Genome-wide association study identifies CAMKID variants involved in blood pressure response to losartan: the SOPHIA study.

BACKGROUND: Essential hypertension arises from the combined effect of genetic and environmental factors. A pharmacogenomics approach could help to identify additional molecular mechanisms involved in its pathogenesis. AIM: The aim of SOPHIA study was to identify genetic polymorphisms regulating blood pressure response to the angiotensin II receptor blocker, losartan, with a whole-genome approach. MATERIALS & METHODS: We performed a genome-wide association study on blood pressure response in 372 hypertensives treated with losartan and we looked for replication in two independent samples. RESULTS: We identified a peak of association in CAMK1D gene (rs10752271, effect size -5.5 ± 0.94 mmHg, p = 1.2 × 10(-8)). CAMK1D encodes a protein that belongs to the regulatory pathway involved in aldosterone synthesis. We tested the specificity of rs10752271 for losartan in hypertensives treated with hydrochlorothiazide and we validated it in silico in the GENRES cohort. CONCLUSION: Using a genome-wide approach, we identified the CAMK1D gene as a novel locus associated with blood pressure response to losartan. CAMK1D gene characterization may represent a useful tool to personalize the treatment of essential hypertension.

[Administrative databases of the Local Health Unit: possible use for clinical governance of chronic kidney disease]. / Gli archivi amministrativi delle Aziende Sanitarie: possibile uso per il governo clinico della malattia renale cronica.

Nowadays a large amount of medical data are available, although they are not always homogeneous, they arise from different backgrounds and are used for different purposes. The aggregation of these data could give huge boost to the epidemiology and, in particular, to nephrology. In many parts of Italy there is the aim to reorganize the hospital health care, as well as the territorial setting. In this framework, the role of nephrology is evaluated without data to support the ongoing decisions, therefore the linkage among the data stored in the administrative and clinical databases of the Local Health Unit could contribute to the planning of nephrological (but not only) activities, in order to ensure the best cost-effectiveness possible for each different reality.

Glycemic control and diabetes-related health care costs in type 2 diabetes; retrospective analysis based on clinical and administrative databases.

BACKGROUND: Diabetes is one of the most prevalent chronic diseases, and its prevalence is predicted to increase in the next two decades. Diabetes imposes a staggering financial burden on the health care system, so information about the costs and experiences of collecting and reporting quality measures of data is vital for practices deciding whether to adopt quality improvements or monitor existing initiatives. The aim of this study was to quantify the association between health care costs and level of glycemic control in patients with type 2 diabetes using clinical and administrative databases. METHODS: A retrospective analysis using a large administrative database and a clinical registry containing laboratory results was performed. Patients were subdivided according to their glycated hemoglobin level. Multivariate analyses were used to control for differences in potential confounding factors, including age, gender, Charlson comorbidity index, presence of dyslipidemia, hypertension, or cardiovascular disease, and degree of adherence with antidiabetic drugs among the study groups. RESULTS: Of the total population of 700,000 subjects, 31,022 were identified as being diabetic (4.4% of the entire population). Of these, 21,586 met the study inclusion criteria. In total, 31.5% of patients had very poor glycemic control and 25.7% had excellent control. Over 2 years, the mean diabetes-related cost per person was: €1291.56 in patients with excellent control; €1545.99 in those with good control; €1584.07 in those with fair control; €1839.42 in those with poor control; and €1894.80 in those with very poor control. After adjustment, compared with the group having excellent control, the estimated excess cost per person associated with the groups with good control, fair control, poor control, and very poor control was €219.28, €264.65, €513.18, and €564.79, respectively. CONCLUSION: Many patients showed suboptimal glycemic control. Lower levels of glycated hemoglobin were associated with lower diabetes-related health care costs. Integration of administrative databases and a laboratory database appears to be suitable for showing that appropriate management of diabetes can help to achieve better resource allocation.

Systolic blood pressure and mortality in chronic hemodialysis patients: results of a nationwide italian study.

