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OBJECTIVE: To determine whether vaginal application of 40 mg isosorbide-5-mononitrate (ISMN) has a comparable cervical ripening efficacy to and lesser side effects than 400 µg misoprostol in women scheduled for the first trimester induced abortion using a manual vacuum aspirator (MVA). METHODS: We conducted a prospective randomized open- label study in 70 women at 6–12 weeks of pregnancy at the R G Kar Medical College and Hospital, Kolkata, India, over a period of two years from 2015 to 2017. Forty milligrams of ISMN and 400 µg misoprostol were vaginally applied for cervical priming. The primary outcome measure was the cervical response assessed by the passage of the appropriate and largest sized MVA cannula through the internal os without resistance, at the beginning of the procedure. RESULTS: The base line cervical dilatation was found to be significantly higher in the misoprostol group than in the ISMN group (7.65±1.38 vs. 6.9±1.26 mm; P=0.025, 95% confidence interval, −1.4046 to −0.953). However, when the women were sub-analyzed based on parity, there was no statistically significant difference in the same parameters among the multigravid women. The need for further cervical dilatation was significantly higher in the ISMN group when the primigravid women were compared, although the multigravid women responded favorably to ISMN. CONCLUSION: In the primigravid women, misoprostol appears to exert a higher efficacy as a cervical ripening agent in contrast to ISMN. However, ISMN can be used in multigravid women for the same purpose as in this group, misoprostol did not show any significant improvement in efficacy over ISMN.
Subject(s)
Female , Humans , Pregnancy , Abortion, Induced , Catheters , Cervical Ripening , India , Labor Stage, First , Misoprostol , Outcome Assessment, Health Care , Parity , Pregnancy Trimester, First , Prospective Studies , VacuumABSTRACT
OBJECTIVE: To study the effect of isosorbide-5-mononitrate (5-ISMN) on ivabradine hydrochloride pharmacokinetics in Beagles.
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It is difficult to est isosorbide 5-mononitrate in biological specimen due to its unsignificant UV absorption and thermal instability. Therefore, uarious methods such as HPLC, GC-ECD, GC-MS and HPLC-MS/MS were established to meet the needs of assay sensitivity and specificity. Research progress in the chromatography is reviewed in this paper.
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B The 45-minute dissolubilities of all the 5-ISMN capsules were higher than 85%,but the dissolubility parameters,m,T50,Td,had significant differences among them
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Objective Isosorbide-5-mononitrate(ISMN), a long-acting venous dilator,has been shown to decrease portal pressure and used in cirrhotic patients to prevent esophageal variceal bleeding(EVB). We performed a meta-analysis to evaluate ISMN in prevention of EVB. Methods Data from Medline(1968-2003), EMBASE(1986-2003), Cochrane Library(issue 3,2003),CJFD(1994-2003) were searched to retrieve randomized controlled trials comparing ISMN combined with or without other treatments to placebo or other treatments in prevention of EVB.Outcome measure was odds ratio( OR ) of bleeding rate. Mantel-Haeszel method was used in fixed model, while Der Simonian and Laird methods were used in random model. Results Seven trials were identified including prevention of first bleeding and rebleeding. The results of meta-analysis indicated that ISMN had no effect on prevention of EVB[study group vs control group: 88/463 vs 117/465, random model: OR (95% CI ): 0.63(0.37, 1.08 )]. Based on sensitivity analysis compared with control group, ISMN had no effect [43/314 vs 40/314, fixed model: OR :0.63(0.37, 1.08)]on prevention of first bleeding, but had therapeutic efficacy [45/149 vs 77/151, fixed model: OR :0.39 (0.24,0.65)]on prevention of rebleeding. Combination therapy of ISMN and ?-blocker revealed more effective than single therapy with ?-blocker[53/327 vs 74/329, fixed model: OR :0.64(0.42, 0.98)]in prevention of rebleeding [25/80 vs 41/81, fixed model: OR :0.44(0.23, 0.85 )], but had no significant difference in prevention of first bleeding[28/247 vs 33/248, fixed model: 0.84(0.48, 1.44)]. Conclusions ISMN is effective in prevention of esophageal variceal rebleeding. Furthermore , combination with ?-blockers has more therapeutic efficacy in prevention of esophageal variceal rebleeding.
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PURPOSE: To evaluate the vasodilation effect of intracoronary isosorbide mononitrate (ISMN) on the coronary arteries, systolic aortic pressure (SAP) and cardiac rhythms. METHODS: Forty patients aged 61 (40-72) years, 30 (75) male, were randomized to receive on a double blind fashion, 20 mg of ISMN or placebo. The two groups had similar baseline characteristics. Quantitative coronary arteriography [by cardiovascular measurement system (CMS)] and SAP were compared before and after ISMN. We also observed the cardiac rhythm. RESULTS: There were no arrhythmias. Reference vessel diameter increased from 2.6 +/- 0.5 mm before to 2.9 +/- 0.4 mm after ISMN and did not change, mean 2.9 +/- 0.5 mm, before and after placebo. There was a difference between ISMN and placebo (p < 0.0001). There was no difference in the SAP change between the two groups, 4.2 +/- 0.7 mmHg with ISMN and 1.8 +/- 0.5 mmHg with placebo (p = NS). CONCLUSION: ISMN promotes a safe and effective vasodilation of the coronary arteries with no major effects in cardiac rhythm and systolic aortic pressure.
