AUSTRALIAN COMPARATIVE OUTCOME TRIAL OF ANGIOTENSIN-CONVERTING ENZYME INHIBITOR- AND DIURETIC-BASED TREATMENT OF HYPERTENSION IN THE ELDERLY (ANBP2): OBJECTIVES PROTOCOL

1. ANBP2 is a comparative outcome trial of angiotensin-converting enzyme inhibitor- and diuretic-based treatment of hypertension in the elderly using a prospective randomized open-label design with blinding of endpoint assessments. 2. The primary objective is to determine, in hypertensive subjects 65–84 years of age, whether there is any difference in total cardiovascular events (fatal and non-fatal) over a 5 year treatment period between the two treatment regimens. 3. The study is being conducted in general practices throughout Australia and will recruit 6000 subjects over 2–3 years (3000 in each arm of the study) to provide 30000 years of patient observation. This will allow detection of a 25% difference in the primary outcome variable at the 5% level with a power of 90%. 4. Following randomization to one of the treatment arms, each subject's blood pressure (BP) is managed by the general practitioner according to his/her usual practice to achieve goal BP with guidelines for drug therapy relevant to each treatment arm. 5. Study endpoint information is gained from a review of practice records every 3 months and these data are then assessed by an Endpoint Committee blinded for treatment randomization. 6. Interim analyses of endpoint data will be conducted at the end of randomization and then annually until the final analysis after 5 years of observation in each subject.     

A CONTROLLED STUDY OF THE EFFECTS OF AEROBIC EXERCISE ON ANTIHYPERTENSIVE DRUG REQUIREMENTS OF ESSENTIAL HYPERTENSIVE PATIENTS IN THE GENERAL PRACTICE SETTING

1. To investigate the effect of an exercise training programme on antihypertensive drug requirements, 19 sedentary subjects (14 men and five women) with mild essential hypertension (systolic blood pressure greater than 140 mmHg but less than 180 mmHg), aged 29-55 years, were randomly assigned to 16 weeks of moderate intensity exercise or light intensity exercise (control), and titrated on antihypertensive drug therapy (captopril and hydrochlorothiazide) until resting systolic blood pressure (sitting) of less than 140 mmHg was achieved. 2. The moderate exercise group (n = 11) followed a graded walk-jog programme to greater than 60% age-predicted maximum heart rate (HRmax), attending 45 min sessions, three times each week. The light exercise group (n = 8) followed a programme of flexibility (stretching exercises) and walking to less than 60% age-predicted HRmax, attending 45 min sessions, three times each week. 3. There was no difference between treatment groups for the level of reduction in both resting systolic and diastolic blood pressure over the 16 weeks (15.64 +/- 10.6/12.81 +/- 9.97 mmHg in the moderate intensity group and 15.31 +/- 10.9/7.7 +/- 7.1 mmHg in the light intensity group). The change in 24 h ambulatory blood pressure profile was also similar in both treatment groups. The final antihypertensive drug requirements to achieve these changes in blood pressure was not significantly different between the two treatment groups. This was despite a significant improvement in submaximal exercise performance in the moderate intensity exercise group (P less than 0.001). 4.(ABSTRACT TRUNCATED AT 250 WORDS)     

BLOOD PRESSURE LOWERING IN PATIENTS WITH CEREBROVASCULAR DISEASE: RESULTS OF THE PROGRESS (PERINDOPRIL PROTECTION AGAINST RECURRENT STROKE STUDY) PILOT PHASE

1. Among patients with cerebrovascular disease, there is a direct and continuous association between blood pressure and the risk of stroke, but previous trials of blood pressure lowering in this patient group have been inconclusive. 2. PROGRESS (Perindopril Protection Against Recurrent Stroke Study) is a multicentre, randomized, placebo-controlled trial that aims to determine reliably the effect of angiotensin converting enzyme (ACE) inhibitor-based blood pressure lowering on stroke risk in patients with a history of cerebrovascular disease. If a 4 week run-in period on active perindopril is well tolerated, participants are randomized to either perindopril (4 mg) ± indapamide (2.5 mg) or matching placebo(s). The primary study outcome is stroke and follow-up is for a minimum of 4 years. 3. For the pilot study nearly 5000 medical records were screened and 60 patients with recent cerebrovascular events were approached directly in hospital or at a clinic visit. Sixtyseven patients entered the run-in phase (52 from retrospective screening and 15 by prospective approach) and 60 patients proceeded to randomization. Treatment with perindopril was well tolerated; only three patients were withdrawn due to side effects and four were withdrawn for other reasons. The mean age of randomized patients was 68 years; 70% were male and 55% were ‘non-hypertensive'. The mean entry blood pressure was 142/83 mmHg and following pre-randomization treatment this was reduced by 7/4 mmHg. 4. Most patients were identified by retrospective review of medical records, but this was less efficient than prospective methods. Blood pressure lowering was well tolerated by both hypertensive and non-hypertensive patients with cerebrovascular disease. The small numbers of patients and the nonrandomized nature of the data reported limit the conclusions that can be drawn, but the results confirm the feasibility of the main study.