Incidence of diabetic ketoacidosis and its trends in patients with type 1 diabetes mellitus identified using a U.S. claims database, 2007-2019.

Diabetic ketoacidosis (DKA) is a common complication of type 1 diabetes mellitus (T1DM). We found that the incidence of DKA was 55.5 per 1000 person-years in US commercially insured patients with T1DM; age-sex-standardized incidence decreased at an average annual rate of 6.1% in 2018-2019 after a steady increase since 2011.

Exenatide is non-inferior to insulin in reducing HbA1c: an integrated analysis of 1423 patients with type 2 diabetes.

OBJECTIVE: The objective was to compare the treatment effects between exenatide and insulin, which are 2 injectable peptide hormone-based therapy options for the treatment of type 2 diabetes mellitus. METHODS: Data from 4 randomized, open-label, comparator-controlled clinical trials in 1423 patients with type 2 diabetes followed for 16 to 52 weeks were pooled and analyzed. RESULTS: At 26 weeks, glycemic control with exenatide (-1.2% HbA1c) was non-inferior to insulin (-1.1%; exenatide vs insulin; P = 0.09). In a tertile analysis of HbA1c reduction from baseline, exenatide induced similar reductions compared with insulin, with the greatest reductions observed in the tertile with the highest baseline HbA1c (9%-12.7%). Exenatide treatment induced weight loss (-2 kg) and reduced systolic blood pressure (SBP) from baseline (SBP, -4.9 mm Hg, exenatide vs insulin; P < 0.0001). In contrast, insulin treatment increased body weight (1.8 kg) and decreased SBP by -0.4 mm Hg. Overall, about 3-fold more exenatide-treated patients (70%) experienced weight loss compared with those treated with insulin (21%). Occurrence of nocturnal mild-to-moderate hypoglycemia was lower with exenatide (15%) treatment than with insulin (29%; difference, -14; [95% CI, -18, -9.8]). Effects of exenatide on HbA1c and weight were sustained at 52 weeks. CONCLUSION: These findings indicate that exenatide is non-inferior to insulin for glycemic control. Further studies are warranted to explore the effects of exenatide on blood pressure and body weight, and the potential for long-term effects on cardiovascular outcomes.

Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes.

OBJECTIVE: To evaluate whether exenatide administered before breakfast and dinner (BD) or before lunch and dinner (LD) provided similar glycemic control in Latin American patients with type 2 diabetes mellitus (T2DM) who consume a small breakfast. METHODS: In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks). Treatment assignment was determined by a computer-generated random sequence using an interactive response system. Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast. The primary endpoint was HbA(1c) change from baseline to endpoint. Secondary endpoints included fasting serum glucose (FSG) level, 7-point SMBG profile, and safety. Clinicaltrials.