(Hypertension. 1999;33:1002-1007.)
© 1999 American Heart Association, Inc.
Scientific Contributions |
Hypertension in Diet Versus Pharmacologically Treated Diabetics
Mortality Over a 5-Year Follow-Up
From the Cardiac Rehabilitation Institute and the Bezafibrate Infarction Prevention Coordinating Center, Neufeld Cardiac Research Institute, the Chaim Sheba Medical Center, Tel-Hashomer, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Correspondence to Alexander Tenenbaum, MD, PhD, Cardiac Rehabilitation Institute, Chaim Sheba Medical Center, 52621 Tel-Hashomer, Israel. E-mail zfisman{at}post.tau.ac.il
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Abstract |
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Abstract—The natural history of non–insulin-dependent diabetes mellitus (NIDDM) differs markedly between patients with diet treated and pharmacologically treated disease. However, the interrelationship between hypertension and these common diabetes types has not been specifically addressed in previous studies. This study was designed to evaluate the prognostic significance and prevalence of hypertension in coronary patients with diet versus pharmacologically treated NIDDM over a 5-year follow-up period. The study sample comprised 11 515 patients aged 45 to 74 years with a previous myocardial infarction and/or anginal syndrome who had been screened but were not included in the Bezafibrate Infarction Prevention study. Among them, 9033 were nondiabetics and 2482, diabetics (987 diet treated and 1495 pharmacologically treated). The prevalence of hypertension among nondiabetics, diet-treated diabetics, and pharmacologically treated diabetics was 31%, 42%, and 43%, respectively. Crude all-cause mortality (CM) was lower in the nondiabetic patients (11.2% versus 22.0%; P<0.001). Among diabetics, 548 patients died: 81 diet treated normotensives (CM 14%); 100 diet-treated hypertensives (CM 24.4%); 205 pharmacologically treated normotensives (CM 24.2%); and 162 pharmacologically treated hypertensive patients (CM 25.0%). Age-adjusted mortality was lowest for the normotensive patients in the diet-treated group and highest for the hypertensive pharmacologically treated patients. Multivariate analysis shows that hypertension is a strong and independent predictor of increased CM in diet-treated but not in pharmacologically treated NIDDM: hazard ratio (HR) was 1.68 (95% confidence interval [CI] 1.24 to 2.29) for the diet-treated versus 1.01 (95% CI 0.82 to 1.26) for the pharmacologically treated diabetics. The contribution of hypertension to stroke mortality was substantial for both diet treated and pharmacologically treated NIDDM: hazard ratios were 3.17 (95% CI 1.12 to 8.98) and 2.21 (95% CI 0.72 to 6.77), respectively. The increased risk of mortality associated with hypertension in relatively mild diet-treated NIDDM strongly supports the clinical benefit of early blood pressure control among diabetic patients with ischemic heart disease.
Key Words: coronary disease • diabetes mellitus • hypertension • mortality
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Introduction |
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Hypertension and diabetes are common chronic conditions that coexist more frequently than predicted by chance.1 2 3 4 5 6 Hypertensive patients with diabetes may face some additional problems associated with both more pronounced organ damage and drug interactions and side effects.7 8 9 The natural history of non–insulin-dependent diabetes mellitus (NIDDM) differs markedly among patients who are on diet treatment only (usually relatively mild disease with lower fasting glucose level) and patients with pharmacological antihyperglycemic medications (usually more advanced disease). However, the interrelationship between hypertension and these common diabetes types ("diet treated" versus "pharmacologically treated" diabetes) has not been specifically addressed in previous studies. Patients who have both hypertension and diabetes present a substantially increased risk of developing ischemic heart disease (IHD).1 8 10 However, there are few data analyzing the significance of this frequent triple coexistence: hypertension, diabetes, and IHD. This study was designed to evaluate the prevalence and prognostic significance of hypertension in cardiac patients with diet versus pharmacologically treated NIDDM over a 5-year follow-up period.
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Methods |
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Subjects
The study sample comprised 11 575 patients between 45 and 74 years of age with a previous myocardial infarction (0.5 to 5 years before commencement of follow-up) and/or stable anginal syndrome (within 2 years preceding inclusion). The patients had been screened for participation in but not included in the bezafibrate infarction prevention (BIP) study.11 In the present study, we excluded 60 patients with incomplete data regarding their diabetes and/or hypertensive status. Among the remaining 11 515 patients, 9033 were nondiabetics and 2482 were diabetics. The diabetics were divided into 4 groups on the basis of their therapeutic regimen at screening (status of the patients at entry to the study) and presence or absence of a history of hypertension. The groups were divided as follows: (1) diet-treated normotensive patients; (2) diet-treated hypertensive patients; (3) pharmacologically treated normotensive patients; and (4) pharmacologically treated hypertensive patients. (The terms "diet treated" and "pharmacologically treated" were related to NIDDM management only.)
