American Society of Hypertension (ASH): Annual Scientific Meeting

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

NEW YORK – Patients treated with carvedilol not only had a reduced frequency of intradialytic hypertension but showed improvements in endothelial cell function, in a small study.

After 8 weeks of treatment with carvedilol, mean systolic postdialysis blood pressure dropped from 159 mm Hg at baseline to 142 mm Hg, reported Dr. Julia Inrig, assistant professor of nephrology at the University of Texas Southwestern Medical Center in Dallas.

"Our laboratory has been very interested in this phenomenon of intradialytic hypertension," she said at the annual meeting of the American Society of Hypertension. When most patents come for dialysis, there is a gradual reduction in their systolic blood pressure. "However, up to 20% of patients have this gradual increase in their systolic blood pressure during their dialysis. So they leave their dialysis session much more hypertensive than when they showed up, despite similar amounts of fluid removed."

In addition, "we’ve identified that this is an important prognostic indicator." In a cohort of 450 dialysis patients, those with increased blood pressure during dialysis had an almost twofold increased odds for hospitalization or death at 6 months (Kidney Int. 2007;71:454-61).

The researchers in the Mechanisms and Treatment of Intradialytic Hypertension (MATCH) pilot study prospectively enrolled 25 hemodialysis patients with intradialytic hypertension into an open-label intervention study. Once patients were accepted into the study, they underwent baseline testing, including 44-hour ambulatory blood pressure, lipids, albumin, sodium, and C-reactive protein, as well as postdialysis endothelin-1, asymmetric dimethylarginine, endothelial progenitor cells, pulse-wave velocity, and brachial artery flow. In 8 weeks, the baseline lab work was repeated.

Patients were started on carvedilol 6.25 mg twice daily, and the dose was eventually titrated to 50 mg twice daily. "Our goal was to reach a delta [systolic] blood pressure less than zero with regard to their postdialysis blood pressure no longer increasing," said Dr. Inrig. However, she and her colleagues were also targeting a postdialysis systolic BP of less than 130 mm Hg as an alternate goal.

The average patient age was 54 years, and the group was 80% male. Roughly two-thirds of the population was Hispanic (64%), and more than a third was black (36%). Almost all (88%) had diabetes, and 32% had cardiovascular disease. Many of the patients were on ACE inhibitors or angiotensin II receptor blockers (64%), beta-blockers (68%), or calcium channel blockers (60%) at baseline.

Mean predialysis blood pressure was roughly the same regardless of carvedilol treatment (144 mm Hg vs. 146 mm Hg). The frequency of intradialytic hypertension declined from 77% of hemodialysis sessions at baseline to 28% by the study’s end, a significant difference.

Treatment with carvedilol showed a trend toward improvement of brachial artery flow–mediated dilation. However there was no change in C-reactive protein or pulse-wave velocity.

"With regard to safety, patients tolerated carvedilol fairly well," said Dr. Inrig. There was a low incidence of side effects.

Dr. Inrig reported that she has received an investigator-initiated research grant from Genzyme. She has also participated in industry-sponsored research for Keryx Biopharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The newly approved angiotensin II receptor blocker azilsartan combined in a fixed-dose with chlorthalidone lowered clinic systolic blood pressure significantly more than did the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide in patients with type 2 hypertension.

At 12 weeks, both low-dose and high-dose azilsartan reduced in-clinic systolic blood pressure by an average of 42.5 mm Hg and 44.0 mm Hg, respectively. In comparison, the average reduction for patients on olmesartan was 37.1 mm Hg. The results were presented at the annual meeting of the American Society of Hypertension by Dr. William C. Cushman, chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

Azilsartan was approved by the Food and Drug Administration in February for the treatment of hypertension, alone or in combination with other antihypertensive treatment. The drug is being marketed as Edarbi by Takeda Pharmaceuticals North America.

In this phase III, double-blind trial, 1,071 patients with type 2 systolic hypertension were randomized to receive azilsartan 20 mg and the diuretic chlorthalidone 12.5 mg, azilsartan 40 mg and chlorthalidone 12.5 mg, or olmesartan (Benicar) 20 mg and hydrochlorothiazide 12.5 mg, following a 3-4 week washout with a 2-week placebo run-in.

