Factors associated with noncompletion during the run-in period before randomization and influence on the estimated benefit of LCZ696 in the PARADIGM-HF trial
Journal article
Desai, Akshay S., Solomon, Scott, Claggett, Brian L., McMurray, John, Rouleau, Jean L., Swedberg, Karl, Zile, Michael, Lefkowitz, Martin P., Shi, Victor C. and Packer, Milton. (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), pp. 1 - 6. https://doi.org/10.1161/CIRCHEARTFAILURE.115.002735
Authors | Desai, Akshay S., Solomon, Scott, Claggett, Brian L., McMurray, John, Rouleau, Jean L., Swedberg, Karl, Zile, Michael, Lefkowitz, Martin P., Shi, Victor C. and Packer, Milton |
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Abstract | 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. |
Keywords | angiotensin-converting; enzyme inhibitor; clinical trial; heart failure; LCZ696; neprilysin; renin; angiotensin system; sacubitril |
Year | 2016 |
Journal | Circulation: Heart Failure |
Journal citation | 9 (6), pp. 1 - 6 |
Publisher | Lippincott Williams & Wilkins |
ISSN | 1941-3289 |
Digital Object Identifier (DOI) | https://doi.org/10.1161/CIRCHEARTFAILURE.115.002735 |
Scopus EID | 2-s2.0-84975795326 |
Open access | Open access |
Page range | 1 - 6 |
Research Group | Mary MacKillop Institute for Health Research |
Publisher's version | |
Place of publication | United States |
https://acuresearchbank.acu.edu.au/item/88q59/factors-associated-with-noncompletion-during-the-run-in-period-before-randomization-and-influence-on-the-estimated-benefit-of-lcz696-in-the-paradigm-hf-trial
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