Hypertension is a major threat to human health disease, is an independent risk factor for cardiovascular disease, known as " negative killer ". In our country the hypertension prevalence rate increased year by year, 18 years of age or older adults, hypertension prevalence rate of 18.8%, there are approximately 200000000 patients with hypertension, and hypertension in diabetic patients a higher incidence, according to statistics, in patients with diabetes mellitus and hypertension in about 40-50%, 3-4 times higher than the general population, especially in recent years the metabolic syndrome with a high morbidity, the hypertension and diabetes and other risk factors cluster are more common phenomenon. Current guidelines recommend, essential hypertension complicated with diabetes mellitus, blood pressure value is less than 130/80mmHg, however recent clinical trials and meta-analyses have raised doubt to this, the European Society of hypertension ( ESH ) is best recommended systolic blood pressure below 140mmHg, but did not make the hypotension target. Why is it so? We first examine the following recent clinical trials and meta-analyses.
A clinical trial of ACCORD-BP
ACCORD-BP the results of clinical trials in 2010 April published, test in the 4733 cases of high risk diabetic patients, including 34% patients with cardiovascular disease, were randomly divided into two groups, one group of intensified antihypertensive treatment, SBP20mmHg, another group as the standard treatment group, SBP<140mmHg, after 1 years in two groups the average systolic blood pressure is 119 and 134mmHg, followed for an average of 4.7 years. The primary endpoint is nonfatal myocardial infarction, nonfatal stroke or cardiovascular death. Experimental analysis shows, two groups of the primary endpoint or total mortality risk and there is no difference, however, the preset level two endpoints of stroke risk in intensified antihypertensive treatment group was significantly reduced, at the same time, serious adverse reaction mainly occurs in the strengthening group ( 3.3% vs 1.3% ). INVEST study in 22500 cases of hypertension with coronary heart disease patients, compared with trandolapril plus verapamil group and A Tilolga hydrochlorothiazide group effects on cardiovascular disease, the primary endpoint is all-cause mortality, nonfatal myocardial infarction or stroke, a mean follow-up of 2.7 years, among the subgroup analyses showed that, in hypertensive patients with diabetes, coronary heart disease the crowd, SBP higher than those in group 140mmHg and less than 130mmHg group and SBP in 130-139mmHg group compared with the primary end point was significantly increased, indicating that patients with coronary heart disease not suitable for intensive blood pressure control.
The NDR-BP registry study
Sweden NDR registry study began in 1996, recently published observational studies ( NDR-BP ) for 12677 patients with type 2 diabetes mellitus patients, from the NDR registry study, exclusion of patients with heart failure, followed up for 5 years, from 2002 to 2007. Observation on hypotensive after treatment with different SBP levels on lethal / non lethal coronary heart disease, stroke and cardiovascular disease risk.
In the SBP 110-180mmHg range, coronary heart disease and the risk of stroke with the baseline blood pressure or mean SBP increased in all groups, not found in lower blood pressure levels in the presence of J type curve. With SBP110-129mmHg as the control, SBP>140mmHg ( average 152mmHg), the HR1.37 correction of coronary heart disease, stroke 1.86, cardiovascular disease in 1.44, and SBP 130-139 marked increase in cardiovascular events, but no statistical significance. In another analysis, when the baseline SBP110-129mmHg, further lowering of blood pressure increase in coronary heart disease and the risk of cardiovascular disease, but the pathogenesis of stroke risk is not increased, however, the baseline blood pressure above 130mmHg, further lowering of blood pressure can obviously reduce coronary heart disease, stroke and cardiovascular risk. Similar results were also found in the ONTARGET study ( 38% with diabetes ), baseline blood pressure SBP<130mmHg, along with SBP reduction, cardiovascular mortality increased significantly. In fact, clinical trial results of NDR-BP and ACCORD-BP and INVEST clinical results, SBP less than 140mmHg marked cardiovascular disease risk benefit.
ADVANCE clinical study
The study included 11140 patients with type 2 diabetes mellitus ( 38% from Asia, which accounts for 30% of observation of Chinese ), ACET ( perindopril ) and indapamide antihypertensive therapy on the microvascular and macrovascular complications, follow-up of 4.3 years, the drug treatment group SBP to 135mmHg, while the placebo group SBP remains in the 140mmHg so, the primary endpoint is macrovascular and microvascular complications with end point, such as cardiovascular death, nonfatal myocardial infarction or stroke, new or worsening nephropathy or diabetic ophthalmopathy. Results the primary endpoint of relative risk reduction of 9%, microvascular and macrovascular complications of reduction is similar, but did not reach statistical significance, only to cardiovascular disease and total mortality reduction reached statistical significance.
Studies have shown that, combined antihypertensive therapy and intensive diabetes treatment so that the total mortality was reduced by 18%, in the subsequent Post-hoc analysis, combined with SBP in the treatment group decreased to less than 140mmHg, SBP is 7mmHg, HbA1c is 0.6%. Several clinical endpoints in the combined treatment group were significantly reduced, such as new onset or worsening of the disease was reduced 33%, the new large amounts of albumin urine decreased 54%, new-onset microalbuminuria decreased by 26%.
Meta analysis
Bangalore on some clinical studies conducted meta-analyses, all of the selected patient must be of type 2 diabetes or impaired fasting glucose, impaired glucose tolerance patients, at least 100 people, in the intensified antihypertensive treatment group SBP ≤135mmHg, SBP≤ 140mmHg standard antihypertensive treatment, follow-up events for at least 1 years, the evaluation is macrovascular or microvascular complications. The final selection of patients for a total of 37736 patients, results in the intensive therapy unit all cause mortality decreased by 10%, reducing 17% stroke, serious adverse events is increased by 20%, while the other macrovascular and microvascular complications ( cardiac, renal, retinal lesions ) did not respond to reduce. Further analysis found, SBP≤ 130mmHg, only the incidence of stroke was significantly reduced, other macrovascular and microvascular complications did not change, but the occurrence of serious adverse reactions increased by 40%. SBP<120mmHg, stroke risk reduction is still very obvious. Therefore, the author thinks, type 2 diabetes or impaired fasting glucose, impaired glucose tolerance patients SBP down to 130-135mmHg target is acceptable, but the SBP is further reduced to below 130mmHg, observed in the target organs improve inconsistent, because of the risk of stroke continued to diminish, while other macrovascular and microvascular complications did not change at the same time, the incidence of serious adverse events were significantly increased.
Reboldi also conducted meta-analyses, assessment of diabetic patients blood pressure reduction on myocardial infarction and stroke effect. In 31 clinical trials, approximately 73913 of patients of test group decreased by 9%, stroke, myocardial infarction, a decrease of 11%, further analysis found, intensified antihypertensive group of stroke was reduced by 31%, and the risk of myocardial infarction was not significantly reduced. Meta regression analysis found again, SBP 5mmHg, DBP per each reduction to reduce 2mmHg can make the stroke by 13%, and the risk of myocardial infarction and blood pressure reduction was not associated with reduced. Therefore the author thinks, diabetic patients with antihypertensive increase reduces the risk of stroke, myocardial infarction but to no effect.
Through the clinical trials and meta-analyses found that diabetes patient blood pressure, it falls to any target level is very difficult, so in each patient must concrete analysis, specific treatment, if diabetic stroke risk higher blood pressure drop can be a little low, but must be on guard against coronary heart disease and total mortality may increase. Notably, we Chinese stroke incidence is higher, and hypertension is a major virulence factors, therefore antihypertensive treatment can be enhanced, especially if the patient has no family history of early-onset stroke, coronary heart disease, SBP can be reduced to below 130mmHg.
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