Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion

被引：34

作者：

Zannad, Faiez ^{[1
,2
,3
]}

Stough, Wendy Gattis ^{[4
]}

Lipicky, Raymond J. ^{[5
]}

Tamargo, Juan ^{[6
]}

Bakris, George L. ^{[7
]}

Borer, Jeffrey S. ^{[8
]}

Garcia, Maria de los Angeles Alonso ^{[9
,10
,11
]}

Hadjadj, Samy ^{[12
]}

Koenig, Wolfgang ^{[13
,14
]}

Kupfer, Stuart

McCullough, Peter A. ^{[16
]}

Mosenzon, Ofri ^{[17
]}

Pocock, Stuart ^{[15
,18
]}

Scheen, Andre J. ^{[19
]}

Sourij, Harald ^{[20
]}

Van der Schueren, Bart ^{[21
]}

Stahre, Christina ^{[22
]}

White, William B. ^{[23
]}

Calvo, Gonzalo ^{[24
]}

机构：

[1] Univ Lorraine, CHU Nancy, Ctr Invest Clin 1433, INSERM, F-54500 Nancy, France

[2] Univ Lorraine, CHU Nancy, U1116, F-54500 Nancy, France

[3] F CRIN INI CRCT, F-54500 Nancy, France

[4] Campbell Univ, Coll Pharm & Hlth Sci, Buies Creek, NC 27506 USA

[5] Lipicky LLC, North Potomac, MD USA

[6] Univ Complutense, Sch Med, Dept Pharmacol, Madrid, Spain

[7] Univ Chicago Med, ASH Comprehens Hypertens Ctr, Chicago, IL USA

[8] Suny Downstate Med Ctr, Howard Gilman Inst, Brooklyn, NY USA

[9] European Med Agcy, Sci Advice Working Party, London, England

[10] Med & Healthcare Prod Regulatory Agcy MHRA, London, England

[11] Imperial Coll Healthcare NHS Trust, Dept Cardiol, London, England

[12] Univ Poitiers, Endocrinol, CHU Poitiers, INSERM CIC1402, Poitiers, France

[13] Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany

[14] Munich Heart Alliance, DZHK German Ctr Cardiovasc Res, Munich, Germany

[15] Takeda Pharmaceut Int, Deerfield, IL USA

[16] Baylor Univ, Med Ctr, Baylor Heart & Vasc Inst, Dallas, TX USA

[17] Hadassah Hebrew Univ Hosp, Diabet Unit, Jerusalem, Israel

[18] London Sch Hyg & Trop Med, Dept Med Stat, London, England

[19] Univ Liege, CHU Liege, Div Clin Pharmacol, Div Diabet Nutr & Metab Disorders, Liege, Belgium

[20] Med Univ Graz, Ctr Biomarker Res Med, Div Endocrinol & Diabetol, Graz, Austria

[21] Univ Leuven, Lab Expt Med & Endocrinol, Leuven, Belgium

[22] AstraZeneca, Gothenburg, Sweden

[23] Univ Connecticut, Sch Med, Calhoun Cardiol Ctr, Farmington, CT USA

[24] Hosp Clin Barcelona, Barcelona, Spain

来源：

EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY | 2016年 / 2卷 / 03期

关键词：

Diabetes mellitus; Clinical trials; Cardiovascular disease; DIPEPTIDYL PEPTIDASE-4 INHIBITORS; HEART-FAILURE; CLINICAL-TRIALS; GLUCOSE CONTROL; POOLED ANALYSIS; FOLLOW-UP; SAFETY; METAANALYSIS; OUTCOMES; EVENTS;

D O I：

10.1093/ehjcvp/pvw007

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus.

引用

页码：200 / 205

页数：6

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