Main characteristics of the included studies
Trial |
Treatments |
Patients |
Methods |
ABCD, 1998
|
nisoldipine (long acting)
versus
enalapril
|
patients with non-insulin-dependent diabetes and hypertension
|
follow-up 5 y
n=235/235
Factorial plan
Double blind
USA
|
FACET, 1997
|
amlodipine (long acting) 10 mg daily
versus
fosinopril 20 mg daily
|
hypertensive patients with NIDDM
|
follow-up 3.5 y
n=191/189
Parallel groups
open
Italy
|
UKPDS 39, 1998
|
captopril 25 mg/d aiming at a BP <150/85
versus
atenolol 50mg/d aiming at a BP <150/85
|
hypertensive patients with type 2 diabetes
|
follow-up ND
n=400/358
Parallel groups
open
UK
|
UKPDS 38, 1998
|
tight control of blood pressure aiming at a BP <150/85 (with the use of captopril or atenolol as main treatment, other treatment were added if the control criteria were not met)
versus
less tight control aiming at a blood pressure of <180/105 (avoiding treatment with ACE inhibitors or beta-blockers)
|
hypertensive patients with type 2 diabetes
|
follow-up 8.4y (median)
n=758/390
Parallel groups
open
UK
|
SHEP (diabetic subgroup), 1996
|
low dose of chlorthalidone (12.5-25.0 mg/d) with a step-up to atenolol (25.0-50.0 mg/d) or reserpine (0.05-0.10 mg/d) if needed
versus
placebo
|
men and women aged 60 years and older , non-insulin-treated diabetic (sub group) patients with isolated systolic hypertension (systolic BP >= 160 mm Hg; diastolic BP, <90 mm Hg)
|
follow-up 5 year
n=583/0
Parallel groups
double-blind
|
Syst-Eur (diabetic subgroup), 1999
|
Calcium-channel blocker
versus
placebo
|
subgroup of diabetic patients, age, >=60 years) with systolic blood pressure of 160 to 219 mm Hg and diastolic pressure below 95 mm Hg
|
follow-up 2 years
n=252/240
Parallel groups
double blind
|
HOPE (diabetic subgroup), 2000
|
ramipril 10 mg once per day orally
versus
placebo
|
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
|
follow-up 4.5 years
n=1808/1759
Factorial plan
double-blind
North, South america, Europe
|
RENAAL, 2001
|
losartan 50 to 100 mg once daily
versus
placebo
|
patients with type 2 diabetes and nephropathy
|
follow-up 3.4 y
n=751/762
Parallel groups
double-blind
America, Europe, Asia
|
IPDM, 2001
|
irbesartan, at a dose of either 150 mg daily or 300 mg daily
versus
placebo
|
hypertensive patients with type 2 diabetes and microalbuminuria
|
follow-up 2 years
n=389/201
Parallel groups
double-blind
Worldwide
|
CAPP (diabetic subgroup), 1999
|
Captopril initial dose of 50 mg daily given in one or two doses
versus
thiazide diuretic or beta-blocker
|
Patients aged 25-66 years with a measured diastolic blood pressure of 100 mm Hg or more on two occasions; subgroup of diabetic patients
|
follow-up 6.1 year
n=309/263
Parallel groups
open with blinded assessment
Sweden, Finland
|
NORDIL (diabetic subgroup), 2000
|
Diltiazem 180�360 mg diltiazem daily at step one
versus
thiazide diuretic or
a beta-blocker at step one
|
diabetic patients (subgroup), aged 50-74 years who had diastolic blood pressure of 100 mm Hg or more
|
follow-up 4.5 y
n=351/376
Parallel groups
open
Norway, Sweden
|
INSIGHT (diabetic subgroup), 2000
|
Nifedipine GITS 30 mg daily
versus
co-amilozide hydrochlorothiazide 25 mg plus amiloride 2.5 mg
|
diabetic (subgroup) patients aged 55-80 years with hypertension (blood pressure >= 150/95 mm Hg, or >= 160 mmHg systolic)
|
follow-up
n=649/653
Parallel groups
double-blind
Europe, Israel
|
STOP-2 CCB (diabetic subgroup), 2000
|
Calcium-channel blocker
versus
diuretic or beta-blocker
|
diabetic (subgroup) elderly patients aged 70-84 years
|
follow-up 5.03y
n=231/253
Parallel groups
open with blind assessment
Sweden
|
STOP-2 ACEI (diabetic subgroup), 2000
|
ACE inhibitor
versus
