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PubMed1988

Effect of isosorbide dinitrate and atropine on the lower esophageal sphincter pressure in Chagasic patients.

The effect of isosorbide dinitrate (5 mg, sublingually) and of atropine (12 micrograms/kg i.v.) on the lower esophageal sphincter pressure of chagasic patients with esophageal involvement and of control subjects was studied by the manometric method. The pressure was measured at 5 minute intervals for 60 minutes after drug administration. When the effect of isosorbide dinitrate was studied, basal sphincter pressure (mean +/- SEM) was 15.3 +/- 1.9 mmHg in chagasic patients (N = 15) and 25.4 +/- 5.6 mmHg in controls (N = 9) (P greater than 0.05). Isosorbide dinitrate reduced sphincter pressure between 10 and 20 minutes and at 40 minutes in controls, and froM 5 to 60 minutes in chagasics (P less than 0.05). The reduction was more intense in chagasics throughout the time of measurement (P less than 0.05). When the effect of atropine was studied, basal sphincter pressure was 20.6 +/- 1.8 mmHg in chagasic patients (N = 14) and 23.7 +/- 2.5 mmHg in controls (N = 9) (P greater than 0.05). Atropine reduced sphincter pressure both in chagasics and controls, but more intensely so in controls during the first 30 minutes of the study (P less than 0.05). The action of the musculature itself may be the main factor in the maintenance of sphincter pressure in chagasics, with secondary participation of the cholinergic excitatory system.

Administration, Sublingual↗
PubMed1998

Treatment of chronic anal fissure with isosorbide dinitrate: long-term results and dose determination.

PURPOSE: Anal fissure is a tear of the anoderm, which eventually can become an ulcer. Chronic anal fissure is perpetuated by contraction of the internal sphincter, believed to reduce perfusion. Nitric oxide is a neurotransmitter mediating vasodilation and internal anal sphincter relaxation. The aim of the present study was to evaluate both the effect and the effective dose regimen of isosorbide dinitrate, a nitric oxide donor, as a treatment for chronic anal fissure. METHODS: Isosorbide dinitrate, Isoket spray (Schwarz-Pharma, Mannheim, Germany), was used to treat 41 patients with chronic anal fissure. Anal manometry was performed in all patients before they entered the study. The treatment program consisted of digital application of isosorbide dinitrate in a dose of 1.25 mg or 2.5 mg three times each day for four weeks. At the end of the trial, patients were followed up for an average time of 11 +/- 1 months. RESULTS: In 34 (83 percent) patients, the fissure healed within one month of treatment (mean, 3 +/- 0.1 weeks). The average time for symptoms to disappear was 6.5 +/- 0.7 days. In six (14.6 percent) patients the anal fissure did not heal even after four weeks of further treatment, and they underwent lateral sphincterotomy. Six patients relapsed during the follow-up period, but responded to another course of treatment. A dose of 2.5 mg of isosorbide dinitrate caused a greater reduction in maximum anal resting pressure than a dose of 1.25 mg. CONCLUSIONS: Topical isosorbide dinitrate is an effective and safe treatment for chronic anal fissure. In our experience the optimal dose regimen is 2.5 mg three times each day.

Administration, Topical↗
PubMed1989

[Comparison of isosorbide dinitrate and nifedipine in the treatment of variant angina pectoris. Randomized study].

The effects of isosorbide dinitrate single dose 120 mg daily and nifedipine 20 mg twice daily were studied in 17 patients with variant angina pectoris due to coronary artery spasm. After a placebo phase the patients were randomized to treatment with either isosorbide dinitrate or nifedipine. After six weeks the patients were crossovered for another six weeks period of treatment. There was significant decrease of number of angina attacks during both treatment regimens. Using 24 hours Holter monitoring we also proved significant decrease of number of ST segment elevation or depression, either symptomatic or asymptomatic. There was increase of performed work during exercise tests after both treatment periods. The efficacy of Isoket 120 mg and Adalat Retard 2 x 20 mg daily in the treatment of patients with active variant angina pectoris was comparable in our study. 3 patients suffered untolerable headache during isosorbide dinitrate phase and had to terminate treatment after first day only.

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↗
PubMed1998

Effects of isosorbide dinitrate on oxygen uptake kinetics in cardiac patients.