At week 4, all patients underwent a forced titration, doubling the amount of azilsartan or olmesartan. At week 8, another forced titration doubled the amount of chlorthalidone or hydrochlorothiazide. At week 12, a final ambulatory blood pressure measurement was taken.

A total of 355 patients were in the low-dose azilsartan group, 352 were in the high-dose azilsartan group, and 364 were in the olmesartan group. Patients were at least 18 years old and had a systolic blood pressure between 160 and 190 mm Hg at a postwashout visit. Patients were excluded if they had secondary hypertension, had a sitting trough clinical diastolic blood pressure measurement more than 119 mm Hg, an estimated glomerular filtration rate less than 30 mL/min per 1.73 m², a major cardiovascular event in the last 6 months, poorly controlled diabetes (hemoglobin A_1c less than 8%), or hyper/hypokalemia.

The change in 24-hour mean systolic blood pressure was a reduction of 33.9 mm Hg and 36.3 mm Hg for the low and high doses of azilsartan, respectively, compared with a reduction of 27.5 mm Hg for the olmesartan group. The differences were significant. Likewise, the reduction in clinical diastolic blood pressure was also greater for those on azilsartan (18.8 mm Hg and 20.5 mm Hg) compared with those on olmesartan (16.4 mm Hg). These differences were also significant.

The percentage of patients reporting any adverse events was greater for those on azilsartan (71%) than for those on olmesartan (60%). However, the number of discontinuations due to adverse events was moderately greater in the high-dose azilsartan group.

The study was sponsored by the Takeda Global Research and Development Center. Three of the study authors are employees of Takeda. Dr. Cushman has reported significant financial relationships with several pharmaceutical companies, including Takeda Pharmaceuticals.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – The rise of the medical home along with the publication of large clinical trials will likely influence updated Joint National Committee guidelines for the management of hypertension, according to several experts at the annual meeting of the American Society of Hypertension.

Updated guidelines may and should address home and ambulatory monitoring of blood pressure, greater reliance on global risk assessment, a revision of target blood pressures in high-risk groups, greater use of individualization in setting pressure targets, greater clarity on when to start drug therapy, earlier use of fixed-dose combination antihypertensive therapy, revocation of beta-blockers as frontline therapy, and specific recommendations on how to overcome therapeutic inertia, they said.

The panel of experts explored how hypertension management has evolved since the Seventh Report of the Joint National Committee (JNC 7) was published in 2003. According to the National Heart, Lung, and Blood Institute, JNC 8 is expected to be released next year. None of the panelists are members of the JNC guideline panel.

The so-called medical home – where a patient stays within a care system with a primary care physician coordinating care – is causing a "paradigm shift," according to Dr. Jan Basile, professor of medicine at the Medical University of South Carolina in Charleston. "We’ve always been paid for face-to-face interactions, and we really need to be paid for energy and effort," he said. "For example, why aren’t we incentivized to use novel means of tracking blood pressure at home through telemonitoring and other techniques?"

The reorganization of primary care and the publication of JNC 8 may create significant opportunities to get nonphysician members of the medical home team, such as nurses, pharmacists, and dieticians, more involved in controlling blood pressure, the panelists said. Dr. Angela Brown, assistant professor of medicine at Washington University, St. Louis, noted that hypertensive patients in her clinic already receive 6 months of dietician counseling. Dr. Leonard Fromer, a family physician and University of California, Los Angeles, faculty member, noted his network recently launched five care team pilot programs in large integrated networks.

Ambulatory monitoring may also play a more prominent role in the revised guidelines, according to Dr. George Bakris, president of the American Society of Hypertension and professor of medicine at the University of Chicago. "Ambulatory blood pressure is most likely going to be recommended for everyone who has documented nuanced hypertension, and the reasons for that include blood pressure variability, the dramatic increase in the appreciation of masked hypertension, and the dipping and nondipping phenomenon, all of which contribute to higher mortality," he said. Dr. Bakris was a member of the JNC 7 executive committee.

Personalized follow-up is also important to make sure patients get their medications and take them as directed, Dr. Basile said. "I or someone from my office staff often calls patients within 48 hours and asks them, ‘Have you filled your prescription? Are you taking the medications? Are you having any problems taking them?’ Someone in the medical home needs to do that."

Dr. Brown suggested that routine screening for albuminuria should become part of the global assessment for the hypertensive patient in the primary care setting. "It is very important from a risk assessment standpoint because it may guide our therapy," Dr. Brown said.

