Related trials
ACCOMPLISH (diabetic subgroup), 2010 - benazepril + amlodipine vs benazepril + hydrochlorothiazide
ACCORD blood pressure, 2010 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie
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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ABCD, 1998 - nisoldipine vs enalapril
UKPDS 38, 1998 - captopril or atenolol vs control
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 |
ACE inhibitor
enalapril 10 mg or lisinopril 10 mg daily. if the target blood pressure (
|
Control treatment |
conventional treatment (diuretic or beta-blocker)
atenolol 50 mg, metoprolol 100 mg, pindolol 5 mg, or
fixed-ratio hydrochlorothiazide 25 mg plus amiloride 2·5 mg
daily. Patients on beta-blockers were given
hydrochlorothiazide 25 mg plus amiloride 2·5 mg as additional
treatment if the target blood pressure (
|
Patients
Patients |
diabetic (subgroup) elderly patients aged 70-84 years with hypertension |
Inclusion criteria |
hypertension (blood pressure >=180 mm Hg systolic, >=105 mmHg diastolic, or both); aged 7084 years; isolated systolic hypertension could be included |
Remarks |
Of all 6614 patients included in the trial, 719 had diabetes |
Baseline characteristics |
Glycosylated hemoglobin |
7.6% |
BP (systolic/diastolic) |
195/96 mmHg |
Female (%) |
60% |
Age |
75.8 y |
subgroup |
yes |
hypertension (%) |
100% |
|
Method and design
Randomized effectives |
235 / 253 (studied vs. control) |
Design |
Parallel groups |
Blinding |
open with blind assessment |
Follow-up duration |
5.03y |
Number of centre |
312 |
Geographic area |
Sweden |
Primary endpoint |
cardiovascular mortality |
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
Cardiovascular mortality |
39 / 235 (16,6%) |
45 / 253 (17,8%) |
0,93 |
[0,63;1,38] |
|
Fatal myocardial infarction |
4 / 235 (1,7%) |
9 / 253 (3,6%) |
0,48 |
[0,15;1,53] |
|
Fatal stroke |
5 / 235 (2,1%) |
9 / 253 (3,6%) |
0,60 |
[0,20;1,76] |
|
Sudden death |
11 / 235 (4,7%) |
12 / 253 (4,7%) |
0,99 |
[0,44;2,19] |
|
Other cardiovascular mortality |
19 / 235 (8,1%) |
15 / 253 (5,9%) |
1,36 |
[0,71;2,62] |
|
All myocardial infarction |
17 / 235 (7,2%) |
26 / 253 (10,3%) |
0,70 |
[0,39;1,26] |
|
All stroke |
34 / 235 (14,5%) |
39 / 253 (15,4%) |
0,94 |
[0,61;1,43] |
|
All major cardiovascular events |
67 / 235 (28,5%) |
82 / 253 (32,4%) |
0,88 |
[0,67;1,15] |
|
Total mortality |
56 / 235 (23,8%) |
67 / 253 (26,5%) |
0,90 |
[0,66;1,22] |
|
Atrial fibrillation |
18 / 235 (7,7%) |
26 / 253 (10,3%) |
0,75 |
[0,42;1,32] |
|
Congestive heart failure |
22 / 235 (9,4%) |
29 / 253 (11,5%) |
0,82 |
[0,48;1,38] |
|
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]
cardiovascular event (fatal and non fatal)
NA / 719
NA / 0
0,85 [0,62;1,17]
Cardiovascular death
NA / 719
NA / 0
0,91 [0,59;1,40]
All cause death
NA / 719
NA / 0
0,88 [0,62;1,25]
stroke (fatal and non fatal)
NA / 719
NA / 0
0,88 [0,56;1,39]
myocardial infarction (fatal and non fatal)
NA / 719
NA / 0
0,68 [0,37;1,25]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
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
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
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)
-
Lindholm LH, Hansson L, Ekbom T, Dahlöf B, Lanke J, Linjer E, Scherstén B, Wester PO, Hedner T, de Faire U.
Comparison of antihypertensive treatments in preventing cardiovascular events in elderly diabetic patients: results from the Swedish Trial in Old Patients with Hypertension-2. STOP Hypertension-2 Study Group..
J Hypertens 2000;18:1671-5
Pubmed
|
Hubmed
| Fulltext
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Hansson L, Lindholm LH, Ekbom T, Dahlöf B, Lanke J, Scherstén B, Wester PO, Hedner T, de Faire U.
Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study..
Lancet 1999;354:1751-6
Pubmed
|
Hubmed
| Fulltext
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Hansson L, Hedner T, Dahlöf B.
Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point..
Blood Press 1992;1:113-9
Pubmed
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Hubmed
| Fulltext
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