Papers
Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39
This paper was prepared for publication by Rury Holman, Robert Turner, Irene Stratton, Carole Cull, Valeria Frighi, Susan Manley, David Matthews, Andrew Neil, Eva Kohner, David Wright, David Hadden, and Charles Fox.
UK Prospective Diabetes Study Group Correspondence to: Professor R Holman, UK
Prospective Diabetes Study Group, Diabetes Research Laboratories,
Radcliffe Infirmary, Oxford OX2 6HE
Members of the
study group are given at the end of the accompanying paper on
p 703.
Objective: To determine whether tight control of
blood pressure with either a
Most randomised controlled trials of treatment for hypertension in
patients with diabetes have evaluated blood pressure lowering in
comparison with a conventionally treated group of patients who had
higher blood pressure.1 These trials mainly used a single
agent rather than comparing blood pressure lowering with different
agents.
We reported results from the hypertension in diabetes study, part of
the United Kingdom prospective diabetes study, in the accompanying
paper.2 Tight control of blood pressure with either an
angiotensin converting enzyme inhibitor or Studies with angiotensin converting enzyme inhibitors in hypertensive
patients with type 1 diabetes have usually reported a decrease in
urinary albumin excretion,
3 4
and some have reported
prevention of an increase in such excretion.5-7 These studies have not assessed whether the reduction in albuminuria was due
to blood pressure lowering or to the use of an angiotensin converting
enzyme inhibitor in itself. Chan et al have suggested that enalapril
may have a greater effect than nifedipine in reducing albuminuria,8 but neither their study nor other studies
have been sufficiently large or had long enough follow up to evaluate the effect of treatment on clinical complications.
Both angiotensin converting enzyme inhibitors and In this paper we report the results of a direct comparison of the
treatment of hypertension in patients with type 2 diabetes with the
angiotensin converting enzyme inhibitor captopril and the Hypertensive patients with type 2 diabetes were studied in the
hypertension in diabetes study, which was introduced in a factorial design to the UK prospective diabetes study in 1987 to 20 of the 23 centres. Full details of this study, including the recruitment and
randomisation procedure, are reported in the accompanying paper.2 A total of 1148 patients (637 men (55%)) with a
mean (SD) age of 56 (8) years were recruited for this study during 1987-91.12 Table 1 shows the biometric and biochemical
characteristics of patients at allocation to captopril or
atenolol.
Table 1.
Abstract
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
blocker or an angiotensin converting enzyme inhibitor has a specific advantage or disadvantage in preventing the macrovascular and microvascular complications of type 2 diabetes.
Design: Randomised controlled trial comparing an
angiotensin converting enzyme inhibitor (captopril) with a blocker (atenolol) in patients with type 2 diabetes aiming at a blood pressure
of <150/<85 mm Hg.
Setting: 20 hospital based clinics in England,
Scotland, and Northern Ireland.
Subjects: 1148 hypertensive patients with type 2 diabetes (mean age 56 years, mean blood pressure 160/94 mm Hg). Of the
758 patients allocated to tight control of blood pressure, 400 were
allocated to captopril and 358 to atenolol. 390 patients were allocated
to less tight control of blood pressure.
Main outcome measures: Predefined clinical end
points, fatal and non-fatal, related to diabetes, death related to
diabetes, and all cause mortality. Surrogate measures of microvascular
and macrovascular disease included urinary albumin excretion and
retinopathy assessed by retinal photography.
Results: Captopril and atenolol were equally
effective in reducing blood pressure to a mean of 144/83 mm Hg and
143/81 mm Hg respectively, with a similar proportion of patients
(27% and 31%) requiring three or more antihypertensive treatments.
More patients in the captopril group than the atenolol group took the
allocated treatment: at their last clinic visit, 78% of those
allocated captopril and 65% of those allocated atenolol were taking
the drug (P<0.0001). Captopril and atenolol were equally effective in
reducing the risk of macrovascular end points. Similar proportions of
patients in the two groups showed deterioration in retinopathy by two
grades after nine years (31% in the captopril group and 37% in the
atenolol group) and developed clinical grade albuminuria 
300 mg/l
(5% and 9%). The proportion of patients with hypoglycaemic attacks
was not different between groups, but mean weight gain in the atenolol
group was greater (3.4 kg v 1.6 kg).
