Atorvastatin calcium: SAFETY(1)
Safety data for atorvastatin have been reported for 4271 patients: 2502 patients from an integrated safety database from 21 completed clinical trials and 1769 patients from 23 ongoing studies, with the latter data contributing additional analyses for liver and muscle safety . Patients from the integrated safety database received atorvastatin for a total of 1845 years of patient exposure. Of the 2502 patients, 69% were treated for six months, and 50% were treated for one year. Of the 4271 patients, over 900 have been treated for at least two years, representing greater than 3000 patient-years of exposure. buy ampicillin
In patients with varying types of dyslipidemia, atorvastatin at doses from 10 mg/day to 80 mg/day is generally well tolerated . Adverse reactions have usually been mild and transient. The overall adverse event profile for atorvasta-tin is similar to that observed with other HMG-CoA reductase inhibitors. As with the other HMG-CoA reductase inhibitors, the most common adverse events reported for atorvastatin are constipation, flatulence, dyspepsia and abdominal pain.
Analysis of data from the integrated safety database from the completed clinical trials indicated that less than 2% of the 2502 patients withdrew from these studies due to effects considered related to atorvastatin treatment. Similarly, analysis of data from the comparative studies with other HMG-CoA reductase inhibitiors indicated that 3% of patients treated with the other HMG-CoA reductase inhbitors withdrew due to adverse reactions associated with treatment . Events leading to withdrawal included nausea, pain, myalgia, abdominal pain and abnormal liver function tests. These events occurred in less than 0.3% of atorvastatin-treated patients. There was no apparent dose-dependence in the withdrawal rate across the dose range for atorvastatin (10 mg to 80 mg/day).