Novartis reply to the ATMOSPHERE data monitoring committee

New England Journal of Medicine

Volumn 374, Issue 16, 2016, Pages 1586-1587

  Tougas, Gervais ^a   Aftring, R Paul ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALISKIREN; AMIDE; FUMARIC ACID DERIVATIVE;

CLINICAL STUDY; CLINICAL TRIAL (TOPIC); CLINICAL TRIAL FACILITATION GROUP; DIABETES MELLITUS; HEART FAILURE; HUMAN; LETTER; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PROFESSIONAL STANDARDS REVIEW ORGANIZATION; RISK FACTOR; TREATMENT CONTRAINDICATION; TREATMENT WITHDRAWAL; DIABETES MELLITUS, TYPE 2; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AMIDES; CLINICAL TRIALS DATA MONITORING COMMITTEES; DIABETES MELLITUS, TYPE 2; FUMARATES; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84964466991     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1603515     Document Type: Letter

References (4)

1. Swedberg K, Borer JS, Pitt B, Pocock S, Rouleau J. Challenges to data monitoring committees when regulatory authorities intervene. N Eng J Med 2016; 374:1580-4.
2. McMurray JJ, Krum H, Abraham WT, et al. Aliskiren, enalapril, or aliskiren and enalapril in heart failure N Engl J Med 2016; 374:1521-32.
3. Parving H-H, Brenner BM, McMurray JJV, et al. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med 2012; 367: 2204-13.
4. Gheorghiade M, Böhm M, Greene SJ, et al. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA 2013; 309: 1125-35.