PURPOSE: Although nitrates are known to improve indices of exercise capacity in patients with coronary artery disease, their effects on oxygen uptake kinetics during the onset of exercise have not been clarified. We evaluated the acute effects of isosorbide dinitrate on the kinetics of oxygen uptake during the onset of exercise at a constant work rate in patients with coronary artery disease. METHODS: We studied 14 patients with coronary artery disease who performed 6 min of low-intensity exercise at a constant work rate on a cycle ergometer 30 min after oral administration of 10 mg of isosorbide dinitrate or placebo in a double-blind, crossover manner. Oxygen uptake was calculated from breath-by-breath analysis of respired gases. The time constant of oxygen uptake kinetics during the onset of exercise was determined by fitting a single exponential function to the oxygen uptake response. RESULTS: Heart rate was significantly increased at rest, and systolic blood pressure was significantly decreased both at rest and during exercise after administration of isosorbide dinitrate. The time constant of oxygen uptake was significantly shorter (the kinetics were faster) after administration of isosorbide dinitrate (39.4+/-10.1 vs 44.5+/-10.5 s, P = 0.038). CONCLUSIONS: Isosorbide dinitrate was found to speed the kinetics of the increase in oxygen uptake during constant work-rate exercise. The time constant of oxygen uptake, which reflects the rapidity of cardiovascular adaptation at the onset of exercise, seems to be a useful parameter of the effectiveness of therapy in patients with coronary artery disease.

Adult↗
PubMed1983

Sex-related difference in the metabolism of isosorbide dinitrate following incubation in human blood.

Isosorbide dinitrate (ISDN) (at a concentration of 100 ng/ml) was incubated aerobically at 37 degrees in whole blood from five male and five female normal volunteers. Following incubation of the blood samples for 0, 30, 60, 120, 240 and 360 min, the samples were centrifuged and the plasma was assayed for ISDN. A linear relationship was observed between the logarithm of the concentration of ISDN remaining and incubation time, and there was a significant difference between the T1/2 of ISDN in blood from males (90.6 min) and females (161.4 min). Very little ISDN metabolism was observed when ISDN was incubated with plasma rather than whole blood. When erythrocytes, resuspended in saline, were incubated with ISDN, there was a time-dependent loss of ISDN from the saline incubation medium. Investigation of the soluble fraction obtained after hemolysis of these erythrocytes also showed a time-dependent loss of ISDN. The saline incubation medium contained sufficient concentrations of the two major ISDN metabolites (isosorbide 2- and 5-mononitrate) to account for the observed disappearance of ISDN. The results indicate that ISDN is metabolized in the cellular compartment of blood and that the metabolic rate in males is greater than that in females.

Adult↗
PubMed1992

[Studies on transdermal delivery system of isosorbide dinitrate].

A transdermal delivery system of isosorbide dinitrate (ISDN-TDS) and an HPLC method for the measurement of ISDN were developed. The system is composed of backing, drug reservoir, control membrane, contact adhesive and protective layer. The influences of drug reservoir, solvent, control membrane, viscosity and penetration enhancer azone on the release of ISDN were investigated. The cumulative released amount of ISDN/time profile indicated that ISDN was permeated through excised skin in a zero-order kinetic in 48 h. The release of ISDN from ISDN-TDS can last 72 h at least. The mean permeation rate is 13.76 micrograms.h-1/cm2. Releasing ISDN from ISDN-TDS was more stable than that from Frandol tape-s whose release profile was found to follow a linear Q vs t1/2 relationship with a release flux of 114.39 micrograms.h-1/cm2.

Administration, Cutaneous↗
PubMed1980

Dilation of coronary artery stenoses after isosorbide dinitrate in man.

The effect of isosorbide dinitrate (ISDN), 5 mg sublingually, on the diameters of coronary artery stenoses (n = 27) was examined in 20 patients. Another 18 patients with angiographically normal coronary arteries received the same amount of ISDN and were used as controls. Prestenotic and stenotic diameters were measured with a vernier calliper having an accuracy of 0.05 mm. The degree of stenosis was expressed as percentage of cross-sectional area reduction. ISDN caused uniform dilatation of every normal epicardial artery; mean increase in diameter was 21 per cent (range: 17 to 26%). In 18 stenoses (28 to 95% obstruction) there was very little change after ISDN. The mean prestenotic diameter increased from 2.82 +/- 0.48 mm to 3.05 +/- 0.43 mm and the mean stenotic diameter from 1.45 +/- 0.49 mm to 1.59 +/- 0.51 mm. However, in the nine other stenoses (35 to 89% obstruction) the mean degree of obstruction decreased significantly from 68 +/- 15.6 per cent to 47 +/- 15.6 per cent after ISDN. This improvement was a result of a significant increase of the mean stenotic diameter from 1.71 +/- 0.47 mm to 2.41 +/- 0.55 mm, whereas the prestenotic diameter showed only an insignificant increase from 3.17 +/- 0.63 mm to 3.31 +/- 0.58 mm after ISDN. In four patients with two obstructions in different coronary branches ISDN dilated one without significantly affecting the other lesion. From the data we conclude that ISDN can dilate some coronary artery stenoses but that this response may vary from one site to another even in the same patient.