Studies on the relationship between blood pressure (BP) and mortality among hemodialysis patients have yielded conflicting results. Reports have come mostly from North America and have dealt with dialysis patients as a homogenous population and differed in methods and time of BP measurement and the optimal BP target. In a prospective nationwide study in 3674 unselected Caucasian patients with end-stage renal disease undergoing chronic hemodialysis from 73 dialysis units, the authors sought to examine the relationship between the different measurements of BP and mortality according to antihypertensive treatment. The mean age of patients was 67.2±14.1 years and the prevalence of diabetes was 19.5%. During follow-up (26.5±10.5 months), 977 deaths were recorded. In the whole cohort, BP was not associated with mortality. After grouping the patients according to antihypertensive treatment, the analysis showed that only in patients who did not take antihypertensive medications (1613) was there an inverse relationship between postdialysis systolic BP and mortality. These patients differed from the others in BP, dialysis vintage, prevalence of diabetes, and type of dialysis technique. This study suggests that with respect to the relationship of BP with mortality, dialysis patients are not a homogenous population. Differences in demographic characteristics and in dialysis technique may therefore explain the reported variability of previous results.

Adherence to statin treatment and health outcomes in an Italian cohort of newly treated patients: results from an administrative database analysis.

BACKGROUND: Adherence to statin treatment is expected to be associated with health outcomes. Much of the available evidence is derived from studies conducted on selected populations (eg, Medicaid population), on specific cohorts of patients (eg, patients with diabetes mellitus or those who have experienced acute myocardial infarction [AMI]), or with respect to a single outcome (eg, only death or only AMI). OBJECTIVE: The aim of this study was to evaluate the association between adherence to statin therapy and all-cause mortality and cardiovascular morbidity (AMI and stroke) in an unselected cohort of newly treated patients. METHODS: We performed a population-based retrospective cohort study that included adult patients with a first prescription of a statin from January 1, 2004, through December 31, 2006, using data from the administrative databases of the Local Health Unit of Florence in Italy. Adherence to statin treatment was estimated as the proportion of days covered (PDC) by filled prescriptions and classified as low (PDC, 21%-40%), intermediate-low (PDC, 41%-60%), intermediate-high (PDC, 61%-80%), and high (PDC, >80%). Cases with PDC ≤20% were excluded. A Cox regression model was used to investigate the association between adherence to treatment and all-cause mortality and hospitalization for AMI or stroke. RESULTS: The cohort consisted of 19,232 patients (9823 men and 9409 women) aged 18 to 102 years (mean [SD], 66.5 [11.4] years): 20.1% had been previously hospitalized for cardiovascular events and 17.6% had been treated with hypoglycemic drugs. Adherence to statins was low in 4427 patients (23.0%), intermediate-low in 3117 (16.2%), intermediate-high in 3784 (19.7%), and high in 7904 (41.1%). Lower-adherent patients were younger and had fewer comorbidities compared with higher-adherent patients. In our multivariable analyses, high adherence was significantly associated with decreased risk of all-cause death, AMI, or stroke. Compared with low adherence (hazard ratio [HR] = 1), the risk was lower in intermediate-low adherence (HR = 0.83; 95% confidence interval [CI], 0.71-0.98; P < 0.05) and much lower in intermediate-high (HR = 0.60; 95% CI, 0.51-0.70; P < 0.001) and high adherence (HR = 0.61; 95% CI, 0.54-0.71; P < 0.001). CONCLUSIONS: In this Italian cohort of newly treated patients, suboptimal adherence to statins occurred in a substantial proportion of patients and was associated with increased risk of adverse health outcomes.

Awareness of albuminuria in an Italian population-based cohort of patients treated with hypoglycemic drugs.

