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Background: Allergic rhinitis (AR), asthma, chronic obstructive pulmonary disease (COPD), and rhinosinusitis are common and little studied in the Asia-Pacific region. Objectives: We sought to investigate real-world practice patterns for these respiratory diseases in India, Korea, Malaysia, Singapore, Taiwan, and Thailand. Methods: This cross-sectional observational study enrolled adults (age ≥18 years) presenting to general practitioners (GP) or specialists for physician-diagnosed AR, asthma, COPD, or rhinosinusitis. Physicians and patients completed study-specific surveys at one visit, recording patient characteristics, health-related quality of life (QoL), work impairment, and healthcare resource use. Findings by country and physician category (GP or specialist) were summarized. Results: Of the 13,902 patients screened, 7,243 (52%) presented with AR (18%), asthma (18%), COPD (7%), or rhinosinusitis (9%); 5,250 of the 7,243 (72%) patients were eligible for this study. Most eligible patients (70–100%) in India, Korea, Malaysia, and Singapore attended GP, while most (83–85%) in Taiwan and Thailand attended specialists. From 42% (rhinosinusitis) to 67% (AR) of new diagnoses were made by GP. On average, patients with COPD reported the worst health-related QoL, particularly to GP. Median losses of work productivity for each condition and activity impairment, except for asthma, were numerically greater for patients presenting to GP vs. specialists. GP prescribed more antibiotics for AR and asthma, and fewer intranasal corticosteroids for AR, than specialists (p < 0.001 for all comparisons). Conclusions: Our findings, albeit mostly descriptive and influenced by between-country differences, suggest that practice patterns differ between physician types, and the disease burden may be substantial for patients presenting in general practice.

Although dog vaccination has been demonstrated to reduce and eliminate rabies in humans, during meetings there are often calls for further pilot studies. The assembled data proves that a widespread approach is now required. While zoonotic rabies has a minimal presence in developed nations, it is endemic throughout most of Asia and Africa, where it is considered to be a neglected tropical disease. In these areas, rabies causes an estimated annual mortality of at least 55,000 human deaths. Worldwide rabid dogs are the source of the vast majority of human rabies exposures. The World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations and the World Organization for Animal Health (OIE) advocate a collaborative One Health approach involving human public health and veterinary agencies, with mass canine vaccination programs in endemic areas being the mainstay of strategies to eliminate dog-mediated human rabies. While post-exposure prophylaxis (PEP) is effective in preventing deaths in people exposed to rabies, it is comparatively expensive and has little impact on the canine reservoir that is the primary source of zoonotic rabies. Indiscriminate culling of the dog population is expensive and there is little evidence that it is effective in controlling rabies in non-island locations. Mass canine vaccination programs using a One Health framework that achieves a minimum 70% vaccination coverage during annual campaigns have proven to be cost-effective in controlling zoonotic rabies in endemic, resource-poor regions. Case studies, such as in Tanzania and Bhutan, illustrate how an approach based on mass canine rabies vaccination has effectively reduced both canine and human rabies to minimal levels. The multiple benefits of mass canine rabies vaccination in these cases included eliminating rabies in the domestic dog reservoirs, eliminating human rabies cases, and decreasing the rabies economic burden by reducing expenditures on PEP.

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in ...

Introduction and objectives There is limited data that characterizes osteoarthritis (OA) patients who experience moderate to severe pain despite analgesic treatment in Mexico. In this study, we estimate the real-world prevalence of inadequate pain relief (IPR) among individuals with knee and/or hip OA who have been prescribed analgesic therapy and characterize this patient population for each country separately. Materials and methods This is a multinational, multi-site, cross-sectional, observational study. Participating physicians enrolled patients over 50 years of age with diagnosed knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit, extracted data from their medical charts, and collected patient data using established questionnaires. Results 301 patients treated by 35 physicians in Mexico were enrolled in the study. More than half of the patients (53%) met the definition of IPR. Patients with IPR were significantly older (66.8 vs. 63.5 years, p = 0.002) and were more likely to be obese (24.2% vs. 11.9%, p = 0.006). Patients in the IPR group were more likely to report moderate/severe problems across all 5 dimensions of the EQ-5D and reported higher scores, indicating worse outcomes, on all three WOMAC subscales. Patients in the IPR group also reported reduced work productivity and greater treatment dissatisfaction compared to patients without IPR. Discussion and conclusions IPR is highly prevalent among individuals with knee and/or hip OA in Mexico. Patients with IPR experience decreased health-related quality of life HRQoL and work productivity, impaired function, and poor treatment satisfaction. Health care professionals need to be aware of the high prevalence of IPR, work toward improving OA patient management, and facilitate early intervention or changes in drug and other treatment modalities.

Background: Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. Objective: The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Methods: Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1‐15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Results: Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. Conclusion: MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.

Orally disintegrating tablets (ODTs) offer a valuable treatment option, particularly when swallowing solid tablets with water is difficult or inconvenient. Montelukast is an effective treatment for asthma and allergic rhinitis (AR), and an ODT formulation became available in Japan in 2015. This study investigated levels of satisfaction with this new formulation among adults with asthma and/or AR in Japan.Patients aged 20 years or older who were refilling a prescription for montelukast ODT in pharmacies across Japan completed questions on satisfaction with key features of montelukast ODT and the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Study variables were analyzed descriptively. Factors associated with TSQM-9 global satisfaction and convenience domain scores were examined using analysis of covariance.Of the 201 patients who participated, 89.6% reported overall satisfaction with montelukast ODT. Overall satisfaction was highest in patients with AR only (94.7% satisfied) or with asthma and AR (90.2% satisfied), and in patients with treatment duration4 weeks (98.5% satisfied). Mean TSQM-9 global satisfaction and convenience domain scores were 58.9 and 66.7, respectively; scores were higher for patients with both asthma and AR and for those with longer disease duration. Overall ease of taking and dissolving speed were most closely associated with TSQM-9 global satisfaction scores, and ability to take without water and taste were most closely associated with TSQM-9 convenience scores.The generalizability of the findings was limited by the convenience sample and the descriptive, single-arm study design. The study was limited to adults with asthma and/or AR.Montelukast ODT may be an acceptable dosage formulation for adults with mild-to-moderate asthma and/or AR in Japan. Satisfaction was high, particularly with respect to tablet size, dissolving speed, taste, and ease of taking.

