Safety of regadenoson with theophylline reversal during dynamic computed tomography perfusion and magnetic resonance imaging in patients with coronary artery disease
Anna OleksiakMariusz KrukMateusz ŚpiewakBarbara Miłosz‐WieczorekMagdalena MarczakMarcin DemkowCezary Kępka
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Background: The use of regadenoson in dynamic computed tomography perfusion (CTP) and magnetic resonance myocardial perfusion imaging (MR MPI) is off‑label. Aims: The study aimed to assess the safety of regadenoson with theophylline reversal during CTP and MR MPI in patients with coronary artery disease (CAD). Methods: In this prospective study, patients with 1 or more intermediate coronary artery stenoses on computed tomography angiography underwent CTP and MR MPI with 0.4 mg of regadenoson. After examinations, 200 mg of theophylline was given intravenously in 100 ml of saline. Changes in blood pressure (BP) and heart rate (HR) were repeatedly assessed. All side effects and adverse events were recorded. Results: Out of 106 examinations in 53 patients (25 females, 63.5 [8.5] years), all were diagnostic. There were no deaths, myocardial infarctions, severe arrhythmias, high‑grade atrioventricular blocks, or bronchospasms. The most common symptoms were palpitations (17%), hot flushing (8%), chest discomfort (4%), and mild dyspnea (3%). There were no differences between baseline and peak BP. There was an increase in median (interquartile range) peak HR after regadenoson as compared with baseline (MR MPI, 63 [59–75] bpm vs 93 [86–102] bpm; P < 0.001; and CTP, 65 [60–70] bpm vs 95 [86–107] bpm; P < 0.001). The hemodynamic response to regadenoson and its side effects were completely reversible by theophylline. Conclusions: Regadenoson may be a safe vasodilator for CTP and MR MPI in patients with CAD. The administration of theophylline after perfusion is safe and reverses side effects of regadenoson.Keywords:
Regadenoson
Aminophylline
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Steady-state serum theophylline concentrations following equal doses of intravenous aminophylline and oral theophylline were compared in 30 preterm infants with gestational age of 29.2 ± 2.9 weeks. The result showed no significant statistical difference between the mean serum concentration of theophylline (8.2 ± 2.2 μg/mL vs. 8.4 ± 1.9 μg/mL; p = 0.483). This indicates that a dose reduction of 20%, which is currently recommended, is not required when changing from intravenous aminophylline to oral theophylline. We conclude that in preterm infants, equal doses of intravenous aminophylline and oral theophylline maintain the same serum theophylline concentration.
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1 The pharmacokinetics of theophylline and aminophylline was compared after oral administration and intravenous infusion. 2 Theophylline (250 mg) and aminophylline (390 mg) were taken orally by eight healthy volunteers in a randomized cross‐over study. 3 In another cross‐over study theophylline and aminophylline were administered intravenously to six healthy volunteers at a dose corresponding to 5 mg/kg pure theophylline. 4 The protein binding of the theophylline in serum collected during the intravenous study was studied by ultrafiltration. The serum concentration of theophylline was measured by high pressure liquid chromatography. 5 Almost identical concentration‐time curves were found for theophylline and aminophylline in both of the studies. No significant difference was found in the pharmacokinetic parameters or protein binding with the two preparations.
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We compared serum theophylline concentrations in patients treated with one of two commercially available theophylline preparations: a sustained-release aminophylline and a sustained-release theophylline. Two comparable groups of 15 out-patients with stable, chronic obstructive lung diseases were studied: one group was given sustained-release aminophylline while the other took sustained-release theophylline. Both drugs were administered orally for 7 days at a daily dose, equivalent to 12 mg/kg in terms of anhydrous theophylline. Serum theophylline concentrations were always significantly lower after treatment with sustained-release aminophylline than after treatment with sustained-release theophylline, which latter frequently caused undesirable side-effects. Moreover, patients receiving sustained-release aminophylline always showed serum theophylline concentrations lower than 10 mcg/ml. Pulmonary function tests were unaffected by the administration of either drug. We conclude that sustained-release theophylline is more effective than sustained-release aminophylline in terms of induced serum theophylline concentrations. However neither drug was suitable for the treatment of patients with chronic obstructive lung disease without other concomitant therapy.
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Based on animal data, aminophylline (theophylline ethylene diamine) and caffeine have been said to be contraindicated in patients susceptible to malignant hyperthermia (MH) (1,2). Aminophylline and the ophylline are frequently indicated for bronchospastic disease and caffeine is found in many beverages. Intravenous preparations of aminophylline contain 75–85% theophylline by weight (3). We diagnosed four MH susceptible patients by caffeine-halothane con-tracture response. Additional skeletal muscle fascicles from these patients were exposed in vitro to theophylline with and without the presence of 1% halothane. Results allow for recommendations concerning administration or consumption of these methylxanthines for known MH susceptible patients.