BACKGROUND: Albuminuria is a powerful predictor of renal and cardiovascular outcomes in type 2 diabetes and a good indicator of the evolution of renal disease. Our aim was to obtain information concerning the identification of albuminuria as well as the utilization of antihypertensive, lipid-lowering and antiplatelet drugs in patients with diabetes. METHODS: Subjects were enrolled from individuals registered with 3 Italian local health units by querying the drugs reimbursable, hospital laboratory investigation and hospital discharge databases. The determination of albumin to creatinine ratio (ACR) throughout 2007 and 2008 was defined as the index date. Patients who received at least 2 prescriptions of hypoglycemic drugs in the 12 months before the index date were classified as diabetics. We looked also for prescriptions of antihypertensive, lipid-lowering and antiplatelet drugs. RESULTS: Among a population of 701,133 subjects, we identified 29,350 patients with diabetes (4.2% of the cohort). ACR had been determined in 5,644 diabetic subjects (19.2% of that cohort). The prevalence of determination of ACR in nontreated subjects was 16.0%, while in treated subjects, it ranged from 13.6% to 34.9% according to different schedules of treatment. Drugs acting on the renin-angiotensin system were prescribed in more then 80% of diabetics. The ratio of angiotensin receptor blockers to angiotensin-converting enzyme inhibitors regimen was 0.64 in subjects without determination of ACR, 0.88 in subjects with normal albuminuria, 1.02 in subjects with microalbuminuria and 1.43 in subjects with macroalbuminuria. CONCLUSIONS: Our methodology can easily be applied to obtain an epidemiological view of albuminuria and pharmacological treatments of diabetics in a general population.

Adherence to antihypertensive medications and health outcomes among newly treated hypertensive patients.

OBJECTIVE: To evaluate adherence to antihypertensive therapy (AHT) and the association between adherence to AHT, all-cause mortality, and cardiovascular (CV) morbidity in a large cohort of patients newly treated with antihypertensives in a clinical practice setting. METHODS: An administrative database kept by the Local Health Unit of Florence (Italy) listing patient baseline characteristics, drug prescription, and hospital admission information was used to perform a population-based retrospective study including patients newly treated with antihypertensives, ≥18 years of age, with a first prescription between January 1, 2004 and December 31, 2006. Patients using antihypertensives for secondary prevention of CV disease, occasional spot users, and patients with early CV events, were excluded from the study cohort. Adherence to AHT was calculated and classified as poor, moderate, good, and excellent. A Cox regression model was conducted to determine the association among adherence to AHT and risk of all-cause mortality, stroke, or acute myocardial infarction. RESULTS: A total of 31,306 patients, 15,031 men (48.0%), and 16,275 women (52.0%), with a mean age of 60.2 ± 14.5 years was included in the study. Adherence to AHT was poor in 8038 patients (25.7% of included patients), moderate in 4640 (14.8%), good in 5651 (18.1%), and excellent in 12,977 (41.5%). Compared with patients with poor adherence (hazard ratio [HR] = 1), the risk of all-cause death, stroke, or acute myocardial infarction was significantly lower in patients with good (HR = 0.69, P < 0.001) and excellent adherence (HR = 0.53, P < 0.001). CONCLUSIONS: These findings indicate that suboptimal adherence to AHT occurs in a substantial proportion of patients and is associated with poor health outcomes already in primary prevention of CV diseases. For health authorities, this preliminary evidence underlines the need for monitoring and improving medication adherence in clinical practice.

The relationship between body weight and drug costs: An Italian population-based study.

