Clinical trials are research studies conducted to evaluate the safety and effectiveness of medications. In a typical clinical trial, groups of patients are asked to take a certain medication. This may be a specific dose of an existing medication, a dose of a new medication, or a placebo (sugar pill). Researchers then gather data over time and analyze the results.
ECLIPSE was a 24-week clinical trial involving 1,036 high-risk patients who had high cholesterol at the beginning of the trial. Patients were given one of the following statin medications: CRESTOR® (rosuvastatin calcium) or Lipitor® (atorvastatin calcium). The researchers then compared the percentage of patients achieving bad (LDL) cholesterol goal at different dosages and time points (6, 12, 18, 24 weeks) between the two medicines. At each time point and dose comparison, significantly more high-risk patients taking CRESTOR achieved the guideline recommended goal of <100 mg/dL for bad (LDL) cholesterol versus Lipitor. The most common adverse events were muscle aches and pains, chest pains, and inflammation of the nose and throat.
STELLAR was a 6-week clinical trial involving 2,240 patients who had high cholesterol at the beginning of the trial. Patients were given different dosages of one of the following statin medications: CRESTOR® (rosuvastatin calcium), Lipitor® (atorvastatin calcium), Zocor® (simvastatin), and Pravachol® (pravastatin sodium). The researchers then compared the changes in the patients' LDL-C between the different drugs and dosages. In the STELLAR trial, the occurrence of adverse events was similar between treatment groups. The most common adverse events were pain, sore throat, muscle ache, and headache.