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Flow‐chart indicating the number of citations retrieved by individual searches and the final number of trials included in this analysis. Reasons for exclusion are provided.
Figuras y tablas -
Figure 1

Flow‐chart indicating the number of citations retrieved by individual searches and the final number of trials included in this analysis. Reasons for exclusion are provided.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 1 All‐cause mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 1 All‐cause mortality.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 2 Doubling of serum creatinine.
Figuras y tablas -
Analysis 1.2

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 2 Doubling of serum creatinine.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 3 ESRD.
Figuras y tablas -
Analysis 1.3

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 3 ESRD.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 4 Normo to micro or macroalbuminuria.
Figuras y tablas -
Analysis 1.4

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 4 Normo to micro or macroalbuminuria.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 5 Adverse events.
Figuras y tablas -
Analysis 1.5

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 5 Adverse events.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 6 Blood pressure.
Figuras y tablas -
Analysis 1.6

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 6 Blood pressure.

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Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 7 Normo to microalbuminuria by hypertension.
Figuras y tablas -
Analysis 1.7

Comparison 1 ACE inhibitors versus placebo/no treatment, Outcome 7 Normo to microalbuminuria by hypertension.

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Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 1 All‐cause mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 1 All‐cause mortality.

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Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 2 Doubling of serum creatinine.
Figuras y tablas -
Analysis 2.2

Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 2 Doubling of serum creatinine.

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Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 3 ESRD.
Figuras y tablas -
Analysis 2.3

Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 3 ESRD.

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Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 4 Normo to micro or macroalbuminuria.
Figuras y tablas -
Analysis 2.4

Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 4 Normo to micro or macroalbuminuria.

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Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 5 Blood pressure.
Figuras y tablas -
Analysis 2.5

Comparison 2 ACE inhibitors versus calcium channel blockers (CCBs), Outcome 5 Blood pressure.

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Comparison 3 ACE inhibitors versus other agents, Outcome 1 Normo to micro or macroalbuminuria.
Figuras y tablas -
Analysis 3.1

Comparison 3 ACE inhibitors versus other agents, Outcome 1 Normo to micro or macroalbuminuria.

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Table 1. Electronic search strategies

Database

Search terms

CENTRAL

#1. ANTIHYPERTENSIVE AGENTS explode all trees (MeSH)
#2. chlorothiazide
#3. chlorthalidone
#4. hydralazine
#5. hydrochlorothiazide
#6. indapamide
#7. minoxidil
#8. (#1 or #2 or #3 or #4 or #5 or #6 or #7)
#9. captopril
#10 enalpril
#11. cilazapril
#12. enalaprilat
#13. fosinopril
#14. lisinopril
#15. perindopril
#16. ramipril
#17. saralasin
#18. teprotide
#19. (#9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18)
#20. LOSARTAN explode all trees (MeSH)
#21. losartan
#22. imidazole
#23. irbesartan
#24. candesartan
#25. eprosartan
#26. valsartan
#27. olmesartan
#28. telmisartan
#29. (ace near inhibitor*)
#30. (#20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29)
#31. CALCIUM CHANNEL BLOCKERS explode all trees (MeSH)
#32. amlodipine
#33. diltiazem
#34. felodipine
#35. nicardipine
#36. nifedipine
#37. nimodipine
#38. nisoldipine
#39. nitrendipine
#40. verapamil
#41. (#31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40)
#42. ADRENERGIC AGONISTS explode all trees (MeSH)
#43. alprenolol
#44. atenolol
#45. metoprolol
#46. nadolol
#47. oxprenolol
#48. pindolol
#49. propranolol
#50. labetalol
#51. prazosin
#52. (#42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51)
#53. DIURETICS explode all trees (MeSH)
#54. spironolactone
#55. triamterene
#56. bumetanide
#57. chlorthalidone
#58. furosemide
#59. indapamide
#60. chlorothiazide
#61. hydrochlorothiazide
#62. (#53 or #54 or #55 or #56 or #57 or #58 or #59 or #60 or #61)
#63. RECEPTORS ANGIOTENSIN [ai] single term (MeSH)
#64. ANGIOTENSINS [ai] explode tree 1 (MeSH)
#65. (angiotensin near inhibit*)
#66. (angiotensin near antagonist*)
#67. (angiotensin near blocker*)
#68. antihypertensive*
#69. (#64 or #65 or #66 or #67 or #68)
#70. (#8 or #19 or #30 or #41 or #52 or #62 or #69)
#71. DIABETES MELLITUS explode tree 1 (MeSH)
#72. (diabetes next mellitus)
#73. (iddm or niddm)
#74. DIABETIC NEPHROPATHIES single term (MeSH)
#75. (diabetic next nephrop*)
#76. (diabetic next glomerul*)
#77. (diabetic and (kidney next disease*))
#78. (diabetic and (renal next disease*))
#79. (diabetes and (renal next disease*))
#80. (diabetes and (kidney next disease*))
#81. (diabetes and nephro*)
#82. (diabetes and nephri*)
#83. (diabetes and glomerulo*)
#84. (diabetic and glomerulo*)
#85. (diabetic and nephrit*)
#86. (diabetic and nephro*)
#87. (#71 or #72 or #73 or #74 or #75 or #76 or #77 or #78 or #79 or #80 or #81 or #82 or #83 or #84 or #85 or #86)

