See also:

dal-OUTCOMES study, 2012	TRC12830
[NCT00658515]	download pdf: dalcetrapib | CEPT inhibition for cardiovascular prevention

Treatments

Studied treatment	dalcetrapib 600 mg daily beginning 4 to 12 weeks after an index ACS event
Control treatment	placebo
Concomittant treatment	individualized, evidence-based programs for lowering their LDL cholesterol levels by means of statin therapy (if they did not have unacceptable side effects) and diet, with a target LDL cholesterol level of 2.6 mmol per liter or lower and preferably 1.8 mmol per liter or lower.

Patients

Patients

patients with recent acute coronary syndrome

Method and design

Randomized effectives	7938 / 7933 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Follow-up duration	31 montsh (median)
Premature discontinuation	Premature discontinuation for futility
Number of centre	935
Geographic area	27 countries
Primary endpoint	CV events

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
CV events	656 / 7938 (8,3%)	633 / 7933 (8,0%)	1,04	[0,93;1,15]
Death from coronary heart disease	118 / 7938 (1,5%)	125 / 7933 (1,6%)	0,94	[0,73;1,21]
Nonfatal acute myocardial infarction	414 / 7938 (5,2%)	407 / 7933 (5,1%)	1,02	[0,89;1,16]
Hospitalization for unstable angina	84 / 7938 (1,1%)	92 / 7933 (1,2%)	0,91	[0,68;1,22]
Cardiac arrest with resuscitation	14 / 7938 (0,2%)	10 / 7933 (0,1%)	1,40	[0,62;3,15]
Stroke of presumed atherothrombotic cause	91 / 7938 (1,1%)	73 / 7933 (0,9%)	1,25	[0,92;1,69]
Death from any cause	226 / 7938 (2,8%)	229 / 7933 (2,9%)	0,99	[0,82;1,18]
Unanticipated coronary revascularization	674 / 7938 (8,5%)	672 / 7933 (8,5%)	1,00	[0,90;1,11]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

226 / 7938
229 / 7933
0,99 [0,82;1,18]

cardiovascular events

656 / 7938
633 / 7933
1,04 [0,93;1,15]

Coronary death

118 / 7938
125 / 7933
0,94 [0,73;1,21]

Coronary revascularization

674 / 7938
672 / 7933
1,00 [0,90;1,11]

stroke (fatal and non fatal)

91 / 7938
73 / 7933
1,25 [0,92;1,69]

Coronary event

656 / 7938
633 / 7933
1,04 [0,93;1,15] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	226 / 7938 (2,8%)	229 / 7933 (2,9%)	0,99	[0,82;1,18]	Death from any cause
cardiovascular events	656 / 7938 (8,3%)	633 / 7933 (8,0%)	1,04	[0,93;1,15]	CV events
Coronary death	118 / 7938 (1,5%)	125 / 7933 (1,6%)	0,94	[0,73;1,21]	Death from coronary heart disease
stroke (fatal and non fatal)	91 / 7938 (1,1%)	73 / 7933 (0,9%)	1,25	[0,92;1,69]	Stroke of presumed atherothrombotic cause
Coronary revascularization	674 / 7938 (8,5%)	672 / 7933 (8,5%)	1,00	[0,90;1,11]	Unanticipated coronary revascularization
Coronary event	656 / 7938 (8,3%)	633 / 7933 (8,0%)	1,04	[0,93;1,15]	CV events
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 31 montsh (median))
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	2,85%	2,89%	-0,04%
cardiovascular events	8,26%	7,98%	0,28%
Coronary death	1,49%	1,58%	-0,09%
stroke (fatal and non fatal)	1,15%	9,20‰	0,23%
Coronary revascularization	8,49%	8,47%	0,02%
Coronary event	8,26%	7,98%	0,28%

Meta-analysis of all similar trials:

CEPT inhibition in cardiovascular prevention for all type of patients

HDL increasing drugs in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC12830
Trials register #	NCT00658515

• Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.. Am Heart J 2009 Dec;158:896-901.e3
  Pubmed | Hubmed | Fulltext
• Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS. Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome.. N Engl J Med 2012 Nov 5;: - 10.1056/NEJMoa1206797
  Pubmed | Hubmed | Fulltext

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