Drug development research: diabetes favored over cardiovascular disease?

摘要

Some major pharmaceutical companies have begun to distance themselves from traditional areas of cardiovascular research, despite there being many therapeutic targets that could be exploited and unmet medical need being expected to rise substantially; conversely, these companies have maintained research activity in the diabetes field. The probable reasons for this are reflected in the design of recent clinical trials. The JUPITER trial of the HMG-CoA reductase inhibitor rosuvastatin recruited approximately 18,000 patients with no history of coronary artery disease, and was planned to last 4 years, compared with the LEAD clinical development program of the antidiabetic glucagon-like peptide-1 analog liraglutide (Novo Nordisk A/S), which required only 4000 patients with treatment times of several months. In addition, there is less generic competition for antidiabetic drugs compared with anti-atherosclerotic agents. However, regulatory authorities have recently decided that cardiovascular safety studies will be required for novel antidiabetic drugs, and the impact of this requirement on the research efforts of pharmaceutical companies will be of interest.