Background Data are limited regarding adherence to dipeptidyl peptidase-4 inhibitors. Methods The present retrospective cohort study of a claims database involved adults with type 2 diabetes mellitus, continuous enrollment for 12 months before the first prescription of add-on sitagliptin (SITA) or a sulfonylurea (SU) to metformin (MET) monotherapy (index date), and ≥45 days of MET coverage ≤90 days before the index date. The SITA and SU users were matched on duration of follow-up and propensity score (PS). Logistic regression analysis incorporated age, gender, comorbidities, and concomitant medications as independent variables. Results Approximately 99 % of SITA patients were PS matched, resulting in 14 807 well-balanced PS-matched SITA/SU pairs. Mean proportion of days covered (PDC) was significantly higher for SITA (vs SU) + MET after 1 year (P

Aim To compare the change in urinary albumin to creatinine ratio (UACR) in type 2 diabetes (T2DM) patients with albuminuria who initiate sitagliptin to those who initiate a sulfonylurea (SU) as add-on to metformin monotherapy. Method A cohort of T2DM patients with albuminuria (UACR >30mg/g) who initiated sitagliptin or SU as add-on dual therapy to metformin between 2008 and 2014 was extracted from the computerized medical records of a large managed care organization in Israel. Patients with albuminuria and UACR measurements available at treatment initiation and 120–365days afterwards were included. Propensity scores were calculated based on 17 factors, including demography, comorbidities, baseline levels of HbA1c, UACR, BMI, eGFR, and ACE/ARB use, and patients were matched in a 1:1 ratio. Changes in UACR were compared between the matched pairs using generalized estimating equations. Results A total of 282 eligible pairs (sitagliptin:SU) were identified. During a mean follow-up of 9months, median UACR changes were −35% (IQR=−73% to 5%) and −31% (IQR=−72% to 21%) in the sitagliptin and SU groups, respectively. Mean absolute HbA1c reductions among sitagliptin and SU groups were 0.9% and 1.0%, respectively. The magnitude of UACR reduction generally increased with greater magnitude of HbA1c reduction in both treatment groups. However, after controlling for HbA1c reduction and the interaction between HbA1c reduction and UACR reduction, sitagliptin users demonstrated a trend toward an increased likelihood of UACR reduction compared to SU users (odds ratio=1.20; 95% confidence interval: 0.99–1.47, P =0.063). Conclusion Our results suggest that both sitagliptin and SU reduce albuminuria as an add-on therapy to metformin, but that sitagliptin may provide greater reductions in albuminuria independent of glycemic control when compared to SU. Larger population studies are required to further explore this.

The American Diabetes Association (ADA) recommends metformin to treat individuals diagnosed with type 2 diabetes and recommends that hemoglobin A1c (HbA1c) be maintained below or around 7%. If the HbA1c target is not achieved or maintained by metformin monotherapy at maximal tolerated dose over 3 to 6 months, treatment modification with addition of a second oral antihyperglycemic agent or by initiating insulin is recommended. Despite the importance of attaining and maintaining HbA1c goals, actual treatment behavior may not follow ADA guidelines to add a second oral agent or to initiate insulin as expected even considering that individual patient's needs are taken into account when treatment decisions are made.To evaluate treatment addition for metformin monotherapy users with suboptimal glycemic control and associated factors.A retrospective health care claims study identified 7,109 subjects aged 18 to 89 years, treated for type 2 diabetes with an HbA1c7% following at least 60 days of continuous metformin monotherapy. Subjects were required to have 12 months continuous enrollment with the health plan before and after the index lab date. Pharmacological treatment additions after the HbA1c lab result and time to treatment addition were evaluated. A logistic regression model was used to evaluate the patient characteristics and comorbidities associated with the treatment addition.Thirty-eight percent of study subjects had evidence of addition of a second antidiabetic medication to primary metformin monotherapy, 57.5% remained on metformin monotherapy, and 4.5% discontinued metformin altogether. A logistic regression model found age inversely related to treatment addition: age 45-64 versus 18-44 (OR = 0.77, 95% CI = 0.59-0.99) and age 65-89 versus 18-44 (OR = 0.57, 95% CI = 0.43-0.74). HbA1c was positively related to treatment addition:8%-9% versus7%-8% (OR = 2.31, 95% CI = 2.00-2.67);9%-10% versus7%-8% (OR = 2.88, 95% CI = 2.32-3.58); and10% versus7%-8% (OR = 3.54, 95% CI = 2.92-4.28). Evidence of ophthalmic disorder was not related to treatment addition (P = 0.056), but evidence of hypertension (OR = 1.56, 95% CI = 1.28-1.89); hyperlipidemia (OR = 1.28, 95% CI = 1.05-1.55); other cardiovascular diseases (OR = 1.30, 95% CI = 1.16-1.45); obesity (OR = 1.21, 95% CI = 1.08-1.36); and renal disease (OR = 1.35, 95% CI = 1.21-1.51) were associated.The majority of the metformin monotherapy users with suboptimal glycemic control did not initiate add-on therapy as recommended by guidelines, and prolonged time on metformin monotherapy demonstrated clinical inertia in real-world clinical practice. Several factors were associated with this delay including older age, lower index HbA1c, and lack of evidence of certain comorbidities.

Aims/Introduction Dipeptidyl peptidase‐4 inhibitors (DPP‐4i) are a common first‐line treatment for type 2 diabetes in Japan. However, little is known about patients’ medication adherence, persistence and discontinuation in this setting. Materials and Methods This was a retrospective cohort study of new DPP‐4i users in a Japanese claims database. Adult patients (age 18–65 years) with type 2 diabetes diagnosis and no diagnosis of other diabetes or pregnancy during the study period were included if they were prescribed a DPP‐4i as monotherapy or combination oral therapy. Adherence to therapy was measured using the proportion of days covered method over a fixed period of 1 year. The proportion of days covered of ≥80% was considered adherent. Persistence was defined as continuing index DPP‐4i treatment with

Background:Osteoarthritis (OA) of the knee and hip is a leading cause of disability worldwide, particularly due to the primary symptom of pain in the weight-bearing joints. There is limited data that characterizes patients who experience moderate to severe pain despite analgesic treatment in China.Objectives:This study estimates the real-world prevalence of inadequate pain relief (IPR) among patients with knee and/or hip OA who have been prescribed analgesic therapy and characterizes this patient population. The study was conducted in China, the Philippines, Thailand, Russia, and Mexico. This abstract presents results from China.Methods:This is a multinational, multi-site, cross-sectional, observational study. Physicians managing patients with OA were recruited and asked to enroll patients over 50 years of age with knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit. Patients completed a one-time assessment of pain, function, and health-related quality of life (HRQOL) using patient reported outcome (PRO) instruments. Physicians abstracted data from patient charts. IPR was defined as an average pain score of >4/10 on Brief Pain Inventory Question #5 (average pain). Statistical tests including chi-square for categorical variables and Mann-Whitney Wilcoxon test for continuous variables were conducted to assess differences in demographic and clinical characteristics as well as PROs between patients with and without IPR. A multivariate regression analysis was conducted to assess the relationship between IPR and PROs.Results:571 patients treated at 10 hospital centers in China were enrolled. 73% were female, the mean (SD) age was 62 (8.32) years. The number of years with OA ranged from less than one year to over 37 years, suggesting a broad sample of patients. Most patients were impacted by knee OA only (90%). Almost half (43%) of the study population met the definition of IPR. Patients with IPR tended to be older, have greater prevalence of obesity, have more comorbidities, and had longer disease duration. The majority (98%) of patients were receiving nonsteroidal anti-inflammatory drugs (NSAIDS), followed by chondroprotective medications (23%). However, more patients with IPR mentioned being dissatisfied with treatment (38% vs. 21%). After adjusting for covariates, patients with IPR reported worse HRQOL, more functional limitations, and reduced work productivity compared to patients without IPR.Conclusion:IPR is highly prevalent among individuals with knee and/or hip OA in China and is associated with decreased HRQOL and work productivity, impaired function, and treatment dissatisfaction. Developing awareness among healthcare professionals about the presence and potential impact of IPR is important for the ultimate improvement of OA patient management.PROmean (SE)No IPR(N=328)IPR(N=243)EQ-5D Index0.72 (0.01)0.49 (0.02)EQ-5D VAS72.3 (0.85)65.5 (1.00)WOMAC Pain Subscale13.1 (0.78)22.7 (1.52)WOMAC Stiffness Subscale4.2 (0.27)7.4(0.51)WOMAC Physical Function Subscale44.8 (2.61)76.9 (5.07)Work Productivity Loss30.0 (4.07)47.5 (10.46)Multivariate analysis adjusted for age, year since OA diagnosis/follow-up, gender, BMI, number of medication classes, insurance, physician specialty/academic responsibilities, number of affected joints, diabetes, CVD, hyperlipidemia/hypertension, and depression. All differences were statistically significant (p < 0.05) except work productivity loss (p=0.11)Disclosure of Interests:Xiaofeng Zeng Consultant of: MSD Pharmaceuticals, Xiaomei Leng Consultant of: MSD Pharmaceuticals, Knightley Wei Employee of: Employed by MSD Pharmaceuticals (China), Wen Min Tang Employee of: Employed by MSD Pharmaceuticals (China), Cai Hua Tang Employee of: Employed by MSD Pharmaceuticals (China), Kaan Tunceli Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Jyoti Aggarwal Consultant of: Merck & Co., Inc., Dena Ramey Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Fidel Lozano Employee of: Merck & Co. salaried employee, Ishita Doshi Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Cynthia Macahilig Consultant of: Consultant to Merck Sharp & Dohme Corp., Shardul Odak Consultant of: Consultant to Merck Sharp & Dohme Corp., Kelly Johnson Employee of: Employed by Merck & Co., Inc.

