Patient-reported outcomes following treatment with the human GLP-1 analogue liraglutide or glimepiride in monotherapy: results from a randomized controlled trial in patients with type 2 diabetes.

AIM: As weight gain and hypoglycaemia associated with glimepiride therapy can negatively impact weight perceptions, psychological well-being and overall quality of life in type 2 diabetes, we investigated whether liraglutide treatment could improve these factors. METHODS: Seven hundred and thirty-two patients with type 2 diabetes completed a 77-item questionnaire during a randomized, 52-week, double-blind study with liraglutide 1.2 mg (n = 245) or 1.8 mg (n = 242) compared with glimepiride 8 mg (n = 245). RESULTS: Mean (SE) decreases in glycated haemoglobin levels were greater with liraglutide 1.2 mg [-0.84 (0.08)%] and 1.8 mg [-1.14 (0.08)%] than glimepiride [-0.51 (0.08)%; p = 0.0014 and p < 0.0001, respectively]. Patients gained weight on glimepiride [mean (SE), 1.12 (0.27) kg] but lost weight on liraglutide [1.2 mg: -2.05 (0.28) kg; 1.8 mg: -2.45 (0.28) kg; both p < 0.0001]. Patient weight assessment was more favourable with liraglutide 1.8 mg [mean (SE) score: 40.0 (2.0)] than glimepiride [48.7 (2.0); p = 0.002], and liraglutide 1.8 mg patients were 52% less likely to feel overweight [odds ratio (OR) 0.48; 95% confidence interval (CI): 0.331-0.696]. Mean (SE) weight concerns were less with liraglutide [1.2 mg: 30.0 (1.2); 1.8 mg: 32.8 (1.2)] than glimepiride [38.8 (1.2); p < 0.0001 and p < 0.001, respectively], with liraglutide groups 45% less likely to report weight concern (OR 0.55, 95% CI: 0.41-0.73). Mean (SE) mental and emotional health and general perceived health improved more with liraglutide 1.8 mg [476.1 (2.8) and 444.2 (3.2), respectively] than glimepiride [466.3 (2.8) and 434.5 (3.2), respectively; p = 0.012 and p = 0.033, respectively]. CONCLUSIONS: Improved glycaemic control and decreased weight with liraglutide 1.8 mg vs. glimepiride can improve psychological and emotional well-being and health perceptions by reducing anxiety and worry associated with weight gain.

AIDS-related Kaposi's sarcoma: prospective validation of the AIDS Clinical Trials Group staging classification. AIDS Clinical Trials Group Oncology Committee.

PURPOSE: To prospectively validate the AIDS Clinical Trials Group (ACTG) staging classification for AIDS-associated Kaposi's sarcoma (KS). PATIENTS AND METHODS: Two hundred ninety-four consecutive patients enrolled in eight ACTG therapeutic trials for AIDS-associated KS were staged prospectively according to tumor extent (T), severity of immunosuppression (I), and other systemic human immunodeficiency virus type 1 (HIV-1)-associated illness (S) and were observed for survival. Patients were classified as good risk (subscript 0) or poor risk (subscript 1) for each variable according to published ACTG criteria. Univariate and multivariate analyses were used to evaluate the associations between TIS variables and survival; additional analyses were conducted to improve the predictive value of the staging system. RESULTS: Survival was significantly shorter for patients in the poor-risk category for each of the TIS variables. Respective median survivals for patients in the good- and poor-risk categories were 27 and 15 months for T (P < .001); 40 and 13 months for I (P < .001) when I0 included CD4 counts > or = 200/microL and 22 and 16 months for S (P = .04). Multivariate analysis indicated that severity of immunosuppression gave the most predictive information but also showed that T provided significant additional predictive information in patients whose immune function was least impaired. Refined Cox models using a CD4 count of 150/microL rather than 200/microL to distinguish I0 and I1 yielded a simplified model with better fit to the observed data. CONCLUSION: The ACTG TIS classification predicts survival in patients with AIDS-associated KS; CD4 count and tumor stage provide the most predictive information. However, a lower CD4 count than the one originally proposed provides better discrimination between prognostic groups.

