Results from a cross-sectional, observational study to assess inadequate pain relief in patients with knee and/or hip osteoarthritis in Mexico.

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.

Comparative effectiveness of budesonide inhalation suspension and montelukast in children with mild asthma in Korea.

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 Korea.Methods: Claims from Korea's national health insurance database for children (2-17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses.Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p < .001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p < .001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p < .001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p < .001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p < .001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p < .001).Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients.

Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis.

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.

Dyslipidemia: The untreated metabolic dysfunction in people with type 2 diabetes in Latin America. ARETAEUS study outcomes.

OBJECTIVE: To assess oral antihyperglycemic agents (OAHA) and/or statin treatment initiation in patients with type 2 diabetes (T2D) and time from diagnosis to both types of treatment initiation and intensification. RESEARCH DESIGN AND METHODS: We reviewed 662 retrospective medical records of patients with T2D diagnosed by 31 general practitioner or specialist sites across Mexico, Argentina, and Brazil. Demographic and clinical information was abstracted from patients' medical records and summarized using descriptive statistics. Between-group differences were assessed with Student's t-test for continuous variables and Fisher's exact test for categorical variables. The starting time of each therapy (OAHA and statins, separately) was assessed using Kaplan-Meier estimates. RESULTS: At diagnosis, patients' mean age was 53 years; 44% had hypertension, 42% were obese, and 23% had dyslipidemia. During the 2-year follow-up, 95% of patients received OAHAs but only 29% of those eligible for statins received this prescription. Mean ±â€¯SD and median (Q1, Q3) time to first OAHA was 59 ±â€¯141 days and 1 (1, 31) day, respectively, and 230 ±â€¯232 days and 132 (30, 406) days, respectively, for a statin. During follow-up, 51-53% of patients with HbA1c/FPG values above target did not intensify hyperglycemia treatment. CONCLUSION: Dyslipidemia treatment in patients with T2D was delayed despite its known deleterious effect on atherosclerosis development and ß-cell mass/function. Anti-hyperglycemic treatment was not intensified when targets were not attained. This prescriptive inertia needs to be corrected because attainment of HbA1c treatment goals becomes more difficult, favoring the development of diabetes complications.

Dog owner flea/tick medication purchases in the USA.

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.

Cross-sectional study on Asthma Insights and Management in the Gulf and Russia.

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.

A comparative analysis of heartworm medication use patterns for dogs that also receive ectoparasiticides.

BACKGROUND: Heartworm medications and many oral or topical flea and tick products are provided as monthly doses while a newer oral flea/tick product, fluralaner (BRAVECTO® Chew), is re-dosed at a 12-week interval. This study focused on whether there was a difference in the number of heartworm medication doses that were purchased in the 12-months follow-up period for dogs that receive either fluralaner or other flea/tick medications that are dosed monthly. METHODS: Clinic transaction records of heartworm medication purchases for over 200,000 dogs were examined to compare the purchase of heartworm preventative protection by dog owners that also receive flea and tick medications of differing efficacy durations. RESULTS: Annual purchases of heartworm medication for dogs by owners that receive a flea and tick medication dosed at 12-week intervals was incrementally higher than the number of doses purchased for dogs receiving monthly flea and tick medications. The average number of monthly doses per year was slightly over 7 months for both categories of product. The distribution of purchases of monthly doses was also similar between groups. CONCLUSIONS: Dog owners who purchase a longer-acting flea and tick medication purchase as much heartworm medication annually for their dogs as dog owners who purchase monthly flea and tick medication. On average, dog owners who gave their dog fluralaner obtained significantly more months of heartworm preventative protection compared with dog owners who gave their dog a monthly flea and tick medication, although the biological significance of this increase in doses is very small.

Duration of annual canine flea and tick protection provided by dog owners in Spain.

