AimTo evaluate the effect of fluvastatin sodium 40 mg BID on low density lipoprotein (LDLC) level and the tolerability in Chinese patients with stable angina or type 2 diabetes mellitus whose LDLC was failed to achieve LDLC goal according to Chinese lipid guideline(＞100 mg/dL) with fluvastatin sodium 40 mg QN.MethodsA multicenter, prospective and observational post marketing surveillance.251 dyslipidemia patients with stable angina or type 2 diabetes mellitus (T2DM) were enrolled in this study.These patients were failed to achieve their LDLC goal (＜100 mg/dL) by the treatment of fluvastatin sodium 40 mg QN for at least 4 weeks, and were up titrated to fluvastatin sodium 40 mg BID by the discretion of physicians.The follow up duration was 8 weeks.The primary efficacy variable was the percent change in LDLC from baseline at week 8.The Secondary variables were the proportion of patients reaching their targets in LDLC, the percent change from baseline in total cholesterol (TC), high density lipoprotein cholesterol (HDLC), triglyceride (TG )and the tolerability.ResultsTotally 251 intentions to treatment patients (ITT) were in this study.After 8 weeks fluvastatin 40 mg BID reduced LDLC by 27.3%, 25.3% and 28.9% in total patients, stable angina and T2DM respectively (p<0.001).59.4% patients reached their LDLC goal at the end of study, of those 52.9% patients with stable angina and 67.2% patients with T2DM reached their goal.TG was reduced by 17.02%, 16.50% and 17.78% in total patients, stable angina and T2DM respectively (p<0.001).4 (1.6%) patients experienced clinical significant aminotransferase (ALT/AST) elevated ＞3 times the upper limit of normal (ULN), among them 3 patients continued to use fluvastatin after reducing the dose to 40 mg QN. None of the cases were accompanied with any hepatic symptoms or bilirubin abnormal or albumin decrease.No myopathy events were reported and there were no elevations in creatine kinase levels ＞5× ULN.ConclusionsUp titration dose of fluvastatin from 40 mg/day to 80 mg/day allows good efficacy and safety, and provide an alternative treatment method for stable angina and T2DM patients whose LDLC failed to reach the goal by the treatment of 40 mg/day.