Caduet (amlodipine besylate/atorvastatin calcium, Pfizer) was associated with a significantly reduced calculated 10-year risk of coronary heart disease based on a Framingham risk assessment model. In addition, Caduet was shown to reduce calculated fatal cardiovascular disease risk, as a secondary trial endpoint based on the SCORE risk assessment model. The Framingham and SCORE risk assessment models are widely used in the US and EU, respectively. These data from the CRUCIAL (Cluster randomized usual care vs. caduet investigation assessing long-term risk) trial were presented at the 20th Scientific Meeting of the European Society of Hypertension (ESH) in June, in Oslo, Norway.
“The data presented at ESH are important because they show the potential benefit of Caduet, which combines blood pressure and cholesterol-lowering medications in a single pill, over usual care in a real-life clinical setting,” said Jose Zamorano of the Hospital Clinico San Carlos, Madrid, Spain, and chair of the CRUCIAL steering committee. “The findings suggest that Caduet may have the potential to significantly reduce cardiovascular risk in patients with two of the most common modifiable risk factors that contribute to cardiovascular disease: high cholesterol and high blood pressure.”
The CRUCIAL trial randomised 136 physicians to either Caduet or usual care. The physicians then treated a total of 1,461 men and women aged 35–79 who had hypertension, three or more cardiovascular risk factors, no coronary heart disease, and total cholesterol less than or equal to 6.5mmol/l (250mg/dl) with their assigned therapy. Usual care included physicians’ choice of any locally approved medications for lowering blood pressure or cholesterol, including but not limited to amlodipine and atorvastatin, prescribed according to local clinical practice. Physicians in the Caduet arm treated eligible patients with Caduet and, if needed, other blood pressure-lowering drugs.
Caduet reduced patients’ calculated 10-year risk of total coronary heart disease, demonstrating a relative risk reduction of 27% after 12 months of treatment compared with usual care. Risk was assessed using a Framingham model, which calculates heart disease risk based on a combination of health and lifestyle factors, including sex, age, blood pressure, total or LDL-cholesterol, HDL cholesterol, smoking and diabetes status.
A secondary trial endpoint of calculated fatal cardiovascular disease risk reduction showed a 23% relative difference between the two treatment arms, with a greater reduction in the Caduet arm, as measured with SCORE (Systematic Coronary Risk Evaluation), a European model. The risk factors included in the SCORE calculation are sex, age, smoking, systolic blood pressure, and total cholesterol.
In this trial, Caduet was generally well-tolerated. The adverse event profile in the Caduet arm was consistent with previous safety experience for this medication. Caduet is a prescription drug that combines two medicines, Norvasc (amlodipine besylate) and Lipitor (atorvastatin calcium). Norvasc is used to treat hypertension, angina, or coronary artery disease. Lipitor is used along with a low-fat diet to lower the LDL cholesterol and triglycerides in the blood. It can raise the HDL cholesterol as well.