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


Background The baseline incidence of the adverse events of statin therapy varies between countries. Notably, Chinese patients seem more susceptible to myopathy induced by simvastatin.

Objectives This 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.

Methods All 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.

Results Among 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%).

Conclusion In Chinese clinical trials, gastrointestinal symptoms were the most common ADR of statin use for hyperlipidaemia and other cardiovascular diseases.

  • Lipid Metabolism Disorders
  • Clinical Trial
  • Safety
  • Metabolic Diseases

Data availability statement

Data are available in a public, open access repository.

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