Panagiotis Mavros

Incidence of chemotherapy-induced nausea and emesis after modern antiemetics: Perception versus reality

The authors determined the incidence of acute and delayed chemotherapy‐induced nausea and emesis (vomiting) (CINV) among patients receiving highly (HEC) or moderately (MEC) emetogenic chemotherapy. They also assessed whether physicians and nurses accurately recognized the incidence of acute and delayed CINV in their own practices.

Hypoglycemia is associated with increased worry and lower quality of life among patients with type 2 diabetes treated with oral antihyperglycemic agents in the Asia-Pacific region☆

AIMS We examined the relationship of hypoglycemic symptoms with health-related quality of life and worry about hypoglycemia among type 2 diabetic patients using oral antihyperglycemic agents (AHA) in the Asia-Pacific region. METHODS A total of 2257 type 2 diabetic patients with at least 6 months of oral AHA were enrolled in China, Korea, Malaysia, Thailand, and Taiwan. Quality of life was measured with the EuroQol Visual Analog Scale (EQ-VAS) and EuroQol-5 Dimensions questionnaire (EQ-5D), and worry about hypoglycemia with the worry subscale of the Hypoglycemic Fear Survey-II (HFS). RESULTS The mean (SD) age was 58.7 (10.2) years and HbA(1c) was 7.5% (1.5). The proportion of patients with an HbA(1c) <6.5% and <7% was 24.9% and 41.8%, respectively. Hypoglycemic symptoms in the prior 6 months were reported by 35.8% of patients. Mean scores on the EQ-VAS and the EQ-5D were significantly lower for patients who had hypoglycemic symptoms compared to those who did not (73.6 vs. 76.9, p<0.001; 0.88 vs. 0.90, p<0.0001, respectively), whereas mean score on the HFS was significantly higher (12.5 vs. 6.3, p<0.001). In multivariate models, hypoglycemic symptoms were independently associated with scores on the EQ-5D, EQ-VAS, and HFS (all p ≤ 0.01-0.001). Symptom severity was positively associated with fear of hypoglycemia (all p ≤ 0.001). CONCLUSION Hypoglycemic symptoms were associated with reduced quality of life and increased patient worry in patients with type 2 diabetes treated with AHA.

Factors associated with initiation of antihyperglycaemic medication in UK patients with newly diagnosed type 2 diabetes

AimTo assess the factors associated with antihyperglycaemic medication initiation in UK patients with newly diagnosed type 2 diabetes.MethodsIn a retrospective cohort study, patients with newly diagnosed type 2 diabetes were identified during the index period of 2003-2005. Eligible patients were ≥ 30 years old at the date of the first observed diabetes diagnosis (referred to as index date) and had at least 2 years of follow-up medical history (N = 9,158). Initiation of antihyperglycaemic medication (i.e., treatment) was assessed in the 2-year period following the index date. Adjusted Cox regression models were used to examine the association between time to medication initiation and patient age and other factors.ResultsMean (SD) HbA1c at diagnosis was 8.1% (2.3). Overall, 51% of patients initiated antihyperglycaemic medication within 2 years (65%, 55%, 46% and 40% for patients in the 30- < 45, 45- < 65, 65- < 75, 75+ age groups, respectively). Among the treated patients, median (25th, 75th percentile) time to treatment initiation was 63 (8, 257) days. Of the patients with HbA1c ≥ 7.5% at diagnosis, 87% initiated treatment within 2 years. These patients with a higher HbA1c also had shorter time to treatment initiation (adjusted hazard ratio (HR) = 2.44 [95% confidence interval (CI): 1.61, 3.70]; p < 0.0001). Increasing age (in years) was negatively associated with time to treatment initiation (HR = 0.98 [95% CI: 0.97, 0.99]; p < 0.001). Factors significantly associated with shorter time to treatment initiation included female gender and use of cardiovascular medications at baseline or initiated during follow up.ConclusionsIn this UK cohort of patients with newly diagnosed type 2 diabetes, only 51% had antihyperglycaemic medication initiated over a 2-year period following diagnosis. Older patients were significantly less likely to have been prescribed antihyperglycaemic medications. Elevated HbA1c was the strongest factor associated with initiating antihyperglycaemic medication in these patients.

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.

Use of the UKPDS Outcomes Model to predict all-cause mortality in U.S. adults with type 2 diabetes mellitus: Comparison of predicted versus observed mortality

AIMS The applicability of the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model is unknown in populations with type 2 diabetes mellitus (T2DM) outside the United Kingdom. We compared all-cause mortality predicted from the UKPDS model with observed mortality among T2DM subjects in the U.S. METHODS we studied participants with T2DM from the National Health and Nutrition Examination Survey 1988-1994 with characteristics comparable to the UKPDS cohort. The 10-year observed all-cause mortality was compared to the UKPDS model-predicted mortality. The Lifetable method was used to estimate the probability of mortality for 10 years following diagnosis. RESULTS among 156 subjects with characteristics comparable to the UKPDS cohort, mean age was 49.6 years, age at T2DM diagnosis was 47.1 years, and T2DM duration averaged 2.6 years, with follow-up for 10.4 years. The UKPDS model-predicted 10-year mortality was 15.7%, similar to the observed mortality of 14.2%. Corresponding 10-year predicted versus observed mortality was 32.7% versus 32.4% including subjects >age 65, 17.0% versus 19.3% including individuals with pre-existing CVD, and 31.1% versus 20.9% including individuals with diabetes duration ≥ 6 years. CONCLUSION all-cause mortality predicted by the UKPDS model was comparable to observed mortality in U.S. NHANES participants with characteristics similar to the UKPDS.

