Drugs and diabetes: Understanding the new breed of cardiovascular safety trials

The Lancet Diabetes and Endocrinology

Volumn 1, Issue 3, 2013, Pages 175-177

  Adler, Amanda Ingham ^a  

^a ADDENBROOKE S HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DULAGLUTIDE; GLIMEPIRIDE; HEMOGLOBIN A1C; INSULIN DEGLUDEC; LINAGLIPTIN; PLACEBO; ROSIGLITAZONE; ANTIDIABETIC AGENT;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; DRUG APPROVAL; DRUG SAFETY; GLYCEMIC CONTROL; HUMAN; LETTER; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; CARDIOVASCULAR DISEASES; COMPLICATION; DIABETES MELLITUS, TYPE 2; LEGISLATION AND JURISPRUDENCE; PROCEDURES; RISK ASSESSMENT; STANDARDS;

CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; HUMANS; HYPOGLYCEMIC AGENTS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT;

EID: 84885961549     PISSN: 22138587     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2213-8587(13)70137-2     Document Type: Letter

References (10)

1. US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research, Guidance for industry. Diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008.
2. FDA demands more tests of Novo Nordisk's new insulin to gauge heart risks. New York Times Feb 10, 2013, B9. Reuters.
3. Piaggio GED, Pocock SJ, Evans SJW, Altman DG Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA 2012, 308:2594-2604. for the CONSORT Group.
4. Clinical perspective on FDA guidance to industry: diabetes mellitus-evaluating CV risk in new anti-diabetic therapies to treat T2DM (accessed May 31, 2013). http://www.fda.gov/downloads/Drugs/NewsEvents/UCM209087.pdf.
5. Lachin J Biostatistical methods: the assessment of relative risks 2011, John Wiley & Sons, Hoboken, NJ, USA. 2nd edn.
6. Fonseca VA Ongoing clinical trials evaluating the cardiovascular safety and efficacy of therapeutic approaches to diabetes mellitus. Am J Cardiol 2011, 108:52B-58B.
7. Rosenstock J, Marx N, Kahn SE, et al. Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: rationale for the active-comparator CAROLINA trial. Diab Vasc Dis Res 2013, 10:289-301.
8. Rosenstock J, Marx N, Kahn SE, et al. Rationale and design of the CAROLINA trial: an active Caomparator CARdioOvascular Outcome Study of the DPP-4 Inhibitor LINAgliptin in patients with type 2 diabetes at high cardiovascular risk. Abstract 1103-P. In: Proceedings of the 71st Annual Scientific Session of the American Diabetes Association, vol 60 (suppl 1), June 24-28, 2011, San Diego, CA, USA.
9. Gale EA Post-marketing studies of new insulins: sales or science?. BMJ 2012, 344:e3974.
10. International Conference on Harmonisation Expert Working Group. ICH Harmonised Tripartite Guideline; Statistical Principles for Clinical Trials E9. 1998.