OBJECTIVES: This study determined the prevalence of 3 categories of body mass index (BMI)--normal weight, overweight, and obesity--in a sample of subjects from general clinical practice in Ravenna, Italy, and evaluated the impact of comorbidities associated with overweight and obesity on the costs of drug treatment from the perspective of the Italian national health system. METHODS: This was a cross-sectional study conducted in a sample of subjects aged > or =18 years from 10 general practices in the Ravenna local health unit (LHU) in 2001-2002. Subjects were invited to attend a screening visit at which weight and height were measured for determination of BMI, blood pressure was measured, and a fasting blood sample was obtained for laboratory tests. The screening examinations were conducted by 2 physicians at a dedicated practice. Normal weight, overweight, and obesity were defined as a BMI < or =24.9, between 25 and 29.9, and > or =30 kg/m2, respectively. The costs of classes of drug treatment that were reimbursable to the LHU in the 12 months before the screening examination were evaluated using the Ravenna LHU administrative databases. Drug treatments were classified as antihypertensive agents, statins, NSAIDs, gastroprotective drugs, antidiabetic agents, respiratory drugs, antiplatelet agents, antidepressants, and all other drugs. The data were analyzed by age group. RESULTS: Of the 2622 subjects in the sample, 1256 (47.9%) had a normal BMI, 918 (35.0%) were overweight, and 448 (17.1%) were obese. The prevalence of overweight and obesity increased in relation to age up to 50-59 years (P < 0.001), after which it remained stable. Overweight and obese subjects had significantly more exposure to individual and multiple drug treatments compared with subjects with normal weight (P < 0.001). By type of drug treatment, 16.7% of normal-weight subjects, 35.6% of overweight subjects, and 51.8% of obese subjects were exposed to antihypertensives; 4.1%, 8.7%, and 12.1%, respectively, to statins; 14.2%, 22.0%, and 29.0% to NSAIDs; and 1.0%, 4.7%, and 9.4% to antidiabetics. The mean annual cost of drugs was Euro 132.71 in normal-weight subjects, Euro 246.19 in overweight subjects, and Euro 335.64 in obese subjects (P < 0.001). After adjustment for differences in age distribution between the study sample and the overall population of Ravenna, the estimated excess drug costs associated with overweight and obesity in Ravenna were Euro 5,661,126.20 and Euro 6,688,099.85, respectively. CONCLUSIONS: In this study sample, the prevalence of overweight increased by approximately 10% and the prevalence of obesity increased by approximately 5% with each decade of age up to 60 years, after which it remained stable at approximately 40% and approximately 20%, respectively. Overweight and obesity were associated with increased drug exposure and costs in all age groups considered.

Underuse of lipid-lowering drugs and factors associated with poor adherence: a real practice analysis in Italy.

BACKGROUND: Many studies have indicated the adequate use of lipid-lowering drugs (LLDs) as a factor in reducing the risk of cardiovascular disease. However, in clinical practice, a very high percentage of patients are not adequately treated. OBJECTIVE: To analyze the management of hypercholesterolemia in a non-experimental setting and to estimate the factors associated with poor adherence to treatment. METHODS: A longitudinal study was performed using clinical and demographic data recorded in the General Practitioners' database. The sample included all patients, aged 30 years or over, with total blood cholesterol measured between 1 January and 31 December 2000. Utilization of LLDs was defined as the standardized daily dose of the drugs purchased during the 12 months preceding the cholesterol measurement. RESULTS: The study included 4764 patients (mean age 59.4+/-14.1 years, 40.7% males). Of the subjects with a total cholesterol higher than a 6.5 mmol/l, approximately 17% were treated with LLDs. About 39% of the patients with previous atherosclerotic diseases were taking statins. Analysis of patients taking LLDs showed that 40.6% of subjects took less than half of the defined daily dose. Factors associated with poor adherence to treatment were: absence of previous atherosclerotic diseases, absence of concomitant diseases, and smoking. A total cholesterol of less than 5 mmol/l was achieved in 19.9% of patients. CONCLUSIONS: Analyzing the data contained in the general medicine database made it possible to evaluate the use of LLDs in clinical practice and to establish the need to pay greater attention to achieving the objective set by the treatment.

Efficacy and tolerability of manidipine in the treatment of hypertension in patients with non-diabetic chronic kidney disease without glomerular disease. Prospective, randomized, double-blind study of parallel groups in comparison with enalapril.

BACKGROUND: Calcium channel blockers (CCBs) are effective blood pressure lowering agents, giving rise to a prevalent dilation of the afferent arteriole. Manidipine, a long-lasting dihydropyridine CCB, demonstrates its action not only on the afferent arteriole, but also on the efferent one. This suggests theoretically a renoprotective effect in patients with chronic kidney diseases (CKD). METHODS: This was a multicenter, prospective, randomized, double-blind, parallel group study, to evaluate the efficacy and tolerability of manidipine (M; 10-20 mg/day), in comparison with enalapril (E; 10-20 mg/day) in the treatment of hypertension in 136 patients with CKD secondary to primary renoparenchymal disease. Changes in blood pressure values from baseline were considered as the primary outcome of the study. Proteinuria changes and the rate of renal function decline were also evaluated. RESULTS: During a 48-week follow-up, mean SBP decreased from 155+/-11.7 to 138.7+/-13.9 mmHg in M and from 157.3 +/-11.8 to 134.2+/-13.9 mmHg in E; mean DBP decreased from 100.3+/-4.2 to 86.1+/-6.5 mmHg in M and from 100.3+/-4.2 to 84.7+/-6.3 mmHg in E. Proteinuria remained unchanged in M (from 1.6+/-1.59 to 1.62+/-1.79 g/24h), and decreased significantly in E (from 1.37+/-1.45 g/24h to 1+/-1.55 g/24h). No significant difference was observed in the rate of renal function decline in the two groups. CONCLUSIONS: Manidipine was safe and effective, obtaining a significant reduction in SBP and DBP from baseline. Although patients treated with enalapril showed a better antiproteinuric response, the two treatments were equally effective in reducing the rate of CRF progression in patients without glomerular disease.

