Generating Evidence From Computerized Healthcare Utilization Databases

Corrao, Giovanni; Mancia, Giuseppe

doi:10.1161/hypertensionaha.114.04858

Cited by 83 publications

(60 citation statements)

References 76 publications

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“…Second, the implicit exclusion from our analysis of spontaneous and elective pregnancy terminations affects the possibility for outcomes potentially due to drug foetal-exposure to be selectively excluded. Third, a main limitation in using dispensing data relates to whether or not the medicine was consumed, or consumed as directed, and there is no information in this study for either of these aspects [37]. Fourth, privacy concerns prevented us to assess the validity of the information recorded in the Certificates of Delivery Assistance, as well as the diagnostic data from hospital charts.…”

Section: Discussionmentioning

confidence: 99%

Is the Risk of Preterm Birth and Low Birth Weight Affected by the Use of Antidepressant Agents during Pregnancy? A Population-Based Investigation

et al. 2016

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BackgroundUntreated depression during pregnancy increases the risk of morbidity and mortality in the mother and child. Therefore, specific treatments are required for this population.ObjectiveThe study aimed to investigating the effect of antidepressant medication used during pregnancy with reference to the risk of preterm birth (PTB) and low birth weight (LBW).MethodsA population-based study was carried out with data provided by the healthcare utilization database of Lombardy, an Italian region with about ten million inhabitants. The study included 384,673 births from 2005 to 2010. Maternal use of antidepressants before and during pregnancy was investigated. Log-binomial regression was used to estimate the association between the use of antidepressants during pregnancy, compared to the non-use or use just before pregnancy, and the prevalence ratio of PTB and LBW.ResultsWomen who used antidepressants during pregnancy had a 20% (95% CI: 10–40%) increased prevalence of both PTB and LBW compared to those who never used antidepressants. There was no evidence that women who used antidepressants during pregnancy had a higher prevalence of the considered outcomes compared to women who used antidepressants before pregnancy, but stopped during pregnancy. Such findings were confirmed by considering separately the effects of SSRIs and other antidepressants together.ConclusionsOur findings suggest that depression in itself, rather than antidepressant medication, might be implicated in the causal pathway of PTB and LBW.

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Section: Discussionmentioning

confidence: 99%

Is the Risk of Preterm Birth and Low Birth Weight Affected by the Use of Antidepressant Agents during Pregnancy? A Population-Based Investigation

et al. 2016

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“…Two, adherence with treatment was derived from drug prescriptions, that is, a widely used method to estimate adherence to treatment in large populations, 31 which requires, however, the assumption that the proportion of days covered by a prescription corresponds to the proportion of days of drug use. 32 Finally, because allocation of antihypertensive drug therapy was not randomized, the results may be affected by confounding. That is, the reduction in HF risk associated with a better adherence to antihypertensive medicaments might have been generated by factors, accompanying but different from a better adherence to antihypertensive drug treatment.…”

Section: Limitationsmentioning

confidence: 99%

“…However, factors, such as ethnicity or socioeconomic status, can be confidently ruled out because the Lombardy population is largely white, and we have previously found that in Lombardy, income and educational differences play no role in the persistence on antihypertensive drug treatment. 33 Furthermore, it is unlikely that the increased risk of HF in patients with low adherence to antihypertensive drug treatment is accounted for a more compromised clinical status because (1) patients prescribed multiple antihypertensive drugs at the start were excluded to minimize participation in the study of individuals with a more severe hypertension and greater cardiovascular risk 14 , (2) data were adjusted for several demographic, therapeutic, and clinical characteristics, (3) although our database did not make BP values available, 32 adjustment included several proxies of the severity of hypertension and the difficulties of achieving therapeutic results, such as the number of antihypertensive drugs, the switching between antihypertensive drug classes, the number of prescribing physicians, and the addition to antihypertensive drug treatment of nonhypertensive cardiovascular agents, 34 and (4) patients with a more severe hypertension and a higher cardiovascular risk are known to have a better rather than a worse adherence to drug treatment. 35 Of course, this does not entirely eliminate the problem of confounding, one aspect of which is that because adherence may be a surrogate for overall health-seeking behavior, patients more adherent to antihypertensive drugs might also have more regularly followed healthy lifestyle advices, more effectively treated other cardiovascular risk factors, or dealt with HF more frequently as out-rather than in-hospital.…”

