Alessandro Filippi

Adherence to Antihypertensive Medications and Cardiovascular Morbidity Among Newly Diagnosed Hypertensive Patients

Background— Nonadherence to antihypertensive treatment is a common problem in cardiovascular prevention and may influence prognosis. We explored predictors of adherence to antihypertensive treatment and the association of adherence with acute cardiovascular events. Methods and Results— Using data obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database, we selected 18 806 newly diagnosed hypertensive patients ≥35 years of age during the years 2000 to 2001. Subjects included were newly treated for hypertension and initially free of cardiovascular diseases. Patient adherence was subdivided a priori into 3 categories—high (proportion of days covered, ≥80%), intermediate (proportion of days covered, 40% to 79%), and low (proportion of days covered, ≤40%)—and compared with the long-term occurrence of acute cardiovascular events through the use of multivariable models adjusted for demographic factors, comorbidities, and concomitant drug use. At baseline (ie, 6 months after index diagnosis), 8.1%, 40.5%, and 51.4% of patients were classified as having high, intermediate, and low adherence levels, respectively. Multiple drug treatment (odds ratio, 1.62; 95% CI, 1.43 to 1.83), dyslipidemia (odds ratio, 1.52; 95% CI, 1.24 to 1.87), diabetes mellitus (odds ratio, 1.40; 95% CI, 1.15 to 1.71), obesity (odds ratio, 1.50; 95% CI, 1.26 to 1.78), and antihypertensive combination therapy (odds ratio, 1.29; 95% CI, 1.15 to 1.45) were significantly (P<0.001) associated with high adherence to antihypertensive treatment. Compared with their low-adherence counterparts, only high adherers reported a significantly decreased risk of acute cardiovascular events (hazard ratio, 0.62; 95% CI, 0.40 to 0.96; P=0.032). Conclusions— The long-term reduction of acute cardiovascular events associated with high adherence to antihypertensive treatment underscores its importance in assessments of the beneficial effects of evidence-based therapies in the population. An effort focused on early antihypertensive treatment initiation and adherence is likely to provide major benefits.

Patterns of persistence with antihypertensive medications in newly diagnosed hypertensive patients in Italy: a retrospective cohort study in primary care.

Objective To describe patterns of persistence and related primary care costs associated with first antihypertensive treatment. Design and setting Retrospective cohort study during 2000–2001, using information from 320 Italian general practitioners. Participants We studied 13 303 patients with newly diagnosed hypertension, who received a first single antihypertensive prescription within 3 months after diagnosis. Main outcome measures Persistence with first-line single treatment, categorized as follows: continuers: patients continuing the first-line medication for at least 1 year; combiners: patients receiving an additional antihypertensive drug and continuing the initial medication; switchers: patients changing from the first-line to another class of antihypertensive drug and discontinuing the initial treatment; discontinuers: patients stopping the first-line treatment without having another prescription until the end of the follow-up. Primary care costs were expressed as the cost of hypertension management per person-year of follow-up. Results In the study cohort, 19.8% were continuers, 22.1% were combiners, 15.4% were switchers, and 42.6% were discontinuers. Continuation was greatest with angiotensin II type 1 receptor blocking agents (25.2%), calcium channel blockers (23.9%) and angiotensin-converting enzyme inhibitors (23.3%). Severe hypertension [hazards ratio 1.30; 95% confidence interval (CI) 1.18 to 1.43] and severe health status (hazards ratio 1.22; 95% CI 1.15 to 1.30) increased the risk of discontinuation. The likelihood of needing an additional antihypertensive drug was associated with mild-to-severe baseline blood pressure, diabetes (hazards ratio 1.20; 95% CI 1.06 to 1.36), and familial history of cardiovascular disease (hazards ratio 1.24; 95% CI 1.10 to 1.39). Discontinuers accounted for 22.4% of the total primary care cost. Initial treatment with angiotensin II type 1 receptor blocking agents and β-blockers resulted in incremental primary care costs of &U20AC;145.2 and &U20AC;144.2, respectively, compared with diuretics. Combiners and switchers increased the primary care cost by &U20AC;140.1 and &U20AC;11.7, compared with continuers. Conclusion Persistence with first-line single antihypertensive drugs is extremely low during the first year of treatment. Potential cost saving should be possible by reducing the high frequency of discontinuation. Diuretics represent the least expensive therapeutic option, although further investigations in the long-term are needed to analyse the effects of persistence on therapeutic effectiveness and related costs.