Frequency of cardiovascular events in patients treated with anti hypertensive agents: A cohort study based on claims data generated by primary care practice.

BACKGROUND: Large-scale clinical trials have shown that antihypertensive drugs reduce the risk for cardiovascular events. However, little is known about the effectiveness of these drugs in the primary care setting. OBJECTIVE: The aim of this study was to investigate the frequency of cardiovascularevents during treatment with either of 2 of the most frequently prescribed antihypertensive drugs. METHODS: This observational, longitudinal, cohort study considered the entirepopulation listed in the administrative databases of the Local Health Authority of Ravenna, Italy (356,000 residents). The demographic registry and the pharmaceutical and nosocomial databases were cross-linked to determine drug treatment, as well as the frequency of cardiovascular events on a patient-by-patient basis. Each patient aged >18 years receiving a first prescription for amlodipine or enalapril in the period between January 1, 1996, and December 31, 2000, with ≥6 months of continuous treatment with the drug was included. The follow-up period varied from 6 months to 4.5 years. RESULTS: Of the 7500 patients analyzed (4092 women and 3408 men; mean[SD] age, 68.0 [12.4] years), 2231 (29.7%) were given amlodipine and 5269 (70.3%) were given enalapril. The observed rate of cardiovascular events was higher among patients treated with amlodipine (54 per 1000 patient-years vs 46 per 1000 patient-years; P = 0.007), with a hazard ratio 17% higher compared with enalapril (95% Cl, 5.0-24.0; P = 0.007). The result was also confirmed using Cox multivariate regression analysis. The combination of enalapril plus diuretic showed the lowest risk for cardiovascular events (0.73; 95% Cl, -36.0 to -16.0; P < 0.001). CONCLUSION: This analysis showed that treatment with enalapril was associatedwith a significantly lower frequency of cardiovascular events compared with amlodipine.

A retrospective, population-based analysis of persistence with antihypertensive drug therapy in primary care practice in Italy.

BACKGROUND: Many hypertensive patients discontinue drug therapy despite the increased cardiovascular risk associated with inadequately controlled hypertension. However, most experiments do not address this premature discontinuation of therapy, making it difficult to project the appropriateness of antihypertensive drugs in real-world use. OBJECTIVE: The goal of this study was to assess patients' persistence with antihypertensive drug therapy in a nonexperimental setting. METHODS: An administrative database kept by the Local Health Unit of Ravenna, Ravenna, Italy, listing patient baseline characteristics, drug prescriptions, and hospital admissions was used to perform a population-based, retrospective study. The study included all patients who met the following criteria from January I through December 31, 1997: new user of antihypertensive drugs; > or = 20 years of age; receiving a first prescription for a diuretic, beta-blocker, calcium channel blocker, angiotensin II-receptor antagonist (AIIA), or angiotensin-converting enzyme inhibitor. All prescriptions for antihypertensive drugs filled during the 12-month follow-up period were used to define patients as continuers, switchers, or discontinuers on the basis of their persistence with therapy. RESULTS: A total of 16,783 patients were included in the study analyses: 7,409 men (44.1%) and 9,374 women (55.9%), with an average age of 56.1 +/- 18.3 years (range, 20-105 years). Of this study population, 64.9% (n = 10,894) discontinued treatment over the course of follow-up, 26.9% (n = 4508) continued treatment with the initially prescribed medication (with 5.1% [n = 862] adding another medication for combination therapy), and 8.2% (n = 1381) switched medications. Patients initially prescribed AIIAs were more likely to continue treatment than those initiated on other types of antihypertensives (P < 0.001). Discontinuation was associated with younger age, lower prevalence of concurrent chronic pharmacotherapies, and lower prevalence of previous hospitalizations for cardiovascular disease (all P < 0.001). CONCLUSIONS: Health care claims data are a powerful tool for measuring continuation of therapy, providing detailed, populationwide epidemiologic and economic information for analyzing antihypertensive drug treatment. Further studies are required to relate pharmacotherapy to outcomes.

