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PubMed1983

Treatment of portal hypertension with isosorbide dinitrate alone and in combination with vasopressin.

Experimental animal studies have suggested that certain vasodilators could minimize the adverse cardiovascular effects of vasopressin. We investigated the hemodynamic effects of isosorbide dinitrate, alone and in combination with vasopressin, in patients with liver cirrhosis. In 10 patients, isosorbide dinitrate, 5 mg sublingually, reduced portal pressure by 21% as assessed by the gradient between wedged and free hepatic venous pressure, but also decreased mean arterial pressure (MAP) by 20%, pulmonary artery wedge pressure (WP) by 50%, and oxygen delivery (DO2) by 13%. In 6 other patients, isosorbide dinitrate, 5 mg sublingually, combined with vasopressin, 0.4 U/min iv, reduced portal pressure by 37%, increased MAP by 13%, and mean pulmonary artery pressure (MPAP) by 70%, and decreased DO2 by 32%. Thus, isosorbide dinitrate reduces effectively portal hypertension in patients with liver cirrhosis, but also decreases DO2 to the tissues as a consequence of a fall in cardiac output due to decreased preload. At the dosage used in this study, isosorbide dinitrate does not prevent the adverse hemodynamic effects of vasopressin.

Adult↗
PubMed1996

Counterregulatory responses: sustained-release isosorbide-5-mononitrate versus transdermal nitroglycerin.

Therapy with nitroglycerin is associated with the development of counterregulatory responses. This investigation documents the counterregulatory responses to once daily sustained-release isosorbide-5-mononitrate, contrasting them with those observed during continuous transdermal nitroglycerin. Twenty male volunteers were studied in a single-blind, parallel comparison of sustained-release isosorbide-5-mononitrate versus continuous transdermal nitroglycerin. This was a 5-day in-hospital study. Standing systolic blood pressure, heart rate, hematocrit, plasma catecholamines, and plasma renin activity were assessed at baseline (day 1), during 3 days of nitrate therapy (days 2-4), and on day 5, when no therapy was given. The administration of both transdermal nitroglycerin and isosorbide-5-mononitrate was associated with a decrease in systolic blood pressure and an increase in heart rate. There was loss of the systolic blood pressure effects within 48 h in both groups. The effect on heart rate was maintained over time and was greater in the isosorbide-5-mononitrate group. Nitrate therapy caused no change in plasma catecholamine concentrations and only modest changes in plasma renin activity. In both groups, there was a decrease in hematocrit, indicating an increase in plasma volume, which was maintained until the end of day 5. Further investigation revealed that this decrease in hematocrit was not the result of venous sampling and that plasma volume expansion takes > 8 h to resolve after removal of transdermal nitroglycerin. Counterregulatory responses to isosorbide-5-mononitrate are similar to those observed with continuous transdermal nitroglycerin. Plasma volume expansion occurs and is sustained during repeated dosing, whereas neurohormonal activation is modest. The study also revealed new data concerning the time course of reversal of plasma volume expansion after removal of transdermal nitroglycerin.

Administration, Cutaneous↗
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↗
PubMed1978

Improvement in exercise haemodynamics by isosorbide dinitrate in patients with severe congestive cardiac failure secondary to ischaemic heart disease.

Seven patients with severe chronic congestive cardiac failure secondary to ischaemic heart disease performed submaximal supine exercise before and after 5 mg sublingual isosorbide dinitrate at the time of cardiac catheterisation. Exercise before isosorbide dinitrate produced a poor response in left ventricular performance. After isosorbide dinitrate this response was significantly improved. Compared with the control exercise period, cardiac index increased from mean 2.6 to 3.1 1/min per m2 (P less than 0.0025), stroke volume index from mean 22 to 27 ml/m2 (P less than 0.0025), and left ventricular stroke work index from mean 21 to 30 g m/m2 (P less than 0.01). Mean left ventricular filling pressure fell from 37 to 26 mmHg (P less than 0.01). Although isosorbide dinitrate reduced left ventricular filling pressure at rest from mean 26 to 17 mmHg (P less than 0.005), there was no significant change in mean cardiac index or stroke volume index, while left ventricular stroke work index decreased from mean 29 to 22 g m/m2 (P less than 0.05). Isosorbide dinitrate effectively reduces left ventricular filling pressure in the resting patient with congestive cardiac failure but produces a more comprehensive improvement in left ventricular performance during exercise.

