Updated on 7 November 2012
Asians, Orientals, South Asians, Indians and Pacific Islanders were included in the study. Japanese people were not part of this analysis.
A separate analysis was performed on five trials that had been carried out in several countries and a region in Asia (China, South Korea, Taiwan, Thailand and the Philippines) that had enrolled Asian subjects only. The analysis did not find any evidence indicating increased rates of adverse events in the Asian population compared with rates in the overall patient population. The rates of adverse events, serious adverse events, and discontinuations due to adverse events were similar for the Asian
population and the overall patient population. Also, a dose-response relationship in adverse events was not found for the Asian population.
The most frequently reported adverse event in the Asian population and the non-Asian population was gastrointestinal dysfunction. Among patients treated with atorvastatin, the incidence of adverse effects in the muscular system was lower in the Asian population than in the overall patient population, the incidence of myalgia being 8 percent among non-Asian patients and 6.7 percent among Asian patients.
Among Asian patients, treatment-related serious adverse events were extremely rare, and no occurrence of rhabdomyolysis was found. For patients treated with atorvastatin, rates of elevations in liver enzymes for Asian patients were similar for the Asian population and the overall patient population.