Background Veterinary clinic transaction records from the USA were examined to determine dog owner purchase patterns for three prescription ectoparasiticides. In-clinic purchases of formulations of fluralaner (with 12-week duration per dose) were compared with dog owner purchases of afoxolaner and spinosad (both with 4 week duration per dose) in a population of 231,565 dogs over a 12 month period. Prior studies in human and animal medicine have suggested that patients more closely adhere to prescriber dosing recommendations when they receive a longer-duration medication. Results Veterinary clinic transaction records were examined for the period June 2014 through March 2017 using records from approximately 650 veterinary clinics. Ectoparasiticide purchase patterns were compared for two products (afoxalaner and spinosad) with monthly dosing and one product (fluralaner) with an extended (12 week) dosing interval. The average dog owner who obtained fluralaner purchased significantly more months of flea/tick protection (5.7 months) over the 12-month study period than the average dog owner that selected either afoxolaner (4.6 months) or spinosad (3.3 months). The proportion of dog owners who obtained only one dose of ectoparasiticide per 12-month period was 42% for fluralaner, 30% for afoxolaner and 37% for spinosad. The proportion of dog owners who obtained 2 doses or less per 12-month period was 67% for fluralaner, 52% for afoxoalaner and 67% for spinosad. Owners that obtained fluralaner were significantly more likely to obtain 7.0–12.0 months of flea and tick protection and significantly less likely to purchase 1.0–6.9 months compared with dog owners who purchased afoxolaner or spinosad. Conclusions Dog owners who obtained a flea and tick medication with a longer duration of action acquired significantly more months of protection in a year than dog owners who obtained shorter duration (1 month) products. Dog owners were better able to adhere to veterinary recommendations on ectoparasites control with a longer-acting flea/tick medication.

Background: Asthma is a chronic and complex lung disease that is not completely understood. It involves airway inflammation, reversible airflow obstruction, and bronchial hyperresponsiveness. The most common symptoms are recurrent wheezing, chest tightness, shortness of breath, and coughing. Objective: The Asthma Insights and Management study gathered information on the burden of asthma in the Gulf region (United Arab Emirates, Kuwait, Saudi Arabia) and Russia. Methods: This was a cross-sectional, multinational, noninterventional, two-phase study that collected data from patients ages ≥ 12 years, through interviews and a survey questionnaire. Phase 1 consisted of survey questions focused on estimating the asthma prevalence in the community. Phase 2 was designed to assess the level of asthma control, asthma-related perceptions and behaviors, and presentation patterns. Data were summarized by using descriptive analyses. Results: Analysis of data of 711 patients revealed that the prevalence of asthma among patients who lived in the community was 7.9% and that 66% subjectively perceived their asthma as being controlled. However, 97% of the patients' asthma were partially controlled or uncontrolled based on the Global initiative for Asthma control classification. Troubling symptoms were daytime coughing (33.3%) and shortness of breath (20.3%). With respect to medications for asthma, 76.2% of the patients reported the use of quick relief medication and 80.8% of maintenance medication during the past 4 weeks. Asthma exacerbation in the past year was reported by 40% of adults and adolescents in the study. Conclusion: The results showed that a significant proportion of the patients experienced bothersome symptoms and that many had a lack of knowledge about asthma control and treatment recommendations, which indicated that there is a need for improvements in patient education and asthma care in the Gulf and Russia regions.

To evaluate adherence to oral antihyperglycemic monotherapy, we conducted a retrospective cohort study of a UK clinical database. The mean proportion of days covered was 73.5%, and 60.1% of patients were adherent. Younger age and fewer concomitant medications were negatively associated with the likelihood of being adherent.

Aim To assess time to insulin initiation among patients with type 2 diabetes mellitus (T2DM) treated with sitagliptin versus sulphonylurea as add-on to metformin. Methods This retrospective cohort study used GE Centricity electronic medical records and included patients aged ≥18 years with continuous medical records and an initial prescription of sitagliptin or sulphonylurea (index date) with metformin for ≥90 days during 2006–2013. Sitagliptin and sulphonylurea users were matched 1 : 1 using propensity score matching, and differences in insulin initiation were assessed using Kaplan–Meier curves and Cox regression. We used conditional logistic regression to examine the likelihood of insulin use 1–6 years after the index date for each year. Results Propensity score matching produced 3864 matched pairs. Kaplan–Meier analysis showed that sitagliptin users had a lower risk of insulin initiation compared with sulphonylurea users (p = 0.003), with 26.6% of sitagliptin users initiating insulin versus 34.1% of sulphonylurea users over 6 years. This finding remained significant after adjusting for baseline characteristics (hazard ratio 0.76, 95% confidence interval 0.65–0.90). Conditional logistic regression analyses confirmed that sitagliptin users were less likely to initiate insulin compared with sulphonylurea users [odds ratios for years 1–6: 0.77, 0.79, 0.81, 0.57, 0.29 and 0.75, respectively (p

Aims The aim of this study was to examine the relationship between a specific glycated haemoglobin (HbA1c) measurement and a pharmaceutical dispensings-based measure of adherence calculated over the 90 days before each HbA1c measure among patients who have newly initiated metformin therapy. Methods We identified 3109 people with type 2 diabetes who initiated metformin as their first-ever antihyperglycaemic drug, analysing all 9918 HbA1c measurements that were taken over the next 2 years. We used an adaptation of the ‘proportion of days covered’ method for assessing medication adherence that corresponded to an ∼90-day interval preceding an HbA1c measurement, terming the adaptation the ‘biological response-based proportion of days covered’ (BRB-PDC). To account for multiple observations per patient, we analysed the association between HbA1c and BRB-PDC within the generalized estimating equation framework. Analyses were stratified by HbA1c level before metformin initiation using a threshold of 8% (64 mmol/mol). Results After multivariable adjustment using 0% adherence as the reference category, BRB-PDC in the range 50–79% was associated with HbA1c values lower by −0.113 [95% confidence interval (CI) −0.202, −0.025] among patients with pre-metformin HbA1c

Objective Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. Research design and methods Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. Results Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. Conclusions Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find that none of the existing instruments appear to be useful in detecting differences between treatments, therefore limiting their use in clinical and observational research.