The major inclusion and exclusion criteria for the BIP study, as well as the ethical guidelines, were previously reported.11 Mortality data were obtained by matching the patients' identification numbers with their life status in the Israel Population Registry. Death certificates and diagnosis at hospital discharge were coded using the system described in the International Classification of Diseases, ninth revision (ICD-9-CM), in which IHD is denoted by codes 410 to 414 and cerebrovascular accident (CVA) by codes 430 to 438.12 Detailed data on laboratory methods are given in a previous report.13
Definition of Diabetes Mellitus
The diagnosis of NIDDM was made on the basis of the reported
history and medical records. Fasting blood glucose values were
determined in the central laboratory for this study by the
GOD-PAPP method, using a BM/Hitachi 717/911
analyzer.13 To evaluate conformity between a
reported history of diabetes and the measured fasting blood glucose
level, we examined the following: (1) The number of patients with no
previous history of diabetes, who were hyperglycemic (presenting
fasting blood glucose level of 
140 mg/dL). This query was based on
World Health Organization14 and National Diabetes Data
Group1 statements that fasting blood glucose level
>8 mmol/L or >140 mg/dL (7.77 mmol/L), respectively, may be
used as diagnostic criteria for diabetes mellitus in
nonpregnant adults. Of the 9035 nondiabetics, we identified 428 (4.7%)
of these hyperglycemic patients. (2) The number of patients with a
previous history of diabetes who were not receiving any
antihyperglycemic drugs but presented with a fasting blood
glucose level of 5.5 mmol/L (
99 mg/dL). Of 2482 diabetics, 133
(5.4%) had an unconfirmed diagnosis of diabetes.
Definition of Hypertension
Arterial BP was measured with a standard clinical
mercury sphygmomanometer and an appropriate cuff size. The diagnosis of
hypertension was based on patients' medical histories and physicians'
records. The study began in 1990, and the definition of
hypertension corresponded to the WHO criteria15 :
systolic BP 160 mm Hg, a phase 5 diastolic
BP 95 mm Hg, or treatment with antihypertensive drugs. Aiming
to clarify the correspondence among a reported history of hypertension,
measured arterial BP, and antihypertensive treatment, we
examined the following: (1) The number of patients without previous
history of hypertension ("normotensive") who showed blood pressure
values 160/95 mm Hg. Of 7648 "normotensive" patients per
history, 658 (8.6%) exhibited elevated blood pressure on a routine
single measurement. (2) The number of patients with a history of
hypertension who did not receive antihypertensive medications (ACE
inhibitors, calcium antagonists,
diuretics, ß-blockers, and other antihypertensive drugs, such
as central adrenergic inhibitors, 
-adrenergic blockers,
and vasodilators) and maintained a BP of <160/95 mm Hg. Of 3867
patients defined as hypertensive, 222 (5.7%) had an unconfirmed
diagnosis of hypertension.
Statistical Analysis
Data were analyzed using SAS software.16
Continuous variables were presented as mean±SD.
Comparisons between groups were made using 
2
tests for discrete variables and 1-way ANOVA for continuous
variables. Age-adjusted mortality rates per 1000 person-years were
computed using a special SAS macro.17 Kaplan-Meier
survival curves were produced using the LIFETEST
procedure.18 The log-rank test was used for comparing the
curves. Multivariate analysis of mortality was
performed using the stepwise Cox proportional hazard model (PHREG
procedure) to account for differing lengths of follow-up and
correlation with covariates.18 The significance levels for
entering and removing an explanatory variable were set at
P=0.15 and P=0.10, respectively. Adjusted
survival curves were computed using the PHREG
procedure.18
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Results |
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Baseline Data
A total of 987 diabetic patients were treated with diet only; of those, 577 (58%) were normotensive and 410 (42%) were hypertensive. Among 1495 pharmacologically treated diabetics, 1041 patients received sulfonylurea alone, 78 1,1-dimethylbiguanide (Metformin) alone, 266 a combination of Metformin and sulfonylurea, and 110 insulin (alone or in combination with oral medications). Among the pharmacologically treated diabetics, 648 (43%) had a history of hypertension. The prevalence of hypertension among nondiabetics in our study was 31%, reaching 38% among diabetic men and 56% among diabetic women.
