Prevention of heart failure by antihypertensive drug treatment in older persons with isolated systolic hypertension. SHEP Cooperative Research Group. The Australian Therapeutic Trial in Mild Hypertension. Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. Systolic Hypertension in the Elderly Program Cooperative Research Group. Subgroup and per-protocol analysis of the randomized European Trial on Isolated Systolic Hypertension in the Elderly. Reduced cardiovascular morbidity and mortality in hypertensive diabetic patients on first-line therapy with an ACE inhibitor compared with a diuretic/beta-blocker-based treatment regimen: a subanalysis of the Captopril Prevention Project. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT) Effects of immediate versus delayed antihypertensive therapy on outcome in the Systolic Hypertension in Europe Trial Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA) in primary care A randomised trial of a 5 week, manual based, self-management programme for hypertension delivered in a cardiac patient club in Shanghai The Study on COgnition and Prognosis in the Elderly (SCOPE); outcomes in patients not receiving add-on therapy after randomization 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 Evaluation of a pharmaceutical care program for hypertensive patients in rural Portugal. Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial Treatment of mild hypertension: a five year controlled drug trial. The Oslo study.
CONTEXT Heart failure is often preceded by isolated systolic hypertension , but the effectiveness of antihypertensive treatment in preventing heart failure is not known . OBJECTIVE To assess the effect of diuretic-based antihypertensive stepped-care treatment on the occurrence of heart failure in older persons with isolated systolic hypertension . DESIGN Analysis of data from a multicenter , r and omized , double-blind , placebo-controlled clinical trial . PARTICIPANTS A total of 4736 persons aged 60 years and older with systolic blood pressure between 160 and 219 mm Hg and diastolic blood pressure below 90 mm Hg who participated in the Systolic Hypertension in the Elderly Program ( SHEP ) . INTERVENTION Stepped-care antihypertensive drug therapy , in which the step 1 drug is chlorthalidone ( 12.5 - 25 mg ) or matching placebo , and the step 2 drug is atenolol ( 25 - 50 mg ) or matching placebo . MAIN OUTCOME MEASURES Fatal and nonfatal heart failure . RESULTS During an average of 4.5 years of follow-up , fatal or nonfatal heart failure occurred in 55 of 2365 patients r and omized to active therapy and 105 of the 2371 patients r and omized to placebo ( relative risk [ RR ] , 0.51 ; 95 % confidence interval [ CI ] , 0.37 - 0.71 ; P<.001 ; number needed to treat to prevent 1 event [ NNT ] , 48 ) . Among patients with a history of or electrocardiographic evidence of prior myocardial infa rct ion ( MI ) , the RR was 0.19 ( 95 % CI , 0.06 - 0.53 ; P=.002 ; NNT , 15 ) . Older patients , men , and those with higher systolic blood pressure or a history of or electrocardiographic evidence of MI at baseline had higher risk of developing heart failure . CONCLUSION In older persons with isolated systolic hypertension , stepped-care treatment based on low-dose chlorthalidone exerted a strong protective effect in preventing heart failure . Among patients with prior MI , an 80 % risk reduction was observed In the Australian Therapeutic Trial in Mild Hypertension treated patients had significantly lower cardiovascular mortality and a significantly lower incidence of cerebrovascular complications than patients given placebos .  There was , however , no difference in the incidence of nonfatal myocardial infa rct ion or other new manifestations of ischaemic heart disease . Although the evidence of benefit from treatment was clear-cut , the number of cardiovascular complications in the control group was small . This was due to several factors . Patients admitted to the trial had no preceding evidence of cardiovascular complications  , the blood pressure fell spontaneously to below 95 mm Hg in almost half the control group , and patients whose blood pressures rose to levels above 110 mm Hg were given treatment , but remained in the placebo group for analysis . In both treated and placebo groups , trial end-points occurred more frequently in persons whose average diastolic blood pressure during the study remained raised . Ischaemic heart disease and many cases of stroke are due to atherosclerotic arterial disease . This appears not to be favourably influenced by antihypertensive drug therapy OBJECTIVE To assess the effect of low-dose , diuretic-based antihypertensive treatment on major cardiovascular disease ( CVD ) event rates in older , non-insulin-treated diabetic patients