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Pfizer Releases Caduet Crucial Trial Data

Pfizer has released data of Crucial (Cluster Randomised Usual Care vs Caduet Investigation Assessing Long-term Risk) trial which showed that Caduet reduced calculated fatal cardiovascular disease (CVD) risk, as a secondary trial endpoint based on the SCORE risk assessment model.

In the trial Caduet (amlodipine besylate/atorvastatin calcium) was associated with a reduced calculated 10-year risk of coronary heart disease (CHD) based on a Framingham risk assessment model.

Pfizer has presented the data at the 20th Scientific Meeting of the European Society of Hypertension (ESH) in Oslo, Norway.

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 CHD, and total cholesterol =6.5mmol/l (250mg/dl) with their assigned therapy.

Caduet reduced patients’ calculated 10-year risk of total CHD, demonstrating a relative risk reduction of 27% after 12 months of treatment compared with usual care.

A secondary trial endpoint of calculated fatal CVD 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) model.

Jose Zamorano of the Hospital Clinico San Carlos, Madrid, Spain, and chair of the Caduet steering committee, said: “The data presented at ESH are important because they show the benefit of Caduet, which combines blood pressure and cholesterol-lowering medications in a single pill, over usual care in a real-life clinical setting.

“The findings suggest that Caduet may reduce CV risk in patients with high cholesterol and high blood pressure.”