Coronary Disease↗
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↗
PubMed1977

Hemodynamic assessment of oral peripheral vasodilator therapy in chronic congestive heart failure: prolonged effectiveness of isosorbide dinitrate.

To evaluate the effectiveness of oral vasodilator therapy in chronic congestive heart failure, 20 mg of isosorbide dinitrate or placebo was administered orally in double-blind fashion to 25 patients with congestive heart failure. In 15 patients receiving isosorbide dinitrate, pulmonary arterial wedge pressure decreased 5 minutes to 5 hours after drug administration; the peak reduction was observed at 1 hour (from 23 to 14 mm Hg; P less than 0.001). Wedge pressure decreased to normal (12 mm Hg or less) in 8 of the 15 patients (Group I) but remained greater than 12 mm Hg in 7 (Group II). Reductions in mean systemic arterial pressure, systemic vascular resistance and pressure-time per minute also occurred. Indexes of pump output were unchanged in the 15 who received isosorbide dinitrate but tended to decrease slightly in Group I. Stroke index (from 23 to 26 cc/m2) and stroke work index (from 21.4 to 24.1 g-m/m2) increased slightly but significantly (P less than 0.05) in Group II. Thus the prinicpal hemodynamic action of isorbide dinitrate is marked and sustained reduction in left ventricular filling pressure without pronounced effect on cardiac output. This agent should be used in congestive heart failure primarily for relief of congestive symptoms.

Administration, Oral↗
PubMed1995

[Intra-anal application of isosorbide dinitrate in chronic anal fissure].

OBJECTIVE: To evaluate the effect of intra-anal application of isosorbide dinitrate on the healing rate of chronic anal fissure. DESIGN: Prospective, descriptive. SETTING: Outpatient clinic of the department of Surgery, University Hospital Dijkzigt, Rotterdam. METHOD: Sixteen patients with chronic (more than three months' duration) anal fissure were treated by intra-anal application of isosorbide dinitrate ointment every 3 hours, except during the night. The maximal duration of therapy was 12 weeks. Every three weeks the following aspects were investigated: clinical symptoms, side-effects and fissure healing. RESULTS: All patients experienced mild and transient headache shortly after the beginning of the treatment. At three weeks the fissure-related pain was resolved in all patients. At 6, 9 and 12 weeks the fissure was completely healed in 9, 11 and 15 patients respectively. CONCLUSION: The majority of chronic anal fissures can be treated effectively by local application of isosorbide dinitrate. This new and simple treatment modality appears to be an attractive alternative to the currently available surgical procedures.

Administration, Topical↗
PubMed1981

Circulatory improvement after hydralazine or isosorbide dinitrate administration in patients with heart failure. Effect on metabolic responses to submaximal exercise.

Hydralazine and isosorbide dinitrate can increase the cardiac output during submaximal exercise in patients with heart failure but whether this increase improves oxygen delivery to underperfused exercising muscle is uncertain. To investigate this question, we measured three systemic markers of skeletal muscle oxygen availability--exercise VO2, mixed venous lactate concentration and oxygen debt--during submaximal exercise in 15 patients with heart failure both before after hydralazine (nine patients) or isosorbide dinitrate (eight patients) administration. Hydralazine increased the cardiac output during exercise from 4.9 +/- 1.2 liter/min to 6.5 +/- 1.8 liter/min (p less than 0.01) but had no effect on exercise VO2 (control, 531 +/- 135 ml/min; hydralazine, 489 +/- 102 ml/min), peak lactate concentration (control, 18.3 +/- 4.2 mg/dl; hydralazine, 17.9 +/- 3.6 mg/dl) or oxygen debt (control, 474 +/- 213 ml; hydralazine, 465 +/- 170 ml) (all p greater than 0.10). Isosorbide dinitrate increased the cardiac output during exercise from 4.6 +/- 0.9 liter/min to 5.3 +/- 0.8 liter/min (p less than 0.01) but also did not change exercise VO2 (control, 488 +/- 62 ml/min; isosorbide, 473 +/- 44 ml/min), peak lactate concentration (control, 19.2 +/- 6.0 mg/dl; isosorbide, 21.4 +/- 8.2 mg/dl) or oxygen debt (control, 522 +/- 154 ml; isosorbide, 445 +/- 147 ml) (all p less than 0.10). We conclude that short-term administration of hydralazine or nitrates to patients with heart failure can substantially improve circulatory function during exercise but that this improvement probably does not enhance skeletal muscle nutritional flow.

Adult↗
PubMed1977

Vasodilator therapy in acute myocardial infarction. Use of sublingual isosorbide dinitrate.