Conclusion: Blood pressure lowering with captopril or
atenolol was similarly effective in reducing the incidence of diabetic
complications. This study provided no evidence that either drug has any
specific beneficial or deleterious effect, suggesting that blood
pressure reduction in itself may be more important than the treatment
used.
Key messages
blocker (atenolol) gave similar
reductions in blood pressure in hypertensive patients with type 2 diabetes
Introduction
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
blocker resulted in a
reduced risk of both macrovascular and microvascular complications in
hypertensive patients with type 2 diabetes. The risk of any diabetes
related end points was reduced by 24%, strokes by 44%, and
microvascular end points by 37%.2
blockers have
been thought to have specific potential advantages. Studies of
angiotensin converting enzyme inhibitors in diabetic patients have
raised the possibility of a specifically beneficial effect in
preventing microvascular disease in the kidneys. These agents are also
effective in decreasing mortality from heart failure in non-diabetic
subjects.9 Treatment with blockers has a protective
effect on cardiac mortality after myocardial infarction,10 and since this is the major cause of death in patients with type 2 diabetes prophylactic treatment with blockers may be advisable. In
addition, blockers are effective in treating heart
failure.11
blocker
atenolol on the development of clinical complications of diabetes.
Subjects and methods
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
Figure 1 in the accompanying paper shows that two thirds of the
patients (758) were randomly allocated tight control of blood pressure
aiming for a blood pressure of <150/<85 mm Hg by the coordinating
centre; 400 patients were randomly allocated to captopril and 358 to
atenolol.2 The small imbalance in the numbers of patients
allocated to these two treatments occurred by chance as the
randomisation was not blocked. The other 390 patients were randomly
allocated less tight control of blood pressure, aiming at a blood
pressure of <180/<105 mm Hg but avoiding treatment with angiotensin
converting enzyme inhibitors or blockers.2
Captopril was usually started at a dose of 25 mg twice daily, increasing to 50 mg twice daily, and atenolol at a daily dose of 50 mg, increasing to 100 mg if required. If the blood pressure control criteria were not met in the tight control group despite maximum allocated treatment other agents were added, the suggested sequence being frusemide 20 mg daily (maximum 40 mg twice daily), slow release nifedipine 10 mg (maximum 40 mg) twice daily, methyldopa 250 mg (maximum 500 mg) twice daily, and prazosin 1 mg (maximum 5 mg) thrice daily.
Clinical end points
Twenty one clinical end points were aggregated for analysis. The
three predefined primary outcome analyses were the time to the
occurrence of (a) a first clinical end point related to
diabetes; (b) death related to diabetes; and
(c) death from all causes. Four additional clinical end
point aggregates were used to assess the effect of treatments on
different types of vascular disease in secondary outcome analyses.
These were myocardial infarction, stroke, amputation or death from
peripheral vascular disease, and microvascular complications.
50 mg/l and clinical grade albuminuria as 300 mg/l; retinopathy, with progression defined by a two step change in modified ETDRS (early
treatment of diabetic retinopathy study) final grade assessed on
retinal photographs; and visual acuity, with deterioration defined as a
deterioration of three lines in the ability to read an ETDRS chart with
the better eye.2
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2 tests for comparison. Risk reductions were derived
from frequency tables. Survival function estimates were calculated
using the product limit (Kaplan-Meier) method. Blood pressure control
was assessed in the cohort with nine years of follow up. Further
details of the analyses used are described in the accompanying
paper.2
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Results |
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
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Blood pressure control
The patients allocated to captopril and to atenolol both had the
same mean (SD) blood pressure 159 (20)/93 (10) mm Hg at randomisation to blood pressure control policy. Over nine years those allocated to
captopril or atenolol had similarly reduced blood pressures, 144 (14)/83 (8) mm Hg and 143 (14)/81 (7) mm Hg respectively (fig 1). The
differences (95% confidence interval) between the groups given
captopril or atenolol were 1 (
1 to 3)/1 (0 to 2) mm Hg, with no
significant difference for systolic pressure and a clinically small
difference for diastolic pressure (P=0.02). Those allocated to less
tight control of blood pressure, which did not include captopril or
atenolol, had a mean blood pressure of 154 (16)/87 (7) mm Hg over nine
years (fig 1).
