Scientific Publications by FDA Staff

J Pharmacokinet Pharmacodyn 2014 Dec;41(6):693-704

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study.

Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R

Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95 % CI: 967-1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95 % CI: 169-205), 284 (95 % CI: 261-305), and 353 (95 % CI: 331-375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49 % (95 %CI: 44-59 %) and 85 % (95 %CI: 79-99 %), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.