The clinical and laboratory characteristics of the patients are presented in Table 1. No significant age differences were documented among the groups. Most of the patients in all groups were men and had sustained a previous myocardial infarction, and most had a history of anginal syndrome. The proportion of patients with a history of CVA was relatively small, with significantly higher frequency in the hypertensive groups.
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Both mean fasting glucose and triglyceride levels were significantly higher in the pharmacologically treated groups. No considerable differences between the diet-treated and pharmacologically treated groups were found for total cholesterol level. As expected, both systolic and diastolic BP were significantly higher in the patients who were hypertensive per their medical histories, representing differences arising from the definition.
The data regarding treatment with cardiovascular drugs among the 4 diabetic groups are presented in Table 2. Nitrates, calcium antagonists, ß-blockers, and antiplatelet drugs were administered frequently; as expected, more hypertensive patients either on diet or on pharmacological treatment received ACE inhibitors, diuretics, and other antihypertensive medications than their normotensive counterparts.
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Mortality
Patients were followed from 4 to 7 years (mean, 5.1±1.3 years).
During this period, crude all-cause mortality (CM) was lower in the
nondiabetics than in diabetics (11.2% versus 22.0%;
P<0.001). Among the patients with NIDDM, 548 died. CM and
IHD and CVA mortalities among the normotensive and hypertensive
diabetics are shown in Table 3.
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The lowest age-adjusted rates for CM and IHD mortality were documented for the normotensives in the diet-treated group (Figure 1), whereas mortality rates for both diet-treated hypertensives and pharmacologically treated normotensives were markedly higher. The highest mortality was found among hypertensives in the pharmacologically treated group.
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Kaplan-Meier survival curves for CM for the 4 study groups of patients are presented in Figure 2A and 2B. The lowest mortality was observed for the normotensive patients in the diet-treated group (P=0.0001); no significant difference between pharmacologically treated normotensive and hypertensive patients was shown (P=0.49).
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To assess whether the association between hypertension and mortality persisted in diverse categories of cardiovascular status, CM was determined in patients with and without a history of myocardial infarction or anginal syndrome and by functional capacity classes according to the New York Heart Association (NYHA) classification (Table 4). The higher mortality excess associated with hypertension was found in the diet-treated patients versus the pharmacologically treated patients, regardless of the presence or absence of a history of myocardial infarction, anginal syndrome, and all functional NYHA classification classes.
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Multivariate analysis (including age; gender; glucose, cholesterol, and triglyceride levels; myocardial infarction; congestive heart failure; hypertension; peripheral vascular disease; cerebrovascular accident; anginal syndrome; smoking; body mass index; and use of ß-blockers, antiplatelet drugs, and ACE inhibitors) identified hypertension as an independent predictor of increased CM and IHD and CVA mortality in diet-treated NIDDM with hazard ratios (HR) of 1.68 (95% CI 1.24 to 2.29), 1.57 (95% CI 1.02 to 2.41), and 3.17 (95% 1.12 to 8.98), respectively. In cardiac patients with pharmacologically treated NIDDM, hypertension was not an independent predictor of increased CM and IHD mortality, with HR, 1.01 (95% CI 0.82 to 1.26) and 1.04 (95% CI 0.78 to 1.40), respectively. The association of hypertension with increased risk of CVA mortality was consistent in advanced diabetes as well: HR, 2.21 (95% CI 0.72 to 6.77). On further adjustment for concomitant use of medications, results were almost equal. Multivariate adjusted survival curves for CM are presented in Figure 2C and 2D.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The salient findings of our study were (1) that the prevalence of hypertension among diet and pharmacologically treated diabetics was high and similar in both groups and (2) that a strong association between hypertension and increased mortality exists in coronary patients with diet treated but not pharmacologically treated diabetes.
Prevalence
Our analysis confirmed the close association between NIDDM
and hypertension among the patients with clinically established IHD.
Whereas the prevalence of hypertension in nondiabetics in our study was
31%, it reached to 38% in diabetic men and to 56% in diabetic women.