with isolated systolic hypertension ( ISH ) , compared with nondiabetic patients . DESIGN Double-blind , r and omized , placebo-controlled trial : the Systolic Hypertension in the Elderly Program ( SHEP ) . SETTING Multiple clinical and support centers in the United States . PARTICIPANTS A total of 4736 men and women aged 60 years and older at baseline with ISH ( systolic blood pressure [ BP ] , > or = 160 mm Hg ; diastolic BP , < 90 mm Hg ) at baseline , 583 non-insulin-dependent diabetic patients and 4149 nondiabetic patients ( 4 additional patients not so classifiable were r and omized but not included in these analyses ) . Diabetes mellitus defined as physician diagnosis , taking oral hypoglycemic drugs , fasting glucose level of 7.8 mmol/L or more ( > or = 140 mg/dL ) , or any combination of these characteristics . INTERVENTION The active treatment group received a low dose of chlorthalidone ( 12.5 - 25.0 mg/d ) with a step-up to atenolol ( 25.0 - 50.0 mg/d ) or reserpine ( 0.05 - 0.10 mg/d ) if needed . The placebo group received placebo and any active antihypertensive drugs prescribed by patient 's private physician for persistently high BP . MAIN OUTCOME MEASURES The 5-year rates of major CVD events , nonfatal plus fatal stroke , nonfatal myocardial infa rct ion ( MI ) and fatal coronary heart disease ( CHD ) , major CHD events , and all-cause mortality . RESULTS The SHEP antihypertensive drug regimen lowered BP of both diabetic and nondiabetic patients , with few adverse effects . For both diabetic and nondiabetic patients , all outcome rates were lower for participants r and omized to the active treatment group than for those r and omized to the placebo group . Thus , 5-year major CVD rate was lower by 34 % for active treatment compared with placebo , both for diabetic patients ( 95 % confidence interval [ CI ] , 6%-54 % ) and nondiabetic patients ( 95 % CI , 21%-45 % ) . Absolute risk reduction with active treatment compared with placebo was twice as great for diabetic vs nondiabetic patients ( 101/1000 vs 51/1000 r and omized participants at the 5-year follow-up ) , reflecting the higher risk of diabetic patients . CONCLUSION Low-dose diuretic-based ( chlorthalidone ) treatment is effective in preventing major CVD events , cerebral and cardiac , in both non-insulin-treated diabetic and nondiabetic older patients with ISH 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 OBJECTIVE The Captopril Prevention Project ( CAPPP ) evaluated the effects of an ACE inhibitor-based therapeutic regimen on  cardiovascular mortality and morbidity in hypertension .  One planned sub analysis of the CAPPP was to evaluate the outcome in the diabetic patient group . RESEARCH DESIGN AND METHODS In the CAPPP , 572 ( 4.9 % of 10,985 hypertensive patients ) had diabetes at baseline and were studied according to a prospect i ve , r and omized , open , blinded , end point trial design . Patients aged 25 - 66 years with diastolic blood pressure > or = 100 mmHg were included and r and omized to receive either captopril or conventional antihypertensive treatment ( diuretics and /or beta-blockers ) . RESULTS The primary end point , fatal and nonfatal myocardial infa rct ion and stroke as well as other cardiovascular deaths , was markedly lower in the captopril than in the conventional therapy group ( relative risk [ RR ] = 0.59 ; P = 0.018 ) . Specifically , cardiovascular mortality , defined as fatal stroke and myocardial infa rct ion , sudden death , and other cardiovascular death , tended to be lower in the captopril group ( RR = 0.48 ; P = 0.084 ) , and no difference was observed between the study groups for stroke ( RR = 1.02 ; P = 0.96 ) . Myocardial infa rct ions were less frequent in the captopril group than in the conventional therapy group ( RR = 0.34 ; P = 0.002 ) . Furthermore , total mortality was lower in the captopril as compared with the conventional therapy group ( RR = 0.54 ; P = 0.034 ) . Patients with impaired metabolic control seemed to benefit the most from ACE inhibitor-based therapy . CONCLUSIONS Captopril is superior to a diuretic/beta-blocker antihypertensive treatment regimen in preventing cardiovascular events in hypertensive diabetic patients , especially in those with metabolic decompensation OBJECTIVE To assess the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal ( total ) stroke in isolated systolic hypertension . DESIGN Multicenter , r and omized , double-blind , placebo-controlled . SETTING Community-based ambulatory population in tertiary care centers . PARTICIPANTS 4736 persons ( 1.06 % ) from 447,921 screenees aged 60 years and above were r and omized ( 2365 to active treatment , 2371 to placebo ) . Systolic blood pressure ranged from 160 to 219 mm Hg and diastolic blood