Aged↗
PubMed2005

Isosorbide delays gentamicin-induced vestibular sensory cell death.

The efficacy of isosorbide for protection from vestibular sensory cell damage was investigated. The effects of isosorbide on gentamicin-induced production of nitric oxide (NO) and reactive oxygen species (ROS) were studied by means of the fluorescence indicators 4,5-diaminofluorescein diacetate and dihydrotetramethylrosamine. The effect on gentamicin-induced vestibular sensory cell damage was examined by using an in vitro LIVE/DEAD system. Isosorbide inhibited the production of both NO and ROS. Isosorbide limited the vestibular sensory cell damage caused by gentamicin. It is, therefore, suggested that isosorbide may help to treat inner ear disorders.

Animals↗
PubMed1981

Hydralazine and isosorbide dinitrate: comparative central and regional hemodynamic effects when administered alone or in combination.

Central and regional hemodynamic studies were performed before and after the oral administration of 75 mg of hydralazine and/or 20 mg of isosorbide dinitrate in 15 patients with low-output congestive heart failure. Hydralazine increased mean cardiac output 17-25%, mean renal blood flow 19%, and limb blood flow 17% (all p < 0.05). Mean hepatic blood flow did not change significantly with hydralazine. Except for a small increase in cardiac output (6%, p < 0.05) at 30 minutes, isosorbide dinitrate did not significantly alter central, renal, hepatic or limb blood flow. Combining isosorbide dinitrate and hydralazine effected similar increases in cardiac output (17-24%, p < 0.05), renal (17%, p < 0.05) and limb (20%, p < 0.05) blood flow as those elicited by hydralazine alone. The combination did not significantly alter mean hepatic blood flow. Hydralazine, alone or combined with isosorbide dinitrate, increases renal and limb blood flow in congestive heart failure in proportion to the augmented cardiac output; isosorbide dinitrate alone does not alter blood flow to these regions. Neither drug (or combination) changes hepatic blood flow in this clinical setting.

Adult↗
PubMed1984

Treatment of coronary heart disease with isosorbide mononitrate ('Elantan' 20).

An open, multi-centre trial was carried out to investigate the efficacy and tolerance of isosorbide mononitrate used as anti-anginal therapy in a large group of patients under normal general practice conditions. A total of 10,229 patients with coronary heart disease of average duration of 4 years entered the trial, of whom 8769 had sufficiently severe symptoms to be included in the analysis of results. Most of the patients (92.3%) had previously been treated with cardiovascular drugs. In the trial, all patients were treated with oral isosorbide mononitrate, 20 mg 3-times daily, for a period of 14 days. Treatment resulted in an improvement of angina (compared with the situation during previous therapy) in 79.9% of the assessed patients, complete abolition of angina attacks being achieved in 52.1% and a reduction in frequency of attacks in a further 28.7%. This reduction in angina was associated with a reduced acute consumption of nitrates used for the treatment of attacks. In the smaller sub-group of patients who had received no previous anti-anginal therapy, isosorbide mononitrate treatment resulted in improvement in 91% of patients, complete abolition being achieved in 77.5%. Nocturnal angina was almost totally eliminated by isosorbide mononitrate treatment and this can probably be explained in terms of the favourable pharmacokinetic profile of the drug. 'Nitrate headache', observed in 20.5% of the patients, was the only common side-effect of treatment. The absence of hypotension or tachycardia in significant numbers of patients indicates that isosorbide mononitrate should be well tolerated, as well as efficacious, in all patients with coronary heart disease.

Aged↗
PubMed1990

Effects of isosorbide dinitrate on exercise capacity in cardiac patients--relationship between oxygen uptake responses and hemodynamic effects.

