The US FDA was notified that Pfizer will suspend a large, phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality in patients receiving the combination compared to those receiving atorvastatin alone.
With the T/A development programme, as it does with all such development programmes, FDA assured that Pfizer had the appropriate protections in place for patients participating in the drug's development, including informed consent, a Data Safety Monitoring Board (DSMB) for its outcome study, and that the development programme was done in a careful, stepwise manner.
For this trial, the DSMB was conducting a monthly analysis of mortality data and a quarterly analysis of a number of outcomes including stroke, heart attack, and revascularizations (such as coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial.
The system of biomedical research monitoring was effective in this case, assuring that once a certain signal was seen, and the trial was halted. FDA stated that it will continue to work with Pfizer and other sponsors developing molecules in this class of drugs to ensure that appropriate protections are in place to identify any safety signals as early in the development process as possible.
Clinical trials are an integral part of the process for developing new medical innovations and the healthcare system is dependent upon this research, and the patients willing to participate, to advance therapies. Clinical trials often tell us unexpected things, both positive and negative, about new medical products, which is why carefully designed and conducted trials are an essential part of the pre-market process for demonstrating that new drugs are safe and effective before they can be approved for marketing, FDA stated.