Reduced discontinuation of antihypertensive treatment by two-drug combination as first step. Evidence from daily life practice.

Objectives To measure persistence with antihypertensive drug therapy in patients initiating treatment with mono or combination therapy. Methods Data analysis was based on two cohorts of patients, that is, a cohort derived from the registration of drug prescriptions in all residents of the Lombardy region receiving Public Health Service and a cohort of patients followed by general practitioners throughout the Italian territory. Data were limited to patients aged 40–80 years who received their first antihypertensive drug prescription (n = 433680 and 41199, respectively) in whom persistency of treatment was examined over 9 months. A proportional hazards model was fitted to estimate the association between the pattern of initial antihypertensive drug therapy and risk of treatment discontinuation. Data were adjusted for available potential confounders. Results Taking patients starting with diuretic monotherapy as reference, the adjusted risk of treatment discontinuation was progressively lower in patients starting with monotherapy other than a diuretic, a two-drug combination, including a diuretic and a two-drug combination without a diuretic. No significant difference in the risk of discontinuation was seen between extemporaneous and fixed dose combinations, including a diuretic, that is, the only combination reimbursable by Public Health Service and, thus, available in the database. Data were similar for the two cohorts. Conclusion Initiating treatment with a combination of two drugs is associated with a reduced risk of treatment discontinuation.

Secondary Prevention of Stroke in Italy: A Cross-Sectional Survey in Family Practice

Background— Hypertension control and antiplatelet or oral anticoagulant drugs are the basis for secondary prevention of cerebrovascular events. Family physicians (FPs) are usually involved in both aspects of prevention, but no research has been carried out in Italy to evaluate the behavior of FPs in this field of prevention. Methods— Data concerning 318 Italian FPs and 465 061 patients were extracted from the Health Search Database. Patients with coded diagnoses of stroke and transient ischemic attack (TIA) were selected. Demographic records and information regarding presence of concurrent disease and medical records were also obtained. Logistic regression analyses were carried out to assess whether conditions exist that make appropriate control of blood pressure (BP) and prescription of antiplatelet or anticoagulant drugs more likely. Results— We selected 2555 patients with diagnosis of stroke and 2755 with TIA. Among all of the subjects, 32.6% had no BP recorded. Among the remaining subjects, 58.7% reported uncontrolled BP. Isolated systolic hypertension has been shown in 68.8% of patients with uncontrolled BP. Antiplatelet and anticoagulant drugs were prescribed in 72% of these cases. Factors that made the prescription significantly more unlikely were diagnosis of TIA (odds ratio [OR], 0.47; 95% confidence interval [CI], 0.41 to 0.54), total invalidity (OR, 0.66; 95% CI 0.56 to 0.78), and time from event of 5 years or more (OR, 0.81; 95% CI, 0.70 to 0.94). Conclusions— Italian FPs could improve secondary prevention of cerebrovascular accidents. The primary target of intervention should be the control of systolic BP, and the group of patients with unacceptably high BP should be given priority. All of these patients should have been prescribed antiplatelet drugs or anticoagulant agents, except in cases of extremely short life expectancy or substantial contraindications.

Frequency, Patient Characteristics, Treatment Strategies, and Resource Usage of Atrial Fibrillation (from the Italian Survey of Atrial Fibrillation Management [ISAF] Study)