Acute effects of oral isosorbide dinitrate on exercise capacity were evaluated in 14 patients with chronic heart disease measuring the anaerobic threshold and left ventricular function during exercise. A symptom-limited exercise test was performed on a bicycle ergometer with work rates increased by 1W every 6 seconds. Left ventricular function was continuously monitored with a computerized cadmium telluride detector following the intravenous injection of technetium-labeled red blood cells. Thirty minutes after the control exercise test, patients were given isosorbide dinitrate, 5 mg orally. The second exercise test was performed 30 min later. Isosorbide dinitrate improved the anaerobic threshold from 715.4 +/- 172.9 to 774.9 +/- 173.5 ml/min (p less than 0.01) and ejection fraction at peak exercise from 36.7 +/- 11.6 to 39.9 +/- 12.3% (p less than 0.05). However, there was no significant change in maximum work rate or peak oxygen uptake. Those patients for whom isosorbide dinitrate resulted in a 10% or greater improvement in the anaerobic threshold had both higher pre-treatment ejection fractions and greater increases in peak exercise ejection fraction following isosorbide dinitrate. Measurements of the anaerobic threshold and left ventricular function during exercise may be useful in the evaluation of the efficacy of vasodilators in cardiac patients.

Anaerobiosis↗
PubMed1975

Effectiveness of isosorbide dinitrate and nitroglycerin in relieving angina pectoris during uninterrupted exercise.

Twenty patients with ischemic heart disease documented by coronary angiograms or ST segment depression in the ECG during treadmill walking, were administered sublingual nitroglycerin 0.3 to 0.6 mg on one occasion and a chewable form of isosorbide dinitrate 5 mg on another occasion during treadmill walking when anginal discomfort was definitely present at a mild degree of intensity. Despite continued walking at a constant speed and grade, angina was relieved in all patients, completely in most patients, partially in a few. The average time from administration of the medication to onset to relief was 74.7 seconds for nitroglycerin and 107.6 seconds for chewable isosorbide dinitrate. Average time to complete relief or maximal incomplete relief was 190.3 seconds for nitroglycerin and 315.1 seconds for chewable isosorbide dinitrate. Ischemic electrocardiographic changes were reverted toward normal by nitroglycerin in 13 subjects and by isosorbide dinitrate in 15. The differences in onset to complete relief were all statistically significant indicating that nitroglycerin is more rapid in its action than is chewable isosorbide dinitrate.

Administration, Oral↗
PubMed1976

Isosorbide dinitrate and intra-aortic balloon pumping in preinfarctional angina. Effects on central circulatory dynamics.

The dynamics of the central circulation were measured by a radionuclidic technique in 18 men with high-risk preinfarctional angina who received therapy with isosorbide dinitrate (n equals 18), intra-aortic balloon pumping (n equals 8), or both (n equals 8). Administration of 5 mg of isosorbide dinitrate sublinqually was associated with a reduction in stroke volume index (SVI), cardiac index (CI), systemic arterial blood pressure, and left ventricular end-diastolic volume (LVEDV) and with increased left ventricular ejection fraction (LVEF). Intra-aortic balloon pumping did not alter SVI or CI, but decreased systolic blood pressure and LVEDV and increased LVEF and diastolic blood pressure. The combination of therapy with isosorbide dinitrate and intraaortic balloon pumping resulted in decreased SVI, systolic blood pressure, and LVEDV and increased LVEF. Thus, therapy with isosorbide dinitrate reduced left ventricular preload, and intra-aortic balloon pumping reduced blood pressure, which resulted in a decreased LVEDV and an increase in LVEF. Therapy with isosorbide dinitrate and intra-aortic balloon pumping act to alter central circulatory dynamics in favor of reducing myocardial oxygen demand.

Adult↗
PubMed1982

Effect of isosorbide dinitrate on submaximal exercise capacity of patients with chronic left ventricular failure.

The effect of chewable isosorbide dinitrate on submaximal bicycle exercise capacity was evaluated in a double-blind randomized study involving 13 patients with chronic heart failure. All patients had impaired maximal exercise capacity (VO2 max = 12.0 +/- 2.6 ml/kg/min) due to fatigue and dyspnea but not angina. The administration of isosorbide dinitrate lowered the resting mean blood pressure (82 +/- 9. mm Hg to 78 +/- 10 mm Hg, (p less than 0.03)) and the resulting pulmonary wedge pressure (26 +/- 5 mm Hg to 12 +/- 6 mm Hg, (p less than 0.01)). Isosorbide dinitrate acutely improved exercise duration during upright bicycle exercise at a workload fixed at 50 percent of the maximal workload (placebo): 21.8 +/- 14.1 min vs isosorbide dinitrate: 31.4 +/- 13.6 min, (p less than 0.003)) due to reduced exertional dyspnea. Administration of chewable isosorbide dinitrate acutely improved submaximal exercise tolerance in patients with chronic heart failure.