SUMMARY Aim: To describe the drug management of T2DM patients in a real life cohort with suboptimal HbA1c after treatment with metformin monotherapy. Methods: we performed a retrospective cohort analysis of computerized medical records after measuring an HbA1c >7% for the first time following at least 90 days on metformin therapy. Results: Among 7705 eligible patients, 56% (n = 4336) changed treatment within 1-year, by increasing metformin dose (36%), adding drugs (60%), or switching to other medications (4%). Strongest predictors of change were higher HbA1c, younger age and higher socioeconomic status (SES). Conclusion: In this cohort, the extent of inertia appears to be smaller than that reported in previous studies. Nonetheless, disease management programs aimed at improving guideline adherence and reducing inertia are still warranted.

Introduction Previous research has demonstrated a correlation among patient preferences, dosing burden, and medication nonadherence, a well-recognized challenge in type 2 diabetes mellitus (T2DM). The objective of this study was to elicit preferences for alternative dosing regimens for oral antihyperglycemic therapies among patients with T2DM and to quantify differences in dosing preferences among patients with different characteristics. Methods Preferences for dosing of oral antihyperglycemic drugs (OAD) were evaluated by surveying patients with T2DM in the United States (US). Survey participants were adult US patients with T2DM who were taking no or only 1 OAD and no injectable therapies. Each patient completed a web-enabled discrete-choice experiment (DCE) including a series of 8 pairs of hypothetical OAD profiles. Each profile was defined by reductions in average glucose, dosing schedule (e.g., once-weekly, once-daily, or twice-daily dosing), chance of mild-to-moderate gastrointestinal side effects, frequency of hypoglycemia, weight change, incremental risk of congestive heart failure, and cost. Each participant also answered a direct question about dosing preference. Random-parameters logit was used to analyze the DCE data. Prespecified subgroups were analyzed. Results Of 2,262 patients invited to participate, 923 were included in the analysis (mean age 63 years, 45% male, 79% white). Reducing dosing frequency was statistically significantly important to patients; however, it was relatively less important than medication cost or clinical outcomes. On average, patients preferred once-weekly to once-daily dosing. Patients not currently taking an OAD had a stronger preference for once-weekly dosing than patients on treatment (P = 0.012). Patients younger than 45 years had a stronger preference for weekly dosing than older patients (P

Statin combination therapy and statin uptitration have been shown to be efficacious in low-density lipoprotein cholesterol (LDL-C) lowering and are recommended for patients with high-risk coronary heart disease (CHD) who do not reach guideline-endorsed LDL-C goals on statin monotherapy.This analysis evaluated treatment practice patterns and LDL-C lowering for patients with CHD/CHD risk equivalent on statin monotherapy in a real-world practice setting in the United States.In this retrospective, observational study, patients with CHD/CHD risk equivalent on statin therapy were identified during 2004 to 2008 in a US managed care database. Prescribing patterns and effect of switching from statin monotherapy to combination ezetimibe/simvastatin therapy vs uptitration to higher statin dose/potency level and no change from initial statin potency on LDL-C lowering were assessed. Percentage of change from baseline in LDL-C levels and odds ratios for LDL-C goal attainment were estimated with analyses of covariance and logistic regression.Of 27,919 eligible patients on statin therapy, 2671 (9.6%) switched to ezetimibe/simvastatin therapy, 11,035 (39.5%) uptitrated statins, and 14,213 (50.9%) remained on the same statin monotherapy. LDL-C reduction from baseline and attainment of LDL-C100 and70 mg/dL were substantially greater for patients who switched to ezetimibe/simvastatin therapy (-24.0%, 81.2%, and 35.2%, respectively) than for patients who titrated (-9.6%, 68.0%, and 18.4%, respectively) or remained on initial statin therapy (4.9%, 72.2%, and 23.7%, respectively). The odds ratios for attainment of LDL-C100 and70 mg/dL were also higher for patients who switched than for patients who uptitrated and had no therapy change than for patients who titrated vs no therapy change. Similarly, among a subgroup of patients not at LDL-C100 mg/dL on baseline therapy, attainment of LDL-C100 and70 mg/dL was greater for patients who switched than for statin uptitration vs no change, as well as for patients who uptritrated statins vs no therapy change.In this study, LDL-C lowering and goal attainment rates improved substantially for patients with high-risk CHD on statin monotherapy who switched to combination ezetimibe/statin or uptitrated their statin therapies; however, approximately one-third of these patients still did not attain the optional recommended LDL-C goal of70 mg/dL. Moreover, these higher efficacy lipid-lowering therapies were infrequently prescribed, indicating the need for further assessment of barriers to LDL-C goal attainment in actual practice settings.

For high-risk patients who do not achieve guideline-recommended LDL-C levels, more intensive treatment including statin-uptitration to higher doses or potency, as well as combination therapy may be considered. A better understanding of statin treatment patterns in real-world clinical practice may contribute to improved lipid-lowering management in these patients.We determined treatment pattern changes among patients with high risk of cardiovascular disease who were not at low-density lipoprotein cholesterol (LDL-C) goal on statin monotherapy.Treatment pattern changes were evaluated among patients newly initiated on statins between January 1, 2006, and August 31, 2009, in the HealthCore Integrated Research Database. Rates and mean time to first and second treatment changes were examined in patients with claims for coronary heart disease (CHD), atherosclerotic vascular disease (AVD), and diabetes mellitus during 12 months before index, who were not at LDL-C70 mg/dL at their first-eligible LDL-C test (≥ 4 weeks after index). Therapy change was assessed for 12 months after the LDL-C result.Of 11,473 eligible subjects, 61.3% had diabetes, 26.6% had CHD and AVD, and 12.1% had CHD and AVD and diabetes. At index, patients were prescribed medium-potency levels of statins, including simvastatin (44.7%), atorvastatin (31.5%), and other statins (23.8%). Mean ± SD LDL-C before statin initiation was 138 ± 34 mg/dL, and at the first-eligible LDL-C result after index, it was 101 ± 25 mg/dL. During follow-up, 7444 subjects (64.9%) experienced a first treatment change, with mean time to change of 93.8 ± 92 days, whereas 4029 (36.1%) had no treatment change. Discontinuation of index therapy occurred in 46.9% of subjects and medication switches or titration in 18.0% (index statin titration, switch to other statins, other lipid-lowering therapies [LLT], including ezetimibe). Of the discontinuers, 27.4% restarted LLT. Of subjects with a first treatment change who did not discontinue, 48.9% experienced a second therapy change. Results were similar between the 3 high-risk groups.In this managed-care setting, among patients with high risk of cardiovascular disease who were not at LDL-C goal, statins were usually started at medium-potency doses without being titrated up, whereas nearly one-half had a discontinuation of LLT within 12 months. These treatment patterns indicate the need for better patient and provider education as well as other system-wide modifications to improve medication adherence.

