Laboratory of Pharmacoepidemiology

Santa Maria Imbaro, Italy

Laboratory of Pharmacoepidemiology

Santa Maria Imbaro, Italy
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Anecchino C.,Laboratory of Pharmacoepidemiology | Fanizza C.,Laboratory of Pharmacoepidemiology | Marino V.,Pfizer | Romero M.,Laboratory of Pharmacoepidemiology | And 8 more authors.
Clinical and Experimental Rheumatology | Year: 2015

Objective: The aim of this paper is to analyse the use of anti-TNF drugs in current Italian practice, evaluate clinical responses to treatment, and identify possible predictors of negative response in patients with rheumatoid arthritis (RA). Methods: DOSE is a non-interventional, prospective study of patients with active RA treated for the first time with anti-TNF agents in 21 Italian hospitals. Demographic and clinical characteristics of patients, treatments and outcome measures were assessed. Outcome measures used were EULAR response, DAS28 remission and HAQ remission at 12 months. A stepwise logistic regression model was used to study the predictors of non-response. Results: Of 299 RA patients (mean 53.8±12.8 years, 76.1% female), DAS28 was >5.1 in 60.5% of patients and HAQ was >1 in 65.9%. Etanercept was the most prescribed anti-TNF. DMARDs were used in 77.6% of patients (methotrexate in 59.2%). Significant improvements in clinical and laboratory parameters were observed at 12 months. The proportion of patients classed as non-responders remained high, and varied according to assessment criteria. The main predictors independently and significantly associated with a high risk of non-response were: age and female gender for all outcome criteria; high DAS28 value for disease remission; and HAQ >1 for disability remission. Conclusion: In Italian anti-TNF treatment for RA, age, gender, and high values of both disease activity and disability were predictors of non-response to first-line therapy with anti-TNF drugs. Future studies should consider optimal second-line therapies for RA patients who do not achieve remission to their first anti-TNF treatment. © Clinical and Experimental Rheumatology 2015.


MacChia A.,Laboratory of Pharmacoepidemiology | Romero M.,Laboratory of Pharmacoepidemiology | Dettorre A.,Laboratory of Pharmacoepidemiology | Mariani J.,Fundacin GESICA | Tognoni G.,Laboratory of Pharmacoepidemiology
European Heart Journal | Year: 2012

Aims Epidemiological studies reported two contrasting trends: on one hand, a significant improvement in the use of evidence-based treatments of patients discharged with a myocardial infarction (MI). On the other hand, the increasing number of elderly and co-morbid patients who are usually less treated. The aim of this study is to examine whether improvements in the treatment of MI are homogeneously distributed throughout all subgroups of patients.Methods and resultsBased on record linkage of administrative registers, 21 423 patients discharged with MI in three different periods (2003, 2005, and 2007), were identified and followed up for major clinical events up to 1 year. Using as a reference temporal category those patients discharged in 2003 (odds ratios, 95 confidence intervals) and as a demographic category male patients aged ≤75 years (1.00), the study identified: in-hospital mortality significantly decreased in all periods and in all groups of patients; out-of-hospital mortality decreased only in younger patients and not in older patients; prescription of evidence-based treatments increased in all periods for all patients; however, the magnitude of improvement was mostly concentrated in younger patients.ConclusionAlthough there was a mean improvement in the treatment and outcome of patients discharged from an MI, most of these benefits were strongly concentrated in younger, healthier patients. Old and co-morbid populationsalthough representing a substantial proportion of the burden of diseasereceived significant less attention and barely improved their survival. © 2011 The Author.