The haemodynamic effect of a long-acting vasodilator isosorbide dinitrate has been studied in 10 patients after an acute myocardial infarct, all of whom had evidence of left ventricular failure. Left ventricular filling pressure measured as the mean pulmonary artery wedge pressure was raised in all patients and fell significantly from 20+/-6 to 13+/-5 mmHg (P less than 0-001) within 10 minutes of sublingual isosorbide dinitrate. This 35 per cent fall in left ventricular preload was accompanied by significant fall in mean pulmonary artery pressure from 30+/-7 to 20+/-4 mmHg (P +less than 0-001) and mean right atrial pressure from 11+/-3 to 6+/-2 mmHg but cardiac output measured by thermodilution was unchanged. Mean systemic blood pressure was also significantly reduced. This improvement in left ventricular performance resulting from a reduction in left ventricular filling pressure and systemic blood pressure indicates that there may be a place for long-acting vasodilator in the treatment of acute myocardial infarction.

Aged↗
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↗
PubMed1985

Effect of isosorbide dinitrate, verapamil, and labetalol on portal pressure in cirrhosis.

The effects on portal pressure of the vasodilatory drugs isosorbide dinitrate and verapamil and of an alpha and beta blocking agent, labetalol, were assessed in 21 patients with cirrhosis and portal hypertension. The wedged hepatic venous pressure gradient (wedged minus free hepatic venous pressures) was used as an index of portal pressure and was not significantly changed by treatment with labetalol (n = 5) but was significantly decreased by verapamil (n = 6; p less than 0.05) and isosorbide dinitrate (n = 10; p less than 0.01). Long term administration of isosorbide dinitrate also had a significant effect (p less than 0.01).

Humans↗
PubMed1992

Modification of platelet function by isosorbide dinitrate in patients with coronary artery disease.

The effect of a four weeks oral treatment with 100 mg isosorbide dinitrate (ISDN) daily on platelet function was evaluated in 40 patients (aged 40-65 years) with proven coronary artery disease. Isosorbide dinitrate decreased platelet reactivity to ADP (p less than 0.001), increased platelet sensitivity to PGI2 (p less than 0.01) while the production of TXB2 from exogenous arachidonic acid substrate and from endogenous substrate were both significantly reduced. Circulating platelet aggregates as measured by the Wu-test were markedly reduced (p less than 0.001) but there was little change in the plasma concentration of the platelet proteins beta-thromboglobulin and platelet factor 4. Overall, platelet activation correlated with smoking, hypertension and a family history of coronary artery disease. The reduced platelet activation seen during treatment with isosorbide dinitrate may contribute to the therapeutic benefit seen with this drug in patients with coronary artery disease.

Adenosine Diphosphate↗
PubMed1978

Plasma concentrations of isosorbide dinitrate after administration of increasing doses of a sustained-release formulation to human subjects.

Plasma concentrations of isosorbide dinitrate have been measured after administration of increasing doses in the range 20--100 mg as sustained-release tablets (Isoket retard) containing 20 mg to human subjects. Means of peak concentrations of 4.2 ng/ml, 13.1 ng/ml, 20.7 ng/ml, 36.8 ng/ml, and 34.9 ng/ml were measured after doses of 20 mg, 40 mg, 60 mg, 80 mg and 100 mg, respectively. In the plasma of individual subjects, peak concentrations of isosorbide dinitrate increased in proportion to the dose administered. Areas under the plasma isosorbide dinitrate concentration-time curves also increased in proportion to the dose administered. Bioavailability parameters were better correlated to the dose over the range 20--60 mg than over the range 20--100 mg.

Adult↗
PubMed1983

Efficacy of isosorbide dinitrate tape on exercise tolerance of patients with angina pectoris.

Evaluation was made on the efficacy of isosorbide dinitrate tape (ISDN tape, TY-0081, Frandol Tape), a preparation newly developed in Japan, regarding the relationship between the exercise tolerance in patients with stable effort angina pectoris and plasma concentrations of ISDN. Placebo(s) or one to three pieces of isosorbide dinitrate tape (10 cm x 10 cm in size, containing 40 mg/tape) were applied to the patients and ISDN plasma concentrations were measured every 6th(15:00) and 24th (9:00) h after each application (9:00). Treadmill tests were repeated for the measurement of exercise tolerance according to a prescribed protocol where the exercise endpoint was the occurrence of chest pain. Correlation was found between the number of ISDN tape applied and the plasma concentrations, as well as between the isosorbide dinitrate plasma concentration and treadmill exercise time in 7 cases out of 10. Exercise time was increased significantly by the application of one piece of ISDN tape or two to three pieces of the tape, compared to the control or placebo study, respectively. The duration of actions lasted more than 24 h. These results suggest the efficacy of ISDN tape on angina pectoris, especially in its durability of action which lasts over 24 h.

Aged↗