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

Abstract

BackgroundThe baseline incidence of the adverse events of statin therapy varies between countries. Notably, Chinese patients seem more susceptible to myopathy induced by simvastatin.ObjectivesThis research studies the adverse drug reactions (ADRs) of statin therapy in China by analysing trial-based data from the Anti-hyperlipidaemic Drug Database built by the China National Medical Products Administration Information Centre.MethodsAll clinical trials involving statin therapy (including simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin and rosuvastatin) in China from 1989 to 2019 were screened. In total, 569 clinical studies with 37 828 patients were selected from 2650 clinical trials in the database.ResultsAmong the reported cases with ADRs (2822/37 828; 7.460%), gastrointestinal symptoms were the most common (1491/37 828; 3.942%), followed by liver disease (486/37 828; 1.285%), muscle symptoms (444/37 828; 1.174%) and neurological symptoms (247/37 828; 0.653%). Pravastatin (231/1988; 11.620%) caused the most common gastrointestinal side effects, followed by fluvastatin (333/3094; 10.763%). The least likely to cause gastrointestinal irritation was rosuvastatin (82/1846; 4.442%).ConclusionIn Chinese clinical trials, gastrointestinal symptoms were the most common ADR of statin use for hyperlipidaemia and other cardiovascular diseases.

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

“…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).…”

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

“…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.…”

“…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 .…”

The effects of phytochemicals on serum triglycerides in subjects with hypertriglyceridemia: A systematic review of randomized controlled trials

“…Statins are the first‐line treatment for lipid disorders; in addition to lowering LDL‐C, they can also lower TG levels (Oh & Lanier, 2007; Sahebkar, Chew, & Watts, 2014; Simha, 2020). Although statins are generally safe, they might cause side‐effects and intolerance in a proportion of users on long‐term and high dose use (Banach et al, 2015; Muscari, Puddu, & Puddu, 2002; Tsui et al, 2022; Ward, Watts, & Eckel, 2019). Another family of drugs with greater TG‐lowering activity includes fibrates (e.g., gemfibrozil and fenofibrate).…”