Compliance with allocated treatment
Compliance was similar between the two groups over the first four
years but subsequently more patients in the atenolol group than in the
captopril group discontinued taking their allocated treatment
(P<0.0001). The difference in compliance was mostly because impaired
peripheral circulation or bronchospasm occurred in the patients taking
atenolol (table 2). Four per cent of patients allocated captopril
discontinued the treatment because of a cough. Of the five patients in
whom captopril was withdrawn because of a rise in creatinine
concentration, one eventually required renal replacement, but the
initial rise in creatinine had occurred before captopril treatment was
started. During the study patients assigned captopril and atenolol took
their treatment for 80% and 74% respectively of the total person
years of follow up. Figure 2 shows that increasing numbers of blood
pressure lowering agents were required to obtain the tight blood
pressure control target of <150/<85 mm Hg. A similar proportion of
patients were taking three or more agents in the two groups (27% in
the captopril group and 31% in the atenolol group). Nifedipine was
used in 24% of person years of follow up in those allocated to less
tight control of blood pressure, in 36% in those allocated to atenolol
and 27% in those allocated to captopril.
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Primary outcome measures
The incidence of end points related to diabetes, which include
macrovascular and microvascular complications, was similar in
hypertensive patients with type 2 diabetes allocated to either captopril or atenolol treatment (figs 3 and 4). The incidence of
diabetic deaths and all cause mortality was also similar in both groups
(figs 4 and
5).
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Secondary outcome measures
Macrovascular disease
There was no difference in the incidence of myocardial infarction
or strokes between the groups assigned blocker or angiotensin converting enzyme inhibitor (figs 4 and 6). There were no differences in any of the single clinical end points, including heart failure and
angina (fig 7). Neither was there a difference when all end points
relating to macrovascular disease were aggregated.
Microvascular disease
There was no difference in the incidence of aggregate
microvascular clinical end points between the groups allocated blocker or angiotensin converting enzyme inhibitor (figs 4 and 6).
Similar proportions of patients required retinal photocoagulation,
progressed to renal failure, or required an amputation, which can arise
from a combination of macrovascular and microvascular
disease.
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Surrogate end points
Microvascular disease
Retinopathy
The progression of retinopathy was similar in
those allocated to captopril and atenolol; at nine years 37% in the
group assigned captopril (59/160) and 37% in that assigned atenolol
(52/140) had deteriorated by two or more steps of retinopathy compared with 51% in the group assigned to less tight control of blood pressure
(78/152). There was no difference between the captopril and atenolol
groups in the deterioration of visual acuity by one letter on the ETDRS
chart reduction.
Renal failure
The progression of albuminuria was similar in
those allocated to captopril and atenolol. The proportion of patients
who at nine years had a urinary albumin concentration 50 mg/l were
31% (48/153) and 26% (38/146) (P=0.31) and who had clinical
proteinuria 300 mg/l were 5% (7/153) and 10% (14/146) (P=0.090)
respectively. There was also no difference in plasma creatinine
concentrations or in the proportion of patients who had a twofold
increase in creatinine concentration from randomisation. The surrogate
indices of neuropathy and autonomic neuropathy were not different
between the allocations.
Macrovascular disease
There was no difference in the proportion of patients who
developed a silent infarction, shown in an electrocardiogram.
Similarly, there was no difference in non-specific T waves or ST
abnormalities, cardiomegaly assessed by electrocardiography or
chest radiography, or peripheral vascular disease assessed by Doppler
blood pressure recordings or absent peripheral pulses (data not shown).
Other treatment effects
Glycated haemoglobin (haemoglobin A1c)
Over the
first four years of follow up the patients allocated to atenolol had a
higher mean glycated haemoglobin (haemoglobin A1c)
concentration than those allocated captopril (7.5% (1.4%) v 7.0% (1.4%), P=0.0044), although over the second
four years the values were similar (8.4% (1.5%) and 8.3% (1.7%)
respectively). After four years of follow up 66% of the patients
allocated to atenolol were receiving an additional glucose lowering
treatment since randomisation compared with 53% in those allocated to
captopril (P=0.0015). This difference was also present at eight years,
with 81% and 71% respectively requiring an additional treatment
(P=0.029).
