Three multicentre, double-blind, placeb-controlled trials (176 patients) compared atorvastatin at various doses with placebo. Seven clinical trials compared atorvastatin in various doses with other lipid-lowering agents: 3 double-blind RCTs (1,531 patients) and 4 open RCTs (761 patients).
Atorvastatin (2.5 mg to 80 mg per day) lowered LDL-C by 35% to 61% and TG by 14 % to 45% compared with placebo. 6 different doses of atorvastatin were tested resulting in small numbers of patients per dose. There appeared to be a greater reduction with increasing dose of atorvastatin in fasting TC and fasting LDL- C.
Atorvastatin with other lipid lowering agents: Results were difficult to interpret due to multiple doses of both atorvastatin and the comparison drug. Significance levels were reported variably as 'compared with atorovastatin 10mg' and 'compared to atorvastatin 40 mg 'and as 'compared with atorvastatin at milligram equivalent doses'. No information of equivalent doses between atorvastatin and other drugs was given.
Atorvastatin vs niacin (1 open RCT, 108 patients): Atorvastatin 10 mgs/ day led to significantly greater reductions in TC, TG, LDL-C and significantly increased HDL-C compared to niacin.
Atorvastatin vs colestipol (1 open RCT, 86 patients): Atorvastatin 10 mg/day led to significantly greater reductions in TC, TG, LDL-C and significantly increased HDL-C compared to colestipol.
Atorvastatin vs lovastatin (1 multicentre RCT with 1049 patients, plus 1 multicentre RCT with 3 different doses of lovastatin given to 43 patients and 4 different doses of atorvastatin given to 195 patients): inconsistent results between trials and across doses for TC, TG and LDL-C. No difference noted between drugs for HDL- C.
Atorvastatin vs pravastatin: (1 multicentre RCT with 593 patients, plus 1 multicentre RCT with 3 different doses of pravastatin given to 80 patients and 4 different doses of atorvastatin given to 195 patients): results from the trial using multiple doses of both drugs were impossible to interpret. The other trial showed atorvastatin 10 to 20 mg/day led to significantly greater reductions in TC, TG, LDL-C compared to pravastatin 20 to 40 mg/day.
Atorvastatin vs simvastatin (2 RCT with 226 patients plus 1 multicentre RCT with 3 different doses of simvastatin given to 80 patients and 4 different doses of atorvastatin given to 195 patients): results from the trial using multiple doses of drugs were impossible to interpret. The other 2 trials showed Atorvastatin 10 to 20 mg/day led to significantly greater reductions in TC, TG, and LDL-C compared to simvastatin 10 to 20 mg/day.
Atorvastatin vs fluvastatin (1 multicentre RCT with 2 different doses of simvastatin given to 24 patients and 4 different doses of atorvastatin given to 195 patients): results from this trial using multiple doses of both drugs were impossible to interpret and were based on a very small sample size.
Safety data is reported based on pooled data from 21 completed and 23 ongoing clinical trials with 4271 patients on atorvastatin for a total of more than 3000 patient years (see Other Publications of Related Interest no.2). No details of this study were presented. The most frequent adverse effects of atorvastatin were constipation, flatulence, dyspepsia, abdominal pain, and myalgia (in 1% to 3% of patients). These adverse effects occurred in 2% to 5% of patients on other HMG-CoA reductase inhibitors. The 4271 patients on atorvastatin experienced: elevated serum transaminases in 0.7%; no rhabdomyolysis; and myalgia and muscle pain in 21% on atorvastatin compared to 23% of 742 patients on other HMG-CoA reductase inhibitors.