Cardiovascular safety and diabetes drug development
DJ Drucker, AB Goldfine - The Lancet, 2011 - thelancet.com
The Lancet, 2011•thelancet.com
Recent innovations in the pharmacotherapy of type 2 diabetes are important, in view of the
epidemic of type 2 diabetes and the individual and global economic costs of the disease.
Although overall control of the disease has improved, more than 40% of patients on current
therapies do not reach glycated haemoglobin (HbA1C) targets as suggested by clinical
practice guidelines. 1 The pathway for new drug development in diabetes traditionally
involved 6–12-month studies that focussed on reduction of HbA1C. Historically, phase 3 …
epidemic of type 2 diabetes and the individual and global economic costs of the disease.
Although overall control of the disease has improved, more than 40% of patients on current
therapies do not reach glycated haemoglobin (HbA1C) targets as suggested by clinical
practice guidelines. 1 The pathway for new drug development in diabetes traditionally
involved 6–12-month studies that focussed on reduction of HbA1C. Historically, phase 3 …
Recent innovations in the pharmacotherapy of type 2 diabetes are important, in view of the epidemic of type 2 diabetes and the individual and global economic costs of the disease. Although overall control of the disease has improved, more than 40% of patients on current therapies do not reach glycated haemoglobin (HbA1C) targets as suggested by clinical practice guidelines. 1
The pathway for new drug development in diabetes traditionally involved 6–12-month studies that focussed on reduction of HbA1C. Historically, phase 3 clinical trials for a new antidiabetic agent involved 1000–3000 patients in total, a sample size that would be able to detect adverse events at the time of approval with frequency rates greater than 0· 2%. However, emerging concerns about the longterm cardiovascular safety of diabetes drugs, caused in part by meta-analysis of clinical trials, 2 sparked
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