MEDLINE

1. exp antihypertensive agents/
2. (antihypertensive$ adj (agent$ or drug)).tw.
3. chlorothiazide.tw.
4. chlorthalidone.tw.
5. hydralazine.tw.
6. hydrochlorothiazide.tw.
7. indapamide.tw.
8. minoxidil.tw.
9. exp angiotensin converting enzyme inhibitors/
10. captopril.tw.
11. enalapril.tw.
12. cilazapril.tw.
13. enalaprilat.tw.
14. fosinopril.tw.
15. lisinopril.tw.
16. perindopril.tw.
17. ramipril.tw.
18. saralasin.tw.
19. teprotide.tw.
20. exp losartan/
21. losartan.tw.
22. imidazole$.tw.
23. irbesartan.tw.
24. candesartan.tw.
25. eprosartan.tw.
26. valsartan.tw.
27. olmesartan.tw.
28. telmisartan.tw.
29. (ace adj2 inhibitor$).tw.
30. (angiotensin adj2 receptor antagonist$).tw.
31. exp calcium channel blockers/
32. amlodipine.tw.
33. diltiazem.tw.
34. felodipine.tw.
35. nicardipine.tw.
36. nifedipine.tw.
37. nimodipine.tw.
38. nisoldipine.tw.
39. nitrendipine.tw.
40. verapamil.tw.
41. exp adrenergic beta‐antagonists/
42. alprenolol.tw.
43. atenolol.tw.
44. metoprolol.tw.
45. nadolol.tw.
46. oxprenolol.tw.
47. pindolol.tw.
48. propranolol.tw.
49. exp adrenergic alpha‐antagonists/
50. labetalol.tw.
51. prazosin.tw.
52. beta block$.tw.
53. exp diuretics/
54. spironolactone.tw.
55. triamterene.tw.
56. bumetanide.tw.
57. chlorthalidone.tw.
58. furosemide.tw.
59. indapamide.tw.
60. chlorothiazide.tw.
61. hydrochlorothiazide.tw.
62. or/1‐61
63. exp diabetes mellitus/
64. diabetic nephropathies/
65. diabetic nephropath$.tw.
66. diabetic glomerulo$.tw.
67. ((diabetic or diabetes) and (kidney disease$ or renal disease$)).tw.
68. or/63‐67
69. 62 and 68

