Home » Academic Detailing » IMPROVE-IT: What Did The FDA Say?

IMPROVE-IT: What Did The FDA Say?

As an assignment in the academic detailing rotation with PAD, I was tasked with appraising and presenting the results of the FDA Advisory Committee’s assessment of the IMPROVE-IT trial. The pharmaceutical company’s request to make the broad claim that the addition of ezetimibe to a moderate dose statin lowered cardiovascular events was carefully scrutinized by an advisory panel including cardiologists, statisticians and consumer representatives. Of particular interest were not only the advisory’s decision but also their individual reasoning behind the vote. It was a great exercise in critical appraisal, which is in line with my residency learning objective 5) “I will demonstrate the ability to critically appraise literature in a systematic fashion and determine the applicability of the study to a specific patient” and my revised post-midpoint learning objective 3) “I will become a more effective presenter and pharmacy educator.”  Although this was not patient specific, it did provide me with resources to access data not otherwise provided by researchers (such as the effect on missing data). This assignment was in line with my residency learning goals to improve my critical appraisal skills and to become an effective pharmacy educator. I also had the opportunity to closely assess the clinical relevance of composite end points. Even in a seemingly positive result, a careful assessment of the parameters used to measure the out come (such as “non fatal MI”) revealed the fragility of an already questionable endpoint. For more information, my slides are available and I would love any questions you might have!

IMPROVE IT- What did the FDA Say?

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