Dr. Basile wasn’t convinced. "I’m not sure we can afford to spend money on knowing how sick the patient is unless we can show that intervening in those we wouldn’t normally treat would make a difference," he said. Dr. Basile noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that when systolic blood pressures reached 120 mm Hg, microalbuminuria "melted away."

With regard to blood pressure targets, Dr. Bakris said he expects JNC 8 to continue the target of 140/90 mm Hg or less for most patients, and actually to also recommend that as a target for patients with diabetes and chronic kidney disease (currently recommended at 130/80 mm Hg or less in JNC 7). "It’s going to be less than 140/90 mm Hg for most people except for those with advanced kidney disease who have proteinuria," he said. In patients aged 80 years and older, the target pressure may be less than 150/80 mm Hg, according to Dr. Basile.

Meanwhile, Dr. Basile noted that the latest American Diabetes Association guidelines set the target for diabetics at 130/80 mm Hg, and that treatment should be tailored to the individual. "Individualization is going to be a very important word because perhaps, as in ACCORD, if your patient has had a stroke or is stroke prone, you might want to drive the blood pressure lower," Dr. Basile said. "But if the patient is not [stroke prone], you may not want to be as aggressive."

JNC 7 recommends initial combination therapy when systolic blood pressure is more than 20 mm Hg above goal. Since then, two important clinical trials have strengthened the evidence favoring combination over monotherapy: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and the Systolic Blood Pressure Intervention Trial (SPRINT).

The moderator of the discussion, Dr. Michael Bloch of the University of Nevada, Reno, noted that JNC 7 includes beta-blockers as an initial therapy, but that the revised National Institute for Health and Clinical Excellence (NICE) guidelines in the United Kingdom, as well as other guidelines that have come out since JNC 7, do not. "I can only presume that JNC 8 will follow other guidelines," Dr. Brown said.

Dr. Bakris noted that, although some of the newer beta-blockers may be better tolerated and have other potential advantages over some older drugs in that class, recommending those drugs as firstline therapy will be more difficult in the absence of new end-point trials as the JNC 8 panel strives to make the guidelines more evidenced based. "So if you want to be hardcore evidence based, you can’t really argue that those particular drugs are rated better," he said.

The panelists disclosed they have relationships with a variety of pharmaceutical companies.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Intensive therapy to control systolic blood pressure did not appear to be associated with more falls and fractures in a study of patients under age 80 years with hypertension and type 2 diabetes, based on a report presented at the annual meeting of the American Society of Hypertension.

The finding was noted in a subgroup analysis of ACCORD-BONE, an ancillary study of skeletal health in ACCORD study participants. The subgroup analysis looked at ACCORD-BONE participants in the ACCORD Blood Pressure Clinical Trial arm of ACCORD.

For the subgroup analysis, the researchers examined data from 3,282 people who were randomly assigned to standard systolic blood pressure goals of 130-139 mm Hg or to intensive systolic goals of less than 120 mm Hg.

"Intensive control of systolic blood pressure did not result in an increased risk of falls," reported Dr. Karen Margolis of the Health Partners Research Foundation in Minneapolis. "And fewer intensive than standard group patients developed nonspinal fractures."

Average blood pressure at entry was 138/75 mm Hg. Those in the intensive therapy group received a thiazide-type diuretic in combination with another class of antihypertensive drug to a goal of 120 mm Hg. The standard intervention group used the same drugs and combinations, but the systolic goal was 130-135 mm Hg and treatment was only intensified if systolic blood pressure rose above 160 mm Hg, according to Dr. Margolis.

Systolic blood pressure averaged 133 mm Hg in the standard treatment group and 119 mm Hg in the intensive treatment group. Subjects’ average age was 62 years, and patients over age 80 years were excluded; 44% were women; 66% were white, 26% were black, and 2% Latino. Patients’ average body mass index was 32.5 kg/m².

With an average follow-up of almost 5 years, ACCORD-BONE study results bucked conventional wisdom about risk of falls, according to Dr. Margolis. "About 20% in the intensive group and 21% in the standard group fell," she said. The intensive group had a 0.81 relative risk of falling, compared with the standard group. The study found no differences across age, sex, ethnicity, or status of baseline diabetes.

