Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study

Objective This study aims to develop and validate a nomogram-based predictive model for estimating the risk of adverse drug reactions (ADR) to statins in patients with coronary heart disease (CHD). Methods A retrospective cohort study was conducted using clinical data from 351 patients with CHD who...

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Main Authors: Lixiang Zhang, Jiaoyu Cao, Xiaojuan Zhou
Format: Article
Language:English
Published: PeerJ Inc. 2025-07-01
Series:PeerJ
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Online Access:https://peerj.com/articles/19630.pdf
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author Lixiang Zhang
Jiaoyu Cao
Xiaojuan Zhou
author_facet Lixiang Zhang
Jiaoyu Cao
Xiaojuan Zhou
author_sort Lixiang Zhang
collection DOAJ
description Objective This study aims to develop and validate a nomogram-based predictive model for estimating the risk of adverse drug reactions (ADR) to statins in patients with coronary heart disease (CHD). Methods A retrospective cohort study was conducted using clinical data from 351 patients with CHD who received statin therapy in the cardiology department of a tertiary hospital in Anhui Province, China, between February 2021 and January 2022. The dataset was randomly divided into a development cohort (n = 283) and a validation cohort (n = 68) in an 8:2 ratio. Logistic regression analysis was applied in the development cohort to identify independent risk factors for statin-induced ADR. A nomogram was subsequently constructed in R based on the selected predictors, and its clinical utility, discriminative performance, and calibration were evaluated. Results The overall incidence of statin-associated ADR among the 351 subjects was 24.22%, classified into three categories according to the affected system: musculoskeletal toxicity, hepatic/renal dysfunction, and gastrointestinal reactions. Univariate and multivariate logistic regression analyses in the development cohort identified the following as significant independent risk factors (P < 0.05): age ≥60 years, body mass index ≥23 kg/m2, disease duration ≥5 years, presence of ≥3 comorbid conditions, dyslipidemia, history of cerebral infarction, high-dose statin use, and concomitant use of multiple medications. A nomogram model was constructed based on these predictors. The model demonstrated strong discriminative performance, with an area under the receiver operating characteristic (ROC) curve of 0.808 (95% CI [0.751–0.865]) in the development cohort and 0.852 (95% CI [0.752–0.951]) in the validation cohort. Conclusion A nomogram-based risk prediction model was successfully developed to estimate the probability of statin-induced ADR in patients with CHD, based on a set of statistically significant clinical risk factors. The model exhibited favorable predictive accuracy and discrimination. It offers a practical tool for clinicians to identify high-risk individuals and implement early preventive or interventional strategies accordingly.
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spelling doaj-art-3be0bcd414e04a34852647422d8dfd2f2025-08-20T03:28:58ZengPeerJ Inc.PeerJ2167-83592025-07-0113e1963010.7717/peerj.19630Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective studyLixiang Zhang0Jiaoyu Cao1Xiaojuan Zhou2Department of Cardiology, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, Anhui Province, ChinaDepartment of Cardiology, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, Anhui Province, ChinaDepartment of Cardiology, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, Anhui Province, ChinaObjective This study aims to develop and validate a nomogram-based predictive model for estimating the risk of adverse drug reactions (ADR) to statins in patients with coronary heart disease (CHD). Methods A retrospective cohort study was conducted using clinical data from 351 patients with CHD who received statin therapy in the cardiology department of a tertiary hospital in Anhui Province, China, between February 2021 and January 2022. The dataset was randomly divided into a development cohort (n = 283) and a validation cohort (n = 68) in an 8:2 ratio. Logistic regression analysis was applied in the development cohort to identify independent risk factors for statin-induced ADR. A nomogram was subsequently constructed in R based on the selected predictors, and its clinical utility, discriminative performance, and calibration were evaluated. Results The overall incidence of statin-associated ADR among the 351 subjects was 24.22%, classified into three categories according to the affected system: musculoskeletal toxicity, hepatic/renal dysfunction, and gastrointestinal reactions. Univariate and multivariate logistic regression analyses in the development cohort identified the following as significant independent risk factors (P < 0.05): age ≥60 years, body mass index ≥23 kg/m2, disease duration ≥5 years, presence of ≥3 comorbid conditions, dyslipidemia, history of cerebral infarction, high-dose statin use, and concomitant use of multiple medications. A nomogram model was constructed based on these predictors. The model demonstrated strong discriminative performance, with an area under the receiver operating characteristic (ROC) curve of 0.808 (95% CI [0.751–0.865]) in the development cohort and 0.852 (95% CI [0.752–0.951]) in the validation cohort. Conclusion A nomogram-based risk prediction model was successfully developed to estimate the probability of statin-induced ADR in patients with CHD, based on a set of statistically significant clinical risk factors. The model exhibited favorable predictive accuracy and discrimination. It offers a practical tool for clinicians to identify high-risk individuals and implement early preventive or interventional strategies accordingly.https://peerj.com/articles/19630.pdfCoronary heart diseaseStatinsAdverse drug reactionsNomogram
spellingShingle Lixiang Zhang
Jiaoyu Cao
Xiaojuan Zhou
Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
PeerJ
Coronary heart disease
Statins
Adverse drug reactions
Nomogram
title Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
title_full Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
title_fullStr Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
title_full_unstemmed Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
title_short Establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins: a retrospective study
title_sort establishment and validation of a risk prediction model for adverse drug reactions in patients with coronary heart disease after taking statins a retrospective study
topic Coronary heart disease
Statins
Adverse drug reactions
Nomogram
url https://peerj.com/articles/19630.pdf
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