Trial of Nonpharmacologic Intervention in the Elderly (TONE). Design and rationale of a blood pressure control trial. Subgroup and per-protocol analysis of the randomized European Trial on Isolated Systolic Hypertension in the Elderly. The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS): Protocol, Patient Characteristics, and Blood Pressure during the First 12 Months Randomized Pilot Study of a Behavioral Feedback Intervention to Improve Medication Adherence in Older Adults With Hypertension Practitioner's trial on the efficacy of antihypertensive treatment in elderly patients with hypertension II (PATE-hypertension II study) in Japan. Systolic Blood Pressure Goals to Reduce Cardiovascular Disease Among Older Adults Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial Evidence Supporting a Systolic Blood Pressure Goal of Less Than 150 mm Hg in Patients Aged 60 Years or Older: The Minority View The Hypertension Optimal Treatment (HOT) Study: 24-month data on blood pressure and tolerability. Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). Target Blood Pressure for Treatment of Isolated Systolic Hypertension in the Elderly: Valsartan in Elderly Isolated Systolic Hypertension Study A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control. Nonpharmacologic intervention to reduce blood pressure in older patients with mild hypertension. The Hypertension Optimal Treatment (HOT) Study: 12-month data on blood pressure and tolerability. With special reference to age and gender. Treatment of Hypertension in Patients 85 Years of Age or Older: A J-BRAVE Substudy Physician-pharmacist cooperation program for blood pressure control in patients with hypertension: a randomized-controlled trial. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups
National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure ( BP ) . However , data to support such recommendations in older persons are virtually nonexistent . The Trials of Nonpharmacologic Intervention in the Elderly ( TONE ) is a r and omized , controlled trial that will test whether weight loss or a reduced sodium ( Na ) intake or both can maintain satisfactory BP control , without unacceptable side effects , after withdrawal of antihypertensive drug therapy . Medication-treated hypertensives ( aged 60 to 80 years ) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are r and omly assigned to one of four groups : ( 1 ) weight loss alone , ( 2 ) reduced Na intake alone , ( 3 ) combined weight loss and reduced Na intake , or ( 4 ) usual life-style ( control group ) .  Overweight participants are r and omized to one of these four groups , while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group . The interventions , tailored to the needs of older persons , use behavioral approaches to accomplish intervention-specific goals ( weight loss > or = 10 lb , daily Na intake < or = 80 mEqa ) . Three months after the start of intervention , antihypertensive drug therapy is withdrawn . The primary trial end point is a BP of 150/90 mm Hg or higher , resumption of antihypertensive drug therapy , or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up . It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy BACKGROUND In 1989 , the European Working Party on High Blood Pressure in the Elderly started the double-blind , placebo-controlled , Systolic Hypertension in Europe Trial to test the hypothesis that antihypertensive drug treatment would reduce the incidence of fatal and nonfatal stroke in older patients with isolated systolic hypertension . This report addresses whether the benefit of antihypertensive treatment varied according to sex , previous cardiovascular complications , age , initial blood pressure ( BP ) , and smoking or drinking habits in an intention-to-treat analysis and explores whether the morbidity and mortality results were consistent in a per- protocol analysis . METHODS After stratification for center , sex , and cardiovascular complications , 4695 patients 60 years of age or older with a systolic BP of 160 to 219 mm Hg and diastolic BP less than 95 mm Hg were r and omized . Active treatment consisted of nitrendipine ( 10 - 40 mg/d ) , with the possible addition of enalapril maleate ( 5 - 20 mg/d ) and /or hydrochlorothiazide ( 12.5 - 25 mg/d ) , titrated or combined to reduce the sitting systolic BP by at least 20 mm Hg , to below 150 mm Hg . In the control group , matching placebo tablets were employed similarly . RESULTS In the intention-to-treat analysis , male sex , previous cardiovascular complications , older age , higher systolic BP , and smoking at r and omization were positively and independently correlated with cardiovascular risk . Furthermore , for total ( P = .009 ) and cardiovascular ( P = .09 ) mortality , the benefit of antihypertensive drug treatment weakened with advancing age ; for total mortality ( P = .05 ) , the benefit increased with higher systolic BP at entry , while for fatal and nonfatal stroke ( P = .01 ) , it was most evident in nonsmokers ( 92.5 % of all patients ) . In the per protocol analysis , active treatment reduced total mortality by 24 % ( P = .05 ) , reduced all fatal and nonfatal cardiovascular end points by 32 % ( P<.001 ) , reduced all strokes by 44 % ( P = .004 ) , reduced nonfatal strokes by 48 % ( P = .005 ) , and reduced all cardiac end points , including sudden death , by 26 % ( P = .05 ) . CONCLUSIONS In elderly patients with isolated systolic hypertension , stepwise antihypertensive