Glycemic Control and Obesity Among People With Type 2 Diabetes in Europe and Australia: A Retrospective Cohort Analysis.

INTRODUCTION: In people with type 2 diabetes (PwT2D) who also have obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. The objective of this study was to explore the relationship between glycemic control and obesity among PwT2D in Europe and Australia using recent real-world data and applying consistent methodology across countries. METHODS: Retrospective study utilizing IQVIA electronic medical records (EMR) databases grouped into panels based on specialty of contributing physicians. General practitioner (GP) and endocrinologist/diabetologist (E/D) panels were used in Germany and France, while GP panels were used in Italy, UK and Australia. The Spanish database included all physician specialties. The sample included PwT2D with glycated hemoglobin A1c (HbA1c) and body mass index (BMI) values measured within 90 days of each other between January 2015 and December 2018 (second record termed the 'index date'). PwT2D had a 1-year baseline period and a recorded HbA1c at the end of the 1-year post-index period. RESULTS: The final sample comprised 194,729 PwT2D. At baseline, across countries/panels, 36.8-58.0% were above HbA1c target (HbA1c ≥ 7%) and 39.4-56.7% had obesity (BMI ≥ 30.0 kg/m2). Mean HbA1c ranged from 6.9 to 7.6% and mean BMI ranged from 29.3-31.6 kg/m2. At baseline, a higher proportion of PwT2D with obesity (40.8-64.2%) were above HbA1c target compared to their counterparts without obesity (32.2-52.4%). A higher proportion of patients with obesity at baseline (38.1-60.6%) had post-index HbA1c above target compared to their counterparts without obesity (30.9-56.0%). In logistic regression, patients with obesity had substantially lower odds of post-index HbA1c below target compared to those without obesity in all countries/panels except for France (E/D), Spain and Australia. CONCLUSIONS: This study presents data on HbA1c and BMI among type 2 diabetes (T2D) populations in Europe and Australia. A notable proportion of PwT2D had obesity and were above HBA1c target. Higher BMI was associated with poorer glycemic control.

Costs and Outcomes Comparison of Diabetes Technology Usage Among People With Type 1 or 2 Diabetes Using Rapid-Acting Insulin.

BACKGROUND: Does initiation of a continuous glucose monitor (CGM) or insulin pump lower health care utilization and/or costs? METHODS: Distinct cohorts of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using a blood glucose monitor (BGM), CGM, pump, or CGM with pump were identified from a large claims database. Patients ≥40 years old with 12 months of continuous enrollment before and after the device start date qualified for the study. Outcomes included one-year medical utilization and costs (minus device) for events such as hospitalizations and office visits. Generalized linear models were fitted, controlling for numerous baseline covariates. The Holm method corrected for the multiplicity of hypotheses tested. RESULTS: Of the 8235 total patients, the BGM control group was the largest, had the lowest percentage of patients with T1D, and was significantly different from the device groups in most baseline categories. Formally, only two comparisons were statistically significant: Compared with BGM, the pump cohort had greater adjusted first-year total medical and office visit costs. Other secondary outcomes such as days hospitalized, emergency department visits and labs, favored pump. Most endpoints were favorable for CGM. Results for CGM with pump generally were intermediate between CGM and pump alone. CONCLUSIONS: During a one-year follow-up, unadjusted medical costs of both CGM and pump appear lower than BGM, but multivariable modeling yielded adjusted savings only for CGM use. Economic benefits might be observable sooner for CGMs than for pumps. Generalized linear models fitted to health care utilization event rates produced favorable results for both CGM and pump.

Risk of Infection and Types of Infection Among Elderly Patients With Inflammatory Bowel Disease: A Retrospective Database Analysis.

