This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Visual Abstract
Abstract
Background and objectives Little is known about the burden of adverse drug reactions in CKD. We estimated the incidence of overall and serious adverse drug reactions and assessed the probability of causation, preventability, and factors associated with adverse drug reactions in patients seen by nephrologists.
Design, setting, participants, & measurements The Chronic Kidney Disease-Renal Epidemiology and Information Network cohort included 3033 outpatients (65% men) with CKD and eGFR<60 ml/min per 1.73 m2, with follow-up for 2 years. Adverse drug reactions were identified from hospitalization reports, medical records, and participant interviews and finally assessed for causality, preventability, and immediate therapeutic management by experts in pharmacology.
Results Median (interquartile range) age was 69 (60–76) years old; 55% had eGFR≥30 ml/min per 1.73 m2, and 45% had eGFR<30 ml/min per 1.73 m2. Participants were prescribed a median (range) of eight (five to ten) drugs. Over 2 years, 536 patients had 751 adverse drug reactions, 150 (in 125 participants) classified as serious, for rates of 14.4 (95% confidence interval, 12.6 to 16.5) and 2.7 (95% confidence interval, 1.7 to 4.3) per 100 person-years, respectively. Among the serious adverse drug reactions, 32% were considered preventable or potentially preventable; 16 caused death, directly or indirectly. Renin-angiotensin system inhibitors (15%), antithrombotic agents (14%), and diuretics (10%) were the drugs to which the most adverse drug reactions were imputed, but antithrombotic agents caused 34% of serious adverse drug reactions. The drug was discontinued in 71% of cases, at least temporarily. Adjusted hazard ratios for serious adverse drug reaction were significantly higher in patients with eGFR<30 versus ≥30 ml/min per 1.73 m2 (1.8; 95% confidence interval, 1.3 to 2.6), in those prescribed more than ten versus less than five medications (2.4; 95% confidence interval, 1.1 to 5.2), or in those with poor versus good adherence (1.6; 95% confidence interval, 1.4 to 2.4).
Conclusions Adverse drug reactions are common and sometimes serious in patients with CKD. Many serious adverse drug reactions may be preventable. Some specific pharmacologic classes, particularly antithrombotic agents, are at risk of serious adverse drug reactions.
Clinical Trial registry name and registration number Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN), NCT03381950
- chronic kidney disease
- pharmacoepidemiology
- antithrombotic agents
- adverse drug reactions
- risk factors
- diuretics
- Renin-Angiotensin System
- glomerular filtration rate
- Cohort Studies
- Renal Insufficiency
- Chronic
- Drug-Related Side Effects and Adverse Reactions
- hospitalization
- Medical Records
- Received January 24, 2019.
- Accepted May 13, 2020.
- Copyright © 2020 by the American Society of Nephrology
If you are:
- an ASN member, select the "ASN Member" login button.
- an individual subscriber, login with you User Name and Password.
- an Institutional user, select the Institution option where you will be presented with a list of Shibboleth federations. If you do not see your federation, contact publications@asn-online.org.
ASN MEMBER LOGIN
Log in using your username and password
Log in through your institution
Purchase access
Pay Per Article - You may access this article (from the computer you are currently using) for 1 day for US$32.00
Steps for Creating an Account:
Click the "Purchase Access" button. The page will redisplay with the following message at the top of the screen which contains the link to register for an account.
When you create an account, you will be asked for your name, email address and other information. Just like commercial web sites, we do need details from you in order to complete your purchase of an article.
You will then be asked to register a user name, email address and you will need to create a password that is at least eight characters in length. You do not need an ASN Member number to complete the form. As you move through the registration page, you will have to verify you are a person by completing a Captcha request. Lastly, your first and last name will be required.
Once your information is successfully saved, the system will redisplay the home page of the journal. From there, navigate back to the article to purchase. Select the article and at the bottom of the page, use the credentials you just created to login. The article will be added to your shopping cart. You can continue to navigate across JASN and CJASN adding to your cart from both journals. When you are ready to complete your purchse, select the Shopping Cart from the upper right hand corner of the page and follow the onscreen instructions.
In this issue