Prognostic factors in the treatment of human immunodeficiency virus-associated non-Hodgkin's lymphoma: analysis of AIDS Clinical Trials Group protocol 142--low-dose versus standard-dose m-BACOD plus granulocyte-macrophage colony-stimulating factor. National Institute of Allergy and Infectious Diseases.

PURPOSE: The overall results of chemotherapy in human immunodeficiency virus (HIV)-associated non-Hodgkin's lymphoma (NHL) have been poor. To define a subgroup of patients who may have a better outcome, an analysis of prognostic factors was performed of patients treated in AIDS Clinical Trials Group (ACTG) protocol 142, a phase III randomized trial of low-dose versus standard-dose methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) plus granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of patients with newly diagnosed HIV-associated NHL. MATERIALS AND METHODS: The following baseline variables were included as potential predictors of survival among 192 patients who received treatment: age; intravenous drug use (IVDU); specific type of sexual contact as risk factors (homosexual, bisexual, or heterosexual contact); prior AIDS diagnosis; CD4 cell count; serum lactic acid dehydrogenase (LDH); histology; Karnofsky performance status (KPS); stage; B symptoms; race (white/nonwhite); nodal involvement; extranodal involvement; number of extranodal sites; specific sites: bone marrow, liver, kidney, lung, or gastrointestinal tract; and treatment arm (standard-dose m-BACOD/low-dose m-BACOD). RESULTS: Age greater than 35 years, IVDU, stages III/IV, and CD4 cell counts less than 100/microL were adverse prognostic factors in multivariate analyses using the Cox proportional hazards model. The median overall survival for patients with none or one of the adverse factors was 46 weeks, with two was 44 weeks, and with three or four was 18 weeks. At 144 weeks, 29.5% of patients with none or one, 16.9% with two, and 0% with three or four factors were alive (P < .001). CONCLUSION: Long-term survival can be achieved in approximately one third of patients with HIV-associated NHL with favorable characteristics.

Clinical predictors of retinopathy and its progression in patients with type I diabetes during CSII or conventional insulin treatment.

Data from 70 type I diabetic patients with nonproliferative retinopathy participating in a multicenter clinical trial of control and complications were analyzed to test for associations of clinical variables with baseline levels and 8-mo changes in retinopathy. Predictor variables included age, duration of diabetes, systolic blood pressure, inpatient and outpatient plasma glucose levels, glycosylated hemoglobin (HbA1), M-values, serum cholesterol, serum triglycerides, and creatinine clearance. Retinopathy was assessed by fundus photography and graded at the Fundus Photograph Reading Center according to a detailed protocol. For the entire group, baseline retinopathy was positively correlated (P less than 0.05) with baseline systolic blood pressure, plasma glucose, HbA1, serum cholesterol, and duration of disease and negatively correlated with creatinine clearance. Conversely, during treatment, progression of retinopathy was negatively correlated (P less than 0.05) with mean levels during treatment of plasma glucose, HbA1, M-values, serum cholesterol, and with changes during treatment in plasma glucose and serum triglycerides. Two-group and three-group multivariate classification analysis of progression of retinopathy (improved or unchanged versus worsening--mild or moderate) indicated lower plasma glucose as the single best predictor of worsening of retinopathy (P less than 0.05), correctly classifying 71% of patients with positive progression. Decreased creatinine clearance during therapy was found to be the best discriminator between mild and moderate progression. Other multivariate models yielded specificity values of up to 71% and sensitivity values of up to 92%. We conclude that associations among clinical predictors and retinopathy during short-term glycemic control differ strikingly from those at baseline.(ABSTRACT TRUNCATED AT 250 WORDS)

Valuing quality of life and improvements in glycemic control in people with type 2 diabetes.

