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Coronary MR imaging: effect of timing and dose of isosorbide dinitrate administration.

ABSTRACT: To quantify the effect of sublingual isosorbide dinitrate (ISDN) administration on coronary magnetic resonance (MR) imaging.Written informed consent was obtained from all participants, and the HIPAA-compliant protocol was approved by the Institutional Review Board. Coronary MR imaging was performed at 1.5 T before and after administration of ISDN (2.5 or 5 mg) in 25 healthy adult volunteers (mean age, 23 years +/- 4; nine men, 16 women) with three-dimensional targeted (n = 20, randomized into four groups) or whole-heart (n = 5) acquisitions with gradient-recalled echo (GRE) or balanced steady-state free precession (SSFP) sequences. Image quality was assessed by two cardiologists on a four-point scale. Signal-to-noise ratio (SNR), vessel diameter, and vessel sharpness were characterized. A linear mixed-effects model was used for data analysis. A P value of less than .05 was considered to indicate a significant difference.The maximum SNR enhancement with 5 mg of ISDN (GRE: 22.0% +/- 10.7%; SSFP: 20.1% +/- 6.0%) was similar (P > .05) to that with 2.5 mg (GRE: 21.9% +/- 5.4%; SSFP: 19.1% +/- 3.0%). However, the time to maximum SNR enhancement for the 5-mg dose (15.5 minutes +/- 6.0) was earlier (P < .01) than that for 2.5 mg (23.5 minutes +/- 6.7). The increase in vessel diameter with 5 mg of ISDN was greater than that with 2.5 mg (P < .05 for both GRE and SSFP sequences). The coronary images were sharper after ISDN administration (P < .03). Subjective image quality score significantly improved after ISDN administration for GRE images (P < .05 for both doses) but was similar for SSFP images (P = .24 for 2.5 mg; P = .27 for 5 mg). Whole-heart coronary SNR was improved about 10% after ISDN administration (P < .05).Sublingual ISDN improves coronary MR imaging SNR. Practitioners need to consider the dose and temporal effects of ISDN when performing coronary MR imaging.

SUBMITTER: Hu P

PROVIDER: S-EPMC2809925 | biostudies-other | 2010 Feb

REPOSITORIES: biostudies-other

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Project description:BackgroundThe metabolic activity of endogenous nitric oxide (NO) and the medical use of nitrovasodilatory drugs like isosorbide dinitrate have been shown to be potential inducers inducers of cervical ripening prior to surgical evacuation of the uterus.ObjectiveTo assess the therapeutic efficacy and safety of combined isosorbide dinitrate-oxytocin in the management of intrauterine foetal death (IUFD).MethodsSixty women with IUFD after 20 weeks of gestation requesting uterine evacuation were randomly selected to receive isosorbide dinitrate gel solution (80 mg/1.5 mL; n = 30) or misoprostol gel solution (100 mcg/1.5 mL; n = 30) every 3 h with a maximum of four doses or until a Bishop score >7 was reached. Subsequently, patients received a high dose of intravenous oxytocin until complete uterus evacuation was achieved. Therapeutic efficacy was evaluated by mean the relative risk of the foetal expulsion based on comparison of event rates, and the proportion of women induced to labor at 7, 10 and 15 h after the administration of isosorbide dinitrate or misoprostol. Safety was assessed on the basis of woman´s vital signs and evaluation of adverse effects, including headache, abdominal pain, pelvic pain, lower back pain, nausea, dizziness and vomiting.ResultsThe foetal expulsion rate using the isosorbide dinitrate-oxytocin combination was approximately 4.4 times, and at least 2.1 times, the foetal expulsion rate with the misoprostol-oxytocin regimen at any given point in time. The proportion of women achieved vaginal delivery at 15 hours was 100% for the isosorbide dinitrate-oxytocin group and 86.7% for the misoprostol-oxytocin group. The average delivery induction interval was significantly lower when isosorbide dinitrate-oxytocin was used (8.7 ± 3.1 h) than when misoprostol-oxytocin (11.9 ± 3.1 h) was used. A total of 20% of patients in the isosorbide dinitrate-oxytocin group recorded headache, and no cases of uterine tachysystole, haemorrhage or coagulopathy were recorded.ConclusionThis study indicates that intravaginal isosorbide dinitrate followed by intravenous oxytocin was more effective than the conventional method used to induce labour in the medical management of foetal death in pregnancies after 20 weeks of gestation.Trial registrationClinicaltrials.gov NCT02488642.

Project description:We designed two Phase I studies that assessed healthy volunteers in order to evaluate the safety and to optimize the dosing of the combination of the drugs isosorbide dinitrate, a nitric oxide donor, and ibuprofen, a nonsteroidal antiinflammatory drug. We designed these studies with the aim of designing a Phase II trial to evaluate the drugs' efficacy in patients affected by Duchenne muscular dystrophy. For the first trial, ISOFEN1, a single-dose, randomized-sequence, open-label, active control, three-treatment cross-over study, was aimed at comparing the pharmacokinetics of ibuprofen 200 mg and isosorbide dinitrate 20 mg when given alone and concomitantly. The pharmacokinetics of ibuprofen given alone versus ibuprofen given concomitantly with isosorbide dinitrate were similar, as documented by the lack of statistically significant differences in the main drug's pharmacokinetic parameters (time to maximal concentration [Tmax], maximal concentration [Cmax], area under the curve [AUC]0-t, and AUC0-?). Similarly, we found that the coadministration of ibuprofen did not significantly affect the pharmacokinetics of isosorbide dinitrate. No issues of safety were detected. The second trial, ISOFEN2, was a single-site, dose titration study that was designed to select the maximum tolerated dose for isosorbide dinitrate when coadministered with ibuprofen. Eighteen out of the 19 enrolled subjects tolerated the treatment well, and they completed the study at the highest dose of isosorbide dinitrate applied (80 mg/day). One subject voluntarily decided to reduce the dose of isosorbide dinitrate from 80 mg to 60 mg. The treatment-related adverse events recorded during the study were, for the large majority, episodes of headache that remitted spontaneously in 0.5-1 hour - a known side effect of isosorbide dinitrate. These studies demonstrate that the combination of isosorbide dinitrate and ibuprofen does not lead to pharmacokinetic interactions between the two drugs; they also demonstrate that the combination of isosorbide dinitrate and ibuprofen has optimal tolerability and safety profiles that are similar to those previously reported for isosorbide dinitrate and ibuprofen given alone.

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Coronary MR imaging: effect of timing and dose of isosorbide dinitrate administration.

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