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PubMed1988

Changes in myocardial ischaemia during isosorbide dinitrate or indoramin therapy in patients with stable angina using relations between the ST segment and heart rate.

The effect of isosorbide dinitrate or indoramin on myocardial ischaemia was examined in patients with stable angina pectoris. In a prospective trial, randomization resulted in 8 and 9 patients, respectively, given isosorbide dinitrate in a dose of 30-90 mg daily, and indoramin in a dose of 75-225 mg daily; 2 of these patients were serially examined during the two types of therapy. Changes in myocardial ischaemia were assessed by exercise testing using 12 standard electrocardiographic leads and a bipolar lead CM5. Individual and group comparisons showed that isosorbide dinitrate resulted in an increase in ST segment depression, the maximal ST/heart rate slope and the ratio of net ST segment depression to increases in heart rate (at least P less than 0.01). In contrast, with indoramin therapy there were no significant changes in these indices. The results in these patients suggest that isosorbide dinitrate leads more consistently to increases in the severity of myocardial ischaemia than indoramin, although this effect on ischaemia is apparently less than the benefit of these agents on exercise performance.

Adult↗
PubMed1994

Intravenous isosorbide dinitrate inhibits neutrophil aggregation and plasma-mediated stimulation of superoxide anion production.

Polymorphonuclear neutrophils are known to be activated during myocardial ischaemia causing release of free oxygen radicals and capillary plugging by cell aggregates and therefore to exacerbate ischaemic myocardial injury. Nitric oxide has been shown to modulate neutrophil activation within the ischaemic myocardium and therefore reduce myocardial injury during ischaemia. Drugs that act as nitric oxide donors may therefore modify neutrophil activation. We evaluated the effect of intravenous treatment with isosorbide dinitrate on neutrophil aggregation and plasma-mediated stimulation of neutrophil superoxide anion production in patients with ischaemic heart disease. Samples were obtained from patients before treatment and 15 and 30 min after receiving intravenous isosorbide dinitrate. Isosorbide dinitrate decreased neutrophil aggregation visualized in whole blood (25.3 +/- 3.6, 19.0 +/- 2.6 and 18.5 +/- 2.6 per 300 cells, respectively, P < 0.01). When patient's plasma was incubated with neutrophils obtained from healthy donors, superoxide anion release was 18.99 +/- 6.23, 11.38 +/- 2.79 and 11.49 +/- 3.15 nmol O2-/10(6) cells, respectively (P < 0.01). Therefore, intravenous isosorbide dinitrate inhibited both plasma-mediated stimulation of neutrophil superoxide anion production and neutrophil aggregation.

Adult↗
PubMed1993

Blood pressure management during aortic surgery: urapidil compared to isosorbide dinitrate.

The efficacy and hemodynamic effects of urapidil, an arteriolar vasodilator, and isosorbide dinitrate, a venodilator, were compared, when used for blood pressure control during abdominal aortic surgery. Urapidil is an alpha-adrenergic receptor antagonist with serotonin-1A receptor-agonist activity in the central nervous system. Hemodynamic profiles were recorded before and after the administration of the study drug (+/- 10 minutes before aortic clamping), 3 and 10 minutes following aortic clamping, and before and 3 and 10 minutes following the removal of the aortic clamp. Arterial and mixed venous oxygen contents were compared. Both groups of 18 patients were similar with respect to demographic profiles, anesthetic technique, and perioperative fluid therapy. Identical heart rate and blood pressure profiles were obtained. In contrast to isosorbide dinitrate, urapidil produced a 17% (P < 0.05) increase in cardiac index as a result of a 30% (P < 0.001) decrease in systemic vascular resistance before placement of the aortic clamp. In patients treated with urapidil, cardiac index was higher (P < 0.05) 10 minutes after aortic clamping, before removal of the clamp, and 10 minutes later. The arterio-venous oxygen content difference decreased from 3.2 +/- 0.8 mL O2/dL to 2.4 +/- 1.0 mL O2/dL (P < 0.01) following urapidil, but did not change during the administration of isosorbide dinitrate. It is concluded that urapidil is an effective and safe drug for the prevention of the hemodynamic consequences of aortic clamping. Compared to a venodilator (isosorbide dinitrate), urapidil offers the advantage of improving cardiac output and oxygen delivery.