Objetivo - Avaliar o efeito do mononitrato-5 de isossorbida (MNIS) sobre as artérias coronárias, pressão arterial sistêmica média (PAS) e ritmo cardíaco, quando injetado intracoronário. Métodos - Quarenta pacientes, idade entre 40 a 72 (média 61) anos, 30 (75%) homens, foram sorteados para receber, de maneira cega, 20mg de MNIS ou placebo (PL). Os dois grupos tinham características basais semelhantes. A angiografia coronária quantitativa (através do sistema CMS - cardiovascular measurement system) a PAS e o ritmo cardíaco foram comparados antes e após a injeção de MNIS/PL. Resultados -Não houve arritmias. O diâmetro coronário variou de 2,6± 0,5mm, antes, para 2,9±0,4mm, após oMNIS, e nuo variou com a injeção de PL, permanecendo 2,9±0,5mm antes e após, havendo diferença significativa entre o MNIS e o PL (p<0,0001). A variação da PAS não foi diferente entre os 2 grupos, sendo 4,2±0,7mmHg no grupo MNIS e 1,85±0,5mmHg no grupo PL (p=NS). Conclusão - O MNIS promove eficaz e segura dilatação coronária, pois não induz à hipotensão arterial sistêmica ou alteração no ritmo cardíaco
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Vasodilator Agents , Coronary Vessels , Isosorbide Dinitrate , Arterial Pressure/drug effects , Isosorbide Dinitrate , Coronary Angiography , Injections, Intra-Arterial , Double-Blind MethodABSTRACT
AIM: To gain an insight into preference for elderly diabetic patients with angina pectoris between Shexiang Baoxin Pill (SXBXP) (Moschus, Radix Ginseng, Calculus Bovis, etc.) and Extended Release Isosorbide 5-Mononitrate (ERIM). METHODS: Followed a two-week run-in, 56 elderly patients were randomized to take SXBXP 2 pills tid or ERIM 60 mg qd for 4 weeks; then followed a two-week wash-out, patients crossed over to the complementary therapy for another 4 weeks. Daily diary cards were used to record the side effects, the frequency of angina pectoris attacks and use of rescue medication. At the end of the study, participants were asked to complete a 3-item scale questionary to assess their angina pectoris treatment in terms of convenience, side effects and overall preference. RESULTS: No treatment difference in the frequency of angina pectoris attacks and use of rescue medication was found; 71.4% of patients thought use of SXBXP was the same convenient as that of ERIM; patients felt SXBXP had side effects fewer than ERIM and overall 75% of patients preferred SXBXP. CONCLUSION: Elderly diabetic patients with angina pectoris prefer SXBXP to ERIM.
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An open trial was carried out to investigate the efficacy and tolerance of isosorbide 5-mononitrate(Elantan(R)) in 30 patients diagnosed as angina pectoris at Pusan national university hospital. Drugs were given 20mg two times daily for 2 to 3 weeks and the results were assessed in terms of effects on anginal pain and untoward side effects experienced during administration of medication. Treament resulted in an overall improvement in 25 patients(83.4%), complete abolition of anginal attacks in 17 patients(56.7%) and reduction in frequency of attacks in 8 patients(26.7%). So called "Nitrated headache" was observed in 5 patients(16.6%) but improved with proceeding of administration in 3 patients. This trial indicates that isosorbide 5-mononitrate should be efficacious as well as tolerated in patients with coronary heart disease.
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Humans , Angina Pectoris , Coronary Disease , IsosorbideABSTRACT
The antianginal effects of oral isosorbide 5-mononitrate(Elantan(R)) were evaluated in 14 patients with angina pectoris by repeated treadmill exercise test before and after oral Elatan(R) therapy(49 mg/day for 14 days) in Chungnam National University Hospital from Dec., 1988 to Jun., 1989. The results were as follows; 1) The patients were 45 to 71 years old(mean 57) and consisted of 9 men and 5 women. 2) There were no significant effects on resting hemodynamic data such as heart rate, systolic and diastolic blood pressure after Elatan(R) therapy. 3) Peak heart rate, peak blood pressure and peak heart rate-systolic blood pressure product(double prduct) during exercise showed no changes. 4) Exercise durations were prolonged in 11(79%) patients, did not changed in 2(14%), and shorted in 1(7%) patient after therapy(399+/-189 seconds vs 529+/-230, second P<0.01). 5) Three patients complained of headache, but none discontinued medication.
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Female , Humans , Male , Angina Pectoris , Blood Pressure , Exercise Test , Headache , Heart , Heart Rate , Hemodynamics , IsosorbideABSTRACT
Objective:To study the pharmacokinetics and relative bioavailability of isosorbide 5 mononitrate(5 ISMN)sustained release capsules in 12 male healthy volunteers. Methods: A capillary gas chromatography method with electron captured detector was established for the determination of 5 ISMN in plasma, after administrating a daily dose of 40 mg 5 ISMN domestic and imported sustained release capsules in a randomized crossover design.The fluctuation of 5 ISMN valley concentrations observed and the steady state pharmacokinetics was characterized in a multiple dose schedule of 40 mg 5 ISMN sustained release capsules.Results:The steady state of 5 ISMN plasma concentrations reached at the fourth oral administration.The steady state pharmacokinetic parameters after multiple oral dose of 40 mg 5 ISMN domestic and imported sustained release capsules were as follows: t max were (4.8?0.6) and (4.8?0.9) h, c max were (802.46?94.45) and (807.09?109.16) ?g/L, c min were (127.83?23.76) and (121.85?22.00) ?g/L, AUC ss were (8 114.7?1 393.4) and (8 174.8?1 219.7) ?g?h/L, c av were (338.12?58.06) and (340.62?50.82) ?g/L,the degree of fluctuation (DF) were (2.04?0.39) and (2.03?0.33), respectively. Conclusion:The relative bioavailability of multiple oral dose of 40 mg domestic 5 ISMN sustained release capsules is (99.07?5.45)%, there are no significant differences in the main steady state pharmacokinetic parameters between domestic and imported sustained release capsules, and so the 2 capsules are bioequivalent.