Adverse drug reactions of statin therapy in China from 1989 to 2019: a national database analysis

Tsui, Leo; Ye, Peiying; Xu, Shiling; Lin, Yuan; Chen, Bin; Chen, Sy-Ping; Cheng, Ruoh-yi

doi:10.1136/ejhpharm-2022-003333

Cited by 13 publications

(23 citation statements)

References 29 publications

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“…Therefore, we report that no rhabdomyolysis was associated with statin interactions in our study. This contrasts the results of studies from China experienced an adverse drug reaction of statins were 7.460% including gastrointestinal symptoms, liver disease, muscle and neurological symptoms (Tsui, 2022). It suggests that myotoxicity such as rhabdomyolysis is more common in elderly patients taking high-dose statins (Xiaou, 2020).…”

Section: Resultsmentioning

confidence: 82%

Assessment of effect statin-drug interactions in cardiology outpatient department in Teaching Hospital Surabaya

Faizah¹,

Damayanti²,

Nurrahman³

2022

JFG

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Background: HMG-CoA inhibitors, more commonly known as statins, are lipid-lowering agents that have benefits in cardiovascular therapy. Stains are associated with two significant side effects, asymptomatic elevations of liver enzymes and myopathy. Myopathy is the most likely to occur when statins are prescribed with other drugs. Objectives: To evaluate the effect of drug interactions between statins and concomitant drugs in outpatient cardiovascular patients. Methods: This study conducted in a prospective cohort. Checking drug interactions was done through the Lexicomp Drug Interactions software and patient’s complaints were taken thorough interviews. Results: There were 69 patients included in the study sample. A total of 16 patients received atorvastatin, and 53 patients received simvastatin. More than half of sample (59%) have statin-drug interactions. The most drug interactions were severe (41%), followed by moderate (22%) and mild (10%). The most interacting drugs were amlodipine and diltiazem. Based on the results of interview, there were no complaint of myopathy felt by patient. Conclusion: The effects of drug interactions still need to be considered even though the patients did not complain of myopathy in this study. Several factors can determine the impact of drug interactions not experienced by the patient.

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Section: Resultsmentioning

confidence: 82%

Assessment of effect statin-drug interactions in cardiology outpatient department in Teaching Hospital Surabaya

Faizah¹,

Damayanti²,

Nurrahman³

2022

JFG

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“…Compared with Caucasians, statin doses are lower 42 . It was reported that adverse effects of statin are more common in the Chinese population, including rhabdomyolysis, liver damage, and neurological symptoms 7 . Therefore, compared with Caucasians, Chinese patients with coronary heart disease receive a lower dose of statins.…”

Section: Discussionmentioning

confidence: 99%

“…However, several studies have shown that the Chinese have a low tolerance to highintensity statin therapy, and the probability of adverse reactions in the digestive, motor and nervous systems is signi cantly increased. Therefore, there is an urgent need for other lipid-lowering drugs combined with statins to improve lipid levels 7,8 . As an effective new LDL-C lowering agent, proteinconverting enzyme prosubtilisin (PCSK9) inhibitor has been clinically implicated to reduce LDL-C levels and improve cardiovascular adverse events, but its underlying mechanism remains unclear 9 .…”

Section: Introductionmentioning

confidence: 99%

The inhibition of Evolocumab on Non-Infarct-Related Artery Disease in Patients with ST-Elevation Myocardial Infarction

Zhao

Sun

Yue

et al. 2023

Preprint

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Purpose: The effects of combing evolocumab and statin on the clinical outcome and physiological function of coronary arteries in STEMI patients with non-infarct-related artery (NIRA) disease are still unclear. Methods:355 STEMI patients with NIRA were enrolled in this study, who underwent combined anatomical and physiological assessments at baseline and after 12 months of treatment with statin monotherapy or statin plus evolocumab. Plaque composition and functional ischemia were determined via using the quantitative coronary angiography (QCA) and quantitative flow ratio (QFR). Results: Diameter stenosis and lesion length were significantly lower in the group undergoing statin plus evolocumab. While the group exhibited significantly higher minimum lumen diameter (MLD), and QFR values. Statin plus evolocumab (OR=0.350) and plaque lesion length (OR=1.223) were independently associated with rehospitalization for unstable angina (UA) within 12 months. Conclusion: Evolocumab combined with statin therapy can significantly improve the anatomical and physiological function of the coronary arteries and downregulate the re-hospitalization rate due to UA in STEMI patients with NIRA.

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“…The Anti-hyperlipidemic Drug Database encompasses a broad range of data, including 26 columns such as the quantity of clinical trials, total cases, sex-specific cases, cases in the treatment and control groups, age span, average age, associated disease and complications, Chinese generic and trade names of drugs, English names of drugs, dosage forms, specifications, approval numbers, manufacturers, classifications, medication purposes, usage and dosage, combined medication, efficacy evaluation criteria, comparison of therapeutic effects and clinical indications, ADRs reported in the clinical trial, other reported ADRs, information sources and simplified code in pinyin. 7 The database included 2650 clinical trials, both controlled and non-controlled, from 1989 to 2019 (updated to 24 October 2019). The non-statin antihyperlipidaemic drugs were used to treat or prevent CVD in the clinical trial of the database.…”

Section: Methodsmentioning

confidence: 99%

Adverse drug reactions of non-statin antihyperlipidaemic drugs in China from 1989 to 2019: a national database analysis

Tsui

Chen

et al. 2023

BMJ Open

Self Cite

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ObjectiveThis study aims to understand the adverse drug reactions (ADRs) for non-statin antihyperlipidaemic drugs included in the China Anti-hyperlipidemic Drug Database.DesignAn approach of Chinese national database analysis was employed to screen clinical trials involving non-statin antihyperlipidaemic drugs from 1989 to 2019.SettingThe database was provided by the China National Medical Products Administration Information Centre.ParticipantsIn total, 117 clinical studies with 8800 patients were selected from 2650 clinical trials of the Anti-hyperlipidemic Drug Database.InterventionsThe non-statin antihyperlipidaemic drugs were divided into three groups: (1) fibrates (fenofibrate, gemfibrozil, bezafibrate, etofylline clofibrate); (2) nicotinic acid and derivatives (niacin, acipimox) and (3) others (probucol, cholestyramine).ResultsThe results of this study show that first, gastrointestinal symptoms were the most common reactions (6.975%), which account for approximately 50% of the reported cases with ADRs. Second, cholestyramine (16.418%) and gemfibrozil (13.158%) were the most common gastrointestinal side effect-causing non-statin antihyperlipidaemic drugs, which account for one-third of the population. Third, niacin (7.879%) and gemfibrozil (5.000%) were the most likely cause of liver disease symptoms. Finally, niacin (10.909%) and acipimox (18.847%) were the major non-statin antihyperlipidaemic drugs with skin symptoms.ConclusionThis study revealed that gastrointestinal symptoms were the most common ADRs of fibrates, probucol and cholestyramine in the Chinese population. For nicotinic acid and derivatives, the ADRs of skin symptoms were the most common in China.

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Adverse drug reactions of statin therapy in China from 1989 to 2019: a national database analysis

Cited by 13 publications

References 29 publications

Assessment of effect statin-drug interactions in cardiology outpatient department in Teaching Hospital Surabaya

Assessment of effect statin-drug interactions in cardiology outpatient department in Teaching Hospital Surabaya

The inhibition of Evolocumab on Non-Infarct-Related Artery Disease in Patients with ST-Elevation Myocardial Infarction

Adverse drug reactions of non-statin antihyperlipidaemic drugs in China from 1989 to 2019: a national database analysis

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