Abstract
Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.
Highlights
Iodinated contrast media (CM) have been administered safely in millions of people worldwide [1], and constituted a crucial tool that is frequently used for imaging procedures carried out during diagnostic clinical practice
The majority (44.6%) of patients who enrolled were from centres in China, and this study focuses on the detailed analysis of data from these Chinese patients in order to determine the safety and tolerability of Iopromide based on patient parameters such as pre-existing risk factors and use of pre-medication
Adverse Drug Reactions adverse drug reactions (ADRs) findings were similar to the overall adverse events (AEs) profile, since only 14 of the 672 reported events were found to be unrelated to the administration of Iopromide
Summary
Iodinated contrast media (CM) have been administered safely in millions of people worldwide [1], and constituted a crucial tool that is frequently used for imaging procedures carried out during diagnostic clinical practice. Numerous iodinated CM are currently available in China, such as Iodixanol (Visipaque) and Iopromide (Ultravist®; Bayer Healthcare Pharmaceuticals), among others [11] While their safety profiles have already been established as part of routine clinical trials that preceded their marketing and commercialization; extensive post marketing surveillance on a large number of patients is required in order to identify and determine the frequency of all extremely rare adverse drug reactions that may occur. To our knowledge, such a non-interventional study that seeks to quantify the rate of ADR and AE occurrence due to Iopromide use in an unselected Chinese population has not been conducted so far. A subjective analysis of diagnostic image quality based on the investigators’ evaluation has been included in our analyses
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