EMBASE

1. exp antihypertensive agents/
2. (antihypertensive$ adj (agent$ or drug$)).tw.
3. (anti‐hypertensive$ adj (agent$ or drug$)).tw.
4. chlorothiazide.tw.
5. chlorthalidone.tw.
6. hydralazine.tw.
7. hydrochlorothiazide.tw.
8. indapamide.tw.
9. minoxidil.tw.
10. losartan.tw.
11. imidazole$.tw.
12. irbesartan.tw.
13. candesartan.tw.
14. eprosartan.tw.
15. valsartan.tw.
16. olmesartan.tw.
17. telmisartan.tw.
18. exp angiotensin converting enzyme inhibitors/
19. (ace adj2 inhibitor$).tw.
20. (acei or ace‐i).tw.
21. captopril.tw.
22. enalapril.tw.
23. fosinopril.tw.
24. lisinopril.tw.
25. perindopril.tw.
26. ramipril.tw.
27. saralasin.tw.
28. teprotide.tw.
29. exp Angiotensin 2 Receptor Antagonist/
30. exp Angiotensin Receptor Antagonist/
31. Angiotensin II Antagonist/
32. angiotensin II receptor antagonist$.tw.
33. angiotensin 2 receptor antagonist$.tw.
34. angiotensin II receptor block$.tw.
35. angiotensin 2 receptor block$.tw.
36. AT 2 receptor block$.tw.
37. AT 2 receptor antagon$.tw.
38. angiotensin receptor antagonist$.tw.
39. exp Calcium Channel Blockers/
40. amlodipine.tw.
41. diltiazem.tw.
42. felodipine.tw.
43. nicardipine.tw.
44. nifedipine.tw.
45. nimodipine.tw.
46. nisoldipine.tw.
47. nitrendipine.tw.
48. verapamil.tw.
49. exp adrenergic beta‐antagonists/
50. alprenolol.tw.
51. atenolol.tw.
52. metoprolol.tw.
53. nadolol.tw.
54. oxprenolol.tw.
55. pindolol.tw.
56. propranolol.tw.
57. exp adrenergic alpha‐antagonists/
58. labetalol.tw.
59. prazosin.tw.
60. beta block$.tw.
61. exp diuretics/
62. spironolactone.tw.
63. triamterene.tw.
64. bumetanide.tw.
65. furosemide.tw.
66. indapamide.tw.
67. or/1‐66
68. exp Diabetes Mellitus/
69. diabetes mellitus.tw.
70. (IDDM or NIDDM).tw.
71. Diabetic Nephropathies/
72. diabetic nephrop$.tw.
73. diabetic glomerulo$.tw.
74. ((diabetic or diabetes) and (kidney disease$ or renal disease$ or nephro$ or nephrit$ or glomerulo$)).tw.
75. or/68‐74
76. and/67,75

Figuras y tablas -
Table 1. Electronic search strategies
Ir a la tabla de la revisión
Table 2. Effect of antihypertensive agents in RCTs enrolling hypertensive patients

Study

Intervention

All‐cause mortality

Cardiovascular event

All patients
RR (95% CI)

Diabetic
RR (95% CI)

Not diabetic
RR (95% CI)

Pa

All patients
RR (95% CI)

Diabetic
RR (95% CI)

Not diabetic
RR (95% CI)

Pa

ALLHAT 2002
N = 24309
% Diabetic = 35.9
Follow‐up = 58.8 mo

Lisinopril versus chlorthalidone

1.00 (0.94 to 1.08)

1.02 (0.91 to 1.15)

NA

#

1.5 (0.98 to 1.11)b

1.03 (0.93 to 1.14)b

NA

#

ALLHAT 2002
N = 24303
% Diabetic = 36.4
Follow‐up = 58.8 mo

Amlodipine versus chlorthalidone

0.96 (0.89 to 1.02)

0.96 (0.89 to 1.07)

NA

#

1.10 (0.90 to 1.33)b

0.98 (0.69 to 1.41)b

NA

#

CAPPP 1999
N = 10985
% Diabetic = 6.5
Follow‐up = 73.2 mo

Captopril versus conventionalc

0.80 (0.59 to 1.07)

0.54 (0.31 to 0.96)d

NA

#

1.13 (0.98 to 1.30)e

0.59 (0.38 to 0.91)e

NA

#

HOT 1998
N = 12528
% Diabetic = 8.0
Follow‐up = 45.6 mo

DBP‐90 versus 85

0.97 (0.79 to 1.19)

1.03 (0.62 to 1.71)

0.96 (0.78 to 1.19)

0.78

0.99 (0.83 to 1.19)g

1.32 (0.84 to 2.06)g

0.94 (0.77 to 1.14)

0.15

HOT 1998
N = 12526
% Diabetic = 8.0
Follow‐up = 45.6 mo

DBP‐85 versus 80

0.93 (0.77 to 1.14)