Outcomes research is used increasingly for assessing the health economic benefits of new therapeutic programs and interventions. The measurement properties of the outcomes assessment tools are important. If overlooked, they can mislead health care administrators and caregivers regarding the importance and value of these programs and interventions. We reviewed the literature and conducted two analyses to determine the absolute, relative, and operative quality-of-life ranges for people with type 2 diabetes. Quality of life and fasting blood glucose and HbA1c concentrations were measured at baseline and at 4, 8, and 12 weeks of treatment in 569 men and women randomized to either glipizide gastrointestinal therapeutic system (GITS) or placebo in a double-blind, multicenter clinical trial. A subgroup of 290 patients completed a diabetes-specific health states questionnaire at endpoint (week 12 or early termination) rating 10 health-state descriptions on a health thermometer scale ranging from 0 (death) to 100 (full health). Health losses at the higher end of the scale had a greater negative utility than did comparable losses at lower health states, indicating patients' strong preferences for maintaining asymptomatic or mildly symptomatic conditions. Patients rated their current health state at 83.4 +/- 0.8% of full health and indicated that a loss of 27 points below this value would prevent them from living and working as they currently do. The calibration analysis applied to the quality-of-life scales suggested that the targeted range for clinical investigation and quality-of-care evaluation must be more narrowly focused. Effect sizes as seemingly small as 2% (0.25 responsiveness units) on the absolute scale can correspond to quality-of-life losses of 15-20% on the personal operative scale. Differences in glycemic control clearly affected quality of life. Those patients with the best HbA1c responses (decreasing 1.5% or more from baseline) versus those with the worst responses (increasing 1.5% or more from baseline) were separated by 0.6 responsiveness units for the overall quality-of-life summary measure. The calibration analysis suggested that this degree of better glycemic control provides a nearly 50% gain in quality of life according to personal expectations within the operative range. In conclusion, general measures of quality of life may be too crude and insensitive to capture the important gains in health outcomes due to new therapeutic interventions and programs in diabetes. Quality-of-care evaluations for diabetes are at risk of favoring inferior programs with lower costs simply because gains or losses in health outcomes go undetected.

Reproducibility of DXA absorptiometry: a model for bone loss estimates.

The enhanced precision of dual-energy X-ray absorptiometry (DXA) allows the detection of very small changes in bone mineral density (BMD). True clinical changes in BMD in patients must be evaluated with the appropriate error of variance. We evaluated the responsiveness of our measures to true bone loss using a statistical variance components model that characterizes the variability associated with error introduced by the machine, operator, and subjects. Our techniques were applied to data from a prospective study of BMD measurements on spine phantoms and on pre- and postmenopausal women performed on the same day or up to 4 weeks apart with DXA (QDR 1000W, Hologic). Our model determined that most of the error in measurements was introduced by operators' and subjects' variability rather than machine performance. The false-positive rates for true bone change are significantly reduced when the appropriate CV% is used to estimate the significance of bone loss over time. Our study underscores the need to use the appropriate precision error to evaluate the clinical significance of changes in bone mass in individual subjects over time.

Quality of life and calcium channel blockade with nifedipine GITS versus amlodipine in hypertensive patients in Spain. Gastrointestinal Therapeutic System.

OBJECTIVE: Compliance with hypertension treatment is affected by treatment-related factors (complexity, side effects), efficacy and compound-specific effects that impact on quality of life. This study examined the differences in quality of life produced by two once-daily calcium channel blockers using different delivery systems: nifedipine gastrointestinal therapeutic system (GITS) and amlodipine. DESIGN: This was a double-blind, double-dummy, randomized clinical trial comparing nifedipine GITS (30 mg) and amlodipine (5 mg) for 24 weeks following a placebo run-in. Clinical, laboratory evaluations and quality-of-life data were assessed at screening, baseline randomization and three times during active therapy. SETTING: The study was conducted in 13 medical clinics in Spain. PATIENTS: The sample comprised 430 screened and 356 randomized patients with mild to moderate hypertension (diastolic blood pressure 95-114 mmHg). MAIN OUTCOME MEASURES: Change in systolic and diastolic blood pressure and in health-related quality of life were the main outcome measures. RESULTS: There were no significant differences between active treatment groups in the blood pressure changes (systolic blood pressure: nifedipine GITS -15.5 mmHg; amlodipine -15.7 mmHg). Spontaneous adverse events consistent with calcium channel blockage were not different. The nifedipine GITS group improved in all quality-of-life measures except Sexual Symptom Distress and showed a significantly greater improvement than amlodipine in overall Quality of Life (P< 0.05), General Perceived Health (P < 0.026) and its subscale Vitality (P < 0.019). The amlodipine group declined in overall Quality of Life, General Perceived Health, Vitality and Sleep Disturbance, and significantly in Sexual Symptom Distress (P < 0.045). However, this group improved in self-reported Cognitive Functioning (P=0.036), Mental Acuity (P < 0.005) and Detachment/disorientation (P=0.01). CONCLUSIONS: These results suggest compound-specific effects on quality of life that may be due to differences in the delivery system. Nifedipine GITS is short-acting (2 h half-life) and is delivered continuously over a 24 h period, while amlodipine has a half-life of 40 h, which may produce more sustained low-level effects. While a more beneficial profile was observed for nifedipine, amlodipine demonstrated potential positive effects on cognitive functioning.