pressure was less than 90 mm Hg . Of the participants , 3161 were not receiving antihypertensive medication at initial contact , and 1575 were . The average systolic blood pressure was 170 mm Hg ; average diastolic blood pressure , 77 mm Hg . The mean age was 72 years , 57 % were women , and 14 % were black . INTERVENTIONS -- Participants were stratified by clinical center and by antihypertensive medication status at initial contact . For step 1 of the trial , dose 1 was chlorthalidone , 12.5 mg/d , or matching placebo ; dose 2 was 25 mg/d . For step 2 , dose 1 was atenolol , 25 mg/d , or matching placebo ; dose 2 was 50 mg/d . MAIN OUTCOME MEASURES Primary . Nonfatal and fatal ( total ) stroke . Secondary . Cardiovascular and coronary morbidity and mortality , all-cause mortality , and quality of life measures . RESULTS Average follow-up was 4.5 years . The 5-year average systolic blood pressure was 155 mm Hg for the placebo group and 143 mm Hg for the active treatment group , and the 5-year average diastolic blood pressure was 72 and 68 mm Hg , respectively . The 5-year incidence of total stroke was 5.2 per 100 participants for active treatment and 8.2 per 100 for placebo . The relative risk by proportional hazards regression analysis was 0.64 ( P = .0003 ) . For the secondary end point of clinical nonfatal myocardial infa rct ion plus coronary death , the relative risk was 0.73 . Major cardiovascular events were reduced ( relative risk , 0.68 ) . For deaths from all causes , the relative risk was 0.87 . CONCLUSION In persons aged 60 years and over with isolated systolic hypertension , antihypertensive stepped-care drug treatment with low-dose chlorthalidone as step 1 medication reduced the incidence of total stroke by 36 % , with 5-year absolute benefit of 30 events per 1000 participants . Major cardiovascular events were reduced , with 5-year absolute benefit of 55 events per 1000 Background Blood pressure ( BP ) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension , which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age . Non-drug interventions to prevent hypertension have had low effectiveness . In individuals with previous cardiovascular disease or diabetes , the use of BP-lowering agents reduces the incidence of major cardiovascular events . In the absence of higher baseline risk , the use of BP agents reduces the incidence of hypertension . The PREVER-prevention trial aims to investigate the efficacy , safety and feasibility of a population -based intervention to prevent the incidence of hypertension and the development of target-organ damage . Methods This is a r and omized , double-blind , placebo-controlled clinical trial , with participants aged 30 to 70 years , with pre-hypertension . The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo . The primary outcomes will be the incidence of hypertension , adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG . The secondary outcomes will be fatal or non-fatal cardiovascular events : myocardial infa rct ion , stroke , heart failure , evidence of new sub- clinical atherosclerosis , and sudden death . The study will last 18 months . The sample size was calculated on the basis of an incidence of hypertension of 14 % in the control group , a size effect of 40 % , power of 85 % and P alpha of 5 % , result ing in 625 participants per group . The project was approved by the Ethics committee of each participating institution . Discussion The early use of blood pressure-lowering drugs , particularly diuretics , which act on the main mechanism of blood pressure rising with age , may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension . If this intervention shows to be effective and safe in a population -based perspective , it could be the basis for an innovative public health program to prevent hypertension in Brazil . Trial Registration Clinical Trials NCT00970931 Background : High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes , including coronary heart disease , stroke , decompensated heart failure , chronic kidney disease , and decline in cognitive function . Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg . Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease . However , the optimal systolic blood pressure to reduce blood pressure – related adverse outcomes is unclear , and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large , definitive clinical trial . Purpose : To describe the design considerations of the Systolic Blood Pressure Intervention Trial ( SPRINT ) and the baseline characteristics of trial participants . Methods : The Systolic Blood Pressure Intervention Trial is a multicenter , r and omized , controlled trial that compares two strategies for treating systolic blood pressure : one targets the st and ard target of < 140 mm Hg , and the other targets a more intensive target of < 120 mm Hg . Enrollment focused on volunteers of age ≥50 years ( no upper limit ) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease , chronic kidney disease , 10-year Framingham cardiovascular disease risk score ≥15 % , or age ≥75 years . The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups : participants with chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min/1.73 m2 ) , participants with a history of cardiovascular disease , and participants 75 years of age or older . The primary outcome is first the occurrence of a myocardial infa rct ion ( MI ) , acute coronary syndrome , stroke , heart failure , or cardiovascular disease death . Secondary outcomes include all-cause mortality , decline in kidney function or development of end-stage renal disease , incident dementia , decline in cognitive function , and small-vessel cerebral ischemic disease . Results : Between 8 November 2010 and 15 March 2013 , Systolic Blood Pressure Intervention Trial recruited and r and omized 9361 people at 102 clinics , including 3331 women , 2648 with chronic kidney disease , 1877 with a history of cardiovascular disease , 3962 minorities , and 2636 ≥75 years of age . Limitations : Although the overall recruitment target was met , the numbers recruited in the high-risk subgroups were lower than planned . Conclusions : The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants , including those with prior cardiovascular disease , chronic kidney disease , and those aged ≥75 years Background To assess the impact of immediate versus delayed antihypertensive treatment on the outcome of older patients with isolated systolic hypertension  , we extended the double-blind placebo-controlled Systolic Hypertension in Europe ( Syst-Eur ) trial by an open-label follow-up study lasting 4 years . Methods The Syst-Eur trial included 4695 r and omized patients with minimum age of 60 years and an untreated blood pressure of 160–219 mmHg systolic and below 95 mmHg diastolic . The double-blind trial ended after a median follow-up of 2.0 years ( range 1–97 months ) . Of 4409 patients still alive , 3517 received open-label treatment consisting of nitrendipine ( 10–40 mg daily ) with the possible addition of enalapril ( 5–20 mg daily ) , hydrochlorothiazide ( 12.5–25 mg daily ) , or both add-on drugs .  Non- participants ( n = 892 ) were also followed up . Results Median follow-up increased to 6.1 years . Systolic pressure decreased to below 150 mmHg ( target level ) in 2628 participants ( 75.0 % ) . During the 4-year open-label follow-up , stroke and cardiovascular complications occurred at similar frequencies in patients formerly r and omized to placebo and those continuing active treatment . These rates were similar to those previously observed in the active-treatment group during the double-blind trial . Considering the total follow-up of 4695 r and omized patients , immediate compared with delayed antihypertensive treatment reduced the occurrence of stroke and cardiovascular complications by 28 % ( P = 0.01 ) and 15 % ( P = 0.03 ) , respectively , with a similar tendency for total mortality ( 13 % , P = 0.09 ) . In 492 diabetic patients , the corresponding estimates of long-term benefit ( P < 0.02 ) were 60 , 51 and 38 % , respectively . Conclusions Antihypertensive treatment can achieve blood pressure control in most older patients with isolated systolic hypertension . Immediate compared with delayed treatment prevented 17 strokes or 25 major cardiovascular events per 1000 patients followed up for 6 years . These findings underscore the necessity of early treatment of isolated systolic hypertension BACKGROUND The efficacy of new antihypertensive drugs has been question ed . We compared the effects of conventional and newer antihypertensive drugs on cardiovascular mortality and morbidity in elderly patients . METHODS We did a prospect i ve , r and omised trial in 6614 patients aged 70 - 84 years with hypertension ( blood pressure > or = 180 mm Hg systolic , > or = 105 mm Hg diastolic , or both ) . Patients were r and omly assigned conventional antihypertensive drugs ( atenolol 50 mg , metoprolol 100 mg , pindolol 5 mg , or hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily ) or newer drugs ( enalapril 10 mg or lisinopril 10 mg , or felodipine 2.5 mg or isradipine 2 - 5 mg daily ) . We assessed fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease . Analysis was by intention to treat . FINDINGS Blood pressure was decreased similarly in all treatment groups . The primary combined endpoint of fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease occurred in 221 of 2213 patients in the conventional drugs group ( 19.8 events