drug treatment , starting with the dihydropyridine calcium channel blocker nitrendipine , improves prognosis . The per- protocol analysis suggested that treating 1000 patients for 5 years would prevent 24 deaths , 54 major cardiovascular end points , 29 strokes , or 25 cardiac end points . The effects of antihypertensive drug treatment on total and cardiovascular mortality may be attenuated in very old patients The benefits of a systolic blood pressure ( BP ) below 150–160 mmHg are well established ; whether a systolic BP of less than 140 mmHg provides additional benefits remains controversial . This study was design ed to compare the 2-year effect of a strict treatment to maintain systolic BP below 140 mmHg ( group A ) and that of a mild treatment to maintain systolic BP at between 140 and below 160 mmHg ( group B ) . The study design followed the Prospect i ve R and omized Open Blinded End-point ( PROBE ) study . The subjects were elderly patients ( 65–85 years old ) who consistently had a systolic BP of 160 mmHg or higher . The baseline drug was efonidipine hydrochloride ( efonidipine ) , a long-acting dihydropiridine calcium antagonist . The primary endpoints were stroke , cardiac disease , vascular disease , and renal failure . After a run-in period of 2 to 4 weeks , 2,165 patients were assigned to group A and 2,155 patients to group B. There were no significant differences between the groups in sex , age , baseline BP , or other cardiovascular risk factors . The systolic BP was 7.2 mmHg lower ( p<0.0001 ) and the diastolic BP 2.4 mmHg lower ( p<0.0001 ) in group A than in group B after 12 months of treatment . As of this interim analysis , primary endpoints have occurred in 87 patients ( stroke in 58 patients , cardiac disease in 27 patients , occlusive arterial disease in 1 patient , and renal failure in 1 patient ) . Five patients have died of stroke and 2 patients of myocardial infa rct ion . The primary -endpoint-related morbidity rate was 20.9/1,000 patient-years , and the mortality rate was 1.7/1,000 patient-years . Currently available results indicate that this study , one of the largest r and omized trials of antihypertensive therapy in elderly patients in Japan , was conducted safely . The final results are expected to provide important and practical information for the management of hypertension in elderly patients Background and Objectives : Older adults ' adherence to antihypertensive medications is far lower than what is considered necessary for clinical effectiveness , despite the risks for adverse cardiovascular events from uncontrolled blood pressure ( BP ) in the elderly . This pilot study tested a novel 8-week behavioral feedback intervention to improve antihypertensive medication adherence ( MA ) and BP control among older adults on existing treatment for hypertension . Methods : Adults 60 years old , or older taking at least 1 antihypertensive medication were r and omized to receive the nurse-delivered adherence intervention or usual care . Medication adherence was monitored continuously using electronic monitoring for 20 weeks . Intervention-group participants received biweekly MA and BP feedback , habit counseling , medication and disease education , a medication instruction card , and were given an electronic medication bottle cap with a digital display that provided daily adherence feedback during the 8-week intervention . Blood pressure was measured by a nurse at 12 and 20 weeks after r and omization . Adherence and BP outcomes were described using descriptive statistics and analyzed for between- and within-group differences using Mann-Whitney U tests . Results : Fifteen participants ( median age , 71 years ; 73 % female ) were eligible for r and omization . Participants took an average of 5.8 prescription medications and 2.93 over-the-counter medications per day . A nonsignificant difference was noted in baseline MA between groups . At the end of the intervention , the treatment group had better antihypertensive MA than did the control group ( median MA : 100 % vs 27.3 % , U = 5.00 , P = .013 ) . Systolic BP improved slightly in the intervention group during the study and was significantly different at week 12 ( median systolic BP : 130 vs 152 mm Hg ; U = 4.50 , P = .008 ) . Diastolic BP was largely unchanged over the course of the study . Conclusion : The results indicate that the intervention had a positive effect on MA . Additional testing is needed to further evaluate the intervention and its effect on adherence behavior and BP control AIM Reduction of elevated blood pressure ( BP ) has been an important treatment goal in elderly hypertensive patients . However , it has been reported that an excessive reduction of systolic BP to less than 120mmHg might be harmful in such patients . We investigated whether this was the case in a study which assessed long-term antihypertensive efficacy , tolerability and impact on cardiovascular/cerebrovascular ( CV ) morbidity/mortality in a large cohort of Japanese patients . METHODS This study was performed at general practitioners ' offices nationwide with a target sample size of 1500 patients . Hypertensive patients aged 60years or more who achieved successful BP control with c and esartan monotherapy , and who tolerated the treatment for at least 8weeks , were enrolled into the study and followed for 3years . RESULTS BP was maintained below the target level of 140/90mmHg over the 3-year period . The incidence of CV events during the