Kristina S. Boye

Diabetes in Japan: a review of disease burden and approaches to treatment

In recent years there has been rapid growth in diabetes in Japan which now is one of the nations most affected by the worldwide diabetes epidemic. Diabetes has been identified as a healthcare priority by the Ministry of Health, Labour and Welfare (MHLW). Type 1 diabetes is rare in Japan, and type 2 diabetes predominates in both adults and children. The growth in diabetes is due to increases in the number of people with type 2 diabetes associated with increased longevity and lifestyle changes. Approximately 13.5% of the Japanese population now has either type 2 diabetes or impaired glucose tolerance. This high prevalence of type 2 diabetes is associated with a significant economic burden, with diabetes accounting for up to 6% of the total healthcare budget. The costs of diabetes are increased in patients with co‐morbidities such as hypertension and hyperlipidaemia and in patients who develop complications, of which retinopathy has the highest cost. Costs increase with increasing number of complications. Current guidelines from the Japan Diabetes Society (JDS) recommend a target HbA1c of 6.5% for glycaemic control. This is achieved in approximately one third of patients with type 2 diabetes, and Japanese patients typically have lower HbA1c than patients in Western countries (e.g. US, UK). Japanese patients with type 2 diabetes have better adherence with diet and exercise recommendations than their peers in Western countries. Sulfonylureas have been the most widely prescribed first‐line treatment for type 2 diabetes, although there is increasing use of combination therapy and of insulin. Copyright

Treatment approach and HbA1c control among US adults with type 2 diabetes: NHANES 1999-2004

ABSTRACT Objective: To examine the distribution of diabetic medications among adults with type 2 diabetes, and the association between glucose control and treatment approach in the US population. Methods: Interview and prescription medication data from the 1999–2004 National Health and Nutrition Examination Survey (NHANES) were used to determine the treatment approach for US adults with type 2 diabetes. Mean glycosylated hemoglobin (HbA1c) and the proportion of adults meeting recommended guidelines for glucose control were estimated for each treatment approach. The most important study limitation was that participants were not asked what type of diabetes they had. Among adults with diabetes, a classification algorithm was used to identify those with type 2 diabetes. Results: During 1999–2004, approximately 60% of adults with type 2 diabetes used oral agents only to manage their diabetes. The distribution of oral treatment therapies changed over time (p < 0.01); the most prevalent treatment shifted from sulfonylurea monotherapy in 1999–2000 (23.0%) to any oral agent regimen containing thiazolidinedione (TZD) in 2003–2004 (21.4%). Overall, only 52.2% of adults with type 2 diabetes met the American Diabetes Association (ADA) goal for HbA1c control (<7.0%) during 1999–2004. Across oral agent treatment categories, the proportion with HbA1c controlled at the 7.0 level was significantly lower (p < 0.01) for those on triple therapy (31.9%) (TZD, sulfonylurea, and metformin), than those on metformin alone (62.2%), likely reflecting a progressive treatment approach of prescribing additional medications for those with uncontrolled HbA1c levels. Conclusions: Use of multiple oral agents among adults with type 2 diabetes has increased (sulfonylurea and metformin, p = 0.03, triple therapy, p = 0.02). However, nearly half of adults with type 2 diabetes have HbA1c levels above ADA guidelines for control, indicating that available treatments could be used more optimally, and new diabetic agents may be needed.

Improved treatment satisfaction and weight‐related quality of life with exenatide once weekly or twice daily

Aims  To assess treatment satisfaction and weight‐related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID).

Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes.

BackgroundPatient-reported measures can be used to examine whether drug differences other than clinical efficacy have an impact on outcomes that may be important to patients. Although exenatide and insulin glargine appear to have similar efficacy for treatment of type 2 diabetes, there are several differences between the two treatments that could influence outcomes from the patients perspective. The purpose of the current study was to examine whether the two drugs were comparable as assessed by patient-reported outcomes using data from a clinical trial in which these injectable medications were added to pre-existing oral treatment regimens.MethodsPatients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial. At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist – Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Change from baseline to endpoint was analyzed within each treatment group. Group differences were examined with General linear models (GLMs), controlling for country and baseline scores.ResultsA total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine). The sample was primarily Caucasian (79.6%), with slightly more men (55.2%) than women, and with a mean age of 58.5 years. Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale. GLMs found no statistically significant differences between groups in change on the health outcomes instruments.ConclusionThis analysis found that both exenatide and insulin glargine were associated with significant improvements in patient-reported outcomes when added to oral medications among patients with type 2 diabetes. Despite an additional daily injection and a higher rate of gastrointestinal adverse events, treatment satisfaction in the exenatide group was comparable to that of the glargine group, possibly because of weight reduction observed in patients treated with exenatide.

Direct medical costs for type 2 diabetes mellitus complications in the US commercial payer setting: a resource for economic research.

BackgroundMedical complications are the key drivers of the direct medical costs of treating patients with type 2 diabetes mellitus. However, the published literature shows great variability across studies in the number and type of sources from which these costs for diabetes are obtained.ObjectiveTo provide to researchers a set of costs for type 2 diabetes complications, originally developed for input into an established diabetes model, that are empirically based, clearly and consistently defined and applicable to a large segment of managed care patients in the US.MethodsPatients with 1 of 24 diabetes-related complications between 1 January 2003 and 31 December 2004 and with evidence of type 2 diabetes were identified using a nationally representative US commercial insurance claims database. Therapy utilization and complication cost data were extracted for all patients for the 12 months following the first identified complication; data for months 13–24 were obtained for a subset of patients with at least 24 months of follow-up enrolment. Medical costs included both the amounts charged by medical providers and the health plan contracted allowed amounts. Costs were expressed as

Exenatide versus insulin glargine in patients with type 2 diabetes in the UK : a model of long-term clinical and cost outcomes

US, year 2007 values.ResultsA total of 44021 patients with a minimum of 12 months of continuous follow-up enrolment were identified, with a mean age of 56 years; a subset of 32991 patients with at least 24 months of continuous health-plan enrolment was also identified. Among the aggregate sample, 74% of patients were receiving oral antidiabetics, 26% were receiving insulin, 43% were receiving ACE inhibitors and 50% were receiving antihyperlipidaemics/HMG-CoA reductase inhibitors (statins) during the first 12 months following the index complication. The majority of patients had at least one physician office visit (99.8%), laboratory diagnostic test (96.2%) and other outpatient visit (97.5%). Six complications (angina pectoris, heart failure, peripheral vascular disease, renal disease, nonproliferative retinopathy and neuropathy) had a prevalence of at least 10%. Allowed amounts for most complications were 30–45% of charges. Myocardial infarction, heart failure and renal disease had the greatest fiscal impact because of the total number of patients experiencing them (7.2%, 14.0% and 11.0%, respectively) and their associated costs; 12-month mean allowed amounts were

Validation of two generic patient-reported outcome measures in patients with type 2 diabetes

US14853,

Health utility values associated with diabetic retinopathy

US11257 and

Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States

US13876, respectively, and 12-month mean charged amounts were

A network meta-analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo

US41695,