MacChia A.,Laboratory of Pharmacoepidemiology | MacChia A.,Hospital Aleman | Romero M.,Laboratory of Pharmacoepidemiology | Comignani P.D.,Hospital Aleman | And 5 more authors.
Critical Care Medicine | Year: 2012

OBJECTIVES: Results from basic science and narrative reviews suggest a potential role of β-blockers in patients with sepsis. Although the hypothesis is physiologically appealing, it could be seen as clinically counterintuitive. We sought to assess whether patients previously prescribed chronic β-blocker therapy had a different mortality rate than those who did not receive treatment. SETTING: Record linkage of administrative databases of Italian patients hospitalized for sepsis during years 2003-2008 were identified and followed up for all-cause mortality at 28 days. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We identified 9,465 patients aged ≥40 yrs who were hospitalized in critical care units for sepsis. Of these, 1,061 patients were on chronic prescription with β-blockers and 8404 were not previously treated. Despite a higher risk profile, patients previously prescribed with β-blockers had lower mortality at 28 days (188/1061 [17.7%]) than those previously untreated (1857/8404 [22.1%]) (odds ratio 0.78; 95% confidence interval 0.66-0.93; p =.005 for unadjusted analysis, and odds ratio 0.81; 95% confidence interval 0.68-0.97; p =.025 for adjusted analyses). Sensitivity and pair-matched results confirm the primary findings. CONCLUSIONS: As far as we are aware, this pharmacoepidemiologic assessment is the largest to examine the potential association of previous β-blocker prescription and mortality in patients with sepsis. Chronic prescription of β-blockers may confer a survival advantage to patients who subsequently develop sepsis with organ dysfunction and who are admitted to an intensive care unit. Prospective randomized clinical trials should formally test this hypothesis. Copyright © 2012 by the Society of Critical Care Medicine and Lippincott Williams and Wilkins.


Macchia A.,Laboratory of Pharmacoepidemiology | Macchia A.,Gesica Grupo Of Estudio Of Investigacion Clinica En Argentina Foundation | Romero M.,Laboratory of Pharmacoepidemiology | D'Ettorre A.,Laboratory of Pharmacoepidemiology | And 2 more authors.
PLoS ONE | Year: 2013

Background:Combined treatment (CT) with statins and polyunsaturated fatty acids (n-3 PUFA) resulted in a reduction of death and major cardiovascular events when administered after a myocardial infarction (MI). However, recent data suggests that CT may be ineffective because patients are currently treated aggressively and the risk may not be further decreased. We aimed to study the prevalence and the results on major outcomes with CT among patients discharged with a MI in Italy.Methodology/Principal findings:Retrospective cohort study that used linked hospital discharge, prescription databases and vital statistics containing information on 14,704 patients who were discharged for MI between 1/2003 and 12/2003 in 117 hospitals in Italy. All analyses were time-dependent and adjusted for major confounders. Sensibility and paired matched analysis were conducted to further verify main results. A total of 11,532 (78.4%) filled a prescription for a statin. Of these, 4302 (37.3%) were on CT. There were 45,528 patients/years of follow-up. As compared with statins alone, CT was associated with an adjusted higher survival rate (HR = 0.59 [0.52-0.66], p<0.001), survival free of atrial fibrillation (HR = 0.78 [0.71-0.86], p<0.001) and survival free of new heart failure development (HR = 0.81 [0.74-0.88], p<0.001), but not with re-infarction (HR = 0.94 [0.86-1.02], p<0.127). Clinically this means that between 2 to 3 fewer events for each 100 patients/year were obtained in the group under CT.Conclusions/Significance:Among a representative sample of patients discharged with MI in Italy, we observed clinically significant synergism between the effects of statins and n-3 PUFA for most cardiovascular outcomes, including all cause mortality. © 2013 Mariani et al.