study period was 20.4/1000person-years . Investigation of the relationship between BP and the incidence of CV events revealed that patients with higher BP generally had a higher incidence of events . However , very elderly patients ( ≥75years ) with a systolic BP ( SBP ) of less than 120mmHg also had a higher incidence of CV events compared with those with an SBP of 120 - 139mmHg . CONCLUSION This study demonstrated that treatment with c and esartan maintained long-term control of BP in elderly hypertensive patients without serious adverse events . CV events demonstrated a J-curve relationship with SBP in patients aged 75years or older , which suggests that excessive BP reductions might be harmful for very elderly patients Abstract : The 2014 Evidence -Based Guideline for the Management of  High Blood Pressure in Adults Report From the Panel Members Appointed to the Eighth Joint National Committee ( JNC 8) was recently published . This guideline recommended that older adults ( ≥60 years ) without diabetes or chronic kidney disease with systolic blood pressure ( SBP ) ≥150 mm Hg or diastolic blood pressure ( DBP ) ≥90 mm Hg be initiated on antihypertensive medication with a treatment goal SBP/DBP < 150/90 mm Hg . In contrast , the previous 3 JNC guidelines recommended treatment for these individuals be initiated at SBP/DBP ≥140/90 mm Hg with goal SBP/DBP < 140/90 mm Hg . In this article , we review r and omized trials of antihypertensive medication and observational data on SBP and DBP with cardiovascular outcomes among older adults , possible explanations underlying the different findings from these r and omized trials and observational studies , and contemporary antihypertensive treatment patterns among older U.S. adults . In closing , we highlight future research needs related to hypertension and outcomes among older adults Blood pressure ( BP ) control rates around the world are suboptimal . Part 2 of the National Health and Nutrition Educational Survey ( NHANES ) III indicates that only 27.4 % of hypertensive Americans aged 18 to 74 years have a BP of < 140/90 mm Hg . We wanted to assess BP control during the first 2 years and to describe the baseline characteristics of patients enrolled in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints ( CONVINCE ) Study , an international clinical trial that compares outcomes in hypertensive patients r and omized to initial treatment with either controlled-onset extended-release verapamil  or the investigator ’s choice of atenolol or hydrochlorothiazide . At r and omization , BP was < 140/90 mm Hg in only 20.3 % of the 16 602 subjects ( average±SD age 65.6±7.4 years ; 56 % women , 84 % white/7 % black/7 % Hispanic ) . The  average BP  at enrollment was 148/85 mm Hg for patients taking BP medications ( n=13 879 ) and 161/94 mm Hg for previously untreated patients ( n=2723 ) . After medication titration , with a transtelephonic computer that recommended an increase in the dose or number of antihypertensive agents whenever the BP was 140/90 mm Hg , 84.8 % of the subjects attained the goal BP . During 2 years of treatment , BP control was maintained in 67 % to 69 % of the subjects ( 69 % to 71 % for systolic BP of < 140 mm Hg and 90 % for diastolic BP of < 90 mm Hg ) . These data suggest that the control of systolic BP is more difficult than the control of diastolic BP . The US national goal of having 50 % of hypertensives with a BP of < 140/90 mm Hg may be achievable if a forced titration strategy is used . Interested investigators , free care and medications , and well-educated subjects may make the attainment of such a goal easier in the CONVINCE study than in the general population The 2014 Evidence -Based Guideline for the Management of  High Blood Pressure In Adults : Report From the Panel Members Appointed to the Eighth Joint National Committee ( JNC 8) recommends several major changes from the JNC 7 report ( 1 , 2 ) . The 2014 guideline is based on a systematic review of r and omized , controlled trials ( RCTs ) by a multidisciplinary panel using a process informed by Institute of Medicine recommendations for guideline development ( 3 ) . Although there was almost unanimous agreement on nearly all recommendations , a minority of the panel ( the authors of this commentary ) disagreed with the recommendation to increase the target systolic blood pressure ( SBP ) from 140 to 150 mm Hg in persons aged 60 years or older without diabetes mellitus ( DM ) or chronic kidney disease ( CKD ) . This target guides both the initiation of therapy and treatment goals . Although this issue has major clinical and public health implication s , the guideline only briefly summarized the concerns underlying the minority opinion to maintain the target of less than 140 mm Hg . The Institute of Medicine recommendation for guideline development encourages guidelines to provide a description and explanation of any differences of opinion regarding the recommendation ( 3 ) . This summarizes the evidence and rationale underlying the minority opinion to maintain the SBP target of 140 mm Hg or lower in persons aged 60 years or older until there is greater certainty of the risks and benefits of a higher target . First , increasing the target will probably reduce the intensity of antihypertensive treatment in a large population at high risk for cardiovascular disease ( CVD ) ( Table 1 ) . The higher SBP goal would apply to some of the groups at highest cardiovascular risk , such as African