Primary nonadherence to a medication occurs when a drug is prescribed but the patient fails to pick the prescription up from the pharmacy. Managed care organizations that provide integrated care using electronic medical records (EMR) are an ideal setting to study primary nonadherence. To identify patient and provider characteristics that are significantly associated with primary nonadherence to statin medications compared with a population of patients who picked up their first statin order. This was a retrospective cohort study of patients with a new statin prescription. Patients with a new order for a statin prescription between December 1, 2009, and February 28, 2010, were eligible. A statin order was considered new if the patient had no statin prescriptions in the previous 12 months. Study participants were 24 years and older with 12 months of continuous membership prior to the statin order. Patients were defined as primary nonadherent if they did not pick up their new prescription within 90 days. Descriptive and multivariate (conditional logistic regression) analyses of patients who did and did not pick up their new statin prescriptions were performed using demographic and socioeconomic information, health care utilization, health conditions, medical benefits, and prescriber characteristics. A total of 19,826 patients with a new statin order that met all of the inclusion and exclusion criteria was identified. Of these, 3,049 patients (15.4%) did not pick up their statin prescriptions within 90 days of the order date. Primary nonadherent patients tended to be younger (55 vs. 57 years, P less than 0.001) and healthier, with fewer comorbid conditions (Charlson Comorbidity Index ≥ 1, 42.2% vs. 52.3%, P less than 0.001), lower rates of hospitalizations (7.2% vs. 12.0%, P less than 0.001), fewer concurrent prescriptions (3 vs. 4, P less than 0.001) and fewer clinic (4 vs. 5, P less than 0.001) and emergency department visits (18.2% vs. 24.6%, P less than 0.001) in the prior year than adherent patients. Although the multivariate model agreed well with the observed data, the characteristics included had a poor ability to predict primary nonadherence (c-statistic = 0.603). Primary nonadherence has been recognized as a significant problem for many years, and electronic health records are allowing researchers to investigate the extent of the problem. In this study, almost 1 in 6 patients (15.4%) failed to pick up their new statin order within 90 days. However, clinical and demographic information available in electronic health care data may not be useful in predicting primary nonadherence. New methods and interventions need to be developed to improve primary adherence.

Background: Fluralaner is a potent acaricide and insecticide effective against flea and tick (F/T) infestations on dogs and cats. Fluralaner for dogs can be administered orally as a flavored chew with up to a 12-week redosing interval, about three-fold less frequently than monthly F/T medications. This study surveyed dog owners who currently administer fluralaner to their dogs to determine their level of satisfaction with the product and its perceived benefits compared to monthly medications, including the potential for on-time administration compliance. Methods: In the period April to June 2016, dog-owner clients from 25 veterinary practices in 16 U.S. states completed a 10-item survey questionnaire (n=559) that asked respondents about their experience with fluralaner and monthly medications. In multivariate analyses, predictors of treatment satisfaction and predictors of preference with fluralaner have been estimated by an ordered logistic regression and a logistic regression, respectively. Results: Seventy-three percent of survey respondents had used monthly F/T medications prior to fluralaner. Respondents identified convenience (74%), the 12-week dosing interval (69%), and less-frequent dosing (68%) as the three most important benefits of using fluralaner. Sixty six percent were very satisfied and 30% were satisfied with fluralaner and 89% preferred fluralaner versus monthly F/T medications. Pet owners who used monthly F/T products, 65% thought that they were more likely to give the next fluralaner dose on time compared to doses of monthly F/T products, and 88% said that giving repeat doses of fluralaner was more convenient than giving monthly F/T products. In multivariable models, “12 weeks dosing/convenience” and “female gender” were positively associated with treatment satisfaction and preference with fluralaner (p

Aims Accurate measures of hypoglycemia within electronic health records (EHR) can facilitate clinical population management and research. We quantify the occurrence of serious and mild-to-moderate hypoglycemia in a large EHR database in the US, comparing estimates based only on structured data to those from structured data and natural language processing (NLP) of clinical notes. Methods This cohort study included patients with type 2 diabetes identified from January 2009 through March 2014. We compared estimates of occurrence of hypoglycemia derived from diagnostic codes to those recorded within clinical notes and classified via NLP. Measures of hypoglycemia from only structured data (ICD-9 Algorithm), only note mentions (NLP Algorithm), and either structured data or notes (Combined Algorithm) were compared with estimates of the period prevalence, incidence rate, and event rate of hypoglycemia, overall and by seriousness. Results Of the 844,683 eligible patients, 119,695 had at least one recorded hypoglycemic event identified with ICD-9 or NLP. The period prevalence of hypoglycemia was 12.4%, 25.1%, and 32.2% for the ICD-9 Algorithm, NLP Algorithm, and Combined Algorithm, respectively. There were 6128 apparent non-serious events utilizing the ICD-9 Algorithm, which increased to 152,987 non-serious events within the Combined Algorithm. Conclusions Ascertainment of events from clinical notes more than doubled the completeness of hypoglycemia capture overall relative to measures from structured data, and increased capture of non-serious events more than 20-fold. The structured data and clinical notes are complementary within the EHR, and both need to be considered in order to fully assess the occurrence of hypoglycemia.

Data are limited regarding adherence to dipeptidyl peptidase-4 inhibitors.The present retrospective cohort study of a claims database involved adults with type 2 diabetes mellitus, continuous enrollment for 12 months before the first prescription of add-on sitagliptin (SITA) or a sulfonylurea (SU) to metformin (MET) monotherapy (index date), and ≥45 days of MET coverage ≤90 days before the index date. The SITA and SU users were matched on duration of follow-up and propensity score (PS). Logistic regression analysis incorporated age, gender, comorbidities, and concomitant medications as independent variables.Approximately 99 % of SITA patients were PS matched, resulting in 14 807 well-balanced PS-matched SITA/SU pairs. Mean proportion of days covered (PDC) was significantly higher for SITA (vs SU) + MET after 1 year (P 0.001). Adherence (PDC ≥80 %) to SITA (vs SU) + MET was 59.1 % (vs 55.9 %; P 0.001) at 1 year and 52.6 % (vs 49.9 %; P = 0.007) at 2 years. Using logistic regression models including out-of-pocket expense (OPE) as a covariate, we found improved mean PDC and adherence for SITA (vs SU) + MET. Numbers of patients who continued to use SITA (vs SU) + MET were significantly higher after Years 1, 2, and 3 (all P 0.05).Users of SITA + MET had significantly higher mean PDC, adherence, and persistence than those on SU + MET. These trends were robust to model alterations and were more marked when accommodating OPEs.

