Pharmd Case:
A 65-year-old man presents to your hypertension clinic with a past medical history of type 2 diabetes and hypertension. Vital signs in clinic today are blood pressure 134/80 mm Hg, heart rate 78 bpm. Current medications include Metformin 1000 mg twice daily, Levemir 40 units daily, Novolog 10 units before each meal, lisinopril 40 mg daily, and simvastatin 40 mg daily. At the last visit, his lisinopril was increased due to BP of 140/85 mm Hg and his A1C was 7.2%.
Answer
Since the release of JNC 7 guidelines in 2004, the blood pressure goal for patients with type 2 diabetes has been set as less than 130/80 mm Hg based on cohort analyses from the HOT trial and UKPDS groups, which has been additionally recommended by the American Diabetes Association up until 2011.
The importance of BP control has long been known, particularly in patients with type 2 diabetes who are already at high risk of cardiovascular disease; however, no large randomized trial has shown reduction in cardiovascular mortality with lowering BP to less than 140/80 mm Hg. Several large trials published since JNC 7 have called into question our current guideline-recommended goals.
The ACCORD BP trial included 4733 high-risk patients with type 2 diabetes and randomized them to tight systolic BP control (<120 mm Hg, achieved 119/64 mm Hg) or standard control (<140 mm Hg, achieved 133/70 mm Hg). There was no difference found between the 2 groups in the composite outcome of nonfatal myocardial infarction, stroke, and cardiovascular disease death (hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.73-1.06; P = .2).
Potential confounding of patients also randomized to intensive glycemic control was demonstrated in a predefined subgroup analysis which showed intensive BP control may be of benefit in those not randomized to intensive glycemic control (A1C <6%). A post hoc analysis of the INVEST trial refuted the hypothesis that patients who achieved systolic BP less than 130 mm Hg would have reduced risk of cardiovascular events compared with those achieving systolic BP 130 to 140 mm Hg (adjusted HR 1.11; 95% CI 0.93-1.32; P = .24). The ADVANCE trial included 11,140 patients with type 2 diabetes and 1 additional cardiovascular risk factor. Patients were randomized to treatment with ACE/thiazide diuretic combination or placebo instead of specific BP goals. Those in the active treatment arm achieved BP of 5.6/2.2 mm Hg less than the placebo arm and no significant reduction was seen in the composite outcome of macrovascular and microvascular events; however, reduction was seen in death and cardiovascular death.
The American Diabetes Association 2011 Standards of Care reiterated the systolic goal of less than 130 mm Hg for most patients, but noted that most benefit is seen when systolic BP is less than 140 mm Hg. The ACCORD BP trial is the only study to formally determine the difference in outcomes between tighter and less stringent BP goals. The question has not been raised about the diastolic goal of less than 80 mm Hg. In our case above, it would be reasonable to continue current treatment for this patient and not introduce further medications until BP becomes uncontrolled at greater than 140/80 mm Hg. Further clarification of these goals and incorporation of recent literature is expected in JNC 8 guidelines, due out in 2012.
A 65-year-old man presents to your hypertension clinic with a past medical history of type 2 diabetes and hypertension. Vital signs in clinic today are blood pressure 134/80 mm Hg, heart rate 78 bpm. Current medications include Metformin 1000 mg twice daily, Levemir 40 units daily, Novolog 10 units before each meal, lisinopril 40 mg daily, and simvastatin 40 mg daily. At the last visit, his lisinopril was increased due to BP of 140/85 mm Hg and his A1C was 7.2%.
Answer
Since the release of JNC 7 guidelines in 2004, the blood pressure goal for patients with type 2 diabetes has been set as less than 130/80 mm Hg based on cohort analyses from the HOT trial and UKPDS groups, which has been additionally recommended by the American Diabetes Association up until 2011.
The importance of BP control has long been known, particularly in patients with type 2 diabetes who are already at high risk of cardiovascular disease; however, no large randomized trial has shown reduction in cardiovascular mortality with lowering BP to less than 140/80 mm Hg. Several large trials published since JNC 7 have called into question our current guideline-recommended goals.
The ACCORD BP trial included 4733 high-risk patients with type 2 diabetes and randomized them to tight systolic BP control (<120 mm Hg, achieved 119/64 mm Hg) or standard control (<140 mm Hg, achieved 133/70 mm Hg). There was no difference found between the 2 groups in the composite outcome of nonfatal myocardial infarction, stroke, and cardiovascular disease death (hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.73-1.06; P = .2).
Potential confounding of patients also randomized to intensive glycemic control was demonstrated in a predefined subgroup analysis which showed intensive BP control may be of benefit in those not randomized to intensive glycemic control (A1C <6%). A post hoc analysis of the INVEST trial refuted the hypothesis that patients who achieved systolic BP less than 130 mm Hg would have reduced risk of cardiovascular events compared with those achieving systolic BP 130 to 140 mm Hg (adjusted HR 1.11; 95% CI 0.93-1.32; P = .24). The ADVANCE trial included 11,140 patients with type 2 diabetes and 1 additional cardiovascular risk factor. Patients were randomized to treatment with ACE/thiazide diuretic combination or placebo instead of specific BP goals. Those in the active treatment arm achieved BP of 5.6/2.2 mm Hg less than the placebo arm and no significant reduction was seen in the composite outcome of macrovascular and microvascular events; however, reduction was seen in death and cardiovascular death.
The American Diabetes Association 2011 Standards of Care reiterated the systolic goal of less than 130 mm Hg for most patients, but noted that most benefit is seen when systolic BP is less than 140 mm Hg. The ACCORD BP trial is the only study to formally determine the difference in outcomes between tighter and less stringent BP goals. The question has not been raised about the diastolic goal of less than 80 mm Hg. In our case above, it would be reasonable to continue current treatment for this patient and not introduce further medications until BP becomes uncontrolled at greater than 140/80 mm Hg. Further clarification of these goals and incorporation of recent literature is expected in JNC 8 guidelines, due out in 2012.
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