The effects of venlafaxine on social activity level in depressed outpatients.

BACKGROUND: Although most depression treatment outcome scales focus on symptoms, depression also affects daily functioning, social activity, and quality of life. We examined the effects of venlafaxine on social activity, general life functioning, and depressive symptoms in 2 placebo-controlled clinical trials of venlafaxine. METHOD: Subjects were 600 outpatients with major depression (DSM-III-R criteria). Treatment outcomes were examined separately in each study, primarily because of differing lengths of follow-up. RESULTS: Treatment with venlafaxine significantly improved activity level, general life functioning, and depressive symptoms. Treatment accounted for statistically significant changes in both activity level and general life functioning even after controlling for changes in depression. CONCLUSION: We provide evidence that social activity is a behavioral domain distinct from depressive symptoms and that venlafaxine improves social activity level and general life functioning in addition to its positive effects on depressive symptoms in outpatients with major depression.

Commercial research and development in times of financial restraint.

More than most other areas of medical practice, radiology depends on technology for the practice of its specialty, the effectiveness of its specialists, and the contribution it can make to medical care. Consequently, manufacturers of diagnostic imaging equipment and supplies have special importance to radiologists, and there has long been a productive interrelationship between those vendors and radiologists, resulting in rapid growth in the sophistication and effectiveness of diagnostic imaging products. Presumably because the market for imaging equipment and supplies is narrowing, in the past three years there has been some redirection of research expenditures away from pure research into applied research and product development, although absolute levels of research funding have not decreased. Understanding the theory of the firm provides an insight into how vendors might respond to changes in the size of the equipment market or the certainty of the market in the future. Because the research and development activities of these vendors are important to radiology practice, radiologists need to understand corporate behavior, just as managers of companies providing imaging equipment and supplies need to understand the requirements and concerns of their market. Finally, individuals and agencies that determine the ultimate reimbursement for diagnostic medicine should be mindful of the effect their decisions have on costs and efficiencies in this area, particularly the risk that the long-range effect on the cost and quality of medical care is quite different from that intended.

Assessment of quality of life by patient and spouse during antihypertensive therapy with atenolol and nifedipine gastrointestinal therapeutic system.

To evaluate differences in efficacy, safety, and quality of life, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine gastrointestinal therapeutic system (GITS) in a multicenter double-blind trial. A four-week placebo washout was followed by 8 weeks of titration and 12 weeks of maintenance therapy. Quality-of-life evaluation included clinical assessments by the patient and parallel take-home assessments by patient and spouse. Blood pressure was controlled equally in both groups. The total incidence of adverse reactions was similar in both groups, but a greater percentage of nifedipine GITS patients withdrew due to peripheral edema. Patients completing 20 weeks of therapy demonstrated a more favorable quality-of-life profile (P less than .05) for nifedipine GITS over atenolol in psychosocial (P less than .01), well-being (P less than .05), general affect (P less than .05), emotional ties (P less than .01), emotional control (P less than .05), vitality (P less than .05), and leisure (P less than .05) scores. Treatment differences were particularly pronounced for patients over 50 years of age and were not fully detectable until after 14 weeks of therapy. Deterioration in quality of life was associated with withdrawal. Spouses of younger patients receiving atenolol reported deterioration in sexual satisfaction as compared to spouses of patients taking nifedipine GITS (P less than .02). Thus age, length of trial, and third-party observation are important factors in quality-of-life assessment. Comparison of adverse reactions provides an incomplete measure of how well a drug is tolerated. In contrast, findings indicate that even subtle CNS-mediated effects on mood and well-being can be detected by quality-of-life evaluation.

