Qiaoyi Zhang

Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: A survey study.

BackgroundSome oral antihyperglycemic agents may increase risk of hypoglycemia and thereby reduce patient quality of life. Our objective was to assess the impact of the severity and frequency of self-reported hypoglycemia on health-related quality of life (HRQoL) among patients with type 2 diabetes treated with oral antihyperglycemic agents.FindingsA follow-up survey was conducted in participants with self-reported type 2 diabetes treated with oral antihyperglycemic agents from the US National Health and Wellness Survey 2007. Data were collected on the severity and frequency of hypoglycemic episodes in the 6 months prior to the survey, with severity defined as mild (no interruption of activities), moderate (some interruption of activities), severe (needed assistance of others), or very severe (needed medical attention). HRQoL was assessed using the EuroQol-5D Questionnaire (EQ-5D) US weighted summary score (utility) and Worry subscale of the Hypoglycemia Fear Survey (HFS). Of the participants who completed the survey (N = 1,984), mean age was 58 years, 57% were male, 72% reported an HbA1c <7.0%, and 50% reported treatment with a sulfonylurea-containing regimen. Hypoglycemic episodes were reported by 63% of patients (46% mild, 37% moderate, 13% severe and 4% very severe). For patients reporting hypoglycemia, mean utility score was significantly lower (0.78 versus 0.86, p < 0.0001) and mean HFS score was significantly higher (17.5 versus 6.2, p < 0.0001) compared to patients not reporting hypoglycemia. Differences in mean scores between those with and without hypoglycemia increased with the level of severity (mild, moderate, severe, very severe) for utility (0.03, 0.09, 0.18, 0.23) and HFS (6.1, 13.9, 20.1, 25.6), respectively. After adjusting for age, gender, weight gain, HbA1c, microvascular complications, and selected cardiovascular conditions, the utility decrement was 0.045 (by level of severity: 0.009, 0.055, 0.131, 0.208), and the HFS increase was 9.6 (by severity: 5.3, 12.4, 17.6, 23.2). HRQoL further decreased with greater frequency of hypoglycemic episodes.ConclusionsSelf-reported hypoglycemia is independently associated with lower HRQoL, and the magnitude of this reduction increases with both severity and frequency of episodes in patients with type 2 diabetes treated with oral antihyperglycemic agents.

Association between hypoglycemia and inpatient mortality and length of hospital stay in hospitalized, insulin-treated patients

Abstract Objective: To assess the impact of hypoglycemia on clinical outcomes among hospitalized, insulin-treated patients. Methods: In a retrospective study, hospitalizations in 2005–2007 were identified from a US inpatient electronic medical records database. All encounters for insulin-treated patients with valid blood glucose measurement were included, except for those with a length of stay <24 hours or >30 days. In an encounter-based analysis, associations between hypoglycemic (glucose ≤70 mg/dL) or severe hypoglycemic (glucose ≤50 mg/dL) episodes and inpatient mortality, ischemic events, neurologic complications, and length of stay were evaluated. Results: Among 107,312 admissions, hypoglycemia occurred in 21,561 (20%) and severe hypoglycemia in 7539 (7%). Inpatient mortality occurred in 6.5% of hospitalizations with hypoglycemia and 3.8% of those without (p < 0.001). Inpatient mortality occurred in 7.6% of hospitalizations with a severe hypoglycemic event. Ischemic events (8.1 vs. 8.0%) and neurologic complications (3.8 vs. 3.7%) were similar in hospitalizations with and without a hypoglycemic event, respectively. In multivariate logistic regression analyses adjusting for age, gender, and selected comorbidities, hypoglycemia was associated with a significant increase in inpatient mortality risk (adjusted odds ratio (OR) = 1.66 [95% CI: 1.55, 1.78]). Similar results were observed with severe hypoglycemia (adjusted OR = 1.44 [1.38, 1.52]). Length of stay was increased in hospitalizations with hypoglycemia (median [interquartile range]: 8.2 days [4.9, 13.9] vs. 5.2 days [3.1, 8.3]; p < 0.0001). Limitations: Due to the nature of the data source, some data of interest were not available, including insulin dose and dose regimen, outpatient medical histories (including diabetes history), pre-hospitalization medications, and cause of death. Conclusions: Hypoglycemia was common among hospitalized patients receiving insulin and, while a direct causal relationship cannot be assumed, was associated with an increased risk of inpatient mortality and increased length of hospital stay. Hypoglycemia is an undesirable event and efforts to minimize in-hospital hypoglycemic events are warranted across the spectrum of hospitalized patients.

Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis.

Abstract Objectives: To compare effects of fixed-dosed combinations (FDCs) and coadministered dual therapy (CDT) of antihyperglycemic agents on glycemic control (i.e., HbA1c) and medication adherence. Methods: A systematic literature review and meta-analysis were performed to compare the HbA1c response and medication adherence between the two drug regimens. Selected articles were limited to studies that compared equivalent drug components within FDC and CDT. Searches used PubMed, Embase, Web of Knowledge, and Cochrane databases. The search results were independently screened and reviewed by two authors (SH, KI). Of the 1246 identified abstracts, 152 articles were reviewed, and ten met the inclusion criteria. Results were extracted and pooled in a meta-analysis, using a random-effects model. Cohort comparisons were described as mean differences (MDs) with 95% confidence intervals (CIs). Results: The ten articles that met the inclusion criteria had a total study size of 70,573 patients. Four articles reported HbA1c results, which had a total of five cohort comparisons of FDC and CDT use. The meta-analysis revealed a significantly greater HbA1c reduction with FDC (MD = −0.53% [95% CI: −0.78, −0.28]; p < 0.0001). Eight studies evaluated medication adherence (measured as medication possession ratio [MPR]). Of the eight studies reporting MPR results, a total of 12 cohort comparisons were made and were further divided into three subgroups based on comparison types. Five comparisons described MPR for FDC versus CDT cohorts, with significantly higher MPR with FDC (MD = 8.6% [95% CI: 1.6, 15.6]; p = 0.0162]). Four comparisons examined patients who switched from monotherapy to FDC or CDT, with higher MPR for patients who switched to FDC (MD = 7.7% [95% CI: 5.7, 9.6]; p < 0.0001). Three comparisons described results for patients who switched from CDT to FDC or stayed on CDT, with higher MPR for patients who switched to FDC (MD = 5.0% [95% CI: 3.1, 6.8]; p < 0.0001). Limitations: A limited number of published studies were available for this meta-analysis and all of those included were observational studies. There was heterogeneity between studies in the statistical methods used to control for confounding variables and differing population characteristics. Conclusions: In a meta-analysis, use of FDCs with antihyperglycemic agents was associated with lower HbA1c and higher MPR values compared to CDT use in patients with type 2 diabetes.

Multinational Internet-based survey of patient preference for newer oral or injectable Type 2 diabetes medication.

Background: The prevalence of Type 2 diabetes mellitus continues to rise. Although glucagon-like peptide-1 (GLP-1) analog and dipeptidyl peptidase-4 (DPP-4) inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). The objective of this study was to examine patient preferences (and predictors of preferences) for two different medication profiles, one similar to a GLP-1 analog (liraglutide) and another similar to a DPP-4 inhibitor (sitagliptin). Methods: Internet survey data were collected in two waves (wave 1, n = 2402; wave 2, n = 1340) using patients from the US and Europe. Patients were presented with two hypothetical medication profiles (“drug A” and “drug B”, resembling sitagliptin and liraglutide, respectively) and asked to report their preferences. Results: Most patients in wave 1 and wave 2 reported that overall they would prefer a drug with the sitagliptin-like profile (81.9% and 84.4%, respectively) over a drug with the liraglutide-like profile (18.1% and 15.6%, respectively), and >80% of patients reported that they would be able to take a drug with the sitagliptin-like profile as directed by their physician for a longer period. The likelihood of preferring the sitagliptin-like profile significantly increased as age (odds ratio [OR] = 1.02) and importance placed on method of administration (OR = 1.32) increased (P < 0.05). Although the sitagliptin-like profile was preferred by the majority of patients in all subgroups, a lower proportion of patients with obesity, with weight gain, with A1C values above target, and who exercised preferred the sitagliptin-like profile compared with those without obesity (77.0% versus 87.9%), without weight gain (77.8% versus 86.7%), with A1C values at or below target (79.0% versus 86.5%), and who did not exercise (81.6% versus 86.4%), respectively (P < 0.05). Conclusions: This research suggests that patients (across geographies) prefer an oral medication with a profile resembling sitagliptin to an injectable medication with a profile resembling liraglutide.