The definitions of diabetes1 14 and
hypertension15 corresponded to the WHO criteria accepted
at the time the study was begun, in 1990. The new American Diabetes
Association criteria changed the definition of the upper normal limit
for diagnosis of diabetes to 126 mg/dL (7 mmol/L).7
Note that use of the new Joint National Committee on Detection,
Evaluation, and Treatment of High BP criteria (JNC-V and JNC-VI,
respectively, for most patients systolic BP 140 mm Hg
and/or diastolic BP 90 mm Hg; for diabetics,
130/85 mm Hg) would probably lead to a considerable increase in
the number of diabetics diagnosed as hypertensive.19 20 21
In addition, several studies have shown a widespread condition of
unrecognized and accordingly untreated diabetes
mellitus22 23 24 and hypertension.25 26 In our
study, 
5% of the hyperglycemics on routine fasting blood glucose
analysis were undiagnosed as diabetics, and 10% of patients
with elevated BP had been unrecognized previously as hypertensive. On
the other hand, because 24-hour BP monitoring was not used in our
study, we could not account for the number of patients with
"white-coat hypertension," identified previously in 20% of
patients with mild hypertension.27 These observations
stress the necessity for repeat routine reevaluation for possible
diabetes and/or hypertension in IHD patients defined previously as
nondiabetic and normotensive.
It is likely that several mechanisms acting together are involved in a complex interaction between factors predisposing to the BP elevation and metabolic abnormalities of diabetics.4 28 29 30 In turn, diabetics with hypertension are at greater risk of IHD development than normotensive diabetics.1 8 10
Mortality
The natural history of NIDDM differs markedly between diet-treated
(mild disease with lower fasting glucose level) and pharmacologically
treated (usually more advanced disease) diabetics. Previously reported
data31 demonstrated that the presence of hypertension at
the initial presentation of diabetes was associated with
almost doubling the prevalence of microalbuminuria, left
ventricular hypertrophy, and myocardial
ischemia.
We have observed an independent association between a history of
hypertension and increased mortality (70% excess in CM and 60%
excess in IHD mortality) among IHD patients with diet-treated NIDDM
over 4 to 7 years. In cardiac patients with pharmacologically treated
NIDDM, hypertension was not an independent predictor of increased
all-cause and IHD mortality; however, the association with
stroke-related mortality was observed in both diet- and
pharmacologically treated diabetes. There are 3 possible explanations
for this observation. (1) It could have occurred by chance. This
possibility seems to be unlikely, given the strength of statistical
results. (2) Because the combined impact of advanced diabetes and
clinically established IHD on mortality is superimposed on and probably
prevails over the contribution of a history of hypertension, the
relative excess mortality diminishes among coronary patients
with pharmacologically treated NIDDM. Statistically, the presence of 1
or more extremely strong and dominating determinants of excess
mortality may lead to relative eclipse of other less prominent factors
(in terms of relative risk or HR). (3) Diabetes and hypertension may
have partially overlapping mechanisms of pathogenic action mediated
through common metabolic pathways and detracting from total
damage when both diseases coexist.
Our results support the suggestion that hypertension control has the potential to improve prognosis in diabetics with IHD.7 Current recommendations emphasize stricter BP control for diabetics with advanced disease and nephropathy. However, the relative clinical benefit achieved by BP lowering may be even greater in mild diet-treated diabetes than in more advanced pharmacologically treated diabetes because the former has a higher HR of hypertension-associated excess mortality. The benefit of BP reduction has been demonstrated most clearly when treatment is instituted before glomerular filtration rate is markedly reduced (in other words, in relatively early stages of the disease).30 This emphasizes the concept that efforts toward BP control should begin before serum creatinine is elevated.8 For all these reasons, we strongly support the thesis that hypertension and diabetes in patients with clinically established IHD should be recognized and treated very early and aggressively, regardless of target-organ disease.
Study Limitations
This is a prospective observational study in which data have been
collected for different purposes. Therefore, caution should be used in
interpreting our findings. The rate of use of ACE
inhibitors, which have a profoundly favorable effect on
both diabetics and hypertensives, was lower in 1990 than it is today.
Because we had no direct information regarding left
ventricular function evaluation in the study patients, we
used the available NYHA classification as a relevant surrogate for this
purpose. Despite these limitations, the results of our study may be
important for understanding the independent contribution of
hypertension to excess mortality in NIDDM patients with clinically
established IHD.
Conclusions
The prevalence of hypertension among diet- and pharmacologically
treated diabetics was high and similar. The increased risk of mortality
associated with hypertension in relatively mild diet-treated NIDDM
strongly supports the suggestion that clinical benefit from BP control
among IHD diabetics may be greater when performed early.
Received August 19, 1998; first decision October 8, 1998; accepted December 18, 1998.
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