Differentiation of Pseudomonas aeruginosa and Enterobacteriaceae in direct smears based on measurements by scanning electron microscopy.

We believe that experienced observers can often distinguish between Enterobacteriaceae and Pseudomonas aeruginosa, by differences in dimensions in Gram-stained direct smears. Many microbiologists question whether this should be attempted because of overlap in dimensions. We have found that culture results confirm our observations about 80% of the time and that such reporting is helpful in diagnosis and treatment. We decided to try to verify the differences in dimensions objectively. Because of the limitations of making measurements by light microscopy, exudate from clinical specimens and from experimental mouse infections were examined by scanning electron microscopy. Discriminant function analysis was applied to the dimensions of length and width, and this showed that 83% of the organisms in both groups could be correctly classified on the basis of the dimensions. This supports our premise that experienced observers should be able to differentiate between these organisms in Gram-stained direct smears, using light microscopy with sufficient confidence to provide clinically useful information.

Modeling fracture risk using bone density, age, and years since menopause.

INTRODUCTION: Preventive strategies are essential for reducing the incidence of osteoporosis and its consequences. However, simple algorithms that predict an individual's future risk of fractures are scarce. The purpose of the study was to define a clinical decision aid that enables physicians to project an individual's life-time fracture risk and therefore institute preventive therapies. METHODS: A predictor equation for bone loss was developed using bone mineral density (BMD), age, years since menopause, and weight. This was applied to normal and osteoporotic women, ages 40-80 years (n = 117) screened for osteoporosis studies. RESULTS: A spinal BMD cutoff of 0.86 gm/cm2 had a sensitivity of 90% and a specificity of 60% for detecting subjects with vertebral fractures and was therefore defined as a high-risk BMD. Using the parameter estimates from the above equation and an individual's clinical data, we derived prediction curves to forecast the age at which that individual would reach the above defined high-risk BMD, and therefore that person's expected number of remaining life-years at high risk for fractures. CONCLUSIONS: This study proposes a conceptual framework for the development of a clinical decision aid to provide guidelines for the prevention of osteoporosis. A longitudinal study that incorporates other variables such as prevalent fractures and biochemical markers of bone turnover would further validate this model and enhance its application.

A short form for clinical assessment of quality of life among hypertensive patients.

Recently, medical research studies and clinical trials have included quality-of-life assessments, which measure the biomedical, behavioral, and social dimensions of living as a major therapeutic end point. Monitoring the quality of life in routine clinical practice also has the potential to aid clinicians to evaluate the impact of new therapies on the health status of their patients. However, because quality-of-life assessment techniques are quite lengthy and often require the aid of a trained interviewer, the research format is not practical for the typical clinical setting. This study describes the formulation, construction, and testing of an abbreviated quality-of-life questionnaire suitable for the clinical assessment of hypertensive patients. The initial formulation was based on analyses of data from a large-scale clinical trial (626 hypertensive male patients). Using the data at baseline for this group, items were selected such that the variance, internal consistency, and concurrent validity of the response scales were maintained by a reduced subset of items. The sensitivity of the reduced subsets was evaluated using treatment data and found to be as sensitive to treatment differentials as the original research instrument was. A subsequent field test of 87 volunteer subjects indicated that the new shortened version had the qualities of stable internal consistency and test-retest reliability over two successive trials. The questionnaire was self-administered and required less than 10 minutes to complete. It was given as an adjunct to the history and physical exam.(ABSTRACT TRUNCATED AT 250 WORDS)

Interpreting pharmacoeconomic and quality-of-life clinical trial data for use in therapeutics.