To systematically review and analyse evidence for cholesterol-lowering efficacy of at least 4 weeks of add-on ezetimibe vs doubling statin dose, in adults with primary hypercholesterolaemia.MEDLINE, EMBASE and Cochrane databases were searched to identify randomised controlled trials of ezetimibe-statin combination vs statin titration (January 1993 - March 2010). Studies were selected using predefined criteria. Two reviewers conducted screening of articles, critical appraisal and data extraction; a third reviewer resolved disagreements. The difference between treatments was analysed for four co-primary outcomes: mean percentage change from baseline in low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and total cholesterol (TC); and proportion of patients achieving LDL-C treatment goal. Data were combined by two sets of direct comparison fixed and random effects meta-analysis: (1) compared data in the same treatment period between groups; (2) compared the incremental change in lipid levels of add-on ezetimibe vs doubling statin dose. Heterogeneity was assessed using the I(2) statistic.Thirteen studies including 5080 patients were included in the meta-analyses. Data on simvastatin, atorvastatin and rosuvastatin were analysed. Results for primary and secondary outcomes were in favour of the ezetimibe-statin combination. A significantly greater percentage reduction in LDL-C levels was achieved in patients treated with ezetimibe-statin vs statin monotherapy (weighted mean difference [WMD]: -14.1% [-16.1, -12.1], p 0.001). Reduction in LDL-C levels attributed to add-on ezetimibe was significantly greater than that for statin dose doubling (WMD: -15.3% [-19.1, -11.4], p 0.001). Achievement of LDL-C goal favoured add-on ezetimibe over statin titration and was statistically significant (odds ratio: LDL-C treatment goal 2.45 [1.95, 3.08], p = 0.007).Meta-analyses were restricted by the limited number of studies with similar trial design and method of statin titration. Results indicate that add-on ezetimibe is significantly more effective in reducing LDL-C levels than doubling statin dose, enabling more patients to achieve LDL-C goal.

The availability of generic simvastatin in 2006 has prompted substantial changes in formulary recommendations for lipid-management agents.To assess the impact of switches from high-efficacy lipid-lowering therapy to simvastatin on low-density lipoprotein cholesterol (LDL-C) and goal attainment in coronary heart disease (CHD) or CHD risk-equivalent patients in a managed care setting.In this retrospective observational study, we estimated the least squares mean difference in the percent change from baseline LDL-C and the odds ratios for LDL-C goal attainment rates (100 mg/dL and70 mg/dL) at follow-up for each baseline high-efficacy lipid-lowering therapy with the analysis of covariance and logistic regressions, respectively.We identified 18,061 patients who, between September 1, 2004 and October 31, 2008, were either switched from or remained on their initial high-efficacy LDL-C lowering therapy: ezetimibe/simvastatin fixed-dose combination (E/S), rosuvastatin, or atorvastatin. The difference in percent change in LDL-C levels from baseline were 25.2 (95% confidence interval 21.2-29.2), 13.0 (6.0-20.0), and 3.1 (0.3-5.9) greater in switchers to simvastatin in the E/S, rosuvastatin, and atorvastatin comparisons, respectively, after adjusting for age, sex, and starting dose of the initial therapy. For switchers, the percent of patients at LDL-C100 mg/dL at follow-up decreased from 83.5% to 63.8% in the E/S, 67.7% to 52.7% in the rosuvastatin, and 65.1% to 60.2% in the atorvastatin cohorts. The percent of patients at LDL-C70 mg/dL at follow-up was lower for all switcher groups compared with nonswitchers.Among CHD/CHD risk-equivalent patients, switching to simvastatin was associated with increases in LDL-C levels and lower LDL-C goal attainment rates. The public health impact of this phenomenon on population risk and CHD events remains to be determined.

Objective To evaluate the incremental cost-effectiveness ratio (ICER) of switching to ezetimibe/simvastatin (Eze/Simva) compared with doubling the submaximal statin doses, in patients with acute coronary syndrome (ACS) events in the INFORCE study. Methods Lifetime treatment costs and benefits were computed using a Markov model. Model inputs included each patient's cardiovascular risk factor profile and actual lipid values at baseline and 12 weeks (endpoint). Cardiovascular event and drug costs were discounted at 3.5%. Age-specific utilities were based on UK literature values and non–coronary heart disease mortality rates on the Office of National Statistics data. In the INFORCE study, 384 patients taking statins at stable doses for ≥6 weeks before hospital admission were stratified by statin dose/potency (low, medium, and high) and then randomized to doubling the statin dose or switching to Eze/Simva 10/40 mg for 12 weeks. Results The Eze/Simva group ( n = 195) had a higher mean baseline total cholesterol than the double-statin group ( n = 189). Analyses were adjusted for baseline characteristics. In the INFORCE study, Eze/Simva reduced low-density lipoprotein cholesterol (LDL-C) by ∼30% (vs. 4% with doubling statin doses) and significantly enhanced LDL-C goal attainment. In the cost-effectiveness analysis, Eze/Simva conferred 0.218 incremental discounted quality-adjusted life year (QALY) at a discounted incremental cost of £2524, for an ICER of £11,571/QALY (95% confidence interval=£8181–£18,600/QALY). The ICER was £13,552/QALY, £11,930/QALY, and £10,148/QALY in the low-, medium-, and high-potency strata, respectively. Conclusions Switching to Eze/Simva 10/40 mg is projected to be a cost-effective treatment (vs. double-statin) in UK patients with ACS.

Guidelines recommend a low-density lipoprotein cholesterol (LDL-C) measurement of70 mg/dL as a reasonable goal in high-risk patients with coronary heart disease (CHD) or atherosclerotic vascular disease (AVD).This retrospective, cross-sectional study examined LDL-C goal attainment monthly trends from January 1, 2004, to August 31, 2008, in a large, managed-care claims database in the United States. High-risk CHD or AVD patients who had at least one LDL-C test during that time period were included (N = 284,915). Average LDL-C values and percent of patients not achieving LDL-C goal (LDL-C ≥70 mg/dL) were obtained by averaging patient level LDL-C values for each month. A linear trend analysis with first-order autocorrelated errors was conducted.The proportion of patients treated with lipid-lowering therapy gradually increased from 58.5% in 2004 to 70.5% in 2008. Mean LDL-C values in patients treated with lipid-lowering therapy decreased from 100.4 to 96.4 mg/dL, whereas LDL-C remained relatively constant in untreated patients (114.3 mg/dL). In treated patients, the percentage with LDL-C ≥70 mg/dL decreased from 87.5% in January 2004 to 73.8% in December 2006 (P.0001), then gradually declined between January 2007 (79.6%) and August 2008 (76.2%; P.0001). Among untreated patients, 92.9% had LDL-C levels ≥70 mg/dL in January 2004 and 93.0% in August 2008.In conclusion, the percentage of high-risk patients with CHD or AVD treated with lipid-lowering therapy who achieve LDL-C70 mg/dL levels has increased since 2004, although a large proportion of these patients still do not meet this goal. Additionally, 1 of 4 high-risk patients otherwise eligible for lipid-lowering therapy remains untreated. These data suggest the need for renewed efforts to support guideline-based LDL-C lowering in high-risk patients.

PurposeThe purpose of this study is to apply the self-determination theory (SDT) model of health behavior to predict medication adherence, quality of life, and physiological outcomes among patients with diabetes.MethodsPatients with diabetes (N = 2973) receiving care from an integrated health care delivery system in 2003 and 2004 were identified from automated databases and invited to participate in this study. In 2005, patients responded to a mixed telephone-and-mail survey assessing perceived autonomy support from health care providers, autonomous self-regulation for medication use, perceived competence for diabetes self-management, medication adherence, and quality of life. In 2006, pharmacy claims data were used to indicate medication adherence, and patients' non—high-density lipoprotein (HDL) cholesterol, A1C, and glucose levels were assessed.ResultsThe SDT model of health behavior provided adequate fit to the data. As hypothesized, perceived autonomy support from health care providers related positively to autonomous self-regulation for medication use, which in turn related positively to perceived competence for diabetes self-management. Perceived competence then related positively to quality of life and medication adherence, and the latter construct related negatively to non-HDL cholesterol, A1C, and glucose levels.ConclusionsHealth care providers' support for patients' autonomy and competence around medication use and diabetes self-management related positively to medication adherence, quality of life, and physiological outcomes among patients with diabetes.

