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

Abstract

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.

Targeting oxidative stress as a preventive and therapeutic approach for cardiovascular disease

“…Probucol is the only antioxidant drug approved by Food and Drug Administration, and it also shows a very powerful therapeutic effect in CVDs, but it has gradually faded out of the clinical treatment of CVDs because of its side effects such as gastrointestinal discomfort, diarrhea, ventricular tachycardia and severe ventricular arrhythmias [ 309 , 310 ]. Although antioxidants have not been widely used in the treatment of CVDs to date, they should still be taken seriously, especially natural antioxidants, which remain indispensable as potential therapeutic agents for the treatment of CVDs.…”

Fibrates and Fibrate-induced Liver Injury in Primary Biliary Cholangitis

“…59,60 More rarely, fibrates have been associated with an increased risk of cholesterol gallstones, pancreatitis, venous thromboembolism, and pulmonary embolism, although all are uncommon. [56][57][58][59][60][61] The most serious adverse events from fibrates are renal dysfunction, myopathy, and liver injury. A systematic review of 37 studies involving 1,107 patients with cholestatic liver disease (PBC and primary sclerosing cholangitis), treated with both UDCA and fibrates, found that the types of adverse events experienced with these medications were the same as those reported in patients without cholestatic disease, and occurred at similar rates.…”