The pandora project: cost of hypertension from a general practitioner database.

AIM: The Pandora Project is a longitudinal database--implemented by general practitioners since June 1997 in the Ravenna area (Italy)--providing information on patients with hypertension. Data from 1,651 patients were followed up for I year in order to investigate the cost of hypertension. Only direct medical costs were considered in the perspective of the National Healthcare System. FINDINGS: At enrollment, 552 patients were classified as normotensive, 1,099 as hypertensive. After 1 year, among normotensive group, 352 patients remained normotensive and 200 became hypertensive; among hypertensive group, 323 patients became normotensive and 776 remained hypertensive. The average total cost per patient at follow-up was 779.59 Euros. About 46% of total cost was due to anti-hypertensive therapy, irrespective of the evolution of blood pressure levels registered, whilst other direct costs represented 54% of total patient cost in all cohorts. It is possible that co-morbidities play a significant role in this situation. Patient aged 80-89 years generate higher costs. Even if further investigation is needed on the burden of comorbidity on a per-patient cost of hypertension, this work provides evidence that the average total cost per patient is likely to increase with age and co-morbidities. Key words: cost-of-illness, costs, economics, hypertension.

Effects of clinical and individual variables on quality of life in chronic renal failure patients.

BACKGROUND: The purpose of this study was to assess the effects of baseline characteristics of patients, chronic renal failure and its treatment on quality of life. METHODS: To investigate the health status we used a questionnaire, the SF-36, during individual interviews. The study involved i) a cross-sectional observational stage, lasting from 1 Sept. 1997 to 30 April 1999, on all the patients undergoing conservative treatment, hemodialysis, peritoneal dialysis and kidney transplantation in district of Ravenna, and ii) a longitudinal stage, when the subjects were administered two questionnaires at an interval of at least 16 months. The quality of life data collected during the cross-sectional stage were analyzed to establish any correlations between age, type of treatment of chronic renal failure and hemoglobin levels. Patients under dialysis were also examined for any interference caused by the center where dialysis was done. RESULTS: Multivariate analysis on the data collected during the cross-sectional stage showed that chronic renal failure treatment and age affected the quality of life scores for the following parameters: physical activity, bodily pain, general health and vitality (age was inversely related to the scores). Transplanted patients and those on conservative treatment enjoyed the best overall quality of life, followed by those on peritoneal dialysis and those on hemodialysis. The physical domain scores were strongly associated with age, hemoglobin and diabetes. Multivariate analysis of the longitudinal study indicated that the interval between the beginning and the end of the observation period, age and diabetes greatly influenced quality of life. CONCLUSIONS: The data confirmed that age and diabetes have a strong influence on the quality of life and that the long period of treatment, with the absence of any prospect of resolving the clinical situation, has a negative effect on the quality of life in uremic patients.

Cardiovascular risk in hypertensive patients: results of the Pandora project.