The overall rate of self-reported falls was 70/100 person-years, Dr. Margolis said. "This also was lower in the intensive group at 62/100 person-years vs. the standard group at 74/100.

"With regard to nonspinal fractures, the study identified 273 individuals with at least one fracture, including 63 ankle, 34 humerus, 29 foot, 25 wrist, and 19 hip," said Dr. Margolis. "Overall, fracture risk was significantly lower in the intensive vs. the standard blood pressure group with a hazard ratio of 0.78," she said.

Dr. Margolis acknowledged the ACCORD-BONE study had some limits. "One of the most striking findings from the blood pressure treatment data was that there was a very, very large difference in thiazide use – thiazides being known to improve bone density – so that’s a very suggestive mechanism," she said.

Dr. Joseph L. Izzo of the University of Buffalo, N.Y., remarked about obesity in the study group, noting the high average BMI. "I’m not sure that overweight people aren’t protected in some way against blood pressure–related falls," Dr. Izzo said.

Physical activity might also explain why those on intensive therapy were less prone to falls and fractures, noted Dr. Bryan Williams of the University of Leicester, England. "To some extent falls are not always due to just people getting possible hypotension; they’re related to amount of activity," he said.

Dr. Margolis said that a substudy would further investigate physical activity in this population.

The National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases funded the ACCORD-BONE study. Dr. Margolis had no other disclosures to report.

NEW YORK – Boosting patient awareness and use of a new equation for measuring glomerular filtration rate are showing early signs of being the cornerstones to the prevention of chronic kidney disease among people at risk for the disease, according to preliminary results from the National Kidney Foundation’s nationwide screening initiative.

The Kidney Early Evaluation Program (KEEP) has enrolled 150,000 people so far, making it the nation’s largest perpetual chronic kidney disease screening program, according to Dr. Joseph Vassalotti, chief medical officer of the National Kidney Foundation and a faculty member at Mount Sinai School of Medicine, New York.

The point is to identify "individuals in the community with kidney disease along with the risk factors that go with it," said Dr. George Bakris of the University of Chicago Medical Center and a former KEEP principal investigator. All of the participants have some stage of kidney disease or hypertension and are referred to the registry by physicians. Enrollment is voluntary and participants complete a questionnaire and undergo a medical evaluation that includes standard panels plus testing for calcium, phosphorus, and parathyroid hormone. The program does not accept people who have had a kidney transplant or are on dialysis, he said.

Under the program, a new method for estimating glomerular filtration rate (eGFR), known as the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, has been used. This equation is more accurate in determining kidney function than is the Modification of Diet in Renal Disease (MDRD) Study equation, said Dr. Lesley Stevens of Tufts Medical Center, Boston. "The use of the CKD-EPI equation more accurately reflects measured GFR and results in a lower prevalence of eGFR below 60 mL/min per 1.73 m²," said Dr. Stevens, a KEEP committee member. As a result, there are fewer false positives and "ultimately, fewer tests and lower costs," she said.

According to Dr. Stevens, the equation has been validated in two clinical studies (Am. J. Kidney Dis. 2010;55:648-59 and Am. J. Kidney Dis. 2010;55:660-70).

One of the goals of KEEP is to determine factors that help slow the slide into chronic kidney disease, as well as the loss of kidney function over time, Dr. Vassalotti said. "Multiple trials on systolic blood pressure show that untreated hypertension results in a loss of 10-12 mL/min per 1.73 m² eGFR a year," he said. "In individuals with blood pressure in the target range, the annual loss is approximately 2-3 mL/min per 1.73 m². By educating participants and fostering their engagement with local clinicians, KEEP can impact care."

Managing blood pressure early in kidney disease is critical because as eGFR declines, hypertension becomes more difficult to control, Dr. Vassalotti said. Thus, self-reported hypertension is one of the qualifiers for KEEP enrollment, he said. He cited early data from KEEP that showed prevalence, awareness and treatment of hypertension increased with stage of chronic kidney disease, but that didn’t necessarily translate to control with severe disease. Among those with stage 3 disease, only 82% were undergoing treatment, compared with 92% of those with stage 4 disease. However, 38% of the stage 3 group had systolic blood pressure below 140 mm Hg, while only 35% of the stage 4 group did (Am. J. Med. 2008; 121:332-40).

KEEP data have shown an uptick in overall blood pressure control, from 45% at the initial screening to 49% at rescreening, Dr. Vassalotti said, and even some improvement in control without medication. "But I wouldn’t overstate this."

