The phase III study evaluated the combination of torcetrapib and Lipitor (atorvastatin). Torcetrapib is an important drug in Pfizer’s pipeline and is seen as a replacement for Lipitor which loses patent protection in 2010.
Patients in the study who took a combination of torcetrapib and Lipitor experienced an average increase in systolic blood pressure of about two millimeters versus patients taking atorvastatin alone. The results could lead to delays in regulatory approval of the drug.
However the phase III trial of the combination of torcetrapib and atorvastatin did significantly raise good cholesterol (HDL) by 56% and lower bad cholesterol (LDL) by 27%.
Dr Joseph Feczko Pfizer’s chief medical officer commented on the blood pressure results saying it would “not alter the favorable clinical profile of torcetrapib/atorvastatin in the treatment of cardiovascular disease.”
Pfizer said that the studies were not complete and only 25% of patients had been treated in the clinical program. The company also said the trials completed to date vary in duration and size, and preliminary data at this stage may not represent the final results when phase III is completed.
Pfizer is investing a record amount of $800 million in this phase III program. The results of imaging trials of the drug are expected in March.