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1 All authors: Division of Abdominal Imaging and Intervention, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St., Boston, MA 02115.
Received February 2, 2004;
accepted after revision June 30, 2004.
Address correspondence to K. J. Mortelé
(kmortele{at}partners.org).
Abstract
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SUBJECTS AND METHODS. For 2 years, we prospectively recorded all adverse events temporally associated with the administration of iopromide in 29,508 consecutive patients undergoing contrast-enhanced CT at our institution. The types, intensities, treatments, and outcomes of adverse events were recorded along with relevant patient history, including risk factors. Descriptive analyses of the variables, comparisons of means, and proportions using Student's t and chi-square tests, and logistic regressions were conducted.
RESULTS. Adverse events were observed in 211 patients (0.7%) and were categorized as follows: urticaria (n = 161), facial or laryngeal edema (n = 13), bronchospasm (n = 8), severe nausea or vomiting (n = 10), or other (n = 19). One hundred eighty-eight adverse events (89%) were rated mild, 19 moderate (9%), and four severe (2%), including one fatality. Adverse events required treatment in 89 patients (42%). A history of allergy was present in 92 patients (44%), and 29 (14%) had a prior contrast reaction. Other relevant risk factors were identified in 63 patients (30%). No relationship existed between the occurrence of adverse events and any of the following: patient age, dose of iodine administered, or time of study (i.e., month, season, and year). Women (p < 0.001) and outpatients (p < 0.001) had a statistically significant higher incidence of adverse events.
CONCLUSION. The universal use of iopromide as an IV CT contrast agent has a favorable safety profile.
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Randomized, multicenter evaluations of the safety profile of iopromide and other ionic and nonionic iodinated contrast agents are widely available [3–15]. However, these trials have focused on the safety of the contrast agent for selected procedures (e.g., abdominal CT, coronary artery angiography, digital subtraction angiography, and excretory urography) in relatively small patient populations using doses of 42 g of iodine or more [3–15]. To our knowledge, no study has addressed the safety profile of iopromide in a large patient population, across a broad range of CT procedures, using a lower (30 g or less) dose of contrast agent in most patients. We present and analyze our 2-year experience with IV iopromide in a large cohort of consecutive patients undergoing contrast-enhanced CT.
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Before contrast agent administration, all patients completed a standardized form used in the radiology department to screen for contrast reactions (Fig. 1). Patient age, sex, and weight and the type of study were identified. Relevant patient history, including symptoms, known diseases, and concurrent medications, was recorded. In addition, risk factors for contrast agent administration or development of adverse events were identified.
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Adverse Events
All adverse events, volunteered by the patient or observed by the staff,
were recorded by a physician on the standard form. Adverse events were grouped
into 10 distinct categories: urticaria, facial or laryngeal edema,
bronchospasm, hypotension (with tachycardia), vasovagal reaction,
hypertension, seizures, pulmonary edema, severe nausea or vomiting, and others
(e.g., sneezing, throat itching, or dizziness). The intensity of the adverse
events was classified as mild when the event was self-limited and no medical
treatment was required (except for the use of H1-receptor blockers
for treatment of mild dermal reactions), moderate when the patient needed
medical treatment and was transferred to the emergency department for
prolonged observation, or severe when the patient needed immediate medical
treatment for life-threatening events and was admitted overnight for treatment
or died. The management of all adverse events, including observation, and
their outcomes were recorded.
Data Analysis
Descriptive analyses of the variables, comparisons of means, and
proportions using Student's t and chisquare tests, and logistic
regressions were conducted. Patients who experienced adverse events and
patients who did not were compared to evaluate differences in age, sex, dose
of contrast agent (in grams of iodine), patient's status during study (i.e.,
inpatient vs outpatient vs emergency department patient), and time of study
(i.e., month, season, and year).
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The two hundred eleven adverse events were categorized by type as follows: urticaria (n = 161; 76%); facial or laryngeal edema (n = 13; 6%); bronchospasm (n = 8; 4%); severe nausea or vomiting (n = 10; 5%); dermal and severe vomiting (n = 2; 1%); dermal and facial or laryngeal edema (n = 1; 1%); and other, including sneezing, scratchy throat, and dizziness (n = 16; 8%). Overall, 188 adverse events (89%) were rated as mild, 19 (9%) as moderate, and four (2%) as severe, of which one was fatal. The fatal reaction occurred in a 73-year-old male outpatient who underwent CT angiography of the head and neck. The patient had no allergies, had undergone prior contrast-enhanced CT without difficulties, but had a significant medical history of hypertension and arrhythmia. Immediately after contrast administration, the patient experienced facial and laryngeal edema and paroxysmal ventricular tachycardia. Despite immediate treatment, the patient experienced cardiac arrest soon after and died. One hundred eighteen patients (55.9%) were treated with observation only and 89 patients (42%) with a specific treatment. Diphenhydramine was administered to 71 patients, methylprednisone to five patients, and epinephrine to five patients. Three patients were immediately transferred to the emergency department, and the code team was called for three patients. Information on treatment was not available for four patients.
