Related trials
ACCOMPLISH (diabetic subgroup), 2010 - benazepril + amlodipine vs benazepril + hydrochlorothiazide
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ROADMAP, 2010 - olmesartan vs placebo
AVOID, 2008 - aliskiren vs placebo
ADVANCE, 2007 - perindopril and indapamide vs placebo
ABCD (N), 2002 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie
ALLHAT (lisi vs chlor, diabetic subgroup), 2002 - lisinopril vs chlorthalidone
LIFE (diabetic subgroup), 2002 - losartan vs atenolol
ALLHAT (amlodipine vs chlor, diabetic subgroup), 2002 - amlodipine vs chlorthalidone
IPDM, 2001 - irbesartan vs placebo
IDNT amlodipine, 2001 - amlodipine vs placebo
RENAAL, 2001 - losartan vs placebo
IDNT irbesartan, 2001 - Irbesartan vs placebo
IDNT (irbesartan vs amlodipine), 2001 - Irbesartan vs amlodipine
STOP-2 CCB (diabetic subgroup), 2000 - calcium-channel blocker vs diuretic or beta-blocker
INSIGHT (diabetic subgroup), 2000 - Nifedipine vs coamilozide
ABCD (H), 2000 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie
NORDIL (diabetic subgroup), 2000 - Diltiazem vs diuretic or beta-blocker
STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000 - ACE inhibitor vs CCB
HOPE (diabetic subgroup), 2000 - ACE inhibitor vs placebo
STOP-2 ACEI (diabetic subgroup), 2000 - ACE inhibitor vs diuretic or beta-blocker
CAPP (diabetic subgroup), 1999 - captopril vs diuretic or beta-blocker
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See also:
All diabetes clinical trials
All hypertension clinical trials
All clinical trials of anti hypertensive agent
All clinical trials of ACE inhibitor
|
|
Treatments
Studied treatment |
ramipril 10 mg once per day orally
|
Control treatment |
placebo
|
Remarks |
factorial design of ramipril and vitamin E |
Patients
Patients |
patients with diabetes (sub group), aged 55 years or older, who had a previous cardiovascular event or at least one other cardiovascular risk factor, no clinical proteinuria, heart failure, or low ejection fraction |
Remarks |
of all 9541 patients in the HOPE trial, 3654 had diabetes |
Baseline characteristics |
BP (systolic/diastolic) |
142/80 mmHg |
Female (%) |
37% |
Age |
65.4 y |
subgroup |
yes |
hypertension (%) |
56% |
|
Method and design
Randomized effectives |
1808 / 1759 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
4.5 years |
Number of centre |
multicentre |
Geographic area |
North, South america, Europe |
Hypothesis |
Superiority |
Primary endpoint |
CV events |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
cardiovascular event (fatal and non fatal)
277 / 1808
351 / 1759
0,77 [0,67;0,89]
All cause death
196 / 1808
248 / 1759
0,77 [0,65;0,92]
stroke (fatal and non fatal)
76 / 1808
108 / 1759
0,68 [0,51;0,91]
myocardial infarction (fatal and non fatal)
112 / 1808
172 / 1759
0,63 [0,50;0,80]
microvascular events
273 / 1808
312 / 1759
0,85 [0,73;0,99]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
cardiovascular event (fatal and non fatal)
|
277 / 1808 (15,3%) |
351 / 1759 (20,0%) |
0,77 |
[0,67;0,89] |
|
7238 |
All cause death
|
196 / 1808 (10,8%) |
248 / 1759 (14,1%) |
0,77 |
[0,65;0,92] |
|
7238 |
stroke (fatal and non fatal)
|
76 / 1808 (4,2%) |
108 / 1759 (6,1%) |
0,68 |
[0,51;0,91] |
|
7238 |
myocardial infarction (fatal and non fatal)
|
112 / 1808 (6,2%) |
172 / 1759 (9,8%) |
0,63 |
[0,50;0,80] |
|
7238 |
microvascular events
|
273 / 1808 (15,1%) |
312 / 1759 (17,7%) |
0,85 |
[0,73;0,99] |
Dialysis, over nephropathy, laser, dialysis |
7238 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
7238: Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Heart Outcomes Prevention Evaluation Study Investigators.Lancet 2000;355:253-9
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
cardiovascular event (fatal and non fatal) |
15,32% |
19,95% |
-46,3‰
|
All cause death |
10,84% |
14,10% |
-32,6‰
|
stroke (fatal and non fatal) |
4,20% |
6,14% |
-19,4‰
|
myocardial infarction (fatal and non fatal) |
6,19% |
9,78% |
-35,8‰
|
microvascular events |
15,10% |
17,74% |
-26,4‰
|
Meta-analysis of all similar trials:
angiotensin renin system blockade in diabetes for all type of patients
anti hypertensive agent in diabetes for type1 and 2 diabetic patients with hypertension
anti hypertensive agent in hypertension for diabetic patients
Reference(s)
-
.
Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Heart Outcomes Prevention Evaluation Study Investigators..
Lancet 2000;355:253-9
Pubmed
|
Hubmed
| Fulltext
-
Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G.
Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators..
N Engl J Med 2000;342:145-53
Pubmed
|
Hubmed
| Fulltext
|