The efficacy and safety of atorvastatin 10, 20, 40 and 80 mg in Filipino dyslipidemic patients: The lipitor dose-response study in Filipinos.

OBJECTIVE: This trial was conducted among Filipinos with the objective of evaluating the efficacy and safety of Atorvastatin full-dose range in the treatment of dyslipidemia among Filipinos.

METHODS: This is a multicenter, open-label, randomized, parallel, 6-week dose-response study in adult patients with severe dyslipidemia without evidence of coronary heart disease. Eligible subjects were randomized to one of the four treatment groups: 10, 20, 40 or 80 mg.

RESULTS: A total of 131 patients were randomized to receive treatment, with 123 patients having at least one on-treatment evaluation. There were 30 patients with (10 mg) treatment, 34 patients with (20 mg) treatment, 29 patients with (40 mg) treatment and 30 patients with (80 mg) treatment. LDL-C reduction across the full dose range was 46 percent- 64 percent (P0.0001 vs. baseline). For HDLC, the study demonstrated an increase of mean 2.2 percent. For total cholesterol, Atorvastatin 10mg, 20mg, 40 mg or 80 mg daily had a reduction of 33 percent-47 percent (P0.0001) versus baseline. For triglycerides, all treatment dosages had reduction of 12 percent-27 percent. The effect of Atorvastatin showed that a significant LDL-C lowering effect was seen by the 2nd week and near maximum effect by the 4th week. The most frequently occurring adverse events were abdominal pain (4.1 percent), body pain (4.1 percent), chest pain (3.3 percent), fever (3.3 percent), and digestive symptoms such as diarrhea loose stools, flatulence (3.3 percent). There were no cases of rhabdomyolysis. It was also demonstrated that there was no dose relation between Atorvastatin (10, 20, 40, 80 mg) and adverse events.

CONCLUSION: The study demonstrated that Atorvastatin across its full dose range is an effective and well-tolerated treatment for hypercholesterolemia among Filipino patients with dyslipidemia. (Author)