Showing papers by "Bruce Neal published in 1996"

Blood pressure lowering in patients with cerebrovascular disease: results of the progress (perindopril protection against recurrent stroke study) pilot phase

Abstract: SUMMARY 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 Treatment with perindopril was well tolerated; only three patients were withdrawn due to side effects and four were withdrawn for other reasons.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.

PROGRESS - perindopril protection against recurrent stroke study: Status in July 1996

Abstract: Objectives The primary objective of PROGRESS is to determine reliably the efficacy of lowering blood pressure for the prevention of stroke in patients with a history of cerebro-vascular disease. Design PROGRESS is a randomized, double-blind, placebo-controlled trial investigating the effects on the incidence of stroke and other major cardiovascular events and dementia of treatment with the angiotensin-converting enzyme inhibitor perindopril, alone or in combination with the diuretic indapamide. Methods The study population comprises 6000 normotensive or hypertensive patients with a history of stroke or transient ischaemic attack within the previous 5 years. The study is being conducted in over 160 centres in seven regions: Australia and New Zealand, The People's Republic of China, France and Belgium, Italy, Japan, Sweden and the United Kingdom. Computerized randomization to active treatment or placebo is performed by fax direct to Auckland, New Zealand. The primary study outcome is total stroke and secondary outcomes include fatal or non-fatal stroke, total major cardiovascular events and deaths, cognitive function and disability. Patients will be followed for a minimum of 4 years after randomization. Results By 16 July 1996, 162 local clinical centres had been registered across the seven regions, and 1682 patients, 49% with a history of hypertension, had been randomly assigned to receive active treatment or placebo, with 65% allocated to the combination of perindopril and indapamide or double placebo, and 35% to perindopril alone or single placebo. Three months after randomization, the blood pressure difference between the treatment and control groups among the first 182 patients randomized was 11.9 mmHg (systolic) and 3.9 mmHg (diastolic). Six strokes and two non-stroke cardiovascular deaths have been recorded after a total of 3174 patient-months of follow-up. Conclusions Observations made so far confirm that full recruitment into the study is feasible and that treatment with perindopril and indapamide is well tolerated in the study population. The blood pressure differences between control and treatment groups recorded so far suggest that the study should have the power to achieve its primary objectives, provided compliance with treatment is satisfactory and 6000 patients are successfully recruited and followed for 4–5 years.

Forty years of randomised trials in the New Zealand Medical Journal.

Abstract: AIM To identify all randomised trials published in the New Zealand Medical Journal, to document the basic characteristics of these trials and to count the number that were detectable on medline. METHODS All issues of the New Zealand Medical Journal between 1943 and 1995 were systematically hand-searched. All trials identified were characterised and compared against the trials identified using an optimal medline search strategy. RESULTS The handsearch identified 152 randomised controlled trials, the first published in 1955. Half the trials recruited less than 34 participants and more than 90% were of pharmaceutical interventions. Only 18% of studies reported on the method of randomisation and 13% provided evidence that final analyses were conducted on an intention to treat basis. Fifty one percent of trials employed a placebo control group and 28% involved a crossover design. Since 1966, when Medline became available, 143 trials were published of which 89 (62%) were identified by the Medline search. CONCLUSIONS Two of the major difficulties that face those preparing systematic reviews were illustrated by this survey. First, important information on design and analysis is often missing from reports of trials. Second, a large proportion of published randomised trials are not identifiable on Medline. Standard formats for reporting the results of trials and inclusion of trials identified by hand-searching on the Cochrane Collaboration's International Register of Randomised Controlled Trials of Health Care will facilitate the future production of reliable systematic reviews.