BACKGROUND: Inflammatory bowel disease (IBD) treatment in the elderly is challenging in part because of increased risk of infections. The aim of our study was to determine the absolute and relative risk of infections among the elderly IBD patient population and to identify factors affecting the risk of infections in the overall IBD patient population. METHODS: A retrospective study of patients with IBD initiating corticosteroids, immunomodulators (IM), or biologic therapy (January 2010-December 2014) was conducted using the Truven Market Scan database. IM and biologic exposure were assessed in a time-dependent manner. ICD-9 codes identified infection during follow-up. A Cox proportional hazards model was fitted to gauge the association between age, other covariates, and infection risk. RESULTS: We identified 63,759 patients with IBD. We found 2664 infections (incidence rate [IR] = 16.95/100 person-years) among 8788 elderly patients with IBD and 10,515 (IR = 10.49/100 person-years) among the nonelderly group. Pneumonia (39.8%), sepsis (13.2%), and candidiasis (12.9%) were the most common infections in the elderly. Factors associated with a higher risk of infection included being elderly (HR: 1.27, P < 0.0001), anti-TNF therapy (HR: 1.64, P < 0.0001), IM therapy (HR: 1.32, P < 0.0001), and polypharmacy (HR: 1.32, P < 0.0001). CONCLUSIONS: Advanced age, anti-TNF (biologic) therapy, and IM therapy were associated with an increased risk of infection. Pneumonia was the most common infection among the elderly IBD population. Physicians should be mindful of these risks when prescribing medications for elderly patients with IBD, and ensure their patients are adequately vaccinated.

A threshold trajectory was revealed by isolating the effects of hemoglobin rate of rise in anemia of chronic kidney disease.

BACKGROUND: To assess cardiovascular risk among various hemoglobin (Hb) rates of rise (RoR) in chronic kidney disease (CKD) patients with anemia who have initiated therapy with erythropoiesis stimulating agents (ESAs). METHODS: Observational cohort of CKD patients initiating ESA therapy from the Centricity® database, 1990-2011. Proportional hazards models tested the hypothesis that a slower Hb RoR (0 < g/dl/month ⩽ 0.125) is associated with a lower cardiovascular (CV) incidence [composite of fatal/nonfatal myocardial infarction (MI) and stroke] compared with faster RoR (0.125 < g/dl/month ⩽ 2.0, and >2.0 g/dl/month). RESULTS: A total of 9220 patients receiving ESAs were followed for an average of 3.1 years. Slow (group B) RoR versus medium (group C') and fast (group D') RoR in Hb, throughout all Hb milestones, was associated with lower risk of the composite endpoint [B (slow) versus D' (fast) [hazard ratio (HR) = 0.20 (0.11, 0.39), p < 0.0001]; B versus C' (medium) [HR = 0.34 (0.19, 0.62), p = 0.0004], and C' versus D' [HR = 0.60 (0.42, 0.85), p = 0.005]]. Within achieved Hb milestones, HRs were: B versus D' at milestone ⩾ 14.1 g/dl [HR = 0.17 (0.05, 0.56); p = 0.004] and at milestone 12.6-14.0 [HR = 0.18 (0.07, 0.46), p = 0.0004]. CONCLUSION: Rapid Hb rise is associated with adverse CV outcomes, with markedly lower risk for rates below a threshold trajectory of 0.125 g/dl/month, even with complete correction.

Risk of Malignancy in a Nationwide Cohort of Elderly Inflammatory Bowel Disease Patients.

BACKGROUND: Management of elderly inflammatory bowel disease (IBD) patients (≥ 65 years of age) is complicated due to many factors, including a higher risk of cancer, which may impact therapeutic decisions. OBJECTIVE: The aim of this study was to determine the risk of cancer among elderly IBD patients compared with younger IBD patients. Additionally, the absolute risk of malignancy and factors contributing to it were evaluated, and therapeutic patterns among the elderly were assessed. METHODS: This retrospective cohort study extracted data from the Truven Health Analytics MarketScan® database. Among adult IBD patients who were free of cancer before starting on corticosteroids, immunomodulators, or biologics, a Cox model for time to cancer was fitted that adjusted for several covariates, including time-dependent treatment. Baseline results were evaluated by age group, as were the incidence of cancer and the distribution of cancer subtypes. RESULTS: The elderly IBD cohort (n = 8788) had a higher prevalence of cancer and several other ailments before starting treatment, relative to the younger IBD cohort aged 18-64 years (n = 54,971). During follow-up, the elderly IBD cohort experienced a higher incidence of malignancy, confirmed by a hazard ratio (HR) of 3.04 (95% confidence interval [CI] 2.71-3.41) from the Cox model fit. The risk of cancer was also significantly associated with male sex (HR 0.82 female), duration of disease (HR 1.08), several comorbidities and corticosteroid use (HR 1.35), but not with the use of immunomodulators or biologics. Non-Hodgkin's lymphoma, urinary tract malignancy, and prostate, lung, and female breast cancers were observed more commonly in this elderly IBD cohort when compared with the same age group in the Surveillance, Epidemiology, and End Results (SEER) database. CONCLUSIONS: The elderly with IBD have a higher risk of malignancy when compared with younger IBD patients and the general age-matched population, with certain cancers being more common among these patients.