Alfentanil↗
PubMed2005

Novel isosorbide-based substrates for human butyrylcholinesterase.

Butyrylcholinesterase [EC 3.1.1.8] present widely in mammalian tissue does not have a precisely defined biological function or known endogenous substrate. However, it plays an important role in the detoxification of certain xenobiotics and is an established vector for the systemic liberation of other drugs from their prodrugs. While investigating a series of isosorbide-based prodrugs, we discovered that BuChE catalyses the hydrolysis of esters of the simple sugar isosorbide with unusually rapidity and in some cases with remarkable regioselectivity. In this study, a series of isosorbide esters were synthesised and their rates of hydrolysis measured by HPLC following incubation in diluted plasma solution. In general, little hydrolysis of the 5-ester group could be observed but the 2-ester group was usually hydrolysed very rapidly and the hydrolysis rate exhibited an unusual dependence on the identity of the 5-group. The results indicate that while the 5-ester group is not itself hydrolysed it is important for productive binding in isosorbide diesters.

Butyrylcholinesterase↗
PubMed2006

Quantification of isosorbide 5-mononitrate in human plasma by liquid chromatography-tandem mass spectrometry using atmospheric pressure photoionization.

Isosorbide 5-mononitrate (5-ISMN) is an organic nitrate widely used for its vasodilating properties in the treatment of angina pectoris. In the present study, an efficient, sensitive, robust method was developed for the determination and quantification of isosorbide 5-mononitrate, in human plasma, by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS), using photospray ionization. Isosorbide 5-mononitrate was extracted from 0.5 mL human plasma by liquid-liquid extraction (LLE). The method had a chromatographic run of 2.0 min using a C(8) analytical column (100 mm x 2.1 mm i.d.) and the linear calibration curve over the range was linear from 20 to 2000 ng mL(-1) (r(2)>0.995). The between-run precision, based on the relative standard deviation replicate quality controls, was 7.9% (60 ng mL(-1)), 5.2% (300 ng mL(-1)) and 7.0% (1800 ng mL(-1)). The between-run accuracy was 94.9%, 94.1% and 88.8% for the above-mentioned concentrations, respectively. The method herein described was employed in a bioequivalence study of two tablet formulations of isosorbide 5-mononitrate 40 mg.

Atmospheric Pressure↗
PubMed1977

Orally administered isosorbide dinitrate in patients with and without left ventricular failure due to acute myocardial infarction.

The oral effectiveness of 10 mg followed by 20 mg of isosorbide dinitrate in 21 patients with acute mycardial infarction was studied over a period of 13 hours. The patients were grouped according to initial left ventricular filling pressure: group I, pressure less than 20 mm Hg, and group II, pressure more than 20 mm Hg. Patients in group II had left ventricular failure. In both groups isosorbide dinitrate resulted in a significant decrease in pulmonary arterial pressure. The left ventricular filling pressure decreased in group I from 13.6 +/- 4.0 to 7.1 +/- 2.6 mm Hg (mean +/- 1 standard deviation) and in group II from 26.9 +/- 4.6 to 19.0 +/- 3.6 mm Hg (P less than 0.001). Cardiac output decreased in group I from 5.1 +/- 1.0 to 4.5 +/- 0.9 liters/min, whereas in group II it increased significantly from 3.5 +/- 0.8 to 4.1 to 0.9 liters/min (P less than 0.001). In both groups, peripheral arterial blood pressure decreased (P less than 0.60). Heart rate remained constant. Whether cardiac output increased or decreased was found to be dependent on the initial left ventricular filling pressure. In patients with an initially high value (above 20 mm Hg), the increase in cardiac output is probably due to the reduction of afterload. An additional factor may be the decrease in left ventricular filling pressure, which leads to an improved blood supply in the affected mural segments as a result of the decrease in the extravascular component of the coronary resistance. Significant changes in cardiac output and left ventricular filling pressure were achieved 3 to 5 hours after oral administration of isosorbide dinitrate. Clinical signs of failure were less pronounced. Isosorbide dinitrate is, therefore, a therapeutic agent in the treatment of left ventricular failure due to acute myocardial infarction.

