Operative Unit of Territorial Health Services

Milano, Italy

Operative Unit of Territorial Health Services

Milano, Italy
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Corrao G.,University of Milan Bicocca | Parodi A.,University of Milan Bicocca | Zambon A.,University of Milan Bicocca | Heiman F.,BKL Consulting S.r.l. | And 2 more authors.
Journal of Hypertension | Year: 2010

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. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Corrao G.,Unit of Biostatistics and Epidemiology | Corrao G.,University of Milan Bicocca | Nicotra F.,Unit of Biostatistics and Epidemiology | Parodi A.,Unit of Biostatistics and Epidemiology | And 6 more authors.
Hypertension | Year: 2011

Guidelines recommend a combination of 2 drugs to be used as first-step treatment strategy in high-risk hypertensive individuals to achieve timely blood pressure control and avoid early events. The evidence that this is associated with cardiovascular (CV) benefits compared with initial monotherapy is limited, however. The objective of this study was to assess whether, compared with antihypertensive monotherapy, a combination of antihypertensive drugs provides a greater CV protection in daily clinical practice. A population-based, nested case-control study was carried out by including the cohort of 209 650 patients from Lombardy (Italy) aged 40 to 79 years who were newly treated with antihypertensive drugs between 2000 and 2001. Cases were the 10 688 patients who experienced a hospitalization for CV disease from initial prescription until 2007. Three controls were randomly selected for each case. Logistic regression was used to model the CV risk associated with starting on and/or continuing with combination therapy. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders. Patients starting on combination therapy had an 11% CV risk reduction with respect to those starting on monotherapy (95% CI: 5% to 16%). Compared with patients who maintained monotherapy also during follow-up, those who started on combination therapy and kept it along the entire period of observation had 26% reduction of CV risk (95% CI: 15% to 35%). In daily life practice, a combination of antihypertensive drugs is associated with a great reduction of CV risk. The indication for using combination of blood pressure drugs should be broadened. © 2011 American Heart Association, Inc.


Parodi A.,University of Milan Bicocca | Merlino L.,Operative Unit of Territorial Health Services | Corrao G.,University of Milan Bicocca
Journal of Hypertension | Year: 2011

Objectives: Discontinuation of antihypertensive treatment is known to be different for different classes of antihypertensive drugs. No information is available on whether this phenomenon differs for drugs belonging to the same class. This is clinically relevant because treatment discontinuation is mainly responsible for poor blood pressure control in the antihypertensive population. Methods: We studied a large (n = 131 472) cohort of patients aged 40-80 years who lived in Lombardy (Italy) and received their first antihypertensive drug prescription during 2005. Discontinuation was defined by the absence of any antihypertensive drug prescription during the 90-day period following the end of the latest prescription. Class-related and drug-related discontinuation rates were standardized according to the demographic and therapeutic structure of the entire cohort and expressed as number of patients who experienced discontinuation every 100 person-months. Results: Standardized rates of discontinuation ranged from 6.2 to 24.4 events every 100 person-months for patients who started monotherapy with an angiotensin receptor antagonist and a diuretic, respectively. However, there was a significant heterogeneity between treatment discontinuation rates within each class and the heterogeneity differed between classes. The highest discontinuation rate was 13.9-fold for channel blockers, but only 1.7-fold for angiotensin receptor antagonists. Within this class, losartan showed a discontinuation rate significantly greater than that of the other angiotensin receptor antagonists whose discontinuation rate was similar. A significant heterogeneity also characterized initial treatment with fixed-dose combinations of different angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists with a diuretic. Conclusion: Comparison of treatment discontinuation between antihypertensive drug classes masks the fact that this phenomenon is heterogeneous within any given class. This is relevant to calculations of the cost-benefit of treatment, which, thus, should be drug-based rather than class-based. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Corrao G.,University of Milan Bicocca | Romio S.A.,University of Milan Bicocca | Zambon A.,University of Milan Bicocca | Merlino L.,Operative Unit of Territorial Health Services | And 2 more authors.
European Journal of Clinical Pharmacology | Year: 2011