The project involves merging data with the National Death Index and the United States Renal Data System to track survival and chronic kidney failure outcomes, respectively. Future goals include additional data links with Medicare Parts B and D to gain clarity on morbidity and medication use, Dr. Vassalotti said. "Preliminary longitudinal data show that community screening appears to influence hypertension despite progression of chronic kidney disease," he said.

Patient awareness is the cornerstone of hypertension management, noted Dr. Adam Whaley-Connell of the University of Missouri. "Awareness has a very important role in not only understanding blood pressure control, especially in the context of the early stages of kidney disease, but in improving kidney related patient outcomes," he said. However, he noted that awareness of kidney disease, particularly in its early stages, "is alarmingly low."

He noted that KEEP data on awareness reflect that of National Health and Nutrition Examination Survey and other CKD cohort studies: Only about 5% of those with stages 1-3 are aware of their disease. "Roughly 95% of individuals entering into the screening program are unaware they have chronic kidney disease," Dr. Whaley-Connell said.

KEEP enrollees with cardiovascular disease had a keener awareness of the risks of kidney disease, he said. "While awareness may be triggered by cardiovascular disease, those unaware in the earlier stages of kidney disease are particularly vulnerable to poor risk factor control and increased risk for mortality and progression to end-stage renal disease," Dr. Whaley-Connell said. "We advocate for targeted education and awareness at earlier stages of kidney disease to improve risk factor control."

"I think any general practitioner seeing patients needs to pay attention to eGFR," Dr. Bakris said. "If the patient has stage 2 disease and an eGFR of 60-80 mL/min per 1.73 m² now, especially with the CKD-EPI equation, the next question out of his mouth should be, ‘Do you have a family history of kidney disease?’"

However, he cited National Kidney Foundation data that showed only 31% of physicians considered family history an important factor. "If your patient has a family history of kidney disease and an eGFR of 50 mL/min per 1.73 m² ... you really do need to pay attention to that and do something about it."

KEEP is funded by Amgen, Abbott, Siemens, Astellas, Genzyme, Fresenius Medical Care, Pfizer, Nephroceuticals and the LifeScan unit of Johnson & Johnson. Panel participants disclosed affiliations with a variety of device and pharmaceutical companies.

NEW YORK – Boosting patient awareness and use of a new equation for measuring glomerular filtration rate are showing early signs of being the cornerstones to the prevention of chronic kidney disease among people at risk for the disease, according to preliminary results from the National Kidney Foundation’s nationwide screening initiative.

The Kidney Early Evaluation Program (KEEP) has enrolled 150,000 people so far, making it the nation’s largest perpetual chronic kidney disease screening program, according to Dr. Joseph Vassalotti, chief medical officer of the National Kidney Foundation and a faculty member at Mount Sinai School of Medicine, New York.

The point is to identify "individuals in the community with kidney disease along with the risk factors that go with it," said Dr. George Bakris of the University of Chicago Medical Center and a former KEEP principal investigator. All of the participants have some stage of kidney disease or hypertension and are referred to the registry by physicians. Enrollment is voluntary and participants complete a questionnaire and undergo a medical evaluation that includes standard panels plus testing for calcium, phosphorus, and parathyroid hormone. The program does not accept people who have had a kidney transplant or are on dialysis, he said.

Under the program, a new method for estimating glomerular filtration rate (eGFR), known as the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, has been used. This equation is more accurate in determining kidney function than is the Modification of Diet in Renal Disease (MDRD) Study equation, said Dr. Lesley Stevens of Tufts Medical Center, Boston. "The use of the CKD-EPI equation more accurately reflects measured GFR and results in a lower prevalence of eGFR below 60 mL/min per 1.73 m²," said Dr. Stevens, a KEEP committee member. As a result, there are fewer false positives and "ultimately, fewer tests and lower costs," she said.

According to Dr. Stevens, the equation has been validated in two clinical studies (Am. J. Kidney Dis. 2010;55:648-59 and Am. J. Kidney Dis. 2010;55:660-70).

One of the goals of KEEP is to determine factors that help slow the slide into chronic kidney disease, as well as the loss of kidney function over time, Dr. Vassalotti said. "Multiple trials on systolic blood pressure show that untreated hypertension results in a loss of 10-12 mL/min per 1.73 m² eGFR a year," he said. "In individuals with blood pressure in the target range, the annual loss is approximately 2-3 mL/min per 1.73 m². By educating participants and fostering their engagement with local clinicians, KEEP can impact care."