Baseline characteristic differences between patients prescribed sitagliptin vs. other oral antihyperglycemic agents: analysis of a US electronic medical record database

Abstract Aims: This study examined the relationship of baseline characteristics and medication use in patients with type 2 diabetes who were prescribed sitagliptin versus other oral antihyperglycemic agents in clinical practice settings in the United States. Methods: The General Electric Healthcare’s Clinical Data Services electronic medical record (EMR) database, covering 12 million US patients of all ages from 49 states, was used to identify patients with type 2 diabetes, aged ≥30 years, who received their first sitagliptin, metformin, sulfonylurea, or thiazolidinedione prescription between October 2006 and June 2008 (index period) as part of new mono-, dual, or triple therapy regimens. Patient demographics, diagnoses, prescriptions, and laboratory results were extracted for the 12-month period (baseline) prior to the index date (i.e., date of first prescription). Data were stratified by mono-, dual, or triple therapy and compared between sitagliptin regimens and non-sitagliptin regimens with other oral agents (metformin, sulfonylureas, or thiazolidinediones). Adjusted logistic regression analyses were used to estimate odds ratios (OR) associated with prescribing sitagliptin versus other oral monotherapy in relation to patient baseline characteristics. Results: Among 41,836 patients new to oral monotherapy, 876 (2.1%) received sitagliptin. Compared to patients initiating non-sitagliptin monotherapy, patients on sitagliptin monotherapy were older (64 vs. 60 years) and had lower body mass index (33 kg/m2 vs. 34 kg/m2), higher serum creatinine (1.2 vs. 1.0 mg/dL), higher prevalence of chronic renal disease (7.2% vs. 1.9%), greater use of lipid-lowering agents (42% vs. 38%), and higher prevalence of cardiovascular conditions (CVD: 12.7% vs. 8.3%) and microvascular complications (MVD: 13.4% vs. 5.8%) (all p < 0.05). Of 22,683 patients new to dual therapy, 1885 (8.3%) were on sitagliptin regimens. Relative to patients on non-sitagliptin dual therapy regimens, patients prescribed sitagliptin as part of dual therapy regimens were older and had higher serum creatinine, higher prevalence of CVD, MVD, or chronic renal disease, and greater use of lipid-lowering and antihypertensive agents (all p < 0.05). Among 9967 patients new to triple therapy, 2828 (28.4%) were on triple therapy regimens with sitagliptin. Relative to patients on non-sitagliptin triple therapy regimens, patients on sitagliptin as part of triple therapy regimens were older, and had higher serum creatinine and greater use of antihypertensive or lipid-lowering agents (all p < 0.05). Adjusted logistic regression showed that significant predictors of being prescribed sitagliptin monotherapy were older age (OR 1.01, 95% CI 1.00, 1.02), higher HbA1c level (OR 1.10, 95% CI 1.04, 1.17), higher serum creatinine level (OR 1.22, 95% CI 1.08, 1.39), presence of MVD (OR 1.50, 95% CI 1.08, 2.09), and presence of chronic renal disease (OR 2.22, 95% CI 1.41, 3.49). Limitations: Diabetes care delivered by non-participating physicians is not captured in the GE CDS EMR database and, therefore, the prevalence of the diseases identified based on ICD-9 diagnosis/procedure and CPT codes provided in the Appendix may be underestimated. Duration of diabetes was not consistently recorded and some measures were not available. Conclusion: Patients with type 2 diabetes who were prescribed sitagliptin regimens in clinical practice were older and more likely to have pre-existing co-morbid conditions compared to patients receiving non-sitagliptin regimens with other common oral antihyperglycemic agents. These findings have important implications for observational studies in that estimated clinical and health outcome measures may be biased due to channeling of patients to different therapies based on different baseline characteristics.