Objective: To compare the effect of metformin and sulphonylureas on the risks of switching to insulin therapy, hospitalisation for macrovascular disease and all-cause mortality. Methods: The 70,437 residents of the Italian Region of Lombardy aged 40 to 90 years who started diabetes treatment with metformin or sulphonylureas during 2001-2003 entered the study and were followed until July 2007. We estimated the effects of the first-line agent, early compliance, and persistence with first-line therapy on the risks of switching to insulin, hospitalisation for macrovascular disease and all-cause mortality, by fitting a multistate model and adjusting for age, gender and selected clinical factors. Results: Compared with patients who started on metformin, those who started on sulphonylureas were at a higher risk of switching to insulin (adjusted hazard ratio and 95% CI, 1.55; 1.43, 1.68), hospitalisation (1.15; 1.08, 1.21), and death (1.37; 1.26, 1.49). Compared with patients who stayed on sulphonylureas for 3 months or less, those on sulphonylureas for more than 9 months had an adjusted hazard ratio of 1.24 (1.13, 1.35) for switching to insulin and 1.14 (1.05, 1.23) for hospitalisation. The risks of switching to insulin and hospitalisation were both increased among patients who switched from metformin to another oral hypoglycaemic agent or combined initial monotherapy with another agent. Conclusions: Our study provides evidence that the risks of switching to insulin, hospitalisation because of macrovascular events and death changes according to the first prescribed oral hypoglycaemic agent, as well as to the early compliance and persistence with such agent. © 2010 Springer-Verlag.


Corrao G.,University of Milan Bicocca | Soranna D.,University of Milan Bicocca | Merlino L.,Operative Unit of Territorial Health Services | Mancia G.,Instituto Auxologico Italiano
European Journal of Clinical Investigation | Year: 2014

Background: Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. Objective: To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. Design and subjects: A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. Results: There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Conclusions: Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.


Mancia G.,IRCCS Instituto Auxologico Italiano | Mancia G.,Centro Interuniversitario Of Fisiologia Clinica ertensione | Mancia G.,University of Milan Bicocca | Zambon A.,University of Milan Bicocca | And 3 more authors.
Journal of Hypertension | Year: 2014

OBJECTIVES:: We have previously shown that in Italian region of Lombardy (about 10 million citizens), adherence to antihypertensive treatment is low, and that this is associated with a greater risk of hospitalization for cardiovascular events. In this study, we used a healthcare database to study the factors involved in discontinuation of antihypertensive drug prescriptions in real life. METHODS AND RESULTS:: The analysis was restricted to 493 623 new users of antihypertensive drugs (no prescriptions in the previous 3 years) recruited in 2003, 2006 and 2009. Discontinuation was defined as lack of prescription renewal for at least 3 months. Each patient was followed at most for 1 year. The adjusted risk of treatment discontinuation depended on the type of initial antihypertensive treatment (diuretic monotherapy associated with higher risk) and it was lower in men (-17%) and older (-21 to -29%) patients, in patients with co-treatment with antidiabetic drugs, or hospitalization for cardiovascular or renal disease (-12 to -27%), but greater in patients under co-treatment with antidepressant drugs or hospitalization for concomitant pulmonary, rheumatic, neoplastic or neurological diseases (+9 to +32%). An unexpected relationship between discontinuation of treatment and density of the population of patient's residence, with a much greater discontinuation in metropolitan areas, was observed. CONCLUSIONS:: In a real life setting, discontinuation of antihypertensive treatment is affected in an opposite direction by a large number of factors: type of antihypertensive treatment, co-treatments, clinical conditions and even demographic characteristics of the geographical area where the patient lives. Knowledge of these factors may help the effort to reduce this phenomenon.


Corrao G.,University of Milan Bicocca | Soranna D.,University of Milan Bicocca | Casula M.,University of Milan | Merlino L.,Operative Unit of Territorial Health Services | And 2 more authors.
Atherosclerosis | Year: 2014

Objective: To assess the association between acute kidney injury and exposure to either high-potency statins or low-potency statins. Design: A population-based, nested case-control study was performed on a cohort of 316,449 patients from Lombardy (Italy) newly treated with statins between 2007 and 2010 aged 40 years or older. 458 patients experienced acute kidney injury within six months after initial statin prescription. Up to four controls were randomly selected for each case. Logistic regression was used to model the outcome risk associated with high-potency contrasted with low-potency statins dispensed at starting therapy, and during follow-up. Results: Patients at whom high-potency statins were initially dispensed were more likely to be hospitalized for acute kidney injury within six months after starting treatment than those on low-potency statins (adjusted OR 1.54, 95% confidence interval 1.25-1.91). Patients receiving high-potency statins within three weeks before the outcome onset had a significant increased risk respect to those who did not receive statins during the same time-window (adjusted OR 1.45, 95% confidence interval 1.04-2.03). When follow-up was extended from 6 months to 12 months the difference was not significant anymore (adjusted OR 1.17, 95% confidence interval 0.89-1.54). Conclusions: Use of high-potency statins is associated with an increased risk of acute kidney injury compared with low-potency statins in the first 6 months after starting therapy. © 2014 Elsevier Ireland Ltd.