Americans , hypertensive patients with multiple CVD risk factors other than DM or CKD , and those with clinical CVD . Second , the evidence supporting increasing the SBP target from 140 to 150 mm Hg in persons aged 60 years or older was insufficient and inconsistent with the evidence supporting the panel 's recommendations for an SBP target of less than 140 mm Hg in persons younger than 60 years and those aged 60 years or older with DM or CKD . Third , the higher SBP goal in individuals aged 60 years or older may reverse the decades-long decline in CVD , especially stroke mortality ( 4 ) . In the absence of definitive evidence defining the optimum SBP target , observational studies and RCT data that the panel did not systematic ally review more strongly support the SBP goal of less than 140 mm Hg , especially in high-risk individuals . Other recent guideline groups review ing similar evidence have recommended a goal of less than 140 mm Hg , particularly in persons aged 80 years or younger ( 59 ) . Table 1 . U.S. Cardiovascular Disease Death Rates for Persons Younger and Older Than 65 y Persons Aged 60 Years or Older With Hypertension and SBP Controlled to 140 mm Hg or Lower More than half of the 72 million persons with hypertension in the United States are aged 60 years or older ( 10 , 11 ) . Among these individuals , the 2014 guideline recommends the SBP goal of 140 mm Hg or lower only for those with DM and those younger than 70 years with CKD ( 2 ) . Although the prevalence of hypertension in this age group ( 65 % to 67 % ) did not change between 1999 and 2010 , the percentage with adequate blood pressure control increased from 27.4 % ( 19992000 ) to 50.5 % ( 20112012 ) , with 82.2 % now receiving antihypertensive medications ( 10 , 12 ) . Data from NHANES ( National Health and Nutrition Examination Survey ) from 2001 to 2008 show that among treated and untreated hypertensive adults aged 60 years or older , median SBPs were 136 mm Hg and 152 mm Hg , respectively ( 13 ) , and SBPs have been decreasing in this age group over the past 5 decades ( Figure ) ( 4 ) . Thus , a target of less than 150 mm Hg would likely increase blood pressures in the treated hypertensive population and would suggest that nearly half of the untreated hypertensive patients in this age range should remain untreated . The large population at high risk for CVD , with most currently at an SBP of 140 mm Hg or lower , creates concern that a higher SBP target will adversely affect public health . Figure . Smoothed weighted frequency distribution , median , and 90th percentile of systolic blood pressure for persons aged 60 to 74 y : United States , 19592010 . Reproduced from Lackl and and colleagues ( 4 ) . NHANES = National Health and Nutrition Examination Survey ; NHES = National Health Examination Survey . High Risk in Persons With the Higher Goal Age substantially increases risk for cardiovascular events ( Table 1 ) , so differences in cardiovascular risk do not justify different targets for patients older and younger than 60 years . The risk range for white and African American men aged 60 years is 9 % to 30 % , depending on risk factor profile . For men of both ethnicities who are aged 70 years or older and have SBP controlled to 140 mm Hg , even without clinical CVD or DM , the 10-year risk exceeds 20 % ( 14 ) . Thus , on the basis of absolute risk , using an age threshold of 60 years to define eligibility for less aggressive treatment lacks consistency . Persons aged 60 to 79 years are at higher risk than those who are younger , even if the younger persons have DM . Insufficient Evidence for Differential Hypertension Treatment Benefit for Patients Older and Younger Than 60 Years The 2014 guideline panel failed to identify evidence of differential benefits or harms of treatment using an SBP goal of 140 mm Hg with an age threshold of 60 years . There is little RCT evidence of risk or benefit in treating persons younger than 60 years to this target , except in those with diastolic hypertension . The guideline indicates that no qualifying evidence was found comparing an SBP less than 140 mm Hg to any other SBP goal for persons younger than 60 years ( 2 ) . However , in persons aged 60 years or older , the SHEP ( Systolic Hypertension in the Elderly Program ) trial showed benefit of treating hypertension to an SBP goal between 140 and 145 mm Hg ( Table 2 ) ( 15 ) . HYVET ( Hypertension in the Very Elderly Trial ) found a benefit of an SBP target of less than 150 mm Hg on health outcomes , including mortality in persons aged 80 years or older ( 16 ) . Patients in the HYVET treatment group achieved an SBP of 144 mm Hg at 2 years compared with 159 mm Hg in the control group , and blood pressures continued to decrease in both groups until the end of the trial . Therefore , HYVET and the SHEP trial provide evidence that reducing SBP to around 140 mm Hg has substantial benefit without major harm in older persons . Thus , the best evidence available for an SBP target around 140 mm Hg , which meets the guideline RCT criteria , is in persons older than 60 years . The lack of benefit seen in 2 Japanese trials in older individuals ( JATOS [ Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients ] [ 17 ] and the VALISH [ Valsartan in Elderly Isolated Systolic Hypertension ] trial [ 18 ] ) was cited by some to rationalize the higher SBP target , but these trials were underpowered ( Table 2 ) . The SHEP trial and HYVET together reported 365 