Double-Blind Method↗
PubMed2004

Locally applied isosorbide decreases bone resorption in experimental periodontitis in rats.

BACKGROUND: The role of nitric oxide (NO) on bone metabolism is controversial, since it can either stimulate bone formation or resorption. We investigated the effect of local administration of the NO donor isosorbide in an experimental periodontal disease model. METHODS: Wistar rats were subjected to a ligature placement around the cervix of the right second upper molar and were sacrificed after 11 days. Alveolar bone loss was measured in one quadrant as the sum of the distances between the cuspid tip and the alveolar bone along the axis of each molar root, which was subtracted from the contralateral side, used as unligated control. The semiquantitative histopathological scale of the periodontium was based on cell infiltration and alveolar bone and cementum integrity. Groups were treated with a gel containing 1% or 5% isosorbide applied to the vestibular side of the molar gingiva 1 hour before the placement of the ligature and then twice daily until sacrifice. Controls included one group subjected to periodontitis and no treatment (NT) and another that received the gel containing just the vehicle (V). RESULTS: The application of the vehicle gel produced an increase of the alveolar bone resorption, without altering the inflammatory changes, compared to the NT group. The 5% isosorbide produced a significant reduction of the alveolar bone resorption, compared to V and NT. This reduction was confirmed by histological analysis, showing less inflammatory cell infiltration and preservation of the cementum and the alveolar process. CONCLUSION: Local application of isosorbide reduces alveolar bone resorption in experimental periodontal disease in rats, suggesting a local anti-inflammatory effect of isosorbide.

Alveolar Bone Loss↗
PubMed1987

Abrupt withdrawal of isosorbide 5-mononitrate (Imdur) after long term treatment in stable angina pectoris. A preliminary report.

32 patients with stable angina pectoris who had been receiving a controlled-release formulation Durules of isosorbide 5-mononitrate (Imdur) 60 to 120 mg daily with concomitant beta-blocker therapy for at least 1 year were entered into a study to evaluate possible rebound phenomena from the abrupt withdrawal of isosorbide 5-mononitrate and to determine whether nitrate tolerance had developed. Isosorbide 5-mononitrate was abruptly withdrawn and substituted with placebo for 2 weeks, after which the active drug was reintroduced. No deterioration of exercise performance could be detected during withdrawal of therapy, but an increase was seen after reinstitution. No tolerance was found for systolic blood pressure and ST segment changes or for the number of anginal attacks and short-acting glyceryl trinitrate tablets consumed. Three patients had to be hospitalised because of a sudden deterioration of symptoms on withdrawal of isosorbide 5-mononitrate. It was concluded that isosorbide 5-mononitrate in Durules has a beneficial effect and that tolerance does not appear to be clinically relevant.

Adrenergic beta-Antagonists↗
PubMed1999

Isosorbide 5-mononitrate: a review of a sustained-release formulation (Imdur) in stable angina pectoris.

UNLABELLED: Imdur (IMD) is a sustained-release isosorbide 5-mononitrate preparation for the treatment of chronic stable angina pectoris. Controlled medication release is achieved using the Durules principle of insoluble matrix embedding. Data from randomised double-blind trials show that IMD 60 mg once daily (the most widely studied dosage) has significant antianginal and anti-ischaemic effects compared with placebo after 2 weeks' treatment. Efficacy was generally observed approximately 1 to 12 hours after administration, indicating that once-daily administration in the morning will provide effective prophylaxis of symptoms throughout the day. Improvements from baseline are generally maintained during IMD repeated treatment. There was no evidence of classical tolerance to IMD 30 to 240 mg/day in a large well designed study. Although improvements from baseline were maintained over 6 weeks with IMD 30 or 60 mg/day, statistical significance versus placebo was eventually lost because of improved performance in the placebo group. IMD 120 or 240 mg/day were more effective than placebo after 6 weeks. Studies lasting up to 2 weeks found no evidence of tolerance to IMD 60 mg/day. In comparative trials lasting approximately 2 weeks, IMD 60 mg once daily was more effective than isosorbide dinitrate 30 mg 4 times daily and similar to or better than isosorbide dinitrate 20 mg 3 times daily. Preliminary data show that IMD 60 mg once daily has similar efficacy to diltiazem 60 mg 3 times daily and is at least as effective as certain other sustained-release isosorbide 5-mononitrate preparations. There is no evidence for rebound worsening of ischaemia 24 hours after IMD administration. Abrupt discontinuation during long term IMD treatment may exacerbate anginal symptoms. In general, IMD is well tolerated. The most frequently reported adverse event, headache, is usually mild to moderate, improves with long term therapy and rarely leads to treatment withdrawal. Patient compliance is better with once-daily administration of IMD than with twice-daily administration of conventional isosorbide 5-mononitrate. CONCLUSIONS: In patients with chronic stable angina, IMD provides effective antianginal prophylaxis for up to 12 hours and does not seem to be associated with rebound phenomena at the end of the dosage interval. Improvements from baseline are maintained during repeated administration, although loss of statistically significant superiority over placebo was evident during 6 weeks' treatment with IMD < or =60 mg/day in 1 study. Further evaluation of comparative efficacy (particularly with respect to other sustained-release preparations) and long term effects would be beneficial. Nevertheless, the available data suggest that IMD is a useful and convenient agent for the treatment of patients with chronic stable angina pectoris.