Atrial fibrillation (AF) is 1 of the most important healthcare issues and an important cause of healthcare expenditure. AF care requires specific arrhythmologic skills and complex treatment. Therefore, it is crucial to know its real affect on healthcare systems to allocate resources and detect areas for improving the standards of care. The present nationwide, retrospective, observational study involved 233 general practitioners. Each general practitioner completed an electronic questionnaire to provide information on the clinical profile, treatment strategies, and resources consumed to care for their patients with AF. Of the 295,906 patients screened, representative of the Italian population, 6,036 (2.04%) had AF: 20.2% paroxysmal, 24.3% persistent, and 55.5% permanent AF. AF occurred in 0.16% of patients aged 16 to 50 years, 9.0% of those aged 76 to 85 years, and 10.7% of those aged ≥85 years. AF was symptomatic despite therapy in 74.6% of patients and was associated with heart disease in 75%. Among the patients with AF, 24.8% had heart failure, 26.8% renal failure, 18% stroke/transient ischemic attack, and 29.3% had ≥3 co-morbidities. The rate control treatment strategy was pursued in 55%. Of the 6,036 patients with AF, 46% received anticoagulants. The success rate of catheter ablation of the AF substrate was 50%. In conclusion, in our study, the frequency of AF was 2 times greater than previously reported (approximately 0.90%), rate control was the most pursued treatment strategy, anticoagulants were still underused, and the success rate of AF ablation was lower than reported by referral centers.

A national survey of the management of atrial fibrillation with antithrombotic drugs in Italian primary care

The aims of this study were to investigate trends in the incidence of diagnosed atrial fibrillation (AF), and to identify factors associated with the prescription of antithrombotics (ATs) and to identify the persistence of patients with oral anticoagulant (OAC) treatment in primary care. Data were obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database from 2001 to 2004. The age-standardised incidence of AF was: 3.9-3.0 cases, and 3.6-3.0 cases per 1,000 person-years in males and females, respectively. During the study period, 2,016 (37.2%) patients had no prescription, 1,663 (30.7%) were prescribed an antiplatelet (AP) agent, 1,440 (26.6%) were prescribed an OAC and 301 (5.5%) had both prescriptions. The date of diagnosis (p = 0.0001) affected the likelihood of receiving an OAC. AP, but not OAC, use significantly increased with a worsening stroke risk profile using the CHADS2 risk score. Older age increased the probability (p < 0.0001) of receiving an AP, but not an OAC. Approximately 42% and 24% of patients persisted with OAC treatment at one and two years, respectively, the remainder interrupted or discontinued their treatment. Underuse and discontinuation of OAC treatment is common in incident AF patients. Risk stratification only partially influences AT management.

Prevalence and antihyperglycemic prescribing trends for patients with type 2 diabetes in Italy : A 4-year retrospective study from national primary care data

To estimate the prevalence of type 2 diabetes in Italy and to investigate patient-related variables associated with the use of different antihyperglycemic therapies. This study was conducted between the years 2000-2003 from a source population comprising a cumulative sample of 394,719 patients from 320 General Practitioners across Italy, who provide information to the Health Search/Thales Database (HSD). A total sample of 23,729 of patients with type 2 diabetes age 15 years or older was selected from the source population. During the study years, the prevalence of type 2 diabetes increased from 4.7 to 6.0%. A significant increase in the use of antihyperglycemic therapy was also observed between 2000 and 2003. In particular, the use of biguanides increased. During the same period, the use of sulfonylurea monotherapy, oral combination therapy and insulin with oral combination therapy decreased. The results from the multivariate analysis revealed that healthier patients were more likely to be prescribed biguanide and sulfonylurea monotherapy, whereas patients with more diabetes complications and poorer glycemic control were more likely to be prescribed oral combination therapy or insulin (monotherapy or combination therapy). In conclusion, the study results appear to suggest that the prescribing patterns of Italian GPs and the predictors of different antihyperglycemic drug use are consistent with recent scientific evidence.

Out of hospital sudden cardiac death in Italy: a population-based case-control study.