strokes and more than 285 coronary heart disease events , whereas JATOS and the VALISH trial only had a combined total of 125 strokes and 67 coronary heart disease events . In addition , the much larger FEVER ( Felodipine Event Reduction ) trial ( 19 ) did not meet criteria for inclusion in the panel 's deliberation ( Table 2 ) . This trial , which was conducted in a Chinese population ( age range , 50 to 79 years ; mean age , 62 years ) , reported a significant 27 % reduction in its primary outcome , as well as significant reductions in all CVD , total mortality , coronary heart disease , and heart failure in patients treated to an SBP of 137 mm Hg with a thiazide diureticcalcium-channel blocker combination versus 143 mm Hg with a thiazide diuretic plus placebo ( 19 ) . Table 2 . Trials Comparing Different Systolic Blood Pressure Thresholds In addition , generalizability of the Japanese trials to other population s of patients older than 60 years , such as African Americans , is uncertain . African Americans are at highest risk for all complications of hypertension and are historically undertreated . Thus , we believe that recommending less aggressive targets in this or other high-risk population s requires stronger justification than the guideline cites . Three recent guidelines from other countries have concluded that the appropriate cut point for an age-related differential SBP goal is 80 years or older ( 57 ) . We agree that this higher treatment target in frail hypertensive patients aged 80 years or older better reflects existing evidence . Safety and Adverse Event Risk in Hypertensive Patients Aged 60 Years or Older Despite the limited number of end points in JATOS and the VALISH trial , their size and duration provide evidence of safety of the SBP target of less than 140 mm Hg . The VALISH investigators concluded that this target was safe in relatively healthy patients aged 70 years or older with isolated systolic hypertension ( 18 ) . In JATOS , adverse events requiring treatment discontinuation were reported in only 36 patients , with no differences in discontinuation rate between groups ( 17 ) . This evidence and the favorable results at slightly higher blood pressures in the SHEP trial and HYVET provide reassurance of the safety of an SBP goal of less than 140 mm Hg in older , nonfrail persons . Other Trial Evidence of Benefit of Treatment at an SBP of 140 mm Hg or Lower Results of the SPS3 ( Secondary Prevention of Small Subcortical Strokes ) trial indicated that an SBP target of less than 130 mm Hg versus 144 mm Hg in 3020 patients ( mean age , 63 years ) reduced subsequent strokes by 19 % ( P= 0.08 ) and hemorrhagic strokes by nearly 50 % ( P < 0.01 ) ( 20 ) . Of note , the FEVER trial reported a 44 % ( P < 0.001 ) reduction in all strokes in a subgroup analysis of patients older than 65 years ( 17 ) . Finally , 2 meta-analyses The Hypertension Optimal Treatment ( HOT ) Study is an ongoing prospect i ve r and omized , multicentre trial conducted in 26 countries . There are two main aims of the study . The first is to evaluate the relationship between three levels of target diastolic blood pressure ( < or = 90 , < or = 85 or < or = 80 mmHg ) and the incidence of cardiovascular morbidity and mortality in hypertensive patients . The second is to determine the effect on morbidity and mortality of a low dose , 75 mg daily , of acetylsalicylic acid ( ASA , aspirin ) compared with placebo .  Altogether 18,790 patients have been recruited and r and omized , and two-year data are now available for all patients . This is a report on the blood pressures achieved , the tolerability , and other available data after 24 months of follow-up of all patients . Special emphasis is given to the subgroup of elderly patients ( > or = 65 years , n = 5988 ) compared with young patients ( < 65 years , n = 12 802 ) . On average , patients in the < or = 90 mmHg diastolic blood pressure target group have reached 85 mmHg , in the < or = 85 mmHg target group patients have reached 83 mmHg and in the < or = 80 mmHg target group patients have reached 81 mmHg . The percentage of those achieving target blood pressure in each target group at 24 months of follow-up is 85 % in the < or = 90 mmHg target group , 75 % in the < or = 85 mmHg target group and 57 % in the < or = 80 mmHg target group . In the elderly subgroup ( > or = 65 years of age ) , the percentage of patients achieving target at 24 months is higher for all target groups , namely 89 % in the < or = 90 mmHg group , 80 % in the 85 mmHg group and 62 % in the 80 mmHg group . Antihypertensive treatment was initiated with a calcium antagonist , felodipine , at a dose of 5 mg once daily . If target blood pressure was not reached , additional antihypertensive therapy , with either an angiotensin converting enzyme ( ACE ) inhibitor or a beta-adrenoceptor blocking agent , was given . Further dose adjustments were made in accordance with a set protocol . As a fifth , and final , step , a diuretic could be added . There have been relatively few side effects in this large , multinational study of hypertensive patients . Only ankle oedema and coughing exceed a frequency of 0.5 % ( ankle oedema 1.3 % in young and 1.7 % in elderly ; coughing 0.5 % in young and elderly ) . After two years , 84 % of all patients are still taking their baseline therapy , felodipine . The 24-month data presented here indicate that it should be possible to fulfil the primary aims of the HOT Study CONTEXT