Progression to insulin therapy among patients with type 2 diabetes treated with sitagliptin or sulphonylurea plus metformin dual therapy

To assess time to insulin initiation among patients with type 2 diabetes mellitus (T2DM) treated with sitagliptin versus sulphonylurea as add‐on to metformin.

Systematic Literature Review and Meta-analysis of Medication Adherence With Once-weekly Versus Once-daily Therapy.

PURPOSE To compare medication adherence rates for once-weekly (QW) versus once-daily (QD) dosing regimens in patients with chronic disease. METHODS A systematic literature review was conducted to identify articles published in English-language journals examining the rate of adherence to medications in patients with chronic disease. Relevant studies were identified from January 2002 through August 2013 using PubMed, EMBASE, and the Cochrane Library databases. Twenty-two published observational studies reporting adherence were identified by 2 independent reviewers, and 7 articles reported relevant measures for analysis. All studies were conducted in patients with osteoporosis. Meta-analyses estimated (1) mean difference (MD) in adherence (defined using the mean medication possession ratio [MPR]) between QW and QD dosing groups and (2) odds ratio (OR) for adherence (defined using an MPR cutoff of ≥80%) for QW versus QD dosing. Heterogeneity was assessed using Cochrans Q and I(2) values, and meta-analyses used both fixed- and random-effects models. FINDINGS The random-effects meta-analysis revealed a significantly greater MPR with QW compared with QD dosing (pooled MD = 12.29%; 95% CI, 10.76%-13.82%; n = 9 [data reported in 7 publications]). Because of the high level of heterogeneity (I(2) = 83.4%), the fixed-effects model results were not appropriate to report for the pooled MD. When examining the OR for adherence, both fixed- and random-effects models provided similar results due to the low level of heterogeneity (I(2) = 7.9%; n = 5 [data reported in 3 publications]). Using either model, the pooled odds of being adherent (MPR ≥80%) in the QW dosing group was approximately 1.9 times the odds in the QD dosing group (random-effects OR = 1.90; 95% CI, 1.81-2.00; fixed-effects OR = 1.92; 95% CI, 1.84-1.99). IMPLICATIONS In our meta-analysis, QW dosing was associated with better adherence levels and greater odds of being adherent compared with QD dosing in patients with osteoporosis.

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.

Impact of concurrent macrovascular co-morbidities on healthcare utilization in patients with type 2 diabetes in Europe: a matched study

Aim: To examine and to quantify the impact of concurrent macrovascular co‐morbidities (MVC) on healthcare resource utilization among patients with type 2 diabetes mellitus (T2DM) in Europe.

Pre-existing cardiovascular diseases and glycemic control in patients with type 2 diabetes mellitus in Europe: a matched cohort study

BackgroundAlthough there is a growing body of evidence showing that patients with type 2 diabetes mellitus (T2DM) have poor glycemic control in general, it is not clear whether T2DM patients with pre-existing cardiovascular diseases (CVD) are more or less likely to have good glycemic control than patients without pre-existing CVD. Our aim was to examine the degree of glycemic control among T2DM patients in Europe with and without pre-existing CVD.MethodsThis is a matched cohort study based on a multi-center, observational study with retrospective medical chart reviews of T2DM patients in Spain, France, United Kingdom, Norway, Finland, Germany, and Poland. Included patients were aged >= 30 years at time of diagnosis of T2DM, had added a SU or a PPARγ agonist to failing metformin monotherapy (index date) and had pre-existing CVD (cases). A control cohort with T2DM without pre-existing CVD was identified using 1:1 propensity score matching. With difference-in-difference approach, logistic and linear regression analyses were applied to identify differences in glycemic control by CVD during the follow up period, after controlling for baseline demographics, clinical information, and concurrent anti-hyperglycemic medication use.ResultsThe percentage of case patients with adequate glycemic control relative to control patients during the 1st, 2nd, 3rd, and 4th years after the index date was 19.9 vs. 26.5, 16.8 vs. 26.5, 18.8 vs. 28.3, and 16.8 vs. 23.5 respectively. Cases were significantly less likely to have adequate glycemic control (odds ratio: 0.62; 95% confidence interval: 0.46-0.82) than controls after adjusting for baseline differences, secular trend, and other potential confounding covariates.ConclusionsT2DM patients with pre-existing CVD tended to have poorer glycemic control than those without pre-existing CVD, all other factors being equal. It suggests that clinicians may need to pay more attention to glycemic control among T2DM patients with CVD.