Administration, Oral↗
PubMed2001

[Quality of life and angina pectoris. Comparison of the effects of 2 nitrate derivatives administered discontinuously: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day)].

A comparative, randomised, 12-week (two periods of six weeks) cross-over study including 150 patients (mean age: 63.4 years) suffering from stable but symptomatic (a minimum of three attacks per week) angina pectoris was performed in order to compare the effect on quality of life of two discontinuous nitrate treatments: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day). The efficacy and safety were also compared. The two treatments equally and significantly improved patients' quality of life. The number of attacks and sublingual nitrate consumption significantly decreased under treatment. Attack severity was lower under nitroglycerine than isosorbide-5-mononitrate treatment. Finally, even though nitroglycerine more frequently induced headache than did isosorbide-5-mononitrate (13 cases versus 8), patients, and in particular those having received nitroglycerine treatment in the second period of the study, preferred the transdermal nitroglycerine treatment. In conclusion, results did not show any relevant difference in terms of efficacy or tolerability between the two treatments. Nevertheless, the facility of use and the feeling of protection were better under transdermal nitroglycerine patch than oral isosorbide-5-mononitrate treatment.

Administration, Cutaneous↗
PubMed2000

Packed-column supercritical fluid chromatography for the analysis of isosorbide-5-mononitrate and related compounds in bulk substance and tablets.

We describe a packed-column supercritical fluid chromatographic method that can be used for the analysis of isosorbide-5-mononitrate (5-ISMN) bulk substance and the 5-ISMN content of Imdur tablets. The method is based on methanol-modified carbon dioxide as the mobile phase and porous graphitized carbon (PGC, Hypercarb) as column support at 40 degrees C and 100 bar back pressure. The method makes it possible to simultaneously determine 5-ISMN and related compounds. In order to elute NO(3)(-) with acceptable retention time a quarternary ammonium hydrogen sulfate salt is added to the methanol modifier. An almost linear increase of the retention time with increasing carbon content of the counter ion was found. Tetramethyl ammonium hydrogen sulfate 5 mM in methanol was used in the final method as polar modifier for the simultaneous determination of possible degradation products within 12 min. The present method can separate and detect related compounds such as isosorbide-2, 5-dinitrate, isomannidemononitrate and isosorbide-2-mononitrate at the 0.1% (w/w) level as required by regulatory guidelines. Nitrate can be detected down to about 0.02% (w/w). Repeated analyses of ground tablet powder gave an assay precision for isosorbide-5-mononitrate of 1.4% (R.S.D., eight samples and two injections of each). For related substances at an area percent of 0. 1 the precision was less than 10%.

Chromatography↗
PubMed1997

Gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate and related impurities in raw materials and dosage formulations.

A straightforward quantitative method for gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate (IS5MN) and its related impurities such as isosorbide (IS), isosorbide diacetate (ISDA) and isosorbide 2-acetate-5-nitrate (IS2A5N) in raw materials as well as in dosage formulations is developed. The recovery of these materials was found to be 100.4 +/- 2.4, 99.3 +/- 4.7, 97.8 +/- 5.2 and 100.1 +/- 3.1%, while the detection limits were 27.2, 1.26, 1.02 and 0.78 micrograms in dosage formulations for IS5MN, ISDA, IS2A5N, and IS, respectively. The applicability of the method was tested by analysing three different formulations of IS5MN.

Drug Contamination↗
PubMed1983

The acute effects of low flow oxygen and isosorbide dinitrate on left and right ventricular ejection fractions in chronic obstructive pulmonary disease.