Blood pressure control ( < 140/90 mm Hg ) rates for hypertension fall far short of the US national goal of 50 % or more . Achievable control rates in varied practice setting s and geographic regions and factors that predict improved blood pressure control are not well identified . OBJECTIVE To determine the success and predictors of blood pressure control in a large hypertension trial involving a multiethnic population in diverse practice setting s. DESIGN The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial is a r and omized , double-blind , active-controlled clinical trial with a mean follow-up of 4.9 years . Participant enrollment began in February 1994 and follow-up was completed in March 2002 . SETTING A total of 623 centers in the United States , Canada , and the Caribbean . PARTICIPANTS A total of 33,357 participants ( aged > or = 55 years ) with hypertension and at least one other coronary heart disease risk factor . INTERVENTIONS Participants were r and omly assigned to receive ( double-blind ) chlorthalidone , 12.5 - 25 mg/d ( n=15,255 ) , amlodipine 2.5 - 10 mg/d ( n=9048 ) , or lisinopril 10 - 40 mg/d ( n=9054 ) after other medication was discontinued . Doses were increased within these ranges and additional drugs from other classes were added as needed to achieve blood pressure control ( < 140/90 mm Hg ) . MAIN OUTCOME MEASURES The outcome measures for this report are systolic and diastolic blood pressure , the proportion of participants achieving blood pressure control ( < 140/90 mm Hg ) , and the number of drugs required to achieve control in all three groups combined . RESULTS Mean age was 67 years , 47 % were women , 35 % black , 36 % diabetic ; 90 % were on antihypertensive drug treatment at entry . At the first of two pre-r and omization visits , blood pressure was < 140/90 mm Hg in only 27.4 % of participants . After 5 years of follow-up , the percent controlled improved to 66 % . Systolic blood pressure was < 140 mm Hg in 67 % of participants , diastolic blood pressure was < 90 mm Hg in 92 % , the mean number of drugs prescribed was 2.0+/-1.0 , and the percent on > or = 2 drugs was 63 % . Blood pressure control varied by geographic regions , practice setting s , and demographic and clinical characteristics of participants . CONCLUSIONS These data demonstrate that blood pressure may be controlled in two thirds of a multiethnic hypertensive population in diverse practice setting s. Systolic blood pressure is more difficult to control than diastolic blood pressure , and at least two antihypertensive medications are required for most patients to achieve blood pressure control . It is likely that the majority of people with hypertension could achieve a blood pressure < 140/90 mm Hg with the antihypertensive medications available today In this prospect i ve , r and omized , open-label , blinded end point study , we aim ed to establish whether strict blood pressure control ( < 140 mm Hg ) is superior to moderate blood pressure control ( ≥140 mm Hg to < 150 mm Hg ) in reducing cardiovascular mortality and morbidity in elderly patients with isolated systolic hypertension . We divided 3260 patients aged 70 to 84 years with isolated systolic hypertension ( sitting blood pressure 160 to 199 mm Hg ) into 2 groups , according to strict or moderate blood pressure treatment . A composite of cardiovascular events was evaluated for ≥2 years . The  strict control ( 1545 patients ) and moderate control ( 1534 patients ) groups were well matched ( mean age : 76.1 years ; mean blood pressure : 169.5/81.5 mm Hg ) . Median follow-up was 3.07 years . At 3 years , blood pressure reached 136.6/74.8 mm Hg and 142.0/76.5 mm Hg , respectively . The blood pressure difference between the 2 groups was 5.4/1.7 mm Hg . The overall rate of the primary composite end point was 10.6 per 1000 patient-years in the strict control group and 12.0 per 1000 patient-years in the moderate control group ( hazard ratio : 0.89 ; [ 95 % CI : 0.60 to 1.34 ] ; P=0.38 ) . In summary , blood pressure targets of < 140 mm Hg are safely achievable in relatively healthy patients ≥70 years of age with isolated systolic hypertension , although our trial was underpowered to definitively determine whether strict control was superior to less stringent blood pressure targets This was a prospect i ve , cluster r and omized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years ( mean , 61 years ) .  Pharmacists made recommendations to physicians for patients in the intervention clinics ( n=101 ) but not patients in the control clinics ( n=78 ) . The mean adjusted difference in systolic blood pressure ( BP ) between the control and intervention groups was 8.7 mm Hg ( 95 % confidence interval [ CI ] , 4.4 - 12.9 ) , while the difference in diastolic BP was 5.4 mm Hg ( CI , 2.8 - 8.0 ) at 9 months . The 24-hour BP levels showed similar effects , with a mean systolic BP level that was 8.8 mm Hg lower ( CI , 5.0 - 12.6 ) and a mean diastolic BP level that was 4.6 mm Hg ( CI , 2.4 - 6.8 ) lower in the intervention group . BP was controlled in 89.1 % of patients in the intervention group and 52.9 % in the control group ( adjusted odds ratio , 8.9 ; CI , 3.8 - 20.7 ; P<.001 ) . Physician/pharmacist collaboration achieved significantly better mean BP values and overall BP control rates , primarily by intensification of medication therapy and improving patient adherence BACKGROUND Although nonpharmacologic interventions are widely recommended in the therapy of high blood pressure in older adults , surprisingly little data exist to confirm the efficacy of these interventions in older persons . METHODS We conducted a r and omized , controlled clinical trial in persons aged 60 to 85 years with a diastolic blood pressure of 85 to 100 mm Hg . The experimental arm was a nonpharmacologic intervention combining weight reduction , sodium restriction , and increased physical activity . The nonpharmacologic intervention consisted of eight weekly group and two individual sessions during the intensive phase , followed by four monthly group sessions during the maintenance phase . The control group received no treatment during the study .  