It is increasingly recognised that there are important advantages in studying problems and testing potential solutions in the setting where such problems are most often met. Advantages include the easier acceptance and transfer of results and the development of a research oriented attitude, which in medicine would be expected to increase the quality of care.'2 Isolated systolic hypertension is a common risk factor for cardiovascular and cerebrovascular events in the elderly population.34 Because of the attention focused on it in the mid-1980s we decided that treatment of this condition would be a good subject for a test randomised trial in the setting ofgeneral practice. Care of elderly people forms a large part of general practice, and narrowing the gap between research findings and therapeutic behaviour with respect to hypertension is a priority public health target.57 Based on the promising experience of a collaborative epidemiological study8 we planned a randomised controlled trial, which aimed at recruiting a large number of general practitioners on a voluntary basis. We thought that the trial in general practice could produce information confirmatory or complementary to that expected from other large studies then being conducted or planned in clinical settings.3"9The main aim of the study was to test the hypothesis that treatment of isolated systolic hypertension in elderly people reduces mortality and morbidity from cardiovascular and cerebrovascular causes. The secondary aim was to evaluate the hypotensive effect and safety of the most widely used hypotensive regimens. However, after the feasibility phase of the study had been completed the study was ended. The reasons for the failure of this trial could offer an insight into the relation between research findings and methods and attitudes and performance in general practice. The studyPreparation for the study took about 18 months. During this time we tried to establish active collaboration between the general practitioners and the coordinating group; general practitioners were recruited either through an advertisement in a widely read medical journal or from doctors who had already collaborated in studies organised by our institute. We held central and local meetings to discuss each draft of the protocol and written material was distributed periodically. The forms to be used in the study were tested to ensure that their structure was compatible with use in general practice. Much of the discussion with general practitioners was specifically concerned with the acceptability of the rather complex process of recruiting patients (figure).Of Attendance at follow up at three and six months was 94-6% and 93-9% of expected, respectively. During the follow up period no patient was excluded because of general practitioners' unsatisfactory compliance with the study protocol.Because of the small number ofdoctors participating in the study and the low rate of recruitment (a goal of at least 3500 randomised patients had been planned) the coordinating group decided t...
The prevalence of orthostatic hypotension (OH) in an elderly outpatient population was assessed according to the most common criteria given in the literature. Short-term OH variability and relationships between OH and its known risk factors were also analysed. A sample of 3858 elderly outpatients aged 65 years or more was randomly recruited by 444 Italian general practitioners. The patients' blood pressure (BP) and heart rate were recorded in both lying and standing positions at two visits 7 days apart. Three definitions were used for the identification of OH: (1) a decrease in systolic BP greater than 20 mmHg (SOH); (2) a decrease in both systolic (greater than 20 mmHg) and diastolic (greater than 10 mmHg) BP (SDOH); (3) any decrease in systolic BP associated with symptoms (SyOH). Prevalence figures for SOH were 13.8% at the first and 12.6% at the second visit, and respectively 5.3 and 4.8% for SDOH, 14.1 and 11.8% for SyOH. All the criteria were met by less than 2% of subjects at each visit. The diagnosis of OH was confirmed at both visits in 36.3% of cases for SOH, in 25.7% for SDOH, and in 43.9% for SyOH. Each different OH definition identifies a population subgroup characterized by different sets of risk-factors. The presence and prevalence of OH is difficult to define because different people may be identified by the currently accepted criteria or by the same criterion over a short time.
, MD; and general practitioners of SPAA Background: In young and middle-aged people, both systolic (SBP) and diastolic (DBP) blood pressure have a continuous, strong, and independent relationship with subsequent cardiovascular morbidity and mortality. These relationships are not well documented in older people and, until now, studies in the elderly do not provide homogeneous results on the importance of DBP compared with SBP as a cardiovascular risk factor.
Nonsteroidal antiinflammatory drugs may affect blood pressure (BP) control in hypertensive patients receiving drug treatment, but data on the effects of low-dose aspirin are scanty. This study assessed the effects of chronic treatment with low doses of aspirin (100 mg/day) on clinic and ambulatory systolic (SBP) and diastolic (DBP) BP in hypertensives on chronic, stable antihypertensive therapy. The study was conducted in the framework of the Primary Prevention Project (PPP), a randomized, controlled factorial trial on the preventive effect of aspirin or vitamin E in people with one or more cardiovascular risk factors. Fifteen Italian hypertension units studied 142 hypertensive patients (76 men, 66 women; mean age 59 +/- 5.9 years) treated with different antihypertensive drugs: 71 patients were randomized to aspirin and 71 served as controls. All patients underwent a clinic BP evaluation with an automatic sphygmomanometer and a 24-h ambulatory BP monitoring, at baseline and after 3 months of aspirin treatment. At the end of the study the changes in clinic SBP and DBP were not statistically different in treated and untreated subjects. Ambulatory SBP and DBP after 3 months of aspirin treatment were similar to baseline: deltaSBP -0.5 mmHg (95% confidence intervals [CI] from -1.9 to +2.9 mm Hg) and deltaDBP -1.1 mm Hg (95% CI from -2.5 to +0.3 mm Hg). The pattern was similar in the control group. No interaction was found between aspirin and the most used antihypertensive drug classes (angiotensin converting enzyme inhibitors and calcium antagonists). Despite the relatively small sample size our results seem to exclude any significant influence of low-dose aspirin on BP control in hypertensives under treatment.
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