The objectives of this study were to determine the effects of low flow oxygen and isosorbide dinitrate on rest and exercise biventricular ejection fractions in patients with chronic obstructive pulmonary disease and to relate these ejection fraction responses to changes in pressure and flow. Nine patients with stable, moderate to severe chronic obstructive pulmonary disease who had no prior history of heart failure performed supine exercise with simultaneous hemodynamic and radionuclide ventriculographic monitoring. Eight patients performed a second exercise during low flow oxygen breathing and five performed a third exercise after ingesting 10 mg oral isosorbide. Oxygen led to a decrease in exercise pulmonary artery pressure in all subjects and a decline in total pulmonary resistance in five of the seven in whom it was measured. Right ventricular ejection fraction increased 0.05 or more only in subjects who had a decrease in total pulmonary resistance. Isosorbide fed to an increase in rest and exercise right and left ventricular ejection fractions with simultaneous decreases in pulmonary artery pressure, total pulmonary resistance, blood pressure and arterial oxygen tension. These results suggest that in patients with chronic obstructive pulmonary disease but without a history of right heart failure, the right ventricular systolic functional response to low flow oxygen and isosorbide at rest and exercise is, in part, determined by changes in total pulmonary resistance. The chronic relation between right ventricular ejection fraction and pulmonary hemodynamics in patients with chronic obstructive pulmonary disease remains to be evaluated.

Blood Pressure↗
PubMed1985

Double-blind crossover comparison of the antianginal effects of nifedipine and isosorbide dinitrate in patients with exertional angina receiving propranolol.

A double-blind crossover study was performed on 27 patients with proved fixed coronary artery disease and stable angina pectoris. The study was designed to compare the relative efficacy of two combination therapies, nifedipine plus propranolol and isosorbide dinitrate plus propranolol, in terms of antianginal response and effect on exercise tolerance by evaluation of treadmill testing. The combination of nifedipine and propranolol was superior to the combination of isosorbide and propranolol in reducing the number of anginal attacks (p = 0.03), increasing total exercise time (p less than 0.02), increasing oxygen consumption achieved at end of exercise (p less than 0.03), increasing time to onset of pain (p = 0.003) and increasing oxygen consumption achieved at onset of pain (p = 0.003). Analysis of the rate-pressure products suggests that the difference in these results may be explained by the greater effect of nifedipine on afterload reduction. Although nitroglycerin consumption was reduced from baseline levels during combination nifedipine therapy (p less than 0.001), there was no statistical difference between nifedipine combination therapy and isosorbide combination therapy. In conclusion, although both combination therapies were superior to propranolol therapy alone, the combination of nifedipine and propranolol was more effective than the combination of isosorbide and propranolol in reducing the incidence of angina and improving exercise performance. Side effects were experienced at a similar frequency during both combination therapies.

Adult↗
PubMed2000

The effectiveness of tenoxicam vs isosorbide dinitrate plus tenoxicam in the treatment of acute renal colic.

OBJECTIVE: To determine the effectiveness of isosorbide dinitrate in combination with tenoxicam compared with tenoxicam alone for the relief of acute renal colic. PATIENTS AND METHODS: Fifty patients with acute renal colic were randomly and in a double blind fashion divided into two treatment groups of 25 each. Group 1 received tenoxicam (40 mg intravenously) and group 2 received tenoxicam (40 mg intravenously) plus sublingual isosorbide dinitrate (5 mg). The patients were compared for visual pain scores, heart rate and blood pressure between and within the groups before and after treatment. RESULTS: Comparing the groups, group 2 had significantly lower pain scores after treatment (P < 0.05) but no other variables were significantly different (P > 0.05 for each). Within the groups the pain scores were significantly lower after treatment in both groups (P < 0.05). Group 2 also had a significantly lower heart rate and blood pressure after treatment (P < 0.05). There were no side-effects caused by tenoxicam and isosorbide dinitrate in either group. CONCLUSION: The use of tenoxicam alone or combined with isosorbide dinitrate was effective in relieving of renal colic, but the relief obtained with the combination was significantly greater than tenoxicam alone.

Acute Disease↗
PubMed1987

Effect of intervals between doses on the development of tolerance to isosorbide dinitrate.

We studied the development of tolerance to isosorbide dinitrate in 12 patients with chronic stable angina pectoris. The effect of 30 mg of isosorbide dinitrate on treadmill exercise performance was assessed before and at one, three, and five hours after a single dose. As compared with placebo, the drug increased treadmill walking time until the onset of angina and until the development of moderate angina over the five-hour observation period (P less than 0.05). The patients then received 30 mg of isosorbide dinitrate twice, three times, and four times daily for a period of one week, and exercise performance was assessed before and at one, three, and five hours after the final morning dose. During sustained treatment two and three times daily, treadmill walking time was longer throughout the five-hour testing period than during the placebo phase (P less than 0.05). In contrast, during treatment four times daily, treadmill walking time was prolonged at one hour (P less than 0.05) but not at three and five hours after the last dose. We conclude that tolerance to the clinical effects of isosorbide dinitrate develops with a sustained dosage of 30 mg four times daily, but not when the drug is given two or three times daily.