conventional treatment (diuretic or beta-blocker)
|
diabetic (subgroup) elderly patients aged 70-84 years with hypertension
|
follow-up 5.03y
n=235/253
Parallel groups
open with blind assessment
Sweden
|
IDNT irbesartan, 2001
|
Irbesartan 300 mg daily
versus
placebo
|
hypertensive patients with nephropathy due to type 2 diabetes
|
follow-up 2.6 years
n=579/569
Parallel groups
double blind
Worldwide
|
IDNT amlodipine, 2001
|
Amlodipine 10 mg daily
versus
placebo
|
hypertensive patients with nephropathy due to type 2 diabetes
|
follow-up 2.6 years
n=567/569
Parallel groups
double-blind
Worldwide
|
IDNT (irbesartan vs amlodipine), 2001
|
Irbesartan 300 mg daily
versus
amlodipine 10 mg daily
|
hypertensive patients with nephropathy due to type 2 diabetes
|
follow-up 2.6 years
n=579/567
Parallel groups
double blind
Worldwide
|
AVOID, 2008
NCT00097955
|
aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months
versus
placebo
|
patients with hypertension and type 2 diabetes with nephropathy
|
follow-up 6 months
n=301/298
Parallel groups
double blind
15 countries
|
ABCD (H), 2000
|
intensive treatment with a diastolic blood pressure
goal of 75 mmHg
versus
moderate treatment with a diastolic blood pressure goal of 80-89 mmHg
|
diabetes patients with DBP >=90 mmHg
|
follow-up 5 year
n=237/233
Parallel groups
open
|
ABCD (N), 2002
|
intensive treatment (diastolic blood pressure decrease
of 10 mmHg below baseline DBP)
versus
moderate treatment (diastolic blood pressure goal of 80-89 mmHg)
|
diabetes patients with diastolic
blood pressure between 80 and 89mmHg
|
follow-up
n=237/243
Parallel groups
open
|
ACCORD blood pressure, 2010
NCT00000620
|
intensive blood-pressure control, targeting a systolic pressure of less than 120 mm Hg
versus
standard blood-pressure control
|
high-risk patients with type 2 diabetes, high HbA1c concentrations (>7.5%), and cardiovascular disease (or >=2 cardiovascular risk factors)
|
follow-up 4.7 y
n=2363/2371
Factorial plan
open
United States, Canada
|
LIFE (diabetic subgroup), 2002
|
losartan 50mg daily at step 1
versus
atenolol 50mg daily at step 1
|
patients with diabetes (subgroup) , hypertension, and signs of left-ventricular hypertrophy on electrocardiograms
|
follow-up 4.7 years
n=586/609
Parallel groups
double-blind
USA, UK, Nordic countries
|
ALLHAT (lisi vs chlor, diabetic subgroup), 2002
|
lisinopril 10 to 40 mg/d
versus
chlorthalidone 12.5 to 25 mg/d
|
diabetic (subgroup) participants aged 55 years or older with hypertension
|
follow-up
n=3212/5528
Parallel groups
double-blind
|
ALLHAT (amlodipine vs chlor, diabetic subgroup), 2002
|
amlodipine
versus
chlorthalidone
|
diabetic (subgroup) participants aged 55 years or older with hypertension
|
follow-up
n=3323/5528
Parallel groups
double-blind
|
STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000
|
ACE inhibitor
versus
calcium
antagonists
|
diabetic (subgroup) elderly patients aged 70-84 years
|
follow-up 5.03y
n=235/231
open with blind assessment
Sweden
|
ACCOMPLISH (diabetic subgroup), 2010
NCT00170950
|
benazepril, combined with amlodipine
versus
benazepril, combined with hydrochlorothiazide
|
patients with diabetes (subgroup) and hypertension at high risk of cardiovascular and related events
|
follow-up 36 months
n=3478/3468
Parallel groups
double-blind
US, Norway, Denmark, Finland
|
References
ABCD, 1998 :
Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RWThe effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension.
N Engl J Med 1998;338:645-52
[PMID 9486993]
FACET, 1997 :
Tatti et al.
Circulation 1997; 96:I-764 (abstr)
[PMID 0]
FACET, 1997 :
Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G, Strollo FOutcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM.