1.69 (0.94 to 1.05)

0.82 (0.67 to 1.01)

0.02

1.08 (0.89 to 1.29)g

1.54 (0.91 to 2.60)g

1.04 (0.86 to 1.27)

0.17

HOT 1998
N = 12526
% Diabetic = 8.0
Follow‐up = 45.6

DBP‐90 versus 80

0.91 (0.74 to 1.10)

1.76 (0.98 to 3.15)

0.82 (0.68 to 1.02)

0.02

1.07 (0.89 to 1.28)g

2.04 (1.24 to 3.34)g

0.97 (0.80 to 1.19)

0.01

INSIGHT 2000
N = 6321
% Diabetic = 20.6
Follow‐up = 48 mo

Nefedipine versus coamilozide

1.01 (0.81 to 1.26)

NA

NA

##

0.97 (0.85 to 1.10)h

NA

NA

##

NORDIL 2000
N = 10881
% Diabetic = 6.7
Follow‐up = 60 mo

Diltiazem versus conventional

1.41 (1.20 to 1.68)

1.15 (0.69 to 1.92)

1.10 (0.84 to 1.23)

0.64

1.10 (0.89 to 1.16)i

1.15 (0.78 to 1.72)i

1.03 (0.90 to 1.12)

0.60

SHEP 1996
N = 4763
% Diabetic = 12.3
follow‐up = 60 mo

Chlorihalidone, atenolol, reserpine verus placebo

0.88 (0.74 to 1.01)

0.86 (0.58 to 1.27)

0.89 (0.73 to 1.01)

0.88

0.70 (0.61 to 0.80)j

0.73 (0.54 to 0.98)j

0.70 (0.56 to 0.81)

0.79

STOPHYPERTENSION‐2 1999
N = 4418
% Diabetic = 11.0
Follow‐up = 72 mo

Enalapril versus conventionalc

1.02 (0.89 to 1.18)

NA

NA

#

0.90 (0.72 to 1.13)k

NA

NA

#

STOPHYPERTENSION‐2 1999
N = 4409
% Diabetic = 10.9
Follow‐up = 72 mo

Calcium antagonist versus conventionalc

0.99 (0.87 to 1.12)

NA

NA

#

1.18 (0.95 to 1.47)k

NA

NA

#

SYST‐EUR 1999
N = 4695
% Diabetic = 10.5
Follow‐up = 24 mo

Nitrendipine, possible enalapril, hydrochlorothiazide or both versus placebo

0.86 (0.68 to 1.09)

0.59 (0.32 to 1.06)

0.92 (0.71 to 1.12)

0.79

0.86 (0.68 to 1.10)l

0.40 (0.21 to 0.75)l

0.77 (0.61 to 0.96)

0.05

a χ² with 1 degree of freedom for interaction between cohort of diabetic versus cohort of non‐diabetic patients
b Fatal coronary heat disease and non‐fatal myocardial infarction
c Diuretic, beta‐blocker or both
d Data adjusted for age, sex, systolic blood pressure and previous treatment
e fatal and non‐fatal myocardial infarction, stroke and other cardiovascular death
f Diastolic blood pressure mmHg
g Major cardiovascular events including all fatal and non‐fatal myocardial infarctions, all fatal and non‐fatal strokes and all other cardiovascular deaths
h Myocardial infarction, stroke, heart failure and cardiovascular death, non‐cardiovascular deaths, kidney failure, angina and transient ischaemic attack
i Fatal and non‐fatal stroke, fatal and non‐fatal myocardial infarction and other cardiovascular death
j Cardiovascular disease including non‐fatal or fatal myocardial infarction, sudden cardiac death, rapid cardiac death, coronary artery bypass graft, angioplasty, non‐fatal or fatal stroke, transient ischaemic attack, aneurysm and endarterectomy
k Fatal and non‐fatal myocardial infarction
l Fatal and non‐fatal heart failure, fatal and non‐fatal myocardial infarction and sudden death
# Raw data not available to evaluate interaction, however triallists reported no interaction
## Patients with diabetes requiring more treatment and were the group in which nifedipine and coamilozide were most effective for all outcomes