Adult↗
PubMed2003

The effect of isosorbide dinitrate, a donor of nitric oxide, on maternal cerebral blood flow in gestational hypertension and preeclampsia.

OBJECTIVE: The purpose of this study was to investigate the effect of a nitric oxide donor on cerebral perfusion pressure and other blood flow index values in the maternal middle cerebral and basilar arteries. STUDY DESIGN: Sublingual tablets of 5-mg isosorbide dinitrate were administered to 19 hypertensive pregnant patients. Doppler velocimetry of the middle cerebral and basilar arteries was obtained with a transcranial Doppler with the use of the transtemporal and suboccipital approach. RESULTS: The mean (+/-SEM) flow velocity in the middle cerebral artery significantly decreased from a baseline of 65.9 +/- 3.1 cm/s to 55.2 +/- 2.2 and 52.0 +/- 2.1 cm/s at 10 and 20 minutes (P <.0001). Resistance area product insignificantly increased from a baseline of 2.0 +/- 0.1 before isosorbide dinitrate to 2.19 +/- 0.11 at 20 minutes. No significant changes were observed in the resistance and pulsatility indices in the middle cerebral artery. The cerebral perfusion pressure did not change significantly after isosorbide dinitrate (84.5 +/- 7.3, 80.8 +/- 6.6, and 78.5 +/- 5.0 mm Hg at 0, 10, and 20 minutes, respectively) nor did the cerebral blood flow index. CONCLUSION: The results obtained demonstrate that cerebral perfusion pressure is unaltered by isosorbide dinitrate, despite significant changes in maternal blood pressure and in blood flow velocities in the middle cerebral artery.

Administration, Sublingual↗
PubMed1988

Circadian investigation of interval therapy with isosorbide dinitrate in coronary heart disease.

One of the most promising concepts in nitrate therapy is interval therapy, a dosage scheme with marked changes of nitrate concentrations in the 24-h interval. In a single-blind, placebo-controlled study in patients with coronary heart disease we investigated the circadian anti-ischaemia and haemodynamic response to interval therapy with isosorbide dinitrate (120 mg sustained release 1 X 1). 10 male patients (46-75 years, mean 60 years) with chronic stable angina and ST-segment depression during exercise entered the trial. At the end of a 10-day placebo period (medication at 8 am) three exercise tests were performed (10 am, 2 pm, 6 pm), recording ST-segment changes, pulmonary capillary wedge pressure (PCP) and cardiac index (CI). Spontaneous ischaemic events were detected by Holter monitoring until 8 am the next day. After three weeks of therapy with isosorbide dinitrate, the protocol was repeated (statistics: paired t-test, *P less than 0.05). PCP was reduced by 8.3 mmHg* at 10 am, 8.0 mmHg at 2 pm, 2.9 mmHg (NS) at 6 pm with a concomitant increase of cardiac index (+0.8,* +0.7*, +0.3 NS l min-1 m-2). While the haemodynamic improvement was maximal in the morning the anti-ischaemia effect (reduction of ST-depression) was constant during the active day (-0.40*, -0.50*, -0.43* mm). Four transient ischaemia episdodes at night were recorded under placebo, none under isosorbide dinitrate. In conclusion, all parameters studied demonstrate the effectiveness of chronic interval therapy with isosorbide dinitrate.

Aged↗
PubMed1988

The effects of an intravenous infusion of isosorbide dinitrate during open heart surgery.