BACKGROUND: Doses of flea and tick medication acquired by dog owners over a 12 month period were determined from veterinary hospital transaction records in Spain. The number of months of flea and tick protection potentially obtained by dog owners prescribed fluralaner, a flea and tick medication with a 12 week re-dosing interval, was compared with months of flea and tick protection obtained by dog owners prescribed monthly oral or spot-on products. Prior studies in human and veterinary medicine have suggested that longer-acting medications benefit patients by providing improved adherence to provider recommendations. RESULTS: Dog owners took home, on average, significantly more months of protection when they obtained the 12 week duration product fluralaner (4.3 months) than they did when they obtained other flea and tick products providing 1 month of protection [3.24 months (oral), 2.9 months (spot-on)]. Many dog owners (46-64%) obtained only one dose of flea and tick product each year, regardless of the duration of protection offered by the product. Significantly more dog owners obtained 7-12 months of protection when they were prescribed fluralaner (15.7%) by their veterinarians compared with dog owners prescribed monthly flea and tick products [6.8% (oral), 8.3% (spot-on)]. CONCLUSION: Veterinary prescription of fluralaner delivers more months of potential flea and tick protection as shown by dog owner acquisition of flea and tick medication. The use of a longer-acting medication requires the administration of fewer doses and may translate into better adherence to veterinary ectoparasite control recommendations.

Canine babesiosis treatment rates in South African veterinary clinics between 2011 and 2016.

BACKGROUND: South African veterinarians report the perception of a multi-year decline in the number of dogs presenting with clinical babesiosis, a common and serious disease of dogs in the country. This study tested this observation through analysis of veterinary hospital medical records from 2011 through 2016. METHODS: Medical records were collected from 44 participating South African veterinary hospitals. The collected medical records were searched to enumerate the number of Babesia-specific medication treatments administered to dogs at all participating hospitals. A healthcare use rate was calculated for canine babesiosis treatment for each calendar year from 2011 to 2016. The healthcare use rate numerator was the total number of canine babesiosis treatments and the denominator was the total dog visits to all participating veterinary practices over the same period. RESULTS: There were 2.6 million dog visits to 44 participating veterinary practices between 2011 and 2016. The number of canine babesiosis treatments for each year in chronological order starting with 2011 was: 2957; 2679; 2456; 2746; 2272; and 1592. South African regions with the highest number of canine babesiosis treatments were Gauteng, Free State and Mpumalanga. The overall calculated healthcare use rate for canine babesiosis treatment declined 72% over the study period from 1.18% in 2011 to 0.33% in 2016. The steepest decline of 31% was observed between 2015 and 2016. CONCLUSIONS: South African veterinary practices saw a decline in canine babesiosis treatment administration from 2011 to 2016 with the steepest decline beginning in 2015.

Practice Patterns for Chronic Respiratory Diseases in the Asia-Pacific Region: A Cross-Sectional Observational Study.

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.

Assessment of dog owner adherence to veterinarians' flea and tick prevention recommendations in the United States using a cross-sectional survey.

BACKGROUND: Adherence to a prescribed therapeutic regimen is a critical factor for achieving medication effectiveness and therefore treatment success. In the case of companion animal ectoparasite control, suboptimal owner adherence to medication recommendations is thought to be a common cause of treatment failure, and previous reports have found pet owners applying an average of 4.0-4.6 monthly flea and tick treatments per year to their dogs. This study investigated: US veterinary hospital self-reported flea and tick prevention recommendations; dog owner recollection of these recommendations; dog owner opinion on flea/tick recommendations and estimated owner flea and tick medication adherence based on veterinary hospital purchase records. RESULTS: Veterinarians at 24 veterinary hospitals in 4 United States regions provided their flea and tick prevention recommendations. Five hundred fifty-nine dog owners, clients of the 24 hospitals, completed a survey evaluating their recollection of the hospitals' recommendations and their opinions regarding required treatment frequency. Almost all veterinary hospitals in this study recommended 12 months of flea and tick prevention but only 62% of participating dog owners recalled this recommendation. The average owner response was that their dogs require 10.5 months of flea and tick prevention annually. Owner opinions were significantly different among U.S. regions with pet owners in the northeast U.S. believing that they needed significantly less canine flea and tick protection than pet owners in other parts of the United States. The estimated actual flea and tick prevention coverage was 6.1 months based on owner medication purchases over a 12-month period. CONCLUSIONS: In the United States, dog owner opinions and actions show that their flea and tick treatment adherence falls short of veterinarians' recommendations.