Burden of peripheral arterial disease in Europe and the United States: a patient survey

BackgroundThe aim of the current study was to quantify the burden of peripheral arterial disease (PAD) with respect to health-related quality of life, work productivity and activity impairment, and healthcare resource utilization.MethodsData were obtained from the 2010 EU National Health and Wellness Survey (NHWS), which included participants from France, Germany, Italy, Spain, and the UK (5EU, N = 57,805) as well as the 2010 US NHWS (N = 75,000). The NHWS is an annual, cross-sectional, self-administered Internet survey which employs a stratified random sampling frame to match the age and gender characteristics of the NHWS sample with known population statistics. Participants who self-reported a diagnosis of PAD were compared with participants who did not self-report a diagnosis of PAD on health-related quality of life (mental and physical component summary scores and health utilities from the Short Form-12v2), work productivity and activity impairment (Work Productivity and Activity Impairment questionnaire), and healthcare resource use in terms of the number of physician visits, emergency room visits, and hospitalizations in the past six months through regression modeling adjusting for demographics and health characteristics.ResultsA total of 743 (1.29%) and 777 (1.04%) participants self-reported a diagnosis of PAD in the 5EU and US, respectively. After adjusting for demographics and health characteristics, patients with PAD reported worse health-related quality of life, as measured by health utilities (5EU: 0.66 vs. 0.70; US: 0.66 vs. 0.72; all p < .05), greater overall work impairment percentage (5EU: 38.27% vs. 27.48%; US: 23.89% vs. 14.26%) and greater healthcare resource use compared to participants without PAD (all p < .05).ConclusionsThese results suggest a significant burden for patients with PAD in both the 5 EU countries and the US with respect to both quality of life and economic outcomes. Improved management of these patients may have profound effects from both patient and societal perspectives.

Time to treatment initiation with oral antihyperglycaemic therapy in US patients with newly diagnosed type 2 diabetes

Aim: To compare the time from initial diagnosis to initiation with oral antihyperglycaemic treatment in younger versus older patients with type 2 diabetes, and to evaluate factors associated with initiating treatment.

Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study

Abstract Objectives: To estimate the proportion of patients with type 2 diabetes who were eligible for statin treatment per American Diabetes Association (ADA) recommendations and the proportion who were actually prescribed a statin in US clinical practice. Factors associated with receiving a statin prescription were also determined. Methods: Patients ≥25 years diagnosed with type 2 diabetes or had received prescriptions for antihyperglycemic agents between 7/2006 and 6/2008 were identified within a large electronic medical record database. Eligibility for statin therapy was determined according to 2008 ADA recommendations. Statin use was assessed based on prescription records during a 12-month follow-up period. An adjusted logistic regression analysis was performed to estimate the likelihood of statin use in relation to selected baseline characteristics. Results: Of the 125,464 patients identified, 98.5% were eligible for statin therapy. Only 62.9% received a statin prescription during follow-up period. In an adjusted logistic regression, factors associated with increased likelihood of statin use were older age, male gender, smoking, history of cardiovascular conditions, and receiving an antihyperglycemic, antihypertensive, or anticoagulant prescription at baseline (all p < 0.05). Limitations: Of the patients who did not receive statin during follow-up, 13% of them were previously on a statin during the baseline period. The reasons for discontinuing therapy are not known. It cannot be excluded that some of these patients were intolerant or had contraindications to statin. The data on prescription dispensing and compliance were not recorded. Conclusions: Nearly all patients with type 2 diabetes were eligible for statin therapy, but less than two-thirds received statin therapy in US clinical practice. Efforts to minimize this gap are warranted.

Reasons given by general practitioners for non-treatment decisions in younger and older patients with newly diagnosed type 2 diabetes mellitus in the United Kingdom: a survey study.