Blood pressure was assessed by certified technicians ( blinded to group assignment ) using r and om zero sphygmomanometers . RESULTS Of 56 participants r and omized , 47 completed the entire 6-month trial ( 21 in the intervention group and 26 in the control group ) . Attendance at the intervention sessions was excellent . The intervention group lost more weight ( -2.1 kg ) over 6 months than the control group ( + 0.3 kg ) . Trends for decreasing 24-hour urine sodium excretion in both the intervention and control groups , with greater trend in the intervention group , were not statistically significant . The intervention group experienced more reduction in systolic and diastolic blood pressure than did the control group ( mean differences between groups at 6 months , 4.2/4.9 mm Hg , respectively ) . CONCLUSIONS Our data indicate that a nonpharmacologic intervention will lower systolic and diastolic blood pressure levels in older people with borderline or mild elevations of diastolic blood pressure The Hypertension Optimal Treatment ( HOT ) Study is an ongoing prospect i ve , r and omized , multicenter trial conducted in 26 countries . Its two main aims are to evaluate the relationship between three levels of target diastolic blood pressure ( < or = 90 , < or = 85 or < or = 80 mmHg ) and the incidence of cardiovascular morbidity and mortality in hypertensive patients and the effects on morbidity and mortality of a low dose , 75 mg daily , of acetylsalicylic acid ( ASA , aspirin ) compared with placebo .  Altogether 19,193 patients have been recruited and r and omized and one-year data are now available for all patients . This is a report on the blood pressures achieved , the tolerability and other available data after 12 months of follow-up of all patients . Special reference will be given to the subgroup of elderly patients ( > or = 65 years , n = 6,113 ) as compared to younger patients ( < 65 years , n = 13,080 ) . On average , the target group < or = 90 mmHg in diastolic blood pressure has reached 86 mmHg , the target group < or = 85 mmHg has reached 83 mmHg and the target group < or = 80 mmHg has reached 81 mmHg . The percentage of patients that has obtained their target blood pressures is 84 % in the target group < or = 90 mmHg , 72 % in the target group < or = 85 mmHg and 57 % in the target group < or = 80 mmHg at 12 months of follow-up . In the elderly subgroup ( > or = 65 years of age ) the percentage of patients at target is higher for all target groups , being 86 , 76 and 61 % , respectively , at 12 months . Antihypertensive treatment is initiated with a calcium antagonist , felodipine , at a dose of 5 mg once daily . If target blood pressure is not reached , additional antihypertensive therapy , with either an angiotensin converting enzyme ( ACE ) inhibitor or a beta-adrenoceptor blocking agent , is given . Further dose adjustments are made in accordance with a set protocol . As a fifth and final step a diuretic may be added . Side effects have been relatively few in this large multinational series of intensively treated hypertensive patients . Only ankle edema , 2.6 % and 3.0 % , and coughing , 1.3 % and 0.8 % , in young and elderly patients , respectively , exceed a frequency of 1 % , and 88 % of all patients are still taking their baseline therapy felodipine after one year . The one-year data presented here indicate that it should be possible to fulfill the primary aims of the HOT Study Whether the strict control of blood pressure ( BP ) of patients with hypertension who are aged 85 years or older is beneficial is unclear . The Japan ’s Benidipine Research on Antihypertensive Effects in the Elderly study is a prospect i ve , observational 3-year study to evaluate the safety and effectiveness of treatment with a calcium channel blocker benidipine in 8897 hypertensive patients aged 65 years or older as a post-marketing surveillance . We examined the relationship between the achieved BP and cardiovascular events ( i.e. , stroke , myocardial infa rct ion , and heart failure ) in a subgroup of 415 patients aged 85 years or older ( mean age 88 years ) . BP decreased significantly from 165 ± 14/84 ± 10 mmHg to 130 ± 11/71 ± 10 mmHg during treatment in patients with a treated systolic BP ( SBP ) < 140 mmHg ( n = 230 ) and BP decreased significantly from 169 ± 16/86 ± 12 mmHg to 143 ± 13/75 ± 10 mmHg in those with a treated SBP ≥ 140 mmHg ( n = 185 ) . There was a nonsignificant trend toward a lower rate of cardiovascular events and higher rate of total death in patients with a treated SBP < 140 mmHg . On-treatment SBP ≥ 160 mmHg is tended to associate with a higher incidence of cardiovascular events . There was no significant difference in the incidence of adverse reactions between the controlled BP group ( 3.04 % ) and the less