Recent awareness of right ventricular dysfunction during open heart surgery has focused attention upon the importance of protection of the right ventricle and control of right ventricular afterload for the maintenance of the cardiac output. Conventional doses of systemic vasodilators, when used to reduce pulmonary vascular resistance, may produce systemic hypotension, reduce coronary arterial perfusion and even lower the cardiac output. A study of the effects of bolus intravenous isosorbide dinitrate during open heart surgery showed that following cardiopulmonary bypass intravenous isosorbide dinitrate produced highly significant falls in pulmonary artery pressure and induced active pulmonary vasodilatation without systemic side-effects or reduced atrial filling procedures. Treatment with intravenous isosorbide dinitrate by low-dose infusion during and after open heart surgery significantly lowered mean pulmonary artery pressure and pulmonary vascular resistance (P less than 0.001) in patients receiving no sympathomimetic drug support. The results suggest that possibly the effect of low-dose isosorbide dinitrate following cardiopulmonary by-pass is exerted predominantly on the right ventricular afterload if systemic arterial pressure is not elevated. This may have applications in the management of pulmonary hypertension and of acute right heart failure following cardiac surgery.

Adult↗
PubMed1988

Abrupt withdrawal of isosorbide-5-mononitrate in Durules (Imdur) after long term treatment in patients with stable angina pectoris.

In a single-blind study of 6 weeks' duration, 32 patients with stable angina pectoris, who had been receiving controlled-release, Durules, isosorbide-5-mononitrate (Imdur) 60 to 180 mg daily for at least 1 year, were assessed after abrupt withdrawal of the nitrate. After 2 weeks of placebo treatment nitrate therapy was re-instituted, and the patients followed for another 2 weeks. The possibility of development of tolerance and rebound phenomena was also investigated. Three patients experienced severe anginal symptoms necessitating hospitalization when controlled-release isosorbide-5-mononitrate was withdrawn abruptly. Patients complained of more severe anginal symptoms during the placebo period, experienced more frequent anginal attacks and used more glyceryl trinitrate tablets than during active treatment. ST segment changes during exercise were more pronounced with placebo. After controlled-release isosorbide-5-mononitrate was re-introduced, these variables indicated significant improvement. On the other hand, no deterioration occurred in exercise performance during the placebo phase. Responsiveness to glyceryl trinitrate was maintained, as shown by comparisons of exercise tests performed after the long term treatment and during the placebo phase. Controlled-release isosorbide-5-mononitrate retains a beneficial effect in patients with angina pectoris during prolonged use, although some attenuation of the effect is seen. Abrupt withdrawal of the drug is not recommended because of the possibility of severe exacerbation of anginal symptoms, although no clearcut rebound phenomena were seen.

Acute Disease↗
PubMed1992

Effect of lisinopril and isosorbide-5-mononitrate on hemodynamics and mortality in rats with permanent coronary artery occlusion.

We studied the hemodynamic effects of lisinopril and isosorbide-5-mononitrate in rats with permanent coronary occlusion. Rats (n = 35) underwent left coronary occlusion, and ECGs were recorded before and after occlusion. Ventricular arrhythmias were observed in 57% (20 of 35) of animals. Treatment was given immediately after coronary occlusion and for 2 subsequent days. The control group received 100 mg/kg lactose (i.e., 80% vehicle for isosorbide-5-mononitrate). Lisinopril (100 mg/kg body weight) and isosorbide-5-mononitrate (400 mg/kg body weight) reduced systolic blood pressure (SBP) from 134 +/- 9 to 115 +/- 9 mm Hg (p less than 0.05) and from 137 +/- 9 to 126 +/- 9 mm Hg, respectively; the hypotensive effect lasted 2-3 days. No effect on BP was noted in the control group. Overall mortality was 23%; 8 of 35 animals died within 10-15 min of coronary occlusion. Survival after 4 weeks was similar in each group (approximately 80%). Left ventricular pressure (LVP) was measured 4 weeks after coronary artery occlusion and was similar in each group. However, dP/dt was lower in hearts with infarction than in hearts with none (12,608 +/- 906 vs. 8,992 +/- 1,242 mm Hg/s). The extent of the infarction was the same in groups with coronary artery occlusion. Lisinopril is more effective than isosorbide-5-mononitrate in reducing BP after acute myocardial infarction (AMI). Medium-term survival (4 weeks) is not jeopardized by effective treatment with angiotensin-converting enzyme (ACE) inhibitors or long-acting nitrates.

Angiotensin-Converting Enzyme Inhibitors↗