Occurrence of Comorbidities before and after Soft Tissue Sarcoma Diagnosis

Background. Data is limited on the burden of common comorbidities, such as cardiovascular disease (CVD), respiratory disease and diabetes, or comorbidities related to cancer and its treatment, such as anemia and depression, in patients with soft tissue sarcoma (STS). Patients and Methods. From the Dutch Pathology Registry linked to the PHARMO database (including data on drug use and hospitalizations), 533 patients with STS were selected during 2000–2007 and matched 1 : 10 to cancer-free controls. The occurrences of comorbidities were assessed in the 12 months before and after STS diagnosis. Results. STS patients were 2–4 times more likely to have comorbidities at diagnosis compared with cancer-free controls. The incidence of CVD, anemia, and depression after STS diagnosis differed significantly from cancer-free controls and decreased during followup from 40–124 per 1,000 person-years (py) during the first six months to 11–38 per 1,000 py more than 12 months after diagnosis. The incidence of respiratory disease and diabetes among STS patients remained stable during followup (5–21 per 1,000 py) and did not differ significantly from cancer-free controls. Conclusions. STS patients were more likely to have comorbidities before cancer diagnosis and to develop CVD, anemia, and depression after diagnosis compared to cancer-free controls

Glycemic control and long-acting insulin analog utilization in patients with type 2 diabetes

Introduction: The objective was to compare glycemic control, insulin utilization, and body weight in patients with type 2 diabetes (T2D) initiated on insulin detemir (IDet) or insulin glargine (IGlar) in a real-life setting in the Netherlands. Methods: Insulin-naïve patients with T2D, starting treatment with IDet or IGlar between January 1, 2004 and June 30, 2008, were selected from the PHARMO data network. Glycemic control (hemoglobin A1c [HbA1c]), target rates (HbA1c <7%), daily insulin dose, and weight gain were analyzed comparing IDet and IGlar for patients with available HbA1c levels both at baseline and at 1-year follow-up. Analysis of all eligible patients (AEP) and a subgroup of patients without treatment changes (WOTC) in the follow-up period were adjusted for patient characteristics, propensity scores, and baseline HbA1c. Results: A total of 127 IDet users and 292 IGlar users were included in the WOTC analyses. The mean HbA1c dropped from 8.4%-8.6% at baseline to 7.4% after 1 year. Patients at HbA1c goal increased from 9% at baseline to 32% for IDet and 11% to 35% for IGlar, which was not significantly different (OR 0.75, 95% CI 0.46, 1.24). Weight gain (n=90) was less among IDet users (+0.4kg) than among IGlar users (+1.1kg), albeit not significant. The AEP analysis (252 IDet

Haemoglobin A(1c) goal attainment in relation to dose in patients with diabetes mellitus taking metformin

Background and objective: Conclusions from clinical trials suggest possible therapeutic advantages for once-daily agents over twice-daily agents in the treatment of type 2 diabetes mellitus. This study set out to investigate the relationship between metformin dosing frequency and glycosylated haemoglobin (HbA(1c))-goal attainment in daily practice. Methods: This was a nested case-control study. Data were obtained from the PHARMO Record Linkage System, which includes linked drug-dispensing and clinical-laboratory records for approximately three million individuals in defined areas of the Netherlands. The study cohort included new users of oral antihyperglycaemic drugs between 1999 and 2005 with a baseline HbA(1c) >= 7% and at least one further HbA(1c) measurement within 18 months after the index date. Cases attained HbA(1c) goal (<7%) within 18 months; controls did not attain this HbA(1c) goal. Compliant cases and controls taking metformin monotherapy were included in the analyses. Dosing frequency was dichotomized into once daily and twice daily or more frequently. In the multivariate analysis we considered oral antihyperglycaemic dose, baseline HbA(1c), first prescriber and number of HbA(1c) measurements. Results: The study cohort included 3.107 new oral antihyperglycaemic drug users. The analyses included 753 cases and 477 controls taking metformin. Dosing twice daily or more was associated with a 71% higher probability of attaining goal (odds ratio 1.71 [95% CI 1.31, 2.24]) compared with once-daily dosing, after adjustment for baseline HbA(1c), first prescriber, sex and age. We could not distinguish between the effect of dose and dosing frequency as these were closely related. Statistical testing in the analyses stratified by dose was prohibited by small numbers. Conclusion: About 40% of compliant metformin users did not achieve their HbA(1c) goal within 18 months because of dosing problems. However, the strong correlation between total daily dose and dosing frequency did not permit identification of which of these dosing issues was the most important contributor to not achieving HbA(1c) goal