well controlled BP group ( 3.24 % ) . In conclusion , although this study was not powered for definitive conclusion , there was a nonsignificant trend toward a lower rate of cardiovascular events and higher total death in patients aged 85 years or older with a treated SBP < 140 mmHg BACKGROUND The aim of the trial was to evaluate the effectiveness of a program of cooperation between physician and pharmacist to reduce cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle . METHODS The 132 subjects in this r and omized , controlled trial were in the age range of 40 - 79 years . The inclusion criteria were : systolic BP ( SBP ) ranging from 140 - 179 mm Hg and /or diastolic BP ( DBP ) ranging from 90 - 99 mm Hg and treatment-naive ( untreated for hypertension ) ; or on a regimen of medication for hypertension . Of these 132 subjects , 124 ( 94 % ) were already receiving treatment with antihypertensive medications . Equal numbers of subjects were r and omly assigned to one of two groups : a physician-pharmacist intervention group ( n = 66 ) and a control group ( n = 66 ) . RESULTS The 6-month follow-up rate was 97 % in both groups . At 6 months , the mean decrease in SBP/DBP , as measured at home in the morning , was 2.9/3.3 mm Hg in the intervention group relative to baseline ( P = 0.02 and P < 0.0001 for SBP and DBP , respectively ) . The mean decrease in home morning SBP in the intervention group was not significantly greater than in the control group . However , the DBP decline was significantly greater in the intervention than control groups , which showed a mean decrease of 2.8 mm Hg ( confidence interval : -5.5 to -0.1 ; P = 0.04 ) . The percentage of patients in whom control of home morning BP was achieved was 53 % in the intervention group and 47 % in the control group ( P = 0.40 ) . A higher percentage of patients in the intervention group , relative to the control group , were able to reduce the use of antihypertensive medications ( 31 vs. 8 % , P < 0.0001 ) , and fewer patients in this group required additional medications or increases in dosage relative to the controls ( 11 vs. 28 % , P = 0.03 ) . Patients of the intervention group were more likely to show reduction in body mass index and sodium intake and to stop smoking , as compared with the control group . CONCLUSIONS A program of cooperation between physician and pharmacist was successful in reducing cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle Background Evidence on long term effectiveness of public health strategies for lowering blood pressure ( BP ) is scarce . In the Control of Blood Pressure and Risk Attenuation ( COBRA ) Trial , a 2 x 2 factorial , cluster r and omized controlled trial , the combined home health education ( HHE ) and trained general practitioner ( GP ) intervention delivered over 2 years was more effective than no intervention ( usual care ) in lowering systolic BP among adults with hypertension in urban Pakistan . However , it was not clear whether the effect would be sustained after the cessation of intervention . We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up . Methods A total of 1341 individuals 40 years or older with hypertension ( systolic BP 140 mm Hg or greater , diastolic BP 90 mm Hg or greater , or already receiving treatment ) were followed by trained research staff masked to r and omization status .  BP was measured thrice with a calibrated automated device ( Omron HEM-737 IntelliSense ) in the sitting position after 5 minutes of rest . BP measurements were repeated after two weeks . Generalized estimating equations ( GEE ) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up . The multivariable model was adjusted for clustering , age at baseline , sex , baseline systolic and diastolic BP , and presence of diabetes . Findings After 7 years of follow-up , systolic BP levels among those r and omised to combined HHE plus trained GP intervention were significantly lower ( 2.1 [ 4.1–0.1 ] mm Hg ) compared to those r and omised to usual care , ( P = 0.04 ) . Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol ( 2.7 [ 4.8 to 0.6 ] mg/dl . Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up . These findings highlight the potential for scaling-up simple strategies for cardiovascular risk reduction in low- and middle- income countries . Trial Registration Clinical Trials.gov
However , the 95 % confidence intervals of these outcomes suggest the lower BP target is probably not worse , and might offer a clinical ly important benefit .
AUTHORS ' CONCLUSIONS At the present time there is insufficient evidence to know whether a higher BP target ( less than150 to 160/95 to 105 mmHg ) or a lower BP target ( less than 140/90 mmHg ) is better for older adults with high BP .
BACKGROUND Eight out of 10 major antihypertensive trials in older adults attempted to achieve a target systolic blood pressure ( BP ) less than 160 mmHg .
Collectively these trials demonstrated benefit for treatment , as compared to no treatment , for an older adult with BP greater than 160 mmHg .
However an even lower BP target of less than 140 mmHg is commonly applied to all age groups .
At the present time it is not known whether a lower or higher BP target is associated with better cardiovascular outcomes in older adults .
OBJECTIVES To assess the effects of a higher ( less than 150 to 160/95 to 105 mmHg ) BP target compared to the lower BP target of less than 140/90 mmHg in hypertensive adults 65 years of age or older .