Aims Epidemiological studies reported two contrasting trends: on one hand, a significant improvement in the use of evidence-based treatments of patients discharged with a myocardial infarction (MI). On the other hand, the increasing number of elderly and co-morbid patients who are usually less treated. The aim of this study is to examine whether improvements in the treatment of MI are homogeneously distributed throughout all subgroups of patients. Methods and results Based on record linkage of administrative registers, 21 423 patients discharged with MI in three different periods (2003, 2005, and 2007), were identified and followed up for major clinical events up to 1 year. Using as a reference temporal category those patients discharged in 2003 (odds ratios, 95% confidence intervals) and as a demographic category male patients aged 75 years (1.00), the study identified: in-hospital mortality significantly decreased in all periods and in all groups of patients; out-of-hospital mortality decreased only in younger patients and not in older patients; prescription of evidence-based treatments increased in all periods for all patients; however, the magnitude of improvement was mostly concentrated in younger patients. Conclusion Although there was a mean improvement in the treatment and outcome of patients discharged from an MI, most of these benefits were strongly concentrated in younger, healthier patients. Old and co-morbid populations-although representing a substantial proportion of the burden of disease-received significant less attention and barely improved their survival.


PubMed | Laboratory of Pharmacoepidemiology and Pfizer
Type: Journal Article | Journal: Clinical and experimental rheumatology | Year: 2015

The aim of this paper is to analyse the use of anti-TNF drugs in current Italian practice, evaluate clinical responses to treatment, and identify possible predictors of negative response in patients with rheumatoid arthritis (RA).DOSE is a non-interventional, prospective study of patients with active RA treated for the first time with anti-TNF agents in 21 Italian hospitals. Demographic and clinical characteristics of patients, treatments and outcome measures were assessed. Outcome measures used were EULAR response, DAS28 remission and HAQ remission at 12 months. A stepwise logistic regression model was used to study the predictors of non-response.Of 299 RA patients (mean 53.8 12.8 years, 76.1% female), DAS28 was >5.1 in 60.5% of patients and HAQ was >1 in 65.9%. Etanercept was the most prescribed anti-TNF. DMARDs were used in 77.6% of patients (methotrexate in 59.2%). Significant improvements in clinical and laboratory parameters were observed at 12 months. The proportion of patients classed as non-responders remained high, and varied according to assessment criteria. The main predictors independently and significantly associated with a high risk of non-response were: age and female gender for all outcome criteria; high DAS28 value for disease remission; and HAQ >1 for disability remission.In Italian anti-TNF treatment for RA, age, gender, and high values of both disease activity and disability were predictors of non-response to first-line therapy with anti-TNF drugs. Future studies should consider optimal second-line therapies for RA patients who do not achieve remission to their first anti-TNF treatment.


PubMed | Laboratory of Pharmacoepidemiology
Type: Journal Article | Journal: Critical care medicine | Year: 2012

Results from basic science and narrative reviews suggest a potential role of -blockers in patients with sepsis. Although the hypothesis is physiologically appealing, it could be seen as clinically counterintuitive. We sought to assess whether patients previously prescribed chronic -blocker therapy had a different mortality rate than those who did not receive treatment.Record linkage of administrative databases of Italian patients hospitalized for sepsis during years 2003-2008 were identified and followed up for all-cause mortality at 28 days.None.We identified 9,465 patients aged40 yrs who were hospitalized in critical care units for sepsis. Of these, 1,061 patients were on chronic prescription with -blockers and 8404 were not previously treated. Despite a higher risk profile, patients previously prescribed with -blockers had lower mortality at 28 days (188/1061 [17.7%]) than those previously untreated (1857/8404 [22.1%]) (odds ratio 0.78; 95% confidence interval 0.66-0.93; p=.005 for unadjusted analysis, and odds ratio 0.81; 95% confidence interval 0.68-0.97; p=.025 for adjusted analyses). Sensitivity and pair-matched results confirm the primary findings.As far as we are aware, this pharmacoepidemiologic assessment is the largest to examine the potential association of previous -blocker prescription and mortality in patients with sepsis. Chronic prescription of -blockers may confer a survival advantage to patients who subsequently develop sepsis with organ dysfunction and who are admitted to an intensive care unit. Prospective randomized clinical trials should formally test this hypothesis.

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