Section: Limitationsmentioning

confidence: 99%

Adherence With Antihypertensive Drug Therapy and the Risk of Heart Failure in Clinical Practice

et al. 2015

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Abstract-Randomized clinical trials have shown that antihypertensive treatment reduces the risk of heart failure (HF).Limited evidence exists, however, on whether and to what extent this benefit is translated into real-life practice. A nested case-control study was carried out by including the cohort of 76 017 patients from Lombardy (Italy), aged 40 to 80 years, who were newly treated with antihypertensive drugs during 2005. Cases were the 622 patients who experienced hospitalization for HF from initial prescription until 2012. Up to 5 controls were randomly selected for each case. Logistic regression was used to model the HF risk associated with adherence to antihypertensive drugs, which was measured by the proportion of days covered by treatment (PDC). Data were adjusted for several covariates. Sensitivity analyses were performed to account for possible sources of systematic uncertainty. Compared with patients with very low adherence (PDC, ≤25%), low, intermediate, and high adherences were associated with progressively lower risk of HF, reduction in the high-adherence group (>75%) being 34% (95% confidence interval, 17%-48%). Similar effects were observed in younger (40-70 years) and older (71-80 years) patients and between patients treated with angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and diuretics. There was no evidence that adherence with calciumchannel blockers reduced the HF risk. Antihypertensive treatment lowers the HF risk in real-life practice, but adherence to treatment is necessary for a substantial benefit to take place. This is the case with a variety of antihypertensive drugs. Corrao et al Antihypertensive Agents and Heart Failure 743these, those who received at least 1 antihypertensive drug prescription during 2005 were identified, and the first dispensation was defined as the index prescription. Antihypertensive drugs included diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and calcium-channel blockers (CCBs) initially dispensed as monotherapy. Patients with an initial prescription of ≥2 antihypertensive drugs were excluded to reduce the range of hypertension severity, given that compared with monotherapy, need of multiple drug treatment reflects an increased risk of cardiovascular events, including HF. 14 Exclusion was extended to other patient categories, such as patients who (1) received at least 1 antihypertensive drug prescription within the 5 years before the index prescription, to limit inclusion to newly treated individuals; (2) had been hospitalized for cardiovascular disease or used drugs for coronary heart disease or HF, within the 5 years before the index prescription to limit data collection to the setting of primary cardiovascular prevention; (3) were beneficiaries of the National Health Service from <5 years before the start of prescription; and (4) did not reach at least 1 year of followup. Patients who had previously received ≥1 prescriptions of digitalis were also excluded because the use of digi...

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“…Using data that are collected in trials carries the advantage that identification of the outcomes is usually more accurate than that provided by observational studies or other data sources. 11 It has the disadvantage, however, that in randomized trials patients' high motivation and close follow-up make overall adherence uncharacteristically high. In this study, only <15% of the patients reported a lower than 80% use of the medicaments which (1) made the numeric between-group comparisons unbalanced and (2) did not allow to explore the effect of lower adherence levels (so common in real-life antihypertensive treatment) 6,11 on the relationship between visit-to-visit BP variability and outcomes.…”

Section: Mancia Vvv Bp Variability 33mentioning

confidence: 99%

“…11 It has the disadvantage, however, that in randomized trials patients' high motivation and close follow-up make overall adherence uncharacteristically high. In this study, only <15% of the patients reported a lower than 80% use of the medicaments which (1) made the numeric between-group comparisons unbalanced and (2) did not allow to explore the effect of lower adherence levels (so common in real-life antihypertensive treatment) 6,11 on the relationship between visit-to-visit BP variability and outcomes. This is an important issue to address because adherence to treatment has often been shown to markedly improve cardiovascular protection already when it raises to intermediate levels (50% to 75% of the available drugs), with little further advantage when the level increases further.…”

Section: Mancia Vvv Bp Variability 33mentioning

confidence: 99%