Managing blood pressure early in kidney disease is critical because as eGFR declines, hypertension becomes more difficult to control, Dr. Vassalotti said. Thus, self-reported hypertension is one of the qualifiers for KEEP enrollment, he said. He cited early data from KEEP that showed prevalence, awareness and treatment of hypertension increased with stage of chronic kidney disease, but that didn’t necessarily translate to control with severe disease. Among those with stage 3 disease, only 82% were undergoing treatment, compared with 92% of those with stage 4 disease. However, 38% of the stage 3 group had systolic blood pressure below 140 mm Hg, while only 35% of the stage 4 group did (Am. J. Med. 2008; 121:332-40).

KEEP data have shown an uptick in overall blood pressure control, from 45% at the initial screening to 49% at rescreening, Dr. Vassalotti said, and even some improvement in control without medication. "But I wouldn’t overstate this."

The project involves merging data with the National Death Index and the United States Renal Data System to track survival and chronic kidney failure outcomes, respectively. Future goals include additional data links with Medicare Parts B and D to gain clarity on morbidity and medication use, Dr. Vassalotti said. "Preliminary longitudinal data show that community screening appears to influence hypertension despite progression of chronic kidney disease," he said.

Patient awareness is the cornerstone of hypertension management, noted Dr. Adam Whaley-Connell of the University of Missouri. "Awareness has a very important role in not only understanding blood pressure control, especially in the context of the early stages of kidney disease, but in improving kidney related patient outcomes," he said. However, he noted that awareness of kidney disease, particularly in its early stages, "is alarmingly low."

He noted that KEEP data on awareness reflect that of National Health and Nutrition Examination Survey and other CKD cohort studies: Only about 5% of those with stages 1-3 are aware of their disease. "Roughly 95% of individuals entering into the screening program are unaware they have chronic kidney disease," Dr. Whaley-Connell said.

KEEP enrollees with cardiovascular disease had a keener awareness of the risks of kidney disease, he said. "While awareness may be triggered by cardiovascular disease, those unaware in the earlier stages of kidney disease are particularly vulnerable to poor risk factor control and increased risk for mortality and progression to end-stage renal disease," Dr. Whaley-Connell said. "We advocate for targeted education and awareness at earlier stages of kidney disease to improve risk factor control."

"I think any general practitioner seeing patients needs to pay attention to eGFR," Dr. Bakris said. "If the patient has stage 2 disease and an eGFR of 60-80 mL/min per 1.73 m² now, especially with the CKD-EPI equation, the next question out of his mouth should be, ‘Do you have a family history of kidney disease?’"

However, he cited National Kidney Foundation data that showed only 31% of physicians considered family history an important factor. "If your patient has a family history of kidney disease and an eGFR of 50 mL/min per 1.73 m² ... you really do need to pay attention to that and do something about it."

KEEP is funded by Amgen, Abbott, Siemens, Astellas, Genzyme, Fresenius Medical Care, Pfizer, Nephroceuticals and the LifeScan unit of Johnson & Johnson. Panel participants disclosed affiliations with a variety of device and pharmaceutical companies.

NEW YORK – Boosting patient awareness and use of a new equation for measuring glomerular filtration rate are showing early signs of being the cornerstones to the prevention of chronic kidney disease among people at risk for the disease, according to preliminary results from the National Kidney Foundation’s nationwide screening initiative.

The Kidney Early Evaluation Program (KEEP) has enrolled 150,000 people so far, making it the nation’s largest perpetual chronic kidney disease screening program, according to Dr. Joseph Vassalotti, chief medical officer of the National Kidney Foundation and a faculty member at Mount Sinai School of Medicine, New York.

The point is to identify "individuals in the community with kidney disease along with the risk factors that go with it," said Dr. George Bakris of the University of Chicago Medical Center and a former KEEP principal investigator. All of the participants have some stage of kidney disease or hypertension and are referred to the registry by physicians. Enrollment is voluntary and participants complete a questionnaire and undergo a medical evaluation that includes standard panels plus testing for calcium, phosphorus, and parathyroid hormone. The program does not accept people who have had a kidney transplant or are on dialysis, he said.

