ined from fitting a robust Regression model with terms for treatment and baseline)
‡ Geometric mean percent changes from baseline in TG were calculated based on back-transformation via exponentiation of the model-based least square (LS) means and expressed as (geometric mean – 1) multiplied by 100
§ p<0.001 versus ATOZET 10/10
¶ p<0.01 versus ATOZET 10/10
# p<0.05 versus ATOZET 10/10
Þ p<0.001 versus ATOZET 10/20
ß p<0.05 versus ATOZET 10/20
Table 4 does not contain data comparing the effects of ATOZET 10/10 or 10/20 to doses higher than atorvastatin 40 mg or rosuvastatin 20 mg.
In a placebo-controlled study, the Myocardial Ischaemia Reduction with Aggressive Cholesterol Lowering (MIRACL) study, patients with an acute coronary syndrome (non Q-wave MI or unstable angina) were randomised to receive atorvastatin 80 mg/day (n=1538) or placebo (n=1548). Treatment was initiated during the acute phase after hospital admission and lasted for 16 weeks. Atorvastatin 80 mg/day provided a 16% (p=0.048) reduction in risk of the combined primary endpoint: death from any cause, nonfatal MI, resuscitated cardiac arrest, or angina pectoris with evidence of myocardial ischaemia requiring hospitalisation. This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with evidence of myocardial ischaemia (p=0.018).
ATOZET contains atorvastatin. In a placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), the effect of atorvastatin 10 mg on fatal and non-fatal CHD was assessed in 10,305 hypertensive patients, 40-80 years old, with TC levels ≤6.5 mmol/L and at least three cardiovascular risk factors. Patients were followed for a median duration of 3.3 years. Atorvastatin 10 mg significantly (p<0.001) reduced the relative risk for: fatal CHD plus nonfatal MI by 36% (absolute risk reduction = 1.1%); total cardiovascular events and revascularization procedures by 20% (absolute risk reduction = 1.9%); and total coronary events by 29% (absolute risk reduction = 1.4%).
In a placebo-controlled study, the Collaborative Atorvastatin Diabetes Study (CARDS), the effect of atorvastatin 10 mg on cardiovascular disease (CVD) endpoints was assessed in 2838 patients, 40-75 years old, with type 2 diabetes, one or more cardiovascular risk factors, LDL ≤4.1 mmol/L, and TG ≤6.8 mmol/L. Patients were followed for a median duration of 3.9 years. Atorvastatin 10 mg significantly (p<0.05) reduced: the rate of major cardiovascular events by 37% (absolute risk reduction = 3.2%); the risk of stroke by 48% (absolute risk reduction = 1.3%); and the risk of MI by 42% (absolute risk reduction = 1.9%).
Prevention of Cardiovascular Events
In an ezetimibe/simvastatin, multicenter, randomized, double-blind, active-control study, 18,144 patients enrolled within 10 days of hospitalization for acute coronary syndrome (ACS; either acute myocardial infarction [MI] or unstable angina [UA]). All patients were randomized in a 1:1 ratio to receive either ezetimibe/simvastatin 10/40 mg (n=9067) or simvastatin 40 mg (n=9077) and followed for a median of 6.0 years.
Patients had a mean age of 63.6 years; 76% were male, 84% were Caucasian, and 27% were diabetic. The average LDL-C value at the time of study qualifying event was 80 mg/dL (2.1 mmol/L) for those on lipid-lowering therapy (n=6390) and 101 mg/dL (2.6 mmol/L) for those not on previous lipid-lo |