Background Sudden cardiac death (SCD) is a major cause of death in western countries, with coronary heart disease (CHD) being the basis of over 70% of SCD. Incidence in high-CHD risk countries has already been studied, but this information is not available for Mediterranean low-CHD risk countries. Incidence is of paramount importance when cost-effectiveness rate of actions against SCD must be estimated. Methods We estimated the incidence of SCD and its potential risk associated with clinical variables, by a means of a case–control study in a general practice setting. The enrolled general practitioners (GPs) provided data about the total number of their patients, and identified all their patients who suffered an out-of-hospital SCD during the previous 365 days. Two age-matched and gender-matched controls visiting GPs office after the SCD selection were also selected. We used a structured questionnaire to obtain information about potential risk factors for SCD. Covariates that were univariately associated with SCD were included in the multivariate regression analyses. Results In a population of 297 340 (age greater than 14 years), a total of 230 cases were identified (0.77 per 1000 individuals), mostly occurring at home and among persons with known high cardiovascular risk. In the multivariate analysis only CHD (OR: 1.67; 95% CI: 1.09–2.58), arrhythmia (OR: 2.2; 95% CI: 1.3–3.9), obesity (OR: 2.3; 95% CI: 1.5–3.6), alcohol abuse (OR: 1.8; 95% CI: 1.2–2.7), and family history of CHD (OR 3.1; 95% CI: 1.8–5.3) resulted in a significant association with SCD. Conclusions The incidence of SCD in Italy is lower than that reported in high-CHD risk population, most of the cases occurring at home and among persons with known high cardiovascular risk. Implementing recommendations for these patients seems to be the most effective strategy to reduce the incidence of SCD.

How many hypertensive patients can be controlled in “real life”: an improvement strategy in primary care

BackgroundIt is well known that hypertension control is non-satisfactory, but it is not clear how many hypertensive patients can be controlled in real life. We addressed this question implementing a simple, multifaceted improvement strategy in family practice.MethodsEighteen General Practitioner (GPs) agreed upon a simple improvement strategy including: 1) the use of occasional direct/indirect contacts (prescription refilling) to decrease missing blood pressure (BP) recording, and to increase therapeutic adherence, 2) the use of home BP measurements in non-controlled patients, 3) the addition of a new drug in non-controlled, but adequately adherent patients. Results were assessed after one year by automatic data extraction from the clinical records of all hypertensive subjects.ResultsThe patients with a diagnosis of hypertension increased from 6.309 (age 58.5 +/- 12.4; M 45.5%) to 6.717 (age 58.6 +/- 12.9; M 45.7%): prevalence 25.3% to 27.0%. The BP recording increased: 4,305 patients (68.2%) vs 4,948 patients (78.4%) (+ 10.2%, ci 9.4%-10.9%; p < 0.001), as well as the BP control: 3,203 (50.8% of all the diagnosed hypertensive patients and 74.4% of the subjects with recorded BP value) vs 4,043 (64.1% of all the diagnosed hypertensive patients and 81.7% of the subjects with recorded BP value) (+ 13.3%, ci 12.5%-14.2%; p < 0.001 and + 7.3%, ci 6.7%-8.0%; p < 0.001).ConclusionsAlmost 82% of hypertensive subjects who contact their doctors can be easily controlled. Most non-controlled patients simply don’t see their GPs; in almost all the remaining non-controlled patients GPs fail to increase drug therapy. A further improvement is therefore possible.

Pharmacological treatment after acute myocardial infarction from 2001 to 2006: a survey in Italian primary care.

Background Pharmacological preventive therapy after acute myocardial infarction (AMI) is strictly recommended because of its great efficacy. Little is known about long-term utilization of drugs related to cardiovascular secondary prevention in everyday practice. Design A population-based cohort study on the basis of an Italian general practice database. Methods Searching a large primary-care Italian database (Health Search), we selected five cohorts of patients with first occurrence of AMI from 2001 to 2005, respectively, and analyzed prescriptions of antithrombotic agents, β-blockers, statins and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) from 2001 to 2006 (follow-up ranging from 1 to 5 years). Results We identified 4764 patients (mean age 67; 35% female) discharged from hospital after first-ever AMI. The prescription rate in the first year after AMI was suboptimal (β-blockers 35.1%, aspirin or warfarin 75.0%, ACE-inhibitors or ARBs 61.6%, statins 52.8%) but showed a continuous improvement from 2001 to 2005. The prescription rate decreased slightly during the follow-up, but showed a complex pattern with a variable but significant number of patients discontinuing or resuming the therapy. Conclusions The prescription of recommended drugs after AMI has increased from 2001 to 2006 in Italy, but the prescription rate remains largely unsatisfactory. Therapeutic continuity is also suboptimal.