Under the program, a new method for estimating glomerular filtration rate (eGFR), known as the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, has been used. This equation is more accurate in determining kidney function than is the Modification of Diet in Renal Disease (MDRD) Study equation, said Dr. Lesley Stevens of Tufts Medical Center, Boston. "The use of the CKD-EPI equation more accurately reflects measured GFR and results in a lower prevalence of eGFR below 60 mL/min per 1.73 m²," said Dr. Stevens, a KEEP committee member. As a result, there are fewer false positives and "ultimately, fewer tests and lower costs," she said.

According to Dr. Stevens, the equation has been validated in two clinical studies (Am. J. Kidney Dis. 2010;55:648-59 and Am. J. Kidney Dis. 2010;55:660-70).

One of the goals of KEEP is to determine factors that help slow the slide into chronic kidney disease, as well as the loss of kidney function over time, Dr. Vassalotti said. "Multiple trials on systolic blood pressure show that untreated hypertension results in a loss of 10-12 mL/min per 1.73 m² eGFR a year," he said. "In individuals with blood pressure in the target range, the annual loss is approximately 2-3 mL/min per 1.73 m². By educating participants and fostering their engagement with local clinicians, KEEP can impact care."

Managing blood pressure early in kidney disease is critical because as eGFR declines, hypertension becomes more difficult to control, Dr. Vassalotti said. Thus, self-reported hypertension is one of the qualifiers for KEEP enrollment, he said. He cited early data from KEEP that showed prevalence, awareness and treatment of hypertension increased with stage of chronic kidney disease, but that didn’t necessarily translate to control with severe disease. Among those with stage 3 disease, only 82% were undergoing treatment, compared with 92% of those with stage 4 disease. However, 38% of the stage 3 group had systolic blood pressure below 140 mm Hg, while only 35% of the stage 4 group did (Am. J. Med. 2008; 121:332-40).

KEEP data have shown an uptick in overall blood pressure control, from 45% at the initial screening to 49% at rescreening, Dr. Vassalotti said, and even some improvement in control without medication. "But I wouldn’t overstate this."

The project involves merging data with the National Death Index and the United States Renal Data System to track survival and chronic kidney failure outcomes, respectively. Future goals include additional data links with Medicare Parts B and D to gain clarity on morbidity and medication use, Dr. Vassalotti said. "Preliminary longitudinal data show that community screening appears to influence hypertension despite progression of chronic kidney disease," he said.

Patient awareness is the cornerstone of hypertension management, noted Dr. Adam Whaley-Connell of the University of Missouri. "Awareness has a very important role in not only understanding blood pressure control, especially in the context of the early stages of kidney disease, but in improving kidney related patient outcomes," he said. However, he noted that awareness of kidney disease, particularly in its early stages, "is alarmingly low."

He noted that KEEP data on awareness reflect that of National Health and Nutrition Examination Survey and other CKD cohort studies: Only about 5% of those with stages 1-3 are aware of their disease. "Roughly 95% of individuals entering into the screening program are unaware they have chronic kidney disease," Dr. Whaley-Connell said.

KEEP enrollees with cardiovascular disease had a keener awareness of the risks of kidney disease, he said. "While awareness may be triggered by cardiovascular disease, those unaware in the earlier stages of kidney disease are particularly vulnerable to poor risk factor control and increased risk for mortality and progression to end-stage renal disease," Dr. Whaley-Connell said. "We advocate for targeted education and awareness at earlier stages of kidney disease to improve risk factor control."

"I think any general practitioner seeing patients needs to pay attention to eGFR," Dr. Bakris said. "If the patient has stage 2 disease and an eGFR of 60-80 mL/min per 1.73 m² now, especially with the CKD-EPI equation, the next question out of his mouth should be, ‘Do you have a family history of kidney disease?’"

However, he cited National Kidney Foundation data that showed only 31% of physicians considered family history an important factor. "If your patient has a family history of kidney disease and an eGFR of 50 mL/min per 1.73 m² ... you really do need to pay attention to that and do something about it."

KEEP is funded by Amgen, Abbott, Siemens, Astellas, Genzyme, Fresenius Medical Care, Pfizer, Nephroceuticals and the LifeScan unit of Johnson & Johnson. Panel participants disclosed affiliations with a variety of device and pharmaceutical companies.