per 1000 patient-years ) and in 438 of 4401 in the newer drugs group ( 19.8 per 1000 ; relative risk 0.99 [ 95 % CI 0.84 - 1.16 ] , p=0.89 ) . The combined endpoint of fatal and non-fatal stroke , fatal and non-fatal myocardial infa rct ion , and other cardiovascular mortality occurred in 460 patients taking conventional drugs and in 887 taking newer drugs ( 0.96 [ 0.86 - 1.08 ] , p=0.49 ) . INTERPRETATION Old and new antihypertensive drugs were similar in prevention of cardiovascular mortality or major events . Decrease in blood pressure was of major importance for the prevention of cardiovascular events Background Blood pressure ( BP ) lowering in people who have had a stroke or transient ischaemic attack ( TIA ) leads to reduced risk of further stroke . However , it is not clear what the target BP should be , since intensification of therapy may lead to additional adverse effects . PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting , and whether more intensive therapy is associated with adverse effects on quality of life . Methods / Design This is a r and omised controlled trial ( RCT ) in patients with a past history of stroke or TIA . Patients will be r and omised to two groups and will either have their blood pressure ( BP ) lowered intensively to a target of 130 mmHg systolic , ( or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg ) compared to a st and ard group where the BP will be reduced to a target of 140 mmHg systolic . Patients will be managed by their practice at 1 - 3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months.610 patients will be recruited from approximately 50 general practice s. The following exclusion criteria will be applied : systolic BP < 125 mmHg at baseline , 3 or more anti-hypertensive agents , orthostatic hypotension , diabetes mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness . The primary outcome will be change in systolic BP over twelve months . Secondary outcomes include quality of life , adverse events and cardiovascular events . In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals underst and ing and views of BP management . Discussion The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care , and help determine whether or not further research is required before recommending such targets for this population .Trial Registration IS RCT Background In Shanghai there are 1.2 million people with hypertension , many of whom have difficulty in affording medical treatment . Community based , anti-hypertensive clubs have been created to provide health education but education alone is often ineffective . Lifestyle change programmes have shown some potential for reducing blood pressure but in previous trials have required specialist staff and extensive contact . We have previously demonstrated that self-management programmes delivered by health professionals , such as a nurse who has had short training in self-management techniques can change health behaviour and reduce symptoms . This study was design ed to evaluate the benefits of a simple , cognitive-behavioural , self-management programme for hypertension based around a hypertension manual and delivered in the setting of a community anti-hypertensive club in Shanghai . Method The method was a pragmatic r and omised controlled trial with an intention-to-treat analysis . Adult patients with mild-to-moderate primary hypertension , waiting to join a neighbourhood anti-hypertension club , were r and omised to the self-management programme or to an information only control procedure . They attended the group treatment sessions on 4 occasions over 5 weeks for education combined with goal setting for lifestyle change and an introduction to exercise . The main outcome measures were : changes in blood pressure ; blood total cholesterol ; diet ; activity level and health related quality of life 1 month and 4 months after the end of treatment . Results A total of 140 adults with mild-to-moderate primary hypertension took part . All of the main outcomes showed beneficial changes . Four months after the end of treatment the mean blood pressure differences between groups were systolic 10.15 mm Hg ( P < 0.001 , 95 % CI 7.25–13.05 ) , and diastolic 8.29 mmHg ( P < 0.001 , 95 % CI 6.71–9.88 ) . Patients in the intervention group also had significantly reduced weight , lowered blood total cholesterol , increased physical activity and improved quality of life . Conclusion Patients with mild-to-moderate primary hypertension attending a 5 week , group and manual based , cognitive-behavioural self-management programme , delivered through a voluntary club in Shanghai experienced a significant reduction in blood pressure . Trial registration Current Controlled Trials IS RCT Objective To assess clinical