Evaluation of patients with type 2 diabetes mellitus receiving treatment during the pre-diabetes period: Is early treatment associated with improved outcomes?

AIM: This study evaluates the association of pretreatment with oral antidiabetics (OADs) on clinical outcomes and health resource utilization among commercially insured type II diabetes mellitus (T2DM) patients in the United States. METHODS: Using administrative data (Truven MarketScan® Research Databases), patients diagnosed with T2DM between 2007 and 2014 with ⩾6months continuous enrolment pre- and post-diagnosis were evaluated. Pretreatment was defined as OAD use at least 3months prior to T2DM diagnosis. Time-to-insulin initiation and healthcare costs were compared by OAD pretreatment status. RESULTS: Of the 866,605 patients studied, 241,856 (27.9%) were pretreated prior to T2DM diagnosis. Mean follow-up was 2.9years for pretreatment and 3.1years for those without pretreatment. Monthly diabetes-related pharmacy costs were significantly higher among pretreated patients ($66 versus $36, p<0.0001), as were overall monthly pharmacy costs ($255 versus $198, p<0.0001). Pretreated patients had lower mean monthly costs, both total ($625 versus $671, p<0.0001) and diabetes-related ($207 versus $214, p=0.0012). After multivariable adjustment, mean monthly diabetes-related total healthcare costs were higher among pretreated patients (+$60) but total all-cause monthly healthcare costs were significantly lower (-$354) (both p<0.05). Pretreatment was associated with a lower insulin initiation probability for 2years, after which probability was similar; the adjusted hazard ratio for pretreatment in a time-to-insulin model was 0.96 (95% CI, 0.94-0.97). CONCLUSIONS: Pretreatment with OADs is associated with a modest delay in initiating insulin therapy and lower total healthcare costs. The clinical and pharmacoeconomic benefits of pretreatment should be elucidated in a prospective study.

Increased risk of subsequent myocardial infarction in patients with type 2 diabetes: a retrospective cohort study using the U.K. General Practice Research Database.

OBJECTIVE: To compare the risk of subsequent myocardial infarction (MI) between patients with and without type 2 diabetes mellitus (T2DM) in a retrospective cohort study. RESEARCH DESIGN AND METHODS: Patients with their first MI recorded in the U.K. General Practice Research Database in 1997-2008 were classified as T2DM, diagnosed before or within 28 days after the date of the first recorded MI (i.e., the index date), or non-T2DM. Patients diagnosed within 28 days after the index date were assumed to have developed T2DM at baseline (i.e., before the index date). The primary outcome was the first subsequent MI. The secondary outcomes were all-cause death and a composite of all-cause death or subsequent MI. Cox proportional hazards models were fit to obtain hazard ratios (HRs) for all outcomes. RESULTS: A total of 7,411 T2DM (median age 72 years; men 63.4%) and 48,726 non-T2DM patients (median age 69 years; men 65.3%) were included. The crude incidences (per 1,000 patient-years) in T2DM vs. non-T2DM were 32.8 vs. 22.8 for subsequent MI, 83.7 vs. 52.1 for all-cause death, and 106.5 vs. 69.9 for the composite end point. The adjusted HRs for subsequent MI, all-cause death, and their combination were 1.41 (95% CI 1.27-1.56), 1.50 (1.41-1.60), and 1.42 (1.34-1.50), respectively, in women and 1.23 (1.14-1.34), 1.40 (1.33-1.47), and 1.33 (1.27-1.39) in men. CONCLUSIONS: Compared with non-T2DM, T2DM was associated with an increased risk for subsequent MI, all-cause death, and their composite end point. The risk tends to be higher in women than in men.

A comparison of all-cause mortality with pioglitazone and insulin in type 2 diabetes: an expanded analysis from a retrospective cohort study.

