T. O. Morgan

Second Australian National Blood Pressure Study (ANBP2) - Australian Comparative Outcome Trial of ACE inhibitor- and Diuretic-based Treatment of Hypertension in the Elderly

The Second Australian National Blood Pressure Study (ANBP2) is a comparative outcome trial being conducted in general practices throughout Australia of ACE inhibitor- and diuretic-based treatment in 6000 hypertensive patients aged 65-84 years. The study is using a prospective randomised open-label design with blinding of endpoint assessments. The primary objective is to determine whether there is any difference in total cardiovascular events (fatal and non-fatal) over a five year treatment period between the two treatment regimens. Eligible hypertensive patients (average sitting blood pressure at the 2nd and 3rd screening visits > 160 mm Hg systolic and/or > 90 mm Hg diastolic) may be either untreated or previously treated and should have no history of recent cardiovascular morbidity or serious intercurrent illness. Patients are randomised to one of the treatment arms with randomisation stratified for practice and for age. Following randomisation each patients blood pressure is managed by his/her general practitioner according to guidelines relevant to each treatment arm. Over 700 patients have now been randomised with recruitment intended to be complete by the end of 1997.

Australian Comparative Outcome Trial of Angiotensin-Converting Enzyme Inhibitor And Diuretic-Based Treatment of Hypertension in the Elderly (ANBP2): Objectives and 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.

Who's really hypertensive? - Quality control issues in the assessment of blood pressure for randomized trials

The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre‐defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator‐related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi‐centre community‐based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study entry is essential to appropriately characterize hypertension in these elderly patients.

FEASIBILITY OF CONDUCTING CARDIOVASCULAR OUTCOME RESEARCH IN AUSTRALIAN GENERAL PRACTICE: RESULTS FROM THE ANBP2 PILOT STUDY

1. The present study aimed to determine the feasibility of conducting a 5 year cardiovascular outcome trial of the treatment of 6000 elderly hypertensive patients in Australian general practices.

Felodipine Compared to Prazosin as Additional Therapy to a Beta-Blocking Drug

Felodipine was compared with prazosin in patients with essential hypertension whose blood pressure was not controlled by a beta-blocking drug. One hundred patients with a supine diastolic blood pressure greater than or equal to mm Hg after 4 weeks or more on a beta-blocking drug and placebo were randomly assigned to felodipine or prazosin tablets. The drugs were titrated at 2-week intervals if diastolic BP was greater than or equal to 90 mm Hg. Titration steps of felodipine were 5, 10, 20 mg b.i.d. and of prazosin were 1, 2, 4 mg b.i.d. The fall in blood pressure with felodipine 32/21 mm Hg was greater than the fall with prazosin 16/12 mm Hg (p less than 0.001); 36 patients achieved a diastolic blood pressure of less than 90 mm Hg with felodipine, which was a significantly greater number than the 20 patients who obtained such a level with prazosin (p less than 0.01). Both drugs were well tolerated, but more patients complained of vascular type side effects (flushing, peripheral edema) with felodipine than with prazosin. There was significant weight gain with prazosin but not with felodipine. Felodipine was shown to be a well-tolerated, effective antihypertensive agent when used with a beta-blocking drug and to be suitable for people with hypertension who fail to be controlled with a beta-blocking drug.