Interpretation of quality-of-life (QOL) and pharmacoeconomic data for therapeutic decision making and therapeutic policy planning requires a basic understanding of the methods, assumptions and limitations of the data and associated methods of analysis. Measures of the effectiveness of different pharmaceutical agents can be modified by including functions which involve assessment of the treated individual's quality of life. These quality-adjusted effectiveness measures will alter conclusions concerning clinical decisions as well as the cost-effectiveness of the comparative agents under consideration. To provide a conceptual and analytical framework for understanding the relationship between QOL assessment and pharmacoeconomic modelling, interpretations of the quality-adjusted analyses are reviewed, conceptual and analytical models are proposed, and recommendations for using QOL data in pharmacoeconomic models are outlined. Techniques for incorporating QOL measures in pharmacoeconomic models are examined using a hypothetical model involving therapeutic assessments of antiviral treatments for individuals with HIV disease. Adjustments of effectiveness measures based upon QOL-related functions are then globally addressed using stochastic compartmental models. Three specific methods for adjustment used in therapeutic trials are reviewed. Applications of these techniques to 3 studies involving the treatment of HIV disease and hypertension are critically reviewed. Issues relevant to choosing or estimating measures of quality of life for use in pharmacoeconomic models are summarised, and research guidelines are proposed.

A review of the quality-of-life aspects of urinary urge incontinence.

Urinary incontinence (UI) is prevalent and costly, occurring in 15 to 30% of the US population over the age of 60 years. Among people aged 15 to 64 years, UI occurs in 1.5 to 5% of men and 10 to 25% of women. Severe incontinence occurs in 6% of the general US population, and it is estimated that $US10 billion per year is spent in direct costs alone on care for these patients. This review presents a description of the various types of UI and describes the prevalence and costs of the condition. In addition, 3 approaches to assessing the impact of UI on quality of life are discussed, namely generic measures, disease-specific measures and qualitative approaches. We also review papers on UI and sexual functioning, UI in men, and some aspects of treatment. The review was conducted in the process of developing a new disease-specific measure for urinary urge incontinence (UUI). In general, the literature suggests that UUI has a greater impact than stress incontinence on quality of life, and that UI affects social and psychological functioning more than physical functioning. Only in a minority of individuals is the impact of UI disabling; however, most individuals with UI show significant reduction in their social functioning. Several studies suggest that the impact of UI is not solely a function of its severity, but also depends on individual coping abilities. Some studies also indicate that the social problems associated with UI grow with time, but it is not clear if that is a function of increasing severity of the condition, or the particular adaptations required for coping with this problem. An important distinction appears to be the ability of individuals to avoid public notice of their condition because of uncontrolled accidents. In summary, there is a need for a new measure of the quality-of-life impact of UUI that is based on the literature and on in-depth interviews with patients.

The use of six selected teeth in population measures of periodontal status.

Selected teeth have been used to represent the entire dentition in many epidemiological and clinical investigations. The present study sought to assess the relationship between the six selected teeth described by Ramfjord and the entire dentition for the Plaque Index, Gingival Index, Calculus Index and Loss of Attachment. The computations were performed on measurements obtained in investigations of the natural history of periodontal disease in Norway and Sri Lanka. A consistently strong correlation was observed between the tooth subset and whole mouth for all indices in both populations. This relationship persisted even though single members or pairs of the subset of teeth were removed from the calculations. Some bias, however, was observed with all indices. Plaque and gingival indices obtained from the six teeth underestimated whole mouth scores in the low range (less than 1.0) and overestimated scores in the high range (greater than 2.0). Use of the tooth subset for calculus and loss of attachment consistently overestimated scores for the entire dentition.

Defining and measuring quality of diabetes care.

The literature on diabetes mellitus has increasingly focused on the quality of diabetes care and its measurement. Serious and widespread quality problems exist throughout American medicine. Current efforts to improve will not succeed unless we undertake a major, systematic effort to overhaul how we deliver health care services, educate and train clinicians, and assess and improve quality. This article defines the components of quality of diabetes care provision and discusses approaches to their measurement individually and globally.

Correlation of postnatal regression of the anterior vascular capsule of the lens to gestational age.