outcomes in the Study on COgnition and Prognosis in the Elderly ( SCOPE ) in patients who did not receive add-on antihypertensive therapy after r and omization , i.e. in patients that best reflect the original intention of a placebo-controlled trial . Design Post-hoc analysis of a prospect i ve , r and omized , controlled trial . Setting s and participants Five hundred and twenty-seven centres in 15 countries participated in SCOPE . Patients aged 70–89 years , with systolic blood pressure 160–179 mmHg and /or diastolic blood pressure 90–99 mmHg , and preserved cognitive function were eligible . Out of 4937 patients in SCOPE , 2098 did not receive add-on therapy . Intervention The number of patients who received c and esartan 8–16 mg once daily was 1253 , and 845 received placebo . Mean follow-up was 3.7 and 3.5 years , respectively . Main outcome measures Primary : major cardiovascular events ( cardiovascular mortality , non-fatal stroke or non-fatal myocardial infa rct ion ) . Secondary : total mortality , cardiovascular mortality , fatal and non-fatal myocardial infa rct ion , fatal and non-fatal stroke , cognitive function , and dementia . Results The treatment groups were generally well balanced for baseline characteristics . Blood pressure fell by 21.8/11.0 mmHg in the c and esartan group and by 17.2/8.4 mmHg in the placebo group . There were significant relative risk reductions with c and esartan in major cardiovascular events ( 32 % , P = 0.013 ) , cardiovascular mortality ( 29 % , P = 0.049 ) , and total mortality ( 27 % , P = 0.018 ) . There were no significant differences between the treatment groups in cognitive outcomes . Both treatments were generally well tolerated . Conclusions Treatment of elderly patients with mild hypertension is beneficial and supports current recommendations . C and esartan appears an appropriate therapy in such patients , in view of its favourable tolerability profile and ability to reduce major cardiovascular events 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 OBJECTIVES To evaluate the community pharmacist 's capacity to positively influence the results of antihypertensive drug therapy through a pharmaceutical care program and to determine what factors limit the program . DESIGN R and omized , controlled study . SETTING Private pharmacy caring for a semiliterate , rural Portuguese population . PATIENTS R and om sample of 100 patients with a diagnosis of essential hypertension who had been on drug treatment for less than 6 months . Patients were r and omly assigned to an intervention ( n = 50 ) or a control ( n = 50 ) group . INTERVENTION Individualized health promotion by a research pharmacist involving monthly appointments for 6 months to monitor blood pressure ; assess adherence to treatment ; prevent , detect , and resolve drug-related problems ( DRPs ) ; and encourage nonpharmacologic measures for blood pressure control . Control patients received traditional care . MAIN OUTCOME MEASURES Control of blood pressure ; decreases in systolic/diastolic blood pressure ; number of detected , resolved , and prevented DRPs . RESULTS From the initial sample of 100 patients , 41 patients in the intervention group and 41 patients in the control group completed the longitudinal study . After 6 months , prevalence of uncontrolled blood pressure decreased by 77.4 % in the intervention group ( P < .0001 ) and by 10.3 % in the control group ( P = .48 ) . Systolic blood pressure fell from a mean + /- st and ard deviation of 152 mm Hg + /- 23 mm Hg to 129 + /- 15 mm Hg in intervention patients and 148 + /- 16 mm Hg to 143 + /- 20 mm Hg in control patients ( P < .001 ) . Twenty-four of 29 ( 83 % ) detected actual DRPs were resolved . About 40 % of potential DRPs were prevented . CONCLUSION In this rural community , a pharmaceutical care program was associated with significant improvements in blood pressure control in hypertensive patients Background Hypertension is one of the key factors causing cardiovascular diseases . A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values . Shared decision making ( SDM ) is to enhance the active role of patients . As until now there exists little information on the effects of SDM training in antihypertensive therapy , we tested the effect of an SDM training programme for general practitioners ( GPs ) . Our hypotheses are that this SDM training ( 1 ) enhances the participation of patients and ( 2 ) leads to an enhanced decrease in blood pressure ( BP ) values , compared to patients receiving usual care without prior SDM training for GPs . Methods The study was conducted as a cluster r and omised controlled trial ( c RCT ) with GP practice s in Southwest Germany . Each GP practice included patients with treated but uncontrolled hypertension