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See also:
All cardiovascular prevention clinical trials
All clinical trials of HDL increasing drugs
All clinical trials of bezafibrate
|
|
Treatments
Studied treatment |
bezafibrate 400 mg daily
|
Control treatment |
placebo
|
Patients
Patients |
type 2 diabetic subjects without a history of clinical cardiovascular |
Baseline characteristics |
Age (mean), yrs |
51 |
Women (%) |
29% |
prior MI or CHD (%) |
0 |
Total cholesterol (mmol/l) |
12.3 mmol/L |
Diabetes(%) |
100% |
LDL change, end of study (mg/DL) |
-0.3 mmol/L |
|
Method and design
Randomized effectives |
81 / 83 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
3.0 years |
Geographic area |
UK |
Primary endpoint |
B-mode ultrasound |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
6 / 81
17 / 83
0,36 [0,15;0,87]
All cause death
0 / 81
1 / 83
classic
0,20 [0,00;14,85]
cardiac death
0 / 81
0 / 83
classic
1,02 [0,00;259,73]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
6 / 81 (7,4%) |
17 / 83 (20,5%) |
0,36 |
[0,15;0,87] |
|
12545 |
All cause death
|
0 / 81 (0,6%) |
1 / 83 (1,2%) |
0,51 |
[0,02;15,06] |
|
|
cardiac death
|
0 / 81 (0,6%) |
0 / 83 (0,6%) |
1,02 |
[0,02;51,03] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
12545: Jun M, Foote C, Lv J, Neal B, Patel A, Nicholls SJ, Grobbee DE, Cass A, Chalmers J, Perkovic VEffects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis.Lancet 2010 May 10;:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 3.0 years)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
7,41% |
20,48% |
-13,07%
|
Meta-analysis of all similar trials:
cholesterol lowering intervention in cardiovascular prevention for all chronical situations
cholesterol lowering intervention in cardiovascular prevention for diabetic patients
cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD
HDL increasing drugs in cardiovascular prevention for all type of patients
Reference(s)
TrialResults-center ID |
TRC8163
|
Trials register # |
NA
|
-
Elkeles RS, Diamond JR, Poulter C, Dhanjil S, Nicolaides AN, Mahmood S, Richmond W, Mather H, Sharp P, Feher MD.
Cardiovascular outcomes in type 2 diabetes. A double-blind placebo-controlled study of bezafibrate: the St. Mary's, Ealing, Northwick Park Diabetes Cardiovascular Disease Prevention (SENDCAP) Study..
Diabetes Care 1998;21:641-8
Pubmed
|
Hubmed
| Fulltext
|