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 <140/90 mm Hg. For the diabetic patients a target blood pressure of <130/80 mmHg was recommended, but not mandated
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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 <140/90 mm Hg. For the diabetic patients a target blood pressure of <130/80 mmHg was recommended, but not mandated
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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 <40%; myocardial infarction, other
acute coronary syndromes, or coronary revascularizations
within 1 month; stroke or other ischemic cerebrovascular episodes within 3 months; hypertension that is excessively
severe, known to be refractory to treatment, or
known to have a secondary cause; concomitant illness, physical impairment, or mental
condition that could interfere with the effective conduct
of the study |
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
|
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, Dahl�f 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, Dahl�f 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, Dahl�f 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
|