Background Previous studies have shown differences in adherence to inhaled corticosteroids (ICSs) by race-ethnicity, yet little is known about factors that contribute to adherence within these groups. Environmental stressors, such as crime exposure, which has been associated with asthma morbidity, might also predict ICS adherence. Objective We sought to identify factors associated with ICS adherence among patients with asthma and among African American patients and white patients separately. Methods Study patients with asthma were aged 18 to 50 years and were enrolled in a large southeast Michigan health maintenance organization between January 1, 1999, and December 31, 2001. The primary outcome, ICS adherence, was calculated by linking prescription-fill data with dosage information. Predictor variables included age, sex, race-ethnicity, measures of socioeconomic status (SES), average ICS copay, existing comorbidities, and crime rate in area of residence. Results Adherence information was available for 176 patients. ICS adherence was lower among African American patients (n = 75) when compared with white patients (n = 94; 40% vs 58%, respectively; P = .002). Among white patients, adherence was significantly lower for women when compared with men. Among African American patients, age and residential crime rates were positively and negatively associated with ICS adherence, respectively. Area crime remained a predictor of adherence in African American patients, even after adjusting for multiple measures of SES. Conclusions This study suggests that an environmental stressor, area crime, provides additional predictive insight into ICS-adherent behavior beyond typical SES factors. Clinical implications Better understanding of environmental factors that influence ICS adherence might aid in efforts to improve it.

To estimate overall rates of adherence, persistence, and discontinuation for patients with type 2 diabetes mellitus (T2DM) prescribed oral antihyperglycemic agents (OAHAs) by combining results of published studies.A systematic literature review was conducted to identify articles published in English over the last 10 years evaluating the use of OAHAs for the treatment of T2DM. Databases searched included PubMed/MEDLINE, EMBASE, and the Cochrane Library. Seventy studies reporting adherence, persistence or discontinuation were identified by two independent reviewers and 40 reported relevant endpoints for the analysis. Outcomes included: (1) mean adherence defined as the average medication possession ratio (MPR); (2) proportion of adherent patients (MPR ≥ 80%); (3) discontinuation; and (4) persistence. Adherence and persistence were reported in observational studies only. Discontinuation was examined separately in randomized controlled trials (RCTs) and observational studies. Meta-analyses were conducted using both fixed and random effects models. When meta-analysis was not appropriate for a given outcome, descriptive statistics were provided.The pooled mean MPR (95% confidence interval [CI]) was 75.3% (68.8%-81.7%; n = 13) and the proportion of adherent patients (95% CI) was 67.9% (59.6%-76.3%; n = 12). The discontinuation rate (95% CI) in RCTs was 31.8% (17.0%-46.7%; n = 7). Persistence and discontinuation were not assessed via meta-analysis for observational studies due to the limited number of available studies and differences in outcome definitions. In these studies, persistence estimates ranged from 41.0% to 81.1%, with a mean (95% CI) of 56.2% (46.1%-66.3%; n = 6), while discontinuation estimates ranged from 9.9% to 60.1%, with a mean (95% CI) of 31.4% (17.6%-45.3%; n = 6).Limitations include (1) the use of MPR as a proxy for adherence, (2) limited number of studies available, and (3) observed heterogeneity.The results of the analysis demonstrate that medication adherence, persistence, and discontinuation rates are suboptimal in patients with T2DM prescribed OAHAs.

Objective: To determine the relationships between BMI and workforce participation and the presence of work limitations in a U.S. working-age population. Research Methods and Procedures: We used data from the Panel Study of Income Dynamics, a nationwide prospective cohort, to estimate the effect of obesity in 1986 on employment and work limitations in 1999. Individuals were classified into the following weight categories: underweight (BMI < 18.5), normal weight (18.5 ≤ BMI < 25), overweight (25 ≤ BMI < 30), and obese (BMI ≥ 30). Using multivariable probit models, we estimated the relationships between obesity and both employment and work disability. All analyses were stratified by sex. Results: After adjusting for baseline sociodemographic characteristics, smoking status, exercise, and self-reported health, obesity was associated with reduced employment at follow-up [men: marginal effect (ME) −4.8 percentage points (pp); p < 0.05; women: ME −5.8 pp; p < 0.10]. Among employed women, being either overweight or obese was associated with an increase in self-reported work limitations when compared with normal-weight individuals (overweight: ME +3.9 pp; p < 0.01; obese: ME +12.6 pp; p < 0.01). Among men, the relationship between obesity and work limitations was not statistically significant. Discussion: Obesity appears to result in future productivity losses through reduced workforce participation and increased work limitations. These findings have important implications in the U.S., which is currently experiencing a rise in the prevalence of obesity.

Background Early childhood fevers appear to protect against later allergies and asthma. What is not known is the time in which fevers exert this effect and whether the degree of temperature increase is important. Objective We sought to examine the relationship between the time and degree of early fevers and later allergies and asthma. Methods Eight hundred thirty-five children from southeast Michigan were enrolled at birth. Clinic records from their first 2 years were abstracted for episodes of fever. At age 6 to 7 years, children underwent allergy testing. We examined fevers occurring within 6-month intervals in the first 2 years of life and outcomes at age 6 to 7 years. The primary outcome measures were allergic sensitization, asthma, asthma with allergic sensitization, and asthma without allergic sensitization. Results In the unadjusted analysis each episode of fever between 7 and 12 months of age was associated with a lower odds of allergic sensitization (odds ratio [OR], 0.71; 95% CI, 0.54-0.93) and asthma with allergic sensitization (OR, 0.43; 95% CI, 0.21-0.90) at age 6 to 7 years. Likewise, every 1°C increase in the maximum temperature between 7 and 12 months was associated with a lower odds of allergic sensitization (OR, 0.77; 95% CI, 0.61-0.96) and asthma with allergic sensitization (OR, 0.62; 95% CI, 0.40-0.94). After adjusting for potential confounders, each episode of fever between 7 and 12 months was associated with a lower likelihood of asthma with allergic sensitization (adjusted OR, 0.33; 95% CI, 0.11-0.94) at age 6 to 7 years. Conclusions Both the timing and intensity of childhood fevers appear to be important factors in the development of allergies and asthma.