Diabetes Care 1998 Apr;21:597-603
[PMID 9571349]
MIDAS (diabetic sub group), 1997 :
Byington RP, Craven TE, Furberg CD, Pahor MIsradipine, raised glycosylated haemoglobin, and risk of cardiovascular events.
Lancet 1997;350:1075-6
[PMID 10213554]
UKPDS 39, 1998 :
Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group.
BMJ 1998;317:703-13
[PMID 9732337]
UKPDS 39, 1998 :
Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group.
BMJ 1998;317:713-20
[PMID 9732338]
UKPDS 38, 1998 :
Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group.
BMJ 1998;317:713-20
[PMID 9732338]
UKPDS 38, 1998 :
Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group.
BMJ 1998;317:703-13
[PMID 9732337]
SHEP (diabetic subgroup), 1996 :
Curb JD, Pressel SL, Cutler JA, Savage PJ, Applegate WB, Black H, Camel G, Davis BR, Frost PH, Gonzalez N, Guthrie G, Oberman A, Rutan GH, Stamler JEffect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. Systolic Hypertension in the Elderly Program Cooperative Research Group.
JAMA 1996;276:1886-92
[PMID 8968014]
Syst-Eur (diabetic subgroup), 1999 :
Tuomilehto J, Rastenyte D, Birkenh�ger WH, Thijs L, Antikainen R, Bulpitt CJ, Fletcher AE, Forette F, Goldhaber A, Palatini P, Sarti C, Fagard REffects of calcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators.
N Engl J Med 1999;340:677-84
[PMID 10053176]
HOPE (diabetic subgroup), 2000 :
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
[PMID 10675071]
HOPE (diabetic subgroup), 2000 :
Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais GEffects 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
[PMID 10639539]
RENAAL, 2001 :
Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar SEffects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy.
N Engl J Med 2001;345:861-9
[PMID 11565518]
IPDM, 2001 :
Parving HH, Lehnert H, Br�chner-Mortensen J, Gomis R, Andersen S, Arner PThe effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes.
N Engl J Med 2001;345:870-8
[PMID 11565519]
CAPP (diabetic subgroup), 1999 :
Hansson L, Lindholm LH, Niskanen L, Lanke J, Hedner T, Niklason A, Luomanm�ki K, Dahl�f B, de Faire U, M�rlin C, Karlberg BE, Wester PO, Bj�rck JEEffect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial.
Lancet 1999;353:611-6
[PMID 10030325]
NORDIL (diabetic subgroup), 2000 :
Hansson L, Hedner T, Lund-Johansen P, Kjeldsen SE, Lindholm LH, Syvertsen JO, Lanke J, de Faire U, Dahl�f B, Karlberg BERandomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascular morbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study.
Lancet 2000;356:359-65
[PMID 10972367]
INSIGHT (diabetic subgroup), 2000 :
Brown MJ, Palmer CR, Castaigne A, de Leeuw PW, Mancia G, Rosenthal T, Ruilope LMMorbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT).
Lancet 2000;356:366-72
[PMID 10972368] 10.1016/S0140-6736(00)02527-7
STOP-2 CCB (diabetic subgroup), 2000 :
Lindholm LH, Hansson L, Ekbom T, Dahl�f B, Lanke J, Linjer E, Scherst�n B, Wester PO, Hedner T, de Faire UComparison 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
[PMID 11081782]
STOP-2 CCB (diabetic subgroup), 2000 :
Hansson L, Lindholm LH, Ekbom T, Dahl�f B, Lanke J, Scherst�n B, Wester PO, Hedner T, de Faire URandomised 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
[PMID 10577635]
STOP-2 ACEI (diabetic subgroup), 2000 :
Lindholm LH, Hansson L, Ekbom T, Dahl�f B, Lanke J, Linjer E, Scherst�n B, Wester PO, Hedner T, de Faire UComparison 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
[PMID 11081782]
STOP-2 ACEI (diabetic subgroup), 2000 :
Hansson L, Lindholm LH, Ekbom T, Dahl�f B, Lanke J, Scherst�n B, Wester PO, Hedner T, de Faire URandomised 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
[PMID 10577635]
STOP-2 ACEI (diabetic subgroup), 2000 :
Hansson L, Hedner T, Dahl�f BProspective 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
[PMID 1366259]
IDNT irbesartan, 2001 :
Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz IRenoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.