Hypoglycaemia
There was no overall difference in the rates
of hypoglycaemia in the captopril and atenolol groups. In patients
allocated to and taking angiotensin converting enzyme inhibitors and
blockers and those in the group assigned to less tight control of
blood pressure the cumulative proportions of patients who reported
minor or major hypoglycaemic reactions were 41%, 41%, and 43%
respectively and in those who reported a major hypoglycaemic episode
6.5%, 5.6%, and 4.4%. There were no fatal hypoglycaemic events in
patients allocated to these treatments.
Weight gain
The patients allocated to atenolol gained more
weight than those allocated to captopril (mean weight gain 3.4 (8.0) kg
v 1.6 (9.1) kg over nine years, P=0.020).
Lipid concentrations
There were no consistent trends in
concentrations of triglyceride, total cholesterol, or high density
lipoprotein cholesterol over nine years.
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Discussion |
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
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Our accompanying paper showed that tight control of blood pressure with either captopril or atenolol in hypertensive patients with type 2 diabetes significantly reduced the risk of fatal and non-fatal macrovascular and microvascular complications over nine years of follow up.2 This paper compares, within the patients allocated to tight blood pressure control, captopril and atenolol. Both treatments reduced blood pressure to the same extent and were similarly effective in reducing the risk of macrovascular and microvascular complications of diabetes.
Microvascular disease
These results are interesting given the current debate over
whether any specific class of antihypertensive agents, and angiotensin converting enzyme inhibitors in particular, might be more effective than others in protecting against renal disease.
1 13 14
In this study the proportion of patients who developed albuminuria 50 mg/l, proteinuria (300 mg/l), a twofold increase in plasma creatinine concentration, end stage renal failure, or progression of
retinopathy was similar in the groups assigned captopril or atenolol.
Macrovascular disease
The patients allocated to either captopril or atenolol had a
reduced risk of death related to diabetes and stroke compared with the
group assigned to less tight control of blood pressure. The incidence
of myocardial infarction and of heart failure was similar in the
captopril and atenolol groups. The negative inotropic effect of blockers might have been expected to increase the incidence of heart
failure, but the protection against heart failure was as great for
atenolol as for captopril. This suggests that the beneficial effect of
blockade on autonomic control of ventricular function and
myocardial energy balance predominated.17 A trend to fewer
sudden deaths with the blockers than with the angiotensin converting enzyme inhibitor was not significant.
blockers and angiotensin converting enzyme inhibitors have specific beneficial effects or that the decrease in blood pressure
is the important factor and not the type of treatment. The diabetic
subgroup of the systolic hypertension in the elderly programme also
showed prevention of myocardial infarction by blood pressure lowering,
the initial treatment being a thiazide (chlorthalidone), with 20% of
patients also taking atenolol.18
In the hypertension in diabetes study the use of a long acting calcium
antagonist, nifedipine, was recommended as the second blood pressure
lowering agent in the group assigned to less tight control of blood
pressure and as the third agent in the group assigned to tight control.
In view of the possibility, as yet unproved, of an increased risk of
myocardial infarction in type 2 diabetes with a calcium channel blocker
compared with an angiotensin converting enzyme
inhibitor,17 we noted that nifedipine was used in 24% of
person years of follow up in those allocated to less tight control of
blood pressure, 36% in those allocated to atenolol, and 27% in those
allocated to captopril. As the group assigned to tight blood pressure
control had a trend to a reduced risk for myocardial infarction
compared with the group assigned to less tight control, the data do not
support the contention that calcium channel blocking agents are
potentially harmful.18
Side effects
The development of cold feet, intermittent claudication, or
bronchospasm in some patients was the main reason for the slightly lower rate of compliance for atenolol. However, a similar proportion of
patients assigned the two drugs developed peripheral vascular disease,
had absent foot pulses on examination, or had amputations.
