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 benazepril + amlodipine
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Treatments
Studied treatment |
benazepril, combined with amlodipine
starting doses of benazepril 20 mg/day plus amlodipine 5 mg/day. amlodipine dose could be increased to 10 mg/day if required to achieve a target blood pressure goal of
|
Control treatment |
benazepril, combined with hydrochlorothiazide
starting doses of benazepril 20 mg/day plus hydrochlorothiazide 12.5 mg/day. hydrochlorothiazide dose could be increased to 25 mg/day if required to achieve a target blood pressure goal of
|
Remarks |
if needed investigators could
add other antihypertensive agents as beta-blockers, clonidine,
alpha-blockers, and spironolactone |
Patients
Patients |
patients with diabetes (subgroup) and hypertension at high risk of cardiovascular and related events |
Inclusion criteria |
>=60 years of age; systolic BP >=160 mm Hg or currently on antihypertensive therapy; evidence of cardiovascular or renal disease or target organ damage; patients aged 55 to 59 years are eligible if they have evidence of two or more of the cardiovascular diseases or target organ damage |
Exclusion criteria |
current evidence
for angina pectoris; history of
symptomatic heart failure or evidence of left ventricular
ejection fraction
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Remarks |
Of the all 11505 patients included in the trial, 6946 had diabetes (and 2842 high risk diabetes) |
Baseline characteristics |
Glycosylated hemoglobin |
NA |
BP (systolic/diastolic) |
145.2/79.3 mmHg |
Female (%) |
43% |
Age |
67.5 y |
subgroup |
yes |
hypertension (%) |
100% |
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Method and design
Randomized effectives |
3478 / 3468 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double-blind |
Follow-up duration |
36 months |
Number of centre |
548 |
Geographic area |
US, Norway, Denmark, Finland |
Hypothesis |
Superiority |
Primary endpoint |
cardiovascular morbidity and mortality |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
cardiovascular event (fatal and non fatal)
307 / 3478
383 / 3468
0,80 [0,69;0,92]
0
2
1.0
Relative risks
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Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
cardiovascular event (fatal and non fatal)
|
307 / 3478 (8,8%) |
383 / 3468 (11,0%) |
0,80 |
[0,69;0,92] |
|
13212 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
13212: Weber MA, Bakris GL, Jamerson K, Weir M, Kjeldsen SE, Devereux RB, Velazquez EJ, Dahlöf B, Kelly RY, Hua TA, Hester A, Pitt BCardiovascular events during differing hypertension therapies in patients with diabetes.J Am Coll Cardiol 2010;56:77-85
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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) |
8,83% |
11,04% |
-22,2‰
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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)
-
Weber MA, Bakris GL, Jamerson K, Weir M, Kjeldsen SE, Devereux RB, Velazquez EJ, Dahlöf B, Kelly RY, Hua TA, Hester A, Pitt B.
Cardiovascular events during differing hypertension therapies in patients with diabetes..
J Am Coll Cardiol 2010;56:77-85
- 10.1016/j.jacc.2010.02.046
Pubmed
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Hubmed
| Fulltext
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Jamerson K, Weber MA, Bakris GL, Dahlöf B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ.
Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients..
N Engl J Med 2008;359:2417-28
- 10.1056/NEJMoa0806182
Pubmed
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Hubmed
| Fulltext
|