OBJECTIVES: The objectives of this study were to assess and compare all-cause mortality rates between pioglitazone (PIO) and insulin (INS). RESEARCH DESIGN: The study population included 56,536 patients with type 2 diabetes aged ≥45 years who were first-time users of PIO or INS. Data from 1 May 2000 until 30 June 2010 from the i3 InVision Data Mart database were linked to death records of the US Social Security Administration obtained in March 2012, with approval from the Institutional Review Board and in full compliance with the Health Insurance Portability and Accountability Act of 1996. MAIN OUTCOME MEASURES: Kaplan-Meier curves were generated and hazard ratios (HRs) were estimated for the occurrence of deaths in the PIO and INS cohorts using Cox proportional hazards models adjusted with inverse probability weights derived from propensity scores. RESULTS: After adjustment for >40 covariates through inverse probability weights derived from propensity scores, the PIO group showed a significantly lower risk of all-cause mortality (HR 0.33; 95% confidence interval, 0.31, 0.36). The risk of all-cause mortality was also significantly lower in the PIO cohort than the INS cohort among subgroups based on baseline variables such as sex, age (<55 years, ≥55 years), antidiabetic medication use (sulfonylureas or metformin), lipid-altering medication use, and congestive heart failure status. The study has some limitations. Use of a claims database means a potential bias toward a younger cohort. Disease-specific mortality was not identified because of no recorded cause of death. Reliable information regarding the differences in disease deterioration rate and some clinical and lab results were not available, which limits the statistical adjustment of baseline variables. CONCLUSION: PIO was associated with a lower risk of all-cause mortality than INS.

Comparing pioglitazone to insulin with respect to cancer, cardiovascular and bone fracture endpoints, using propensity score weights.

BACKGROUND: Diabetes is an important global disease, associated with significant morbidity and an increased risk of death due to chronic end-organ complications. The thiazolidinediones, used mainly as third-line agents in type 2 diabetes mellitus (T2DM), have been associated with some safety concerns, such as an increased risk of bladder cancer, an increased risk of bone fracture and heterogeneous effects on cardiovascular events. OBJECTIVE: This study aimed to evaluate safety data on pioglitazone for several outcomes and examine them in context with each other as well as with insulin, another third-line treatment for T2DM. METHODS: This retrospective cohort study extracted data from May 1, 2000 until June 30, 2010, from the i3 InVision Data Mart™ database. To adjust for the testing of multiple hypotheses, the Holm method was applied to endpoints representing potential harm from pioglitazone treatment, separately from those representing potential benefit from pioglitazone. The study population included patients with T2DM ≥ 45 years old who were new users of either pioglitazone or insulin. Key outcomes were incident cases of a composite of myocardial infarction (MI) or stroke requiring hospitalization; bone fracture requiring hospitalization; bladder cancer; and a composite of nine other selected cancers. Kaplan-Meier curves were generated and hazard ratios (HRs) for pioglitazone versus insulin were estimated from Cox proportional hazards models adjusted with inverse probability of treatment weights derived from propensity scores. RESULTS: A total of 56,536 patients (pioglitazone group 38,588; insulin group 17,948) qualified for the study. The mean follow-up was 2.2 years for pioglitazone and 1.9 years for insulin patients. Weighted survival analysis of the composite of MI and stroke, as well as the composite of nine cancers, yielded significant differences in favour of pioglitazone. For the composite of MI and stroke, the HR for pioglitazone versus insulin was 0.44 (95 % confidence interval [CI] 0.39-0.50, p < 0.0001). Modelling of the composite of nine selected cancers produced an HR of 0.78 (95 % CI 0.71-0.85, p < 0.0001). A non-statistically significant difference in favour of pioglitazone was observed in the incidence rate of bone fracture requiring hospitalization (HR 0.86, 95 % CI 0.74-1.01, p = 0.058). For bladder cancer, the overall incidence rates were relatively low and showed no significant difference between the two groups; the HR for pioglitazone versus insulin was 0.92 (95 % CI 0.63-1.33, p = 0.64). CONCLUSION: Compared with insulin, pioglitazone was associated with a significant reduction in the risk of MI and stroke requiring hospitalization, and a significant reduction in the risk of other selected cancers. While pioglitazone treatment may be linked with a lower risk of bladder cancer and bone fracture relative to insulin, these differences were not statistically significant.