The AVC of the lens was examined and graded at birth and prospectively at weekly intervals, in 30 preterm infants of gestational age between 27 and 34 weeks. Influence of postnatal age, postnatal nutrition, subsequent development of retinopathy of prematurity as well as intrauterine growth retardation, multiple gestation and prenatal maternal steroid administration on regression of AVC was analyzed. We conclude that examination of the AVC of the lens can reliably be used to estimate gestational age between 27th and 34th weeks, in appropriate as well as small for gestational age infants. Such an examination can be used postnatally, provided that the infant's corrected gestational age is between 27 and 34 weeks. Prenatal steroid administration, postnatal nutritional status or subsequent development of retinopathy of prematurity do not appear to be correlated with the rate of AVC regression.

[Cardiovascular risk factors in a community in Piedmont: changes after 11 years and a comparison with other regional and national data]. / Fattori di rischio cardiovascolare in una comunità del Piemonte: variazioni a distanza di undici anni e confronto con altri dati regionali e nazionali.

BACKGROUND: In 1986 the Cardiology Department, including an outpatient clinic, was established in the community hospital of Savigliano (Italy). In 1987, as a part of a cardiovascular community prevention program, an epidemiological survey on cardiovascular risk factors was carried out. Similar indicators have been object of the study held in 1998 by ANMCO-Istituto Superiore di Sanità: the Italian Cardiovascular Epidemiological Observatory. So, 11 years later, we have had the chance to compare the changes, in the same community, of three important risk factors: tobacco smoking, arterial blood pressure, and obesity. METHODS: The 1987 survey included 280 subjects, aged 20 to 59 years. The 1998 survey has examined 200 subjects, aged 35 to 74 years. In both cases the subjects have been randomly selected from the Electoral Registers; subjects were asked to answer a questionnaire on tobacco smoking; arterial blood pressure measured using a cuff manometer was registered and weight and height have been recorded. In order to have comparable data we have only considered subjects 35 to 59 years old. RESULTS: One hundred and fifty-seven subjects (84 males and 73 females) were included in the 1987 survey and 123 (60 males and 63 females) in the 1998 survey. In 1987, the percentage of smokers was 40.7% (61.4% of males and 17.8% of females), with an average of 23.4 cigarettes/day among males and 14.7 among females. In 1998, the percentage of smokers has dropped to 18.6%, without any differences between sexes, with an average of 11.9 cigarettes/day among males and 12.7 among females. The mean values of blood pressure were lower in 1998 than in 1987 both in males (129.4/85.7 vs 138.0/88.2 mmHg) and females (119.3/80.2 vs 138.4/86.5 mmHg). Although not statistically significant, the percentage of individuals with systolic blood pressure > or = 160 mmHg or diastolic blood pressure > or = 95 mmHg was lower in 1998 (15.9% among males and 14.2% among females) than in 1987 (25.6% among males and 22.8% among females). The mean values of body mass index were unchanged (from 25.4 to 25.2 kg/m2 in males and from 23.4 to 23.1 kg/m2 in females). CONCLUSIONS: The incidence of tobacco smoking and of hypertension has shown a significant reduction in the population of Savigliano between 1987 and 1998. No significant variation was found in body mass index or in the prevalence of obesity. The distribution of these three risk factors seems to be lesser than that reported in northern Italy.

Effects of antihypertensive medications on vitality and well-being.

The effects of captopril, methyldopa, and propranolol were assessed for sense of well-being and vitality among 626 men with mild to moderate hypertension in a multicenter, randomized, double-blind clinical trial. After a 24-week treatment period, patients taking captopril, compared with patients taking methyldopa and propranolol, scored significantly higher on measures of well-being and vitality. In addition, patients on captopril had more favorable results in being able to keep up with their work and in not feeling tired or sleepy at work. The effects of each of the drugs manifested themselves at different periods. For example, the negative effects of methyldopa on vitality were evident by week 8, whereas the negative effects did not become manifest for propranolol until week 24. On the other hand, a steady progressive improvement in vitality scores was evident at week 8 and at week 24 for patients on captopril. The findings of the study also suggest that the effects of the treatment drugs were most marked in patients who had had previous antihypertensive medications and who were on single-drug therapy during the course of the clinical trial. Further, the differences between patients taking captopril and those on methyldopa and propranolol appear to be obscured by the addition of a diuretic. The findings of the study may guide the physician in orienting his or her patient and in planning and implementing a therapeutic regimen.