BACKGROUND: The aim of the Pandora project is to collect epidemiological information, check diagnostic and therapeutic pathways, and assess outcomes in a large hypertensive population. This report presents the results on patients enrolled in the study between 1997-1999. METHODS: Twenty-one general practitioners working in the Ravenna Local Health Service took part in the study. They were supplied with IBM compatible PCs and were trained to enter the patient's data (age, gender, familiarity for cardiovascular diseases, smoking, hospitalisations for cardiovascular disorders, diabetes, blood pressure, total cholesterolemia, creatininemia, antihypertensive therapy) on So.Ge.Pa. software. Cardiovascular risk factors were assessed according to the WHO - ISH joint committee recommendations. RESULTS: 2,608 treated hypertensive patients were enrolled, 65% of whom showed inadequate blood pressure control. The prevalence of inadequate BP control was higher in patients on multiple-drug antihypertensive therapy compared with those on monotherapy (71.9% vs. 47.9%), in older than in younger patients (70.7% vs. 56.1%) and in patients with three cardiovascular risk factors, or diabetes, or affected target organs, compared to those with two or less risk factors (72.4% vs. 63.3%), (p < 0.001 for all). 63.6% of patients were at risk for age, 36.6% for family history of cardiovascular diseases and 31.7% for severe hypercholesterolemia. CONCLUSIONS: BP control was inadequate in a large percentage of patients, but it was particularly unsatisfactory in the elderly and in patients with high cardiovascular risk. A cluster of cardiovascular risk factors was found in both adequately and inadequately controlled hypertensive patients.

Assessment of antihypertensive drug use in primary care in Ravenna, Italy, based on data collected in the PANDORA project.

BACKGROUND: In the clinical-practice setting, only a small percentage of patients treated with antihypertensive drugs become normotensive. Furthermore, the diversity of drug classes used makes comparison of treatments difficult. OBJECTIVE: The goal of this study was to characterize the types and efficacy of antihypertensive treatments used in primary care in the area of Ravenna, Italy. The study was conducted in the context of the PANDORA Project, an open-ended global outcome study. METHODS: Data were gathered from general practitioners (GPs) and were stored by the GPs or through links with national health service databases. The population of interest was patients with essential hypertension taking antihypertensive medication, each of whom was observed for 365 days. Blood pressure was measured in the morning or afternoon using an automated device, in accordance with normal clinical practice. At each office visit, the GP reviewed and made any necessary adjustments to the patient's antihypertensive treatment. Antihypertensive drug use was assessed by calculating the mean daily dose (MDD) of the prescribed drug and the duration of treatment (DT). A DT > or = 273 days constituted continuous therapy, and a DT <273 days constituted discontinuous therapy. Adverse events were not collected. RESULTS: Twenty-one GPs took part in the study. The study population included 969 patients (443 men, 526 women), all of them white, whose ages ranged from 23 to 88 years. At enrollment, 327 patients were normotensive (blood pressure <140/90 mm Hg) and 642 were hypertensive despite drug treatment. More than 25 treatment regimens were identified. Over the course of follow-up, 49 patients had discontinuous therapy and 920 had continuous therapy. Among those who had continuous therapy, 117 (12.7%) took an MDD of <0.5 tablet/d; 297 (32.3%) took > or = 0.5 and <1 tablet/d; 364 (39.6%) took > or = 1 and <2 tablets/d; and 142 (15.4%) took > or = 2 tablets/d. At the end of the observation period, the proportion of normotensive patients had increased by 5.7% (P < 0.001). CONCLUSION: Based on the findings of this study, improper use of antihypertensive drug therapy appears to be one of the reasons for the relatively small proportion of patients who attain blood pressure control with treatment.

Cost allocation in antihypertensive drug therapies.

The objective of this paper is to evaluate persistence with treatment and resources allocation in antihypertensive pharmacotherapy in a 'real world' population. An administrative database listing all purchased drugs was used to perform a longitudinal analysis. The study included all new users over 20 years of age receiving a first prescription for amlodipine, atenolol, fosinopril, indapamide, or losartan, in an enrolment period of 12 months. The follow-up period lasted 12 months. According to prescriptions dynamics, subjects were classified as same therapy, combination, switching, interruption and occasional utilization. The 34.9% study cohort, persisted with treatment (21.1% on same therapy, 4.7% on combination and 9.1% on switching), while 65.1% did not persist (10.9% on interruption and 54.2% on occasional use). The overall drug cost accounted for persistent (69.0%) and nonpersistent subjects (31.0%). The annual average cost ranged from euro32.80 for occasional users to euro274.69 for those in combination. In clinical practice, a high percentage of patients do not receive adequate antihypertensive therapy, since the 65.1% of subjects did not persist with treatment. This results in a level of pharmaceutical expenditure that cannot be considered appropriately allocated.