Risk assessment in drug development for symptomatic indications: A framework for the prospective exclusion of unacceptable cardiovascular risk

被引：16

作者：

Brass, EP

Lewis, RJ

Lipicky, R

Murphy, J

Hiatt, WR

机构：

[1] Univ Colorado, Hlth Sci Ctr, Colorado Prevent Ctr, Dept Med,Sect Vasc Med, Denver, CO 80203 USA

[2] Natl Jewish Med & Res Ctr, Denver, CO USA

[3] Harbor UCLA Med Ctr, Ctr Clin Pharmacol, Torrance, CA 90509 USA

[4] Harbor UCLA Med Ctr, Dept Emergency Med, Torrance, CA 90509 USA

[5] Los Angeles Biomed Res Inst, Torrance, CA USA

[6] LIPICKY LLC, Gaithersburg, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2006年 / 79卷 / 03期

关键词：

D O I：

10.1016/j.clpt.2005.11.012

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：165 / 172

页数：8

共 19 条

[1] PROVING THE NULL HYPOTHESIS IN CLINICAL-TRIALS [J].

BLACKWELDER, WC .

CONTROLLED CLINICAL TRIALS, 1982, 3 (04) :345-353

[2] Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial [J].

Bresalier, RS ;

Sandler, RS ;

Quan, H ;

Bolognese, JA ;

Oxenius, B ;

Horgan, K ;

Lines, C ;

Riddell, R ;

Morton, D ;

Lanas, A ;

Konstam, MA ;

Baron, JA .

NEW ENGLAND JOURNAL OF MEDICINE, 2005, 352 (11) :1092-1102

[3] Selling safety - Lessons from muraglitazar [J].

Brophy, JM .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2005, 294 (20) :2633-2635

[4] A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure [J].

Cohn, JN ;

Goldstein, SO ;

Greenberg, BH ;

Lorell, BH ;

Bourge, RC ;

Jaski, BE ;

Gottlieb, SO ;

McGrew, F ;

DeMets, DL ;

White, BG .

NEW ENGLAND JOURNAL OF MEDICINE, 1998, 339 (25) :1810-1816

[5] Comparison of the effects of cilostazol and milrinone on intracellular cAMP levels and cellular function in platelets and cardiac cells [J].

Cone, J ;

Wang, S ;

Tandon, N ;

Fong, M ;

Sun, B ;

Sakurai, K ;

Yoshitake, M ;

Kambayashi, J ;

Liu, Y .

JOURNAL OF CARDIOVASCULAR PHARMACOLOGY, 1999, 34 (04) :497-504

[6]

*FOOD DRUG ADM, 1998, CARD REN DRUG ADV CO

[7] A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE) [J].

Gent, M ;

Beaumont, D ;

Blanchard, J ;

Bousser, MG ;

Coffman, J ;

Easton, JD ;

Hampton, JR ;

Harker, LA ;

Janzon, L ;

Kusmierek, JJE ;

Panak, E ;

Roberts, RS ;

Shannon, JS ;

Sicurella, J ;

Tognoni, G ;

Topol, EJ ;

Verstraete, M ;

Warlow, C .

LANCET, 1996, 348 (9038) :1329-1339

[8] Risk of cardiovascular events and rofecoxib: cumulative meta-analysis [J].

Juni, P ;

Nartey, L ;

Reichenbach, S ;

Sterchi, R ;

Dieppe, PA ;

Egger, M .

LANCET, 2004, 364 (9450) :2021-2029

[9] The safety of drugs for OTC use: what evidence is required for an NSAID switch? [J].

MacDonald, TM ;

Beard, K ;

Bruppacher, R ;

Hasford, J ;

Lewis, M ;

Logan, RF ;

McNaughton, D ;

Tubert-Bitter, P ;

Van Ganse, E ;

Moore, N .

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2002, 11 (07) :577-584

[10] Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus [J].

Nissen, SE ;

Wolski, K ;

Topol, EJ .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2005, 294 (20) :2581-2586

← 1 2 →