Kaan Tunceli,1 Changgeng Zhao,1 Michael J Davies,2 Kimberly G Brodovicz,3 Charles M Alexander,4 Kristy Iglay,1 Larry Radican1 1Global Health Outcomes, Merck & Co, Inc, Whitehouse Station, NJ, USA; 2Global Scientific and Medical Publications, Merck & Co, Inc, Whitehouse Station, NJ, USA; 3Global Epidemiology, Merck & Co, Inc, Whitehouse Station, NJ, USA; 4Global Medical Affairs, Merck & Co, Inc, Whitehouse Station, NJ, USA Aim: To estimate the rate of adherence to oral antihyperglycemic monotherapy for patients with type 2 diabetes in the US and describe factors associated with adherence in these patients.Materials and methods: In this retrospective cohort analysis, patients aged 18 years or older with a type 2 diabetes diagnosis received between 1 January 2007 and 31 March 2010 were identified using a large US-based health care claims database. The index date was defined as the date of the first prescription for oral antihyperglycemic monotherapy during this period. Patients had to have continuous enrollment in the claims database for 12 months before and after the index date. Adherence was assessed using proportion of days covered (PDC) and an adjusted logistic regression analysis was performed to evaluate factors associated with adherence (PDC ≥80%).Results: Of the 133,449 eligible patients, the mean age was 61 years and 51% were men. Mean PDC was 75% and the proportion of patients adherent to oral antihyperglycemic monotherapy was 59%. Both mean PDC and PDC ≥80% increased with increasing age and the number of concomitant medications, and were slightly higher in men compared to women. Results from the logistic regression demonstrate an increased likelihood of non-adherence for patients who were younger, new to therapy, on a twice-daily dose, female, or on fewer than three concomitant medications compared to their reference groups. Higher average daily out-of-pocket pharmacy expense was also associated with an increased likelihood of non-adherence. All results were statistically significant (P

SummaryAims Hypoglycaemia in patients with diabetes can be induced by insulins and sulfonylureas. We assessed the real-world impact of specific monotherapy and combination regimens on hypoglycaemic events requiring hospitalisation and related secondary costs to the English healthcare system. Methods This retrospective observational study used the Clinical Practice Research Datalink with linked hospital admission data during 2008-2012. Patients with type 2 diabetes mellitus (T2DM) using antihyperglycaemic agents (AHAs) were assigned to mutually exclusive subgroups (insulin- and non-insulin-containing regimens; treatment groups of interest; age group) based on treatment at index date (date of first AHA prescription). Outcomes were number and cost of hospital admissions with hypoglycaemic event-related diagnosis codes. Results We identified 110 206 patients with T2DM (mean age 64.9 years, time since diagnosis 5.4 years, HbA1c at index 7.4%), with 439 hypoglycaemic events requiring inpatient hospitalisation (mean length of stay 6.3 days, mean cost/stay £1351). Event rates and cost of stay were highest in patients treated with sulfonylurea- or insulin-based regimens. Event rates, duration and cost of stay were higher in older patients. Conclusion Rates of severe hypoglycaemic events varied substantially between T2DM regimens. In this study of patients treated in clinical practice in England, sulfonylurea- and insulin-based regimens were associated with the highest event rates and costs associated with hospitalisation for severe hypoglycaemic events; hospitalisation for severe hypoglycaemic events was not observed with dipeptidyl peptidase-4 inhibitor monotherapy or with metformin.

The associations between adverse labor market outcomes and diabetes/diabetes complications are well described (1–8). Clinical guidelines have recommended standards for glycemic, lipid, and blood pressure control (9) that have been shown to prevent or delay the onset and progression of diabetes complications (10–16). It is possible that control of these symptoms can reduce absenteeism in employed patients. Two studies have examined the relationship between glycemic control and labor market outcomes including absenteeism (17,18), and this study adds to that literature by examining the cross-sectional associations between absenteeism from work and glycemic, lipid, and blood pressure control among individuals with diabetes. Patients were identified as having diabetes ( n = 27,407) from administrative data available within a medical group in southeast Michigan between 1 June 2003 and 31 May 2004. From these patients, we selected those who were tested for A1C during the prior 12 months and aged 30–64 years ( n = 11,324). Next, we drew a random sample of 1,000 patients stratified by glycemic control level (A1C

JoAnne M Foody,1 Peter P Toth,2 Joanne E Tomassini,3 Shiva Sajjan,3 Dena R Ramey,3 David Neff,3 Andrew M Tershakovec,3 Henry Hu,3 Kaan Tunceli31Brigham and Women's Hospital, Boston, MA, 2CGH Medical Center, Sterling, IL, and University of Illinois College of Medicine, Peoria, IL, 3Merck & Co., Inc., Whitehouse Station, NJ, USABackground: Many high-risk coronary heart disease (CHD) patients on statin monotherapy do not achieve guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals, and combination lipid-lowering therapy may be considered for these individuals. The effect of adding ezetimibe to simvastatin, atorvastatin, or rosuvastatin therapy versus titrating these statins on LDL-C changes and goal attainment in CHD or CHD risk-equivalent patients was assessed in a large, managed-care database in the US.Methods: Eligible patients (n = 17,830), initially on statin monotherapy who were ≥18 years with baseline and follow-up LDL-C values, no concomitant use of other lipid-lowering therapy, and on lipid-lowering therapy for ≥42 days, were identified between November 1, 2002 and September 30, 2009. The percent change from baseline in LDL-C levels and the odds ratios for attainment of LDL-C

To identify self-reported reasons for not filling a new prescription for statin therapy.A cross-sectional telephone survey.Potential participants were identified from a randomized, controlled trial among Kaiser Permanente Southern California (KPSC) members aged24 years with no record of redeeming a new statin medication, defined as primary nonadherence. Among 1158 eligible patients, 98 were randomly selected and participated in a semi-structured telephone interview that included questions on whether the respondent redeemed their statin prescription, why the patient may have chosen not to use a KPSC pharmacy, reasons for not filling the prescription, use of non-prescription products for elevated cholesterol levels, and questions to assess health literacy.At 12 weeks post-index prescription date, 75% of 98 respondents reported not filling their new statin prescription, 20% reported picking it up from a non-KPSC pharmacy, 4% had already picked up the prescription at a KPSC pharmacy, and 1% did not know if it had been filled. The 3 most commonly cited reasons for primary nonadherence were general concerns about taking the medication (63%), a decision to try lifestyle modifications (63%), and fear of side effects (53%). A substantial proportion (33%) of respondents reported inadequate health literacy.These data suggest the need for interventions that address patients' negative perceptions of statins while emphasizing the benefits of statin therapy for reducing cardiovascular morbidity and mortality in formats accessible to those with limited health literacy.

To assess the time from the first observed diagnosis of type 2 diabetes (T2DM) to initiation of an oral antihyperglycemic agent (OAHA) and statin.In a retrospective US cohort study using the GE electronic medical record database, patients ≥18 years were included if they had a T2DM diagnosis between January 1, 2004 and December 31, 2005 (index period), had a last pre-index HbA1c value ≥7%, and had not received antihyperglycemic agents within one year prior to diagnosis (index date). Patients were eligible for statin therapy but not on a statin within one year before the index date. Patients had medical records for one year prior to (baseline) and two years after (follow up) diagnosis.Of the 2254 eligible patients, 58% were male, mean age was 58 years, mean HbA1c was 8.5%, and mean LDL cholesterol was 115 mg/dL (2.97 mmol/L) at baseline. Additionally, 21% of patients had pre-existing overt cardiovascular disease, 40% had dyslipidemia, 37% were obese, and 11% were smokers. During follow-up, 66.1% and 41.9% of patients initiated an OAHA and a statin, respectively. Among the treated patients, median time from the first observed diabetes diagnosis to therapy initiation was 3 months (interquartile range: 1, 9) for OAHAs and 6 months (2, 13) for statins.Treatment initiation with injectable antihyperglycemic agents and/or non-statin lipid-modifying therapies as well as contraindications to OAHAs or statins were not assessed, therefore their impact on our study results cannot be determined. Laboratory measurements were not available for every patient and thus many patients were excluded from the analysis.Treatment initiation with OAHAs and/or statins was suboptimal in patients with T2DM who were treatment eligible and previously untreated with OAHAs and statins. Of those treated, patients initiated treatment with an OAHA more often and earlier than with a statin.