Corrao G.,University of Milan Bicocca | Ibrahim B.,University of Milan Bicocca | Nicotra F.,University of Milan Bicocca | Soranna D.,University of Milan Bicocca | And 8 more authors.
Diabetes Care | Year: 2014

OBJECTIVE: To investigate the relationship between adherence with statin therapy and the risk of developing diabetes. RESEARCH DESIGN AND METHODS: The cohort comprised 115,709 residents of the Italian Lombardy region who were newly treated with statins during 2003 and 2004. Patients were followed from the index prescription until 2010. During this period, patients who began therapy with an antidiabetic agent or were hospitalized for a main diagnosis of type 2 diabetes were identified (outcome). Adherence was measured by the proportion of days covered (PDC) with statins (exposure). A proportional hazards model was fitted to estimate hazard ratios (HRs) and 95% CIs for the exposure-outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty. RESULTS: During follow-up, 11,154 cohort members experienced the outcome. Compared with patients with very-low adherence (PDC <25%), those with low (26-50%), intermediate (51-75%), and high (≥75%) adherence to statin therapy had HRs (95% CIs) of 1.12 (1.06-1.18), 1.22 (1.14-1.27), and 1.32 (1.26-1.39), respectively. CONCLUSIONS: In a real-world setting, the risk of new-onset diabetes rises as adherence with statin therapy increases. Benefits of statins in reducing cardiovascular events clearly overwhelm the diabetes risk. © 2014 by the American Diabetes Association.


Corrao G.,University of Milan Bicocca | Zambon A.,University of Milan Bicocca | Parodi A.,University of Milan Bicocca | Merlino L.,Operative Unit of Territorial Health Services | Mancia G.,University of Milan Bicocca
American Journal of Hypertension | Year: 2012

Background Aim of the present investigation was to quantify the early discontinuation phenomenon in patients treated for hypertension, dyslipidemia or diabetes, and to assess their clinical characteristics and incidence of cardiovascular (CV) outcomes to see whether an incorrect diagnosis was involved or treatment continuation might have been indicated. Methods Using the health-care databases on beneficiaries of the National Health Service (NHS) living in Lombardy, we studied patients aged 40-79 years who received their first prescription during 2003. Patients were classified according to whether they received only one or multiple prescriptions and data were compared with those obtained in individuals who did not receive any prescription. Crude and standardized rates of hospitalization for CV outcomes were calculated from initial prescription until 2008. Results Among the 203,302 patients on antihypertensive therapy, those experiencing only one prescription (35.7%) showed significant higher rates of cotreatments, comorbidities, and CV hospitalization than those who did not receive antihypertensive medications. Standardized CV rates were respectively 40.0 and 37.8 events every 10,000 person-year at risk (+7%). Similar findings were obtained for antidiabetic or lipid-lowering medications for which the between-group difference in CV rate was even greater (+21% and 18% respectively). Conclusions In general practice management of hypertension, dyslipidemia and diabetes is characterized by a high rate of treatment discontinuation. Patients who early discontinued had an unfavorable risk profile and a greater incidence of CV events than untreated patients. This suggests that they include candidates in whom treatment continuation is advisable. © 2012 American Journal of Hypertension, Ltd.


Corrao G.,University of Milan Bicocca | Parodi A.,University of Milan Bicocca | Nicotra F.,University of Milan Bicocca | Zambon A.,University of Milan Bicocca | And 3 more authors.
Journal of Hypertension | Year: 2011

Objective: The effect of compliance with antihypertensive medications on the risk of cardiovascular outcomes in a population without a known history of cardiovascular disease has been addressed by a large population-based prospective, cohort study carried out by linking Italian administrative databases. Methods: The cohort of 242 594 patients aged 18 years or older, residents in the Italian Lombardy Region, who were newly treated for hypertension during 2000-2001, was followed from index prescription until 2007. During this period patients who experienced a hospitalization for coronary or cerebrovascular disease were identified (outcome). Exposure to antihypertensive drugs from index prescription until the date of hospitalization or censoring was assessed. Proportional hazards models were fitted to assess the association between persistence on and adherence with antihypertensive drug therapy and outcome. Data were adjusted for several covariates. Results: During an average follow-up of 6 years, 12 016 members of the cohort experienced the outcome. Compared with patients who experienced at least one episode of treatment discontinuation, those who continued treatment had a 37% reduced risk of cardiovascular outcomes (95% confidence interval 34-40%). Compared with patients who had very low drug coverage (proportion of days covered ≤25%), those at intermediate (from 51 to 75%) and high coverage (>75%) had risk reductions of 20% (16-24%) and 25% (20-29%), respectively. Similar effects were observed when coronary and cerebrovascular events were considered separately. Conclusions: In the real life setting, fulfillment compliance with antihypertensive medications is effective in the primary prevention of cardiovascular outcomes. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

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