Completeness and Representativeness of the PHARMO General Practitioner (GP) Data: A Comparison with National Statistics

Purpose: When using incomplete or non-representative real-world data (RWD), bias is more likely to occur. The aim of the current study was to assess the completeness and representativeness of the PHARMO GP data for the Dutch population. Patients and Methods: A cross-sectional study was performed. The PHARMO GP data comprise data from electronic health records registered by GPs. Data on the Dutch population were obtained from Statistics Netherlands (CBS), which offers publicly available data on several themes. The standardized difference (std.diff) was used to compare proportions between the PHARMO GP population and the Dutch population. An absolute std.diff >0.2 was considered a difference. Results: On January 1st, 2018, 3,466,321 persons were included in the PHARMO GP data (mean age: 41.6 years, 49.7% males). The sex and age distribution was similar to the Dutch population. The PHARMO GP data captured less not urbanized areas compared to the Dutch population (not urbanized areas: 9.4% vs 17.1% [std.diff: −0.23]). Regarding medication use, only the pharmacological subgroups “viral vaccines” and “hormonal contraceptives for systemic use” differed (std.diff >0.2); use in the GP data was more complete than in the Statistics Netherlands (CBS) data. No differences were observed regarding diagnoses. Conclusion: The PHARMO GP data are representative of the Dutch population with regard to the demographic characteristics and diagnoses in primary care. Medication data in the PHARMO GP data are more complete than national statistics, and differences are related to reimbursement. Use of the data and interpretation of results based on these sources should be done with experts on the data sources, the Dutch healthcare system and (pharmaco)epidemiology

Adherence to evidence-based statin guidelines reduces the risk of hospitalizations for acute myocardial infarction by 40%: a cohort study

AIMS: To investigate the 'real world' effectiveness of robust statin therapy, focusing on the effect of dose and early treatment discontinuation on the risk of hospitalization for acute myocardial infarction (AMI). METHODS AND RESULTS: In the PHARMO database, including among others drug-dispensing and hospital discharge records for more than two million subjects in the Netherlands, 59,094 new users of statins in the period 1 January 1991 until 31 December 2004, >or=18 years of age were identified. In these patients, exposure to statins, both in terms of persistence and dose, was determined over the first two treatment years. To determine the risk for AMI, patients were followed from this 2-year time point until the first hospital admission for AMI, death, or end of the study period. A total of 31,557 patients (53%) discontinued statin use within 2 years; 20 883 patients (35%) were persistent users with an average equipotent dose>or=4. A 30% reduction in risk of hospitalization for AMI with persistent statin use was observed. The protective effect increased with a higher dose (20 and 40% risk reduction with an equipotent dose or=4, respectively). CONCLUSION: These results show that statins are suboptimally used in real life for having the maximum benefit in terms of preventing AM

Characteristics of children and adolescents first prescribed proton pump inhibitors or histamine-2-receptor antagonists: an observational cohort study

OBJECTIVE: To describe the characteristics of pediatric patients prescribed proton pump inhibitors (PPIs) vs those of pediatric patients prescribed histamine-2-receptor antagonists (H2RAs). METHODS: Observational studies were conducted using The Health Improvement Network (THIN) and the PHARMO Database Network. Patients aged 0-18 years who were first prescribed a PPI or H2RA between October 1, 2009 and September 30, 2012 (THIN) or between September 1, 2008 and August 31, 2011 (PHARMO) were included. Patient characteristics were identified and compared between the PPI and H2RA cohorts using odds ratios (ORs) and 95% confidence intervals (CIs) adjusted for age and sex. RESULTS: The mean age (years) was higher in the PPI than in the H2RA cohorts (THIN 12.3 [n = 8204] vs 5.4 [n = 7937], PHARMO 11.0 [n = 15 362] vs 7.1 [n = 6168]). Previous respiratory disease was more common in the PPI than in the H2RA cohort in THIN (OR = 1.19, 95% CI = 1.08-1.30), as were asthma and respiratory medication use in PHARMO (OR = 1.27, 95% CI = 1.12-1.45 and OR = 1.23, 95% CI = 1.10-1.38, respectively) and oral corticosteroid use in both databases (OR = 1.45, 95% CI = 1.10-1.92 [THIN]; OR = 2.80, 95% CI = 2.11-3.71 [PHARMO]). Non-steroidal anti-inflammatory drugs, antibiotics, and oral contraceptives were also more common in PPI than in H2RA cohorts in both databases. CONCLUSIONS: Pediatric patients receiving PPIs and those receiving H2RAs may represent different patient populations. PPIs may be more commonly prescribed than H2RAs among patients with respiratory diseases