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We often see severe asthma attacks occur in patients taking high doses of theophylline and disappear soon after intravenous injection of aminophylline. Theophylline concentration in the serum was investigated in those cases. Twenty five asthmatic patients, 14 males and 11 females, 16-17 years of age, visited our out-patient clinic 41 times in total over a period of 9 months suffering from dyspneic attacks of such severity that they had difficulty in speaking and walking although they had taken at least 200 mg theophylline within 6 hours and 400 mg within 12 hours. All cases were treated with iv infusion of 2.8-14 ml of 2.5% aminophylline for 5-15 minutes until the dyspneic symptoms disappeared. Theophylline levels in the serum (micrograms/ml) before the treatment were 2.0 in 1 case, 6.0-9.8 in 8, 10-20 in 23, and over 20 in 9 cases. Levels after the treatment were 5.8 in 1 case, 10-20 in 15, and over 20 in 25 cases. In one patient, a 27-year-old female, 300-400 mg of theophylline, aminophylline, or choline theophyllinate tablets could increase theophylline concentration in the serum only 4.8 micrograms/ml or less, while her theophylline clearance was normal. The present study revealed that there are asthmatic patients requiring unusually high doses of theophylline, partly because some of them have problems in absorption of theophylline, and partly because many of them need higher levels of blood theophylline than those usually thought of as standard therapeutic concentrations.
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Short-term infusions with theophylline or aminophylline are often infused very quickly. The present study aimed at comparing the tolerance and therapeutic effect of a theophylline short-term infusion (420 mg theophylline) and an aminophylline short-term infusion (theophylline component 351.3 mg). We infused 16 adults suffering from chronic obstructive respiratory disease, daily at 7 a.m. with increasing speed of infusion and in the following week the other one, and recorded undesirable effects and actions on pulmonary function and gas exchange. 3 of 16 patients tolerated only slow speeds of infusion, 7 patients had mild side effects and tolerated like the other 6 patients even the shortest infusion time. On the whole, both preparations were equally well tolerated. FEV1 and peak flow improved clearly, but only in the course of the next few hours. Theophylline short-term infusion was markedly more effective in this regard. The prompt and infusion rate-independent improvement of the transcutaneous O2 and CO2 partial pressures, which took place even during the short-term injection period, was independent of the preparation. Our data show that intravenously administered theophylline or aminophylline are therapeutically acutely useful substances. However, there is evidently no need to administer theophylline or aminophylline short-term infusions very rapidly, i.e. at below 20 minutes infusion time.
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Abstract The metabolism and pharmacokinetics of intravenously administered theophylline and aminophylline (theophylline ethylenediamine) have been studied in 3 volunteers, using 14C-labelled theophylline. Both compounds were metabolized extensively and 1, 3-dimethyl-uric acid, 1-methyluric acid, 3-methylxanthine and two unknown minor metabolites were excreted in the urine, in addition to theophylline. The elimination of theophylline, 1, 3-dimethyluric acid, 1-methyluric acid and the unknown metabolites followed first-order kinetics, but that of 3-methylxanthine followed Michaelis-Menten kinetics. When given as aminophylline, theophylline was metabolized more rapidly and extensively than when given alone. The recovery of 14C in the urine was significantly higher after aminophylline than after theophylline. Abstention from intake of dietary methylxanthines for 7 days resulted in more rapid and extensive metabolism of aminophylline compared with results from the same subjects on their usual diets. The results indicate that, from a metabolic and pharmacokinetic viewpoint, aminophylline and theophylline are not equivalent.
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The possible pharmacokinetic interactions between pirenzepin and theophylline were investigated in an open single blind trial. Aminophylline (6.5 mg/kg body weight) was administered intravenously in five healthy male volunteers before and after chronic oral pirenzepin therapy (50 mg twice daily 5 days before to 2 days after giving aminophylline). To study the theophylline pharmacokinetics, serum and urine samples were collected up to 48 hours after aminophylline administration. It was demonstrated, that pirenzepin does not affect theophylline pharmacokinetics. Therefore, pirenzepin may be combined with aminophylline or theophylline without the risk of an interaction, which usually affect the coadministration of other antiulcer drugs, e.g. cimetidine, with theophylline.
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The comparative effects of a new theophylline preparation (Theodrip) and aminophylline on blood concentrations of theophylline were examined in 74 patients with asthma. Subjects were intravenously administered 200 mg of Theodrip or 250 mg of aminophylline for 1 h. The mean increases in blood theophylline concentration after Theodrip or aminophylline administration were 8.80 +/- 1.80 mg/l and 8.81 +/- 2.15 mg/l, respectively. In addition, these patients were divided into four groups based on baseline theophylline concentrations before infusion of Theodrip or aminophylline: i) naïve patients (not administered theophylline); ii) those with a baseline theophylline concentration of 0-5 mg/l; iii) those with a baseline theophylline concentration of 5-10 mg/l; iv) those with a baseline theophylline concentration of 10-15 mg/l. Mean increases in blood theophylline concentration after administration of Theodrip in each group were similar to those after aminophylline administration. We found no significant differences between Theodrip and aminophylline. However, when the comparative effects of Theodrip and aminophylline on peripheral blood eosinophil counts were examined, Theodrip, but not aminophylline, reduced blood eosinophil counts. With acute exacerbations of bronchial asthma, it is expected that Theodrip, but not aminophylline, may have an antiinflammatory effect. In conclusion, it is suggested that Theodrip is a more useful drug than aminophylline in patients with acute exacerbations of bronchial asthma.
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