NA Not available
Figuras y tablas -
Table 2. Effect of antihypertensive agents in RCTs enrolling hypertensive patients
Ir a la tabla de la revisión
Table 3. Guidelines on pharmacological management of hypertension in diabetic patients

Guideline

Indication

Angiotensin converting enzyme inhibitors (ACEi)

Angiotensin receptor blockers (ARB)

Beta‐blockers

Calcium channel blockers

Diuretics

Alpha‐blockers

Chobanian 2003a
USA

Hypertension

Yes

Yes

Yes

Yes

Yes

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

Yes

ADA 2004b USA

Hypertension

Yes

Yes

Yes

Yesh

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

Yes

K‐DOQI 2003c
USA

Hypertension

Diabetic nephropathy (type 1 diabetes)

Yes

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

Yes

CDA 2003d
Canada

Hypertension

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

Yesi

ESH‐ESC 2003e
Europe

Hypertension

Yes

Yesj

Yes

Yes

Yes

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

Yes

Williams 2004f
UK

Hypertension

Yesk

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Diabetic nephropathy (type 2 diabetes)

Yes

CARI 2003g
Australia

Hypertension

Yes

Diabetic nephropathy (type 1 diabetes)

Yes

Yesl

Diabetic nephropathy (type 2 diabetes)

Yes

Yesl

a Joint National Committee on Prevention, Diagnosis and Management of Hypertension
b American Diabetes Association
c Kidney Disease Outcome Quality Initiative
d Canadian Diabetes Association
e European Society of Hypertension
f British Hypertension Society
g Caring for Australians with Renal Impairment
h Second line agent
i Either ACEi or ARB but ARB only if creatinine clearance <60 mL/min
j Use calcium antagonists for hypertension when can be managed with monotherapy; use any agent for hypertension which requires combination treatment
k If intolerant to other agents
l Only if intolerant to ACEi

Figuras y tablas -
Table 3. Guidelines on pharmacological management of hypertension in diabetic patients
Ir a la tabla de la revisión
Comparison 1. ACE inhibitors versus placebo/no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

4

3284

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.64, 1.03]

2 Doubling of serum creatinine Show forest plot

3

2683

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.24, 2.71]

3 ESRD Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

4 Normo to micro or macroalbuminuria Show forest plot

6

3840

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.43, 0.84]

5 Adverse events Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 Cough

4

3725

Risk Ratio (M‐H, Random, 95% CI)

1.79 [1.19, 2.69]

5.2 Headache

1

2438

Risk Ratio (M‐H, Random, 95% CI)

1.25 [0.44, 3.61]

5.3 Hyperkalaemia

2

2594

Risk Ratio (M‐H, Random, 95% CI)

2.95 [0.31, 28.18]

6 Blood pressure Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

6.1 Systolic blood pressure

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Diastolic blood pressure

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7 Normo to microalbuminuria by hypertension Show forest plot

6

3840

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.43, 0.84]

7.1 Trials of patients with hypertension

4

3284

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.31, 0.88]

7.2 Trials of patients without hypertension

2

556

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.49, 1.06]
Figuras y tablas -
Comparison 1. ACE inhibitors versus placebo/no treatment
Ir a la tabla de la revisión
Comparison 2. ACE inhibitors versus calcium channel blockers (CCBs)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

6

1286

Risk Ratio (M‐H, Random, 95% CI)

0.84 [0.26, 2.73]

2 Doubling of serum creatinine Show forest plot

3

607

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3 ESRD Show forest plot

4

680

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4 Normo to micro or macroalbuminuria Show forest plot

4

1210

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.40, 0.84]

5 Blood pressure Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Systolic blood pressure

2

430

Mean Difference (IV, Random, 95% CI)

4.0 [1.59, 6.41]

5.2 Diastolic blood pressure

2

430

Mean Difference (IV, Random, 95% CI)

1.22 [‐0.42, 2.85]
Figuras y tablas -
Comparison 2. ACE inhibitors versus calcium channel blockers (CCBs)
Ir a la tabla de la revisión
Comparison 3. ACE inhibitors versus other agents

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Normo to micro or macroalbuminuria Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. ACE inhibitors versus other agents
Ir a la tabla de la revisión