Adrenergic beta-Antagonists↗
PubMed2004

Sex-related differences in the pharmacokinetics of isosorbide-5-mononitrate (60 mg) after repeated oral administration of two different original prolonged release formulations.

OBJECTIVE: To identify differences in the disposition of isosorbide-5-mononitrate between male and female volunteers. METHOD: Plasma concentration and area under the concentration-time curve (AUC(SS)) data of isosorbide-5-mononitrate were obtained in a randomized, crossover, multiple-dose bioequivalence study in 24 subjects (12 females and 12 males). Participants received a single oral dose of 60 mg isosorbide-5-mononitrate prolonged-release tablet formulation (formulations I and II) on each of 6 consecutive days. Plasma isosorbide-5-mononitrate concentrations were determined according to validated methods involving liquid chromatography mass spectrometry. RESULTS: A total of 2 x 24 plasma concentration-time curves of the parent drug could be analyzed. The intersubject variation in plasma concentrations ranged from 25-50% (coefficient of variation). With both formulations, the mean plasma concentration-time curves for males and females ran parallel. The parameters Cmax, Cmin, AUC(SS), and AUC(SS)/kg in females were significantly higher than in males (p < 0.0001). This difference was solely attributed to the difference in body weight (p = 0.0024) and body mass index between males and females (p = 0.0113). Seven females showed a t = 0 = 24 h (Cmin) plasma concentration that was twice as high as the other 5 females and all the males; 125 +/- 12.2 ng/ml versus 59.3 +/- 9.2 ng/ml, respectively, in females (p < 0.0001) and 56.3 +/- 6.9 ng/ml in males (p < 0.0001). With both formulations, females in the n = 7 group had a longer t(1/2) and MRT than females in the n = 5 group, 5.06 +/- 0.76 h, 11.2 +/- 0.55 h versus 4.19 +/- 0.56, 9.40 +/- 0.62 h (p = 0.0057). The male group did not show this phenomenon, their disposition was similar to that of the female group of n = 5. CONCLUSION: The difference found in the Cmax and AUC(SS)/kg of isosorbide-5-mononitrate between male and female subjects must be due to the difference in dose/kg, following a standard dose of 60 mg. Fixed dose administration is common practice due to the available pharmaceutical formulations, while in the ideal situation the dose should be based on dose/kg or titrated to the required clinical effect.

Administration, Oral↗
PubMed2000

[Comparative study of isosorbide dinitrates and mononitrates in patients with ischemic heart disease and stable angina pectoris caused by stenosing coronary atherosclerosis].

In an open clinical trial 19 patients with angina pectoris (functional class II-III) received in turn either non-retard tablets of isosorbide dinitrate (nitrosorbid, cardiket) in a mean dose 80 mg/day or isosorbide 5-mononitrate (mono mac) in a mean dose 51.5 mg/day. Each drug was given for a month. The effect was assessed by changes in frequency of anginal attacks and exercise tolerance. Non-retard isosorbide dinitrate and isosorbide 5-mononitrate demonstrate a good antiischemic effect, are safe and well tolerated. Isosorbide dinitrate and mononitrates do not differ significantly in reduction of the anginal attacks and by an increase in exercise tolerance but the effective dose of mono mac was 1.5-2 times less than that of nitrosorbide or cardiket, thus it is more cost-effective.