Direct medical costs of severe hypoglycaemic events in patients with type 2 diabetes in England: A retrospective database study.

AIMS: 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.

Rationale and support for a One Health program for canine vaccination as the most cost-effective means of controlling zoonotic rabies in endemic settings.

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.

Adherence, persistence, and treatment discontinuation with sitagliptin compared with sulfonylureas as add-ons to metformin: A retrospective cohort database study.

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 < 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). CONCLUSIONS: 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.

Early patient experiences with montelukast orally disintegrating tablets in Japan: a cross-sectional survey of treatment satisfaction in patients with asthma and/or allergic rhinitis.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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 duration <4 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. LIMITATIONS: 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. CONCLUSION: 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.

Assessing occurrence of hypoglycemia and its severity from electronic health records of patients with type 2 diabetes mellitus.

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.

The Change in HbA1c Associated with Initial Adherence and Subsequent Change in Adherence among Diabetes Patients Newly Initiating Metformin Therapy.

Introduction. Whether changes in adherence are associated with changes in HbA1c is assumed but not known. Methods. We conducted a observational study of 2,844 type 2 diabetes patients who initiated metformin as their first antihyperglycemic drug. Using HbA1c measures before, 6-12 months after, and up to 3 years after metformin initiation, we analyzed HbA1c change as a function of initial adherence and change in adherence. Results. Compared with no adherence, initial adherence of 50-79% was associated with an adjusted reduction in HbA1c of 0.45% while adherence ≥80% was associated with HbA1c reduction of 0.73%. Change from some initial adherence (1-79%) to total nonadherence was associated with 0.25% increase in HbA1c. Change from some to full adherence was associated with an HbA1c decrease of 0.15%. Those associations were accentuated among patients not in glycemic control: change from some to no adherence was associated with an HbA1c increase of 0.63% and change from some to full adherence was associated with an HbA1c decrease of 0.40%. Conclusions. Initial adherence to newly prescribed metformin therapy produces substantial HbA1c reduction. Among those with modest adherence but suboptimal glycemic control, the difference between moving to full adherence versus nonadherence results in lower HbA1c of one percentage point.

Urinary albumin excretion with sitagliptin compared to sulfonylurea as add on to metformin in type 2 diabetes patients with albuminuria: A real-world evidence study.

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.

Adherence to dipeptidyl peptidase-4 inhibitor therapy among type 2 diabetes patients with employer-sponsored health insurance in Japan.

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 <90-day gap between refills. Patient baseline characteristics were explored as potential predictors of DPP-4i discontinuation and adherence in multivariable models. RESULTS: The final sample contained 2,874 monotherapy and 3,016 dual therapy patients. The mean age was approximately 51 years, and 75% were men. The mean proportion of days covered was 76.6% among monotherapy patients and 82.5% among dual therapy patients, with 67.2% of monotherapy and 74.4% of dual therapy patients classified as adherent. At 12 months, 72.2% of monotherapy and 79.2% of dual therapy patients were persistent. In adjusted models, younger age and having fewer concomitant medications were significantly associated with lower adherence and higher discontinuation, in both treatment groups. CONCLUSIONS: Those under the age of 45 years, and those with fewer concomitant medications were less likely to be adherent and persistent, and more likely to discontinue DPP-4i therapy.

Use of Add-on Treatment to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A U.S. Database Study.

BACKGROUND: 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. OBJECTIVE: To evaluate treatment addition for metformin monotherapy users with suboptimal glycemic control and associated factors. METHODS: A retrospective health care claims study identified 7,109 subjects aged 18 to 89 years, treated for type 2 diabetes with an HbA1c > 7% 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. RESULTS: 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% versus > 7%-8% (OR = 2.31, 95% CI = 2.00-2.67); > 9%-10% versus > 7%-8% (OR = 2.88, 95% CI = 2.32-3.58); and > 10% versus > 7%-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. CONCLUSIONS: 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.