and /or with relevant comorbidity . After baseline assessment ( T0 ) GP practice s were r and omly allocated into an intervention and a control arm . GPs of the intervention group took part in the SDM training . GPs of the control group treated their patients as usual . The intervention was blinded to the patients . Primary endpoints on patient level were ( 1 ) change of patients ’ perceived participation ( SDM-Q-9 ) and ( 2 ) change of systolic BP ( 24h-mean ) . Secondary endpoints were changes of ( 1 ) diastolic BP ( 24h-mean ) , ( 2 ) patients ’ knowledge about hypertension , ( 3 ) adherence ( MARS-D ) , and ( 4 ) cardiovascular risk score ( CVR ) . Results In total 1357 patients from 36 general practice s were screened for blood pressure control by ambulatory blood pressure monitoring ( ABPM ) . Thereof 1120 patients remained in the study because of uncontrolled ( but treated ) hypertension and /or a relevant comorbidity . At T0 the intervention group involved 17 GP practice s with 552 patients and the  control group 19 GP practice s with 568 patients . The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints . Conclusion The study hypothesis that the SDM training enhanced patients ’ perceived participation and lowered their BP could not be confirmed . Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care . Trial registration German Clinical Trials Register ( DRKS ) : In 1972 - -1973 , 785 symptom-free men , aged 40 to 49 years , without target organ damage , with systolic blood pressures between 150 and 179 mm Hg and diastolic blood pressure below 110 mm Hg , were assigned at r and om to one of two groups : ( 406 to a drug treatment group and 379 to a control group ) for a five-year controlled drug treatment trial to evaluate the effect of therapy on cardiovascular complications . Drug treatment started with hydrochlorothiazide . If systolic blood pressure remained above 140 mm Hg and /or diastolic blood pressure above 90 mm Hg , alphamethyldopa was added . If there were side effects , methyldopa was replaced with propranolol . The control group was not given a placebo . The mean observation time was 66 months ( range 60 to 78 months ) . A difference in blood pressure between groups of about 17 mm Hg systolic and 10 mm Hg diastolic was maintained throughout the study . The study protocol had a rather low " ethical " blood pressure roof , 180 mm Hg systolic and /or 110 mm Hg diastolic . Seventeen percent of the control group had an increase in blood pressure above this level during the trial , and drug treatment was started . There was no effect on major cardiovascular morbidity comparing groups as established by r and omization , with 18 events in the treatment group and 20 events in the control group . There was no difference between the groups in total mortality and mortality from cardiovascular events . However , in the subgroups with diastolic blood pressure greater than or equal to 100 mm Hg before r and omization , there was a probable reduction in total morbidity from cardiovascular events in favor or the group receiving drug therapy , 7.6 and 16.4 percent events in the treated and control groups , respectively . Cerebrovascular events occurred only in the control group , 7 versus 0 . Two cases of fatal aortic aneurysms also occurred in the control group . Other " pressure " complications , such as marked left ventricular hypertrophy in the electrocardiogram and left ventricular failure , occurred only in the control group . However , regarding coronary heart disease , including sudden death , the incidence tended to be higher in the treated group , although it was not statistically significant . Only 13 men ( 1.7 percent ) failed to meet for regular examinations . At the end of the study these men were also followed up with regard to possible cardiovascular events
Antihypertensive drugs used in the treatment of adults ( primary prevention ) with mild hypertension ( systolic BP 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) have not been shown to reduce mortality or morbidity in RCTs .
More RCTs are needed in this prevalent population to know whether the benefits of treatment exceed the harms
BACKGROUND People with no previous cardiovascular events or cardiovascular disease represent a primary prevention population .
The benefits and harms of treating mild hypertension in primary prevention patients are not known at present .
This review examines the existing r and omised controlled trial ( RCT ) evidence .
OBJECTIVES PRIMARY OBJECTIVE To quantify the effects of antihypertensive drug therapy on mortality and morbidity in adults with mild hypertension ( systolic blood pressure ( BP ) 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) and without cardiovascular disease .