Of the 211 adverse events, 51 (24.2%) occurred in the summer, 54 (25.6%) in the fall, 47 (22.3%) in the winter, and 59 (27.9%) in the spring. Figure 2 displays the prevalence of adverse events on a monthly basis for the 2-year review period.
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Risk factors were as follows: 92 patients (44%) had a history of allergy of any kind; in 21 of these patients, multiple allergies were present (Table 1). Of 105 patients who had had a prior contrast-enhanced CT scan, 29 patients (28%) had reported a history of a contrast reaction, 71 (67%) did not, and in five (5%) the history was unclear. Documentation of premedication with oral prednisone, 40 mg 12 and 2 hr before the study, was present in 10 of these 29 patients. Other risk factors were identified in 63 patients (30%) and included one or more of the following conditions: asthma, high blood pressure, angina pectoris, heart failure, cardiac arrhythmia, and diabetes mellitus (Table 2).
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Of the remaining 29,297 patients (99.3%) who did not experience adverse events, 16,693 (57%) were female and 12,604 (43%) were male. Their ages ranged from 14 to 101 years (mean age, 54.8 years); 14,342 (49%) were outpatients, 7,797 (27%) were inpatients, and 7,158 (24%) were emergency department patients. Dose data were available for 13,332 patients (scans obtained after July 28, 2002); 75–100 mL of iopromide, 300 mg I/mL (dose, 22.5–30 g of iodine), was administered to 10,885 patients (82%) and 125–150 mL of iopromide, 370 mg I/mL (dose, 46.25–55.5 g of iodine), to 2,361 patients (18%).
No statistically significant relationship was found between the incidence of adverse events and patient age (p = 0.89), contrast agent dose (p = 0.35), or time of study (month [p = 0.7], season [p = 0.5], or year [p = 0.2]). However, a statistically significant relationship was present between the incidence of adverse events and the female sex (p < 0.001). Also, outpatients were more likely to experience adverse events after iopromide administration than were inpatients and emergency department patients (p < 0.001). The logistic regression analysis (Table 3) shows that the incidence of adverse events was 3.1 times higher (statistically significant) in females than males and 7.5 times higher in outpatients than others.
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Randomized, multicenter evaluations of the safety of iopromide and other ionic and nonionic iodinated contrast agents are widely available [3–15]. The overall incidence of adverse advents with universal use of nonionic, monomeric contrast agents ranges from 0.2% to 3.1% [17–21]. However, multicenter trials assessing adverse events typically have focused on the safety of the contrast agent for selected procedures and have been performed on relatively small patient groups [3–15]. Moreover, reports of the incidence of adverse events in larger patient populations lack information on the nature and dose of the contrast agent used and the demographics of the patient population [17–21].
The incidence of 0.7% observed in our study is similar to rates reported for large series by Palmer [17], Katayama et al. [21], and Cochran et al. [18]. The last study, which included patients examined with CT alone, reported an overall adverse event rate of 0.4%, similar to ours. Like other studies on nonionic monomeric agents, most adverse events in our study were mild (89.5%) and allergic. Urticaria and facial or laryngeal edema accounted for most (> 90%) of the adverse events [18].
We observed significantly more adverse events in female patients. Although the underlying mechanism for this observation is unclear, it confirms the results of a prior study of adverse events in 1,181 patients in Spain that also showed women to have a higher incidence of adverse events than men [19].
In contrast to some published reports, we observed no relationship between the incidence of adverse events and the dose of iodine administered [18, 19]. Cochran et al. [18] speculated that contrast dose might play a role in the incidence of reactions, because 70% of severe reactions occurred in patients receiving higher iodine doses for CT angiography. However, Cochran et al. were unaware of the exact number of CT examinations performed using a higher contrast dose; therefore, this speculation may be based on a statistical quirk. Our results are also supported by the fact that most of the events are allergic reactions that are not dose-dependent.
To the best of our knowledge, no prior reports have addressed differences in the incidence of adverse events based on the patient's status at the time of the study (i.e., inpatient vs outpatient vs emergency department patient) or the time of study (i.e., month, season, and year). We did not observe a monthly, seasonal, or yearly variation in the incidence of adverse events during the 2-year study. However, we did observe that outpatients reacted more frequently to iopromide than did either inpatients or emergency department patients. Although the reason is unclear, we speculate that access to clinical information on outpatients is more difficult and less reliable, and perhaps more outpatients with significant risk factors may have undergone contrast-enhanced CT.
Of the patients who reacted, 44% had a history of allergy and 14% had a documented prior contrast reaction. Other relevant risk factors were identified for 30% of patients; overall, asthma was the most common. These results are consistent with a prior report that patients with a history of reactions to contrast media, asthma, and allergy of any kind are the patients most susceptible to contrast reactions [22].
In conclusion, universal use of iopromide as a CT contrast agent has a safety profile comparable to that of other media in its class. In our experience, female patients and outpatients were more likely to react to iopromide. The dose of iodine, patient age, and time of year did not affect the incidence of adverse events.
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