N Engl J Med 2001;345:851-60
[PMID 11565517]
IDNT amlodipine, 2001 :
Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz IRenoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.
N Engl J Med 2001;345:851-60
[PMID 11565517]
IDNT (irbesartan vs amlodipine), 2001 :
Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz IRenoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.
N Engl J Med 2001;345:851-60
[PMID 11565517]
UKPDS 38 10 years, 2008 :
Holman RR, Paul SK, Bethel MA, Neil HA, Matthews DRLong-Term Follow-up after Tight Control of Blood Pressure in Type 2 Diabetes.
N Engl J Med 2008;:
[PMID 18784091]
AVOID, 2008 :
Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NKAliskiren combined with losartan in type 2 diabetes and nephropathy.
N Engl J Med 2008;358:2433-46
[PMID 18525041]
ABCD (H), 2000 :
Estacio RO, Jeffers BW, Gifford N, Schrier RWEffect of blood pressure control on diabetic microvascular complications in patients with hypertension and type 2 diabetes.
Diabetes Care 2000;23 Suppl 2:B54-64
[PMID 10860192]
ABCD (N), 2002 :
Schrier RW, Estacio RO, Esler A, Mehler PEffects of aggressive blood pressure control in normotensive type 2 diabetic patients on albuminuria, retinopathy and strokes.
Kidney Int 2002;61:1086-97
[PMID 11849464] 10.1046/j.1523-1755.2002.00213.x
ACCORD blood pressure, 2010 :
Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes.
N Engl J Med 2010 Jun 29;:
[PMID 20587587] 10.1056/NEJMoa1001288
ACCORD blood pressure, 2010 :
Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles J, Cohen RM, Cuddihy R, Cushman WC, Genuth S, Grimm RH Jr, Hamilton BP, Hoogwerf B, Karl D, Katz L, Krikorian A, O'Connor P, Pop-Busui R, Schubart U, Simmons D, Taylor H, Thomas A, Weiss D, Hramiak IEffect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial.
Lancet 2010 Jun 29;:
[PMID 20594588] 10.1016/S0140-6736(10)60576-4
ACCORD blood pressure, 2010 :
Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski MRationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE).
Am J Cardiol 2007;99:103i-111i
[PMID 17599420] 10.1016/j.amjcard.2007.03.028
ACCORD blood pressure, 2010 :
Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WTEffects of intensive glucose lowering in type 2 diabetes.
N Engl J Med 2008;358:2545-59
[PMID 18539917] 10.1056/NEJMoa0802743
ACCORD blood pressure, 2010 :
Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi FEffects of intensive blood-pressure control in type 2 diabetes mellitus.
N Engl J Med 2010;362:1575-85
[PMID 20228401] 10.1056/NEJMoa1001286
LIFE (diabetic subgroup), 2002 :
Lindholm LH, Ibsen H, Dahl�f B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn SCardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.
Lancet 2002;359:1004-10
[PMID 11937179] 10.1016/S0140-6736(02)08090-X
LIFE (diabetic subgroup), 2002 :
Dahl�f B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristiansson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel HCardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.
Lancet 2002;359:995-1003
[PMID 11937178] 10.1016/S0140-6736(02)08089-3
ALLHAT (lisi vs chlor, diabetic subgroup), 2002 :
Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
JAMA 2002;288:2981-97
[PMID 12479763]
ALLHAT (amlodipine vs chlor, diabetic subgroup), 2002 :
Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
JAMA 2002;288:2981-97
[PMID 12479763]
STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000 :
Lindholm LH, Hansson L, Ekbom T, Dahl�f B, Lanke J, Linjer E, Scherst�n B, Wester PO, Hedner T, de Faire UComparison 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 Nov;18:1671-5
[PMID 11081782]
STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000 :
Hansson L, Lindholm LH, Ekbom T, Dahl�f B, Lanke J, Scherst�n B, Wester PO, Hedner T, de Faire URandomised 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
[PMID 10577635]
ACCOMPLISH (diabetic subgroup), 2010 :
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
[PMID 20620720] 10.1016/j.jacc.2010.02.046
ACCOMPLISH (diabetic subgroup), 2010 :
Jamerson K, Weber MA, Bakris GL, Dahl�f B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJBenazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients.
N Engl J Med 2008;359:2417-28
[PMID 19052124] 10.1056/NEJMoa0806182