See the published version of this preprint at BMC Pharmacology and Toxicology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Research article
Young-Min Ye
Ajou University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7517-1715
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥ 65 years) in comparison to younger individuals (< 65 years).
Methods Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. Subjects exposed to major culprits were extracted from cohorts transformed to the Observational Medical Outcomes Partnership Common Data Model during the study period.
Results In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21–1.44; P < 0.001) and fentanyl (1.49, 1.16–1.92, P = 0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30–0.40, P < 0.001) and iodinated contrast media (ICM) (0.82, 0.76–0.89, P < 0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48–3.15; P < 0.001) and ICM (2.09, 1.36–3.21, P = 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P = 0.019).
Conclusion For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.
Keywords
adverse drug reaction, aged, drug hypersensitivity, pharmacovigilance
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Pharmacology and Toxicology.
No community comments so far
Submission checks complete
On 21 Nov, 2020
Editorial decision: Accept
On 18 Nov, 2020
No comments provided
Review #3 received
Received 11 Nov, 2020
Reviewer #3 agreed
On 01 Nov, 2020
Review #2 received
Received 30 Oct, 2020
Reviewer #2 agreed
On 29 Oct, 2020
Reviewers invited
Invitations sent on 29 Oct, 2020
Reviewer #1 agreed
On 29 Oct, 2020
Review #1 received
Received 29 Oct, 2020
Editor assigned
On 27 Oct, 2020
Submission checks complete
On 26 Oct, 2020
Editor invited
On 26 Oct, 2020
Version 1
Posted 01 Sep, 2020
No comments provided
Review #3 received
Received 29 Sep, 2020
Editorial decision: Major revision
On 29 Sep, 2020
Reviewer #3 agreed
On 17 Sep, 2020
Reviewer #2 agreed
On 14 Sep, 2020
Review #2 received
Received 14 Sep, 2020
Review #1 received
Received 13 Sep, 2020
Reviewers invited
Invitations sent on 31 Aug, 2020
Reviewer #1 agreed
On 31 Aug, 2020
Editor assigned
On 19 Aug, 2020
Submission checks complete
On 18 Aug, 2020
Editor invited
On 18 Aug, 2020
First submitted
On 17 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at BMC Pharmacology and Toxicology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Young-Min Ye
Ajou University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7517-1715
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Pharmacology and Toxicology.
No community comments so far
Submission checks complete
On 21 Nov, 2020
Editorial decision: Accept
On 18 Nov, 2020
No comments provided
Review #3 received
Received 11 Nov, 2020
Reviewer #3 agreed
On 01 Nov, 2020
Review #2 received
Received 30 Oct, 2020
Reviewer #2 agreed
On 29 Oct, 2020
Reviewers invited
Invitations sent on 29 Oct, 2020
Reviewer #1 agreed
On 29 Oct, 2020
Review #1 received
Received 29 Oct, 2020
Editor assigned
On 27 Oct, 2020
Submission checks complete
On 26 Oct, 2020
Editor invited
On 26 Oct, 2020
Version 1
Posted 01 Sep, 2020
No comments provided
Review #3 received
Received 29 Sep, 2020
Editorial decision: Major revision
On 29 Sep, 2020
Reviewer #3 agreed
On 17 Sep, 2020
Reviewer #2 agreed
On 14 Sep, 2020
Review #2 received
Received 14 Sep, 2020
Review #1 received
Received 13 Sep, 2020
Reviewers invited
Invitations sent on 31 Aug, 2020
Reviewer #1 agreed
On 31 Aug, 2020
Editor assigned
On 19 Aug, 2020
Submission checks complete
On 18 Aug, 2020
Editor invited
On 18 Aug, 2020
First submitted
On 17 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Pharmacology and Toxicology.
Background Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥ 65 years) in comparison to younger individuals (< 65 years).
Methods Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. Subjects exposed to major culprits were extracted from cohorts transformed to the Observational Medical Outcomes Partnership Common Data Model during the study period.
Results In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21–1.44; P < 0.001) and fentanyl (1.49, 1.16–1.92, P = 0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30–0.40, P < 0.001) and iodinated contrast media (ICM) (0.82, 0.76–0.89, P < 0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48–3.15; P < 0.001) and ICM (2.09, 1.36–3.21, P = 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P = 0.019).
Conclusion For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
Loading...