Desai, A. S, Solomon, S., Claggett, B. L, McMurray, J., Rouleau, J. L, Swedberg, K., Zile, M., Lefkowitz, M. P, Shi, V. C & Packer, M. (2016). Factors associated with noncompletion during the run-in period before randomization and influence on the estimated benefit of LCZ696 in the PARADIGM-HF trial. Circulation: Heart Failure,9(6), 1-6. United States: Lippincott Williams and Wilkins. Retrieved from https://doi.org/10.1161/CIRCHEARTFAILURE.115.002735
The 8442 patients randomized in the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With an Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial, in which sacubitril/valsartan (LCZ696) reduced both death and HF hospitalization more than enalapril, were a subset of 10 521 patients entering sequential, single-blind run-in periods (enalapril 10 mg twice daily for 2 weeks followed by LCZ696 200 mg twice daily for 4 to 6 weeks) to ensure short-term tolerability of the 2 study medications. We identified the predictors of run-in noncompletion and estimated the implications of noncompletion for the overall study result.
Mary MacKillop Institute for Health Research
Open Access Journal Article