Aged↗
PubMedDate not supplied

Efficacy of Terminalia arjuna in chronic stable angina: a double-blind, placebo-controlled, crossover study comparing Terminalia arjuna with isosorbide mononitrate.

BACKGROUND: Terminalia arjuna, an Indian medicinal plant, has been reported to have beneficial effects in patients with ischemic heart disease in a number of small, open studies. The need for a double-blind, randomized, placebo-controlled study with adequate sample size has long been felt. The bark extract (IPC-53) contains acids (arjunic acid, terminic acid), glycosides (arjunetin arjunosides I-IV), strong antioxidants (flavones, tannins, oligomeric proanthocyanidins), minerals. etc. and exhibits antifailure and anti-ischemic properties. METHODS AND RESULTS: Fifty-eight males with chronic stable angina (NYHA class II-III) with evidence of provocable ischemia on treadmill exercise test received Terminalia arjuna (500 mg 8 hourly), isosorbide mononitrate (40 mg/daily) or a matching placebo for one week each, separated by a wash-out period of at least three days in a randomized, double-blind, crossover design. They underwent clinical, biochemical and treadmill exercise evaluation at the end of each therapy which were compared during the three therapy periods. Terminalia arjuna therapy was associated with significant decrease in the frequency of angina and need for isosorbide dinitrate (5.69+/-6.91 mg/week v. 18.22+/-9.29 mg/week during placebo therapy, p<0.005). The treadmill exercise test parameters improved significantly during therapy with Terminalia arjuna compared to those with placebo. The total duration of exercise increased (6.14+/-2.51 min v. 4.76+/-2.38 min, p<0.005), maximal ST depression during the longest equivalent stages of submaximal exercise decreased (1.41+/-0.55 mm v. 2.21+/-0.56 mm, p<0.005), time to recovery decreased (6.49+/-2.37 min v. 9.27+/-3.39 min, p<0.005) and higher double products were achieved (25.75+/-4.81x10(3) v. 23.11+/-4.83x10(3), p<0.005) during Terminalia arjuna therapy. Similar improvements in clinical and treadmill exercise test parameters were observed with isosorbide mononitrate compared to placebo therapy. No significant differences were observed in clinical or treadmill exercise test parameters when Terminalia arjuna and isosorbide mononitrate therapies were compared. No significant untoward effects were reported during Terminalia arjuna therapy. CONCLUSIONS: Terminalia arjuna bark extract, 500 mg 8 hourly, given to patients with stable angina with provocable ischemia on treadmill exercise, led to improvement in clinical and treadmill exercise parameters as compared to placebo therapy. These benefits were similar to those observed with isosorbide mononitrate (40 mg/day) therapy and the extract was well tolerated. Limitations of this study include applicability of the results to only men with chronic stable angina but not necessarily to women, as they were not studied.

Adult↗
PubMed1992

[Pharmacokinetics and pharmacodynamics of a new 80 mg oral delayed-action isosorbide dinitrate preparation].

A new galenic form of isosorbide dinitrate (consisting of a hydrophilic matrix which allows very slow release of the active drug) was studied from the pharmacokinetic and pharmacodynamic view points in 11 patients with stable angina pectoris under betablocker therapy. After testing their sensitivity to nitrates with a sublingual trinitrin test causing a fall greater than or equal to 20 mmHg in systolic and greater than or equal to 10 mmHg in diastolic blood pressure, the patients were given a single tablet of Risordan LP 80 daily for 7 days. The equilibrium plasma concentrations of isosorbide dinitrate and its mononitrate metabolites (2-isosorbide mononitrate and 5-isosorbide mononitrate) over 24 hours were measured on the 6th treatment day. A method of measuring these nitrate derivatives has been developed and validated. The concentrations measured enabled the study of the pharmacokinetics of this new form, showing an average minimal concentration of 5-isosorbide mononitrate (principal metabolite) of 85 +/- 41 micrograms/l and an amplitude of fluctuation over the 24 hours period of 296 +/- 102 micrograms/l. From the pharmacodynamic point of view, the evaluation of the sensitivity to a single dose of 0.75 mg of trinitrin 24 hours after the first dose of Risordan LP 80, just before the second dose and 24 hours after the seventh dose, showed a significant difference (average decrease of 40 +/- 19 mmHg in systolic blood pressure) with respect to the values observed during the selection phase.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