medication dose in micrograms per minute and retitration episodes were compared at baseline and at 6, 12, 18 and 24 hours. Both drugs significantly (p less than 0.05) lowered pulmonary artery wedge pressure and blood pressure and increased cardiac output. Isosorbide dinitrate required fewer retitration episodes and less increases in dosage than nitroglycerin at 24 hours. In the patient with acute myocardial infarction complicated by high pulmonary artery wedge pressure who requires intravenous nitrates for 24 hours, isosorbide dinitrate may offer the benefit of a more stable hemodynamic effect.

Aged↗
PubMed1989

Comparative effects of theophylline and isosorbide dinitrate on exercise capacity in stable angina pectoris, and their mechanisms of action.

While the role of nitrates in the prevention and treatment of myocardial ischemia is well established, the use of theophylline, proposed almost a century ago, is still controversial. Also controversial is its mechanism of action, initially thought to be coronary dilation. In this randomized, single-blind study, the acute effects on exercise capacity of sublingual isosorbide dinitrate (10 mg) and of intravenous theophylline ethylenediamine (7 mg/kg) were assessed in 10 patients with chronic stable angina and positive exercise test. After the administration of theophylline, the time to onset of angina, the heart rate-blood pressure product at 1-mm ST-segment depression and the exercise duration were similar to that after isosorbide dinitrate administration (9.8 +/- 2.3 vs 9.3 +/- 1.7 minutes, 207 +/- 41 vs 207 +/- 48 beats/min.mm Hg.10(-2) and 10.8 +/- 2 vs 10.4 +/- 2 minutes, respectively). Both drugs significantly (p less than 0.001) improved all these parameters compared to the baseline exercise test. The effect of the 2 drugs on the diameters of angiographically normal segments of large epicardial coronary arteries was then assessed using computerized quantitative angiography in 10 other patients with stable angina. Whereas theophylline failed to increase the coronary diameters compared to that in the baseline angiogram (2.9 +/- 0.6 vs 2.9 +/- 0.6 mm, respectively), the subsequent administration of isosorbide dinitrate resulted in an increase up to 3.2 +/- 0.7 mm (p less than 0.02). Thus, in patients with stable angina, theophylline delays the onset of angina, increases the ischemic threshold and prolongs the exercise duration to the same degree as isosorbide dinitrate.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1991

Enhanced effectiveness of combined sustained-release forms of isosorbide dinitrate and diltiazem for stable angina pectoris.

In 14 patients with documented coronary artery disease, the extent and duration of acute anti-ischemic, antianginal and hemodynamic effects of monotherapies with 120 mg of sustained-release isosorbide dinitrate and diltiazem were compared; their combined therapy administered once daily in the morning with diltiazem given again in the evening were also compared according to a randomized, double-blind, crossover, placebo-controlled protocol including exercise testing for assessment of ST-segment depression (ST decreases) at an identical work load, exercise capacity and determination of plasma concentrations of both substances. Comparison of individual substances revealed more marked and sustained effects of isosorbide dinitrate (ST decreases at 2 hours, -66%; at 6 hours, -50%; p less than or equal to 0.05 for both), remaining statistically significant up to 12 hours (-24%) than of diltiazem (2 hours, -30%; 6 hours, -16%; p less than 0.05). Combined therapy resulted in increased effects (ST decreases at 2 hours, -80%; 6 hours, -76%; 12 hours, -30%; p less than or equal to 0.05) as opposed to individual substances for a period of up to 12 hours. However, therapeutic coverage over 24 hours could not be demonstrated, even with renewed administration of sustained-release diltiazem in the evening. Plasma concentrations of isosorbide-5-mononitrate were greater than 250 ng/ml for 12 hours on days when isosorbide dinitrate was given, decreasing to less than 100 ng/ml at 24 hours. On days when diltiazem was given, plasma levels greater than 50 ng/ml were detected only at 2 and at 6 hours, and at 24 hours only after a second tablet was given.

Angina Pectoris↗