Choice of antihypertensive agents
Angiotensin converting enzyme inhibitors have been recommended for
treatment of hypertension in type 1 or type 2 diabetes on the basis of
studies showing a reduction in urinary albumin concentration or
prevention of an increase in urinary albumin concentration in
comparison with untreated control groups. In most studies patients
treated with angiotensin converting enzyme inhibitors had a lower blood
pressure than the control group,
19 20
and this alone may
have been the main factor in decreasing capillary perfusion, reducing
transcapillary leakage of albumin, and, in the long term, decreasing
the damage to both capillaries and arteries. Similarly, studies of
angiotensin converting enzyme inhibitors in patients with normal blood
pressure have evaluated patients whose blood pressures are in the upper
range of normal values, although not above an arbitrary definition of
hypertension.
5 19
The small decrease in blood pressure in
the group given angiotensin converting enzyme inhibitors may have been
sufficient to decrease urinary albumin excretion. Lewis et al studied
diabetic patients with nephropathy and reported that an angiotensin
converting enzyme inhibitor decreased progression to end stage renal
failure and delayed the increase in plasma creatinine
concentration.21 However, the results may have been
confounded because the group given angiotensin converting enzyme
inhibitors also had lower blood pressures than the control group and
urinary albumin excretion was mismatched at baseline. Although some
studies have discounted the minor difference in blood pressure attained
with angiotensin converting enzyme inhibition in normotensive
patients,19 small differences in blood pressure can affect
cardiac and stroke outcome, both in the general
population
22 23
and in patients with type 2 diabetes.2 This suggests that it may be advantageous to
treat even slight increases in blood pressure.
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Acknowledgments |
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We appreciate the cooperation of the patients and many NHS and non-NHS staff at the participating centres.
Contributors: Details of participating staff and the supervising committees are listed in the accompanying paper.2
Funding: The main grants for this study were from the Medical Research Council, British Diabetic Association, the Department of Health, the National Eye Institute and the National Institute of Digestive, Diabetes and Kidney Disease in the National Institutes of Health in the United States, the British Heart Foundation, Novo-Nordisk, Bayer, Bristol Myers Squibb, Hoechst, Lilly, Lipha, and Farmitalia Carlo Erba. Other funding companies and agencies are listed in the accompanying paper.2
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References |
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Abstract
Introduction
Subjects and methods
Results
Discussion
References
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Kasiske B, Kalil RSN, Ma JZ, Liao M, Keane WF.
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[Abstract/Free Full Text] . -
UK Prospective Diabetes Study Group.
Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38.
BMJ
1998;
317:
703-713
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- Chan JCN, Cockram CS, Nicholls MG, Cheung CK, Swaminathan R. Comparison of enalapril and nifedipine in treating non-insulin dependent diabetes associated with hypertension: one year analysis. BMJ 1992; 305: 981-985.
- Garg R, Yusuf S. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Collaborative Group on ACE Inhibitor Trials. JAMA 1995; 273: 1450-1456.
- Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta blockade during and after myocardial infarction: an overview of the randomised trials. Progr Cardiovascular Dis 1985; 27: 335-371.
- Heidenreich PA, Lee TT, Massie BM. Effect of beta-blockade on mortality in patients with heart failure: a meta-analysis of randomized clinical trials. J Am Coll Cardiol 1997; 30: 27-34.
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- Sawicki PT, Kaiser S, Heinemann L, Frenzel H, Berger M. Prevalence of renal artery stenosis in diabetes mellitus
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[Free Full Text] .- Andersson B, Caidahl K, diLenarda A, Warren SE, Goss F, Waldenstrom A, et al. Changes in early and late diastolic filling patterns induced by long-term adrenergic beta-blockade in patients with idiopathic dilated cardiomyopathy. Circulation 1996; 94: 673-682[Medline].
- Curb JD, Pressel SL, Cutler JA, Savage P, Applegate WB, Black H, et al. Effect 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: 1886-1892[Abstract].
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[Abstract/Free Full Text] .
(Accepted 20 August 1998)
© BMJ 1998
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(2006). Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline.. Circulation
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[Abstract]
Rapid Responses:
Read all Rapid Responses
- Perhaps the differences in albuminuria may be real
- AnnMarie Mackway-Girardi
bmj.com, 17 Sep 1998 [Full text]
