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
AVOID, 2008 - aliskiren 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
Syst-Eur (diabetic subgroup), 1999 - nitrendipine vs placebo
ABCD, 1998 - nisoldipine vs enalapril
UKPDS 38, 1998 - captopril or atenolol vs control
UKPDS 39, 1998 - captopril vs atenolol
FACET, 1997 - amlodipine vs fosinopril
See also:
All diabetes clinical trials
All hypertension clinical trials
All clinical trials of anti hypertensive agent
All clinical trials of calcium-channel blocker
|
|
Treatments
Studied treatment |
Calcium-channel blocker
felodipine 2�5 mg or isradipine 2�5 mg
daily. if the target blood pressure (<160/95 mm Hg) had not
been reached at the 2-month visit or later patients were given any
of the b-blockers in the doses listed
|
Control 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 (<160/95 mm Hg) had not
been reached at the 2-month visit or later. Patients who had started on diuretic treatment were given any
of the b-blockers in the doses listed
|
Patients
Patients |
diabetic (subgroup) elderly patients aged 70-84 years
|
Inclusion criteria |
hypertension (blood pressure >=180 mm Hg systolic, >=105 mmHg diastolic, or both); aged 70�84 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 |
231 / 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 |
renal death |
Remarks |
|
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
Cardiovascular mortality |
33 / 231 (14,3%) |
45 / 253 (17,8%) |
0,80 |
[0,53;1,21] |
|
Fatal myocardial infarction |
7 / 231 (3,0%) |
9 / 253 (3,6%) |
0,85 |
[0,32;2,25] |
|
Fatal stroke |
8 / 231 (3,5%) |
9 / 253 (3,6%) |
0,97 |
[0,38;2,48] |
|
Sudden death |
11 / 231 (4,8%) |
12 / 253 (4,7%) |
1,00 |
[0,45;2,23] |
|
Other cardiovascular mortality |
7 / 231 (3,0%) |
15 / 253 (5,9%) |
0,51 |
[0,21;1,23] |
|
All myocardial infarction |
32 / 231 (13,9%) |
26 / 253 (10,3%) |
1,35 |
[0,83;2,19] |
|
All stroke |
29 / 231 (12,6%) |
39 / 253 (15,4%) |
0,81 |
[0,52;1,27] |
|
All major cardiovascular events |
69 / 231 (29,9%) |
82 / 253 (32,4%) |
0,92 |
[0,71;1,20] |
|
Total mortality |
50 / 231 (21,6%) |
67 / 253 (26,5%) |
0,82 |
[0,59;1,13] |
|
Atrial fibrillation |
24 / 231 (10,4%) |
26 / 253 (10,3%) |
1,01 |
[0,60;1,71] |
|
Congestive heart failure |
24 / 231 (10,4%) |
29 / 253 (11,5%) |
0,91 |
[0,54;1,51] |
|
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
0,91 [0,66;1,26]
Cardiovascular death
NA / 719
NA / 0
0,78 [0,50;1,22]
All cause death
NA / 719
NA / 0
0,79 [0,54;1,15]
stroke (fatal and non fatal)
NA / 719
NA / 0
0,80 [0,49;1,30]
myocardial infarction (fatal and non fatal)
NA / 719
NA / 0
classic
1,31 [0,78;2,20]
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:
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, Dahl�f B, Lanke J, Linjer E, Scherst�n 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, Dahl�f B, Lanke J, Scherst�n 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
|