BackgroundOlder patients with newly diagnosed type 2 diabetes mellitus are less likely to receive antihyperglycaemic therapy compared to their younger counterparts. The purpose of this study was to assess the reasons of general practitioners (GPs) for not treating younger and older patients with newly diagnosed type 2 diabetes mellitus with antihyperglycaemic agents.MethodsIn a survey conducted between November 2009 and January 2010, 358 GPs from the United Kingdom selected reasons for not initiating antihyperglycaemic therapy in younger (< 65 years) and older (≥65 years) patients with newly diagnosed type 2 diabetes mellitus and untreated with any antihyperglycaemic agent for at least six months following diagnosis. Thirty-six potential reasons were classified into four major categories: Mild hyperglycaemia, Factors related to antihyperglycaemic agents, Comorbidities and polypharmacy, and Patient-related reasons. Reasons for non-treatment were compared between younger (n = 1, 023) and older (n = 1, 005) patients.ResultsNon-treatment reasons related to Mild hyperglycaemia were selected more often by GPs for both younger (88%) and older (86%) patients than those in other categories. For older patients, Factors related to antihyperglycaemic agents (46% vs. 38%) and Comorbidities and polypharmacy (33% vs. 19%), both including safety-related issues, were selected significantly (p < 0.001) more often by GPs. No between-group difference was observed for the Patient-related reasons category. The GP-reported HbA1c threshold for initiating antihyperglycaemic therapy was significantly (p < 0.001) lower for younger patients (mean ± standard deviation: 7.3% ± 0.7) compared to older patients (7.5% ± 0.9).ConclusionsGPs selected reasons related to Mild hyperglycaemia for non-treatment of their untreated patients with newly diagnosed type 2 diabetes mellitus, despite nearly one-third of these patients having their most recent HbA1c value ≥7%. The findings further suggest that safety-related issues may influence the non-treatment of older patients with type 2 diabetes mellitus.

Prescriptions for vitamin D among patients taking antiresorptive agents in Canada

ABSTRACT Background: Data on the rate of concomitant vitamin D use with antiresorptive medications are limited. Such information is important because vitamin D is indicated in patients with osteoporosis, including those receiving bisphosphonates, and there is evidence of inadequate use by these patients. Objective: To examine prescription vitamin D utilization patterns. Research design and methods: A retrospective analysis of patients aged ≥ 65 years was conducted in a Canadian pharmacy-insurance organization (RAMQ) who received at least one prescription for an antiresorptive agent (i.e., alendronate, risedronate, raloxifene) from January 1, 1996, through December 31, 2003, and did not switch to any other agent during the 1-year post period. Data on prescriptions of vitamin D formulations on the RAMQ formulary (e.g., alfacalcidol, calcitriol, cholecalciferol, doxercalciferol, ergocalciferol) were also captured. No data on generic or over-the-counter vitamin D preparations were available. A vitamin D and antiresorptive agent possession ratio (RP) was computed as: where ∑DSPVD = the sum of the days of supply with prescription vitamin D and ∑DSARR = the sum of days of supply with alendronate, risedronate, or raloxifene A vitamin D and antiresorptive agent overlap ratio (RO) was computed as: where ∑DSPVDOARR = the sum of days of supply of prescription vitamin D overlapping with alendronate, risedronate, or raloxifene, and ∑DSARR = the sum of the days of supply with alendronate, risedronate, or raloxifene. Results: A total of 46 226 antiresorptive treatment users were identified, > 90% of whom were women. A total of 17 151 (37.1%) had concomitant vitamin D prescriptions. The average duration of prescription therapy with alendronate, risedronate, or raloxifene was 247 days; and the mean duration of prescription vitamin D therapy was 83 days. Patients had a supply of vitamin D for 55% of days of antiresorptive agents therapy (RP = 0.55) and a vitamin D supply overlapping with 24% of their days on antiresorptive agents (RO = 0.24). Possession and overlap ratios were significantly higher in patients receiving once-weekly bisphosphonate prescriptions compared with once-daily regimens (bisphosphonates or raloxifene). Vitamin D prescriptions were also significantly more likely in patients receiving prescriptions for once-weekly bisphosphonates (odds ratio (OR) = 4.65; 95% CI = 4.29–5.05; p < 0.0001) and once-daily bisphosphonates (OR = 1.91; 95% CI = 1.76–2.07; p < 0.0001) compared with once-daily raloxifene. Conclusions: Despite the benefits of vitamin D for osteoporosis, most patients (≈63%) receiving prescriptions for antiresorptive agents were not taking vitamin D, indicating a substantial treatment gap. The study is limited by including data only on (1) pharmacy claims, which do not equate to patient behaviors, such as filling or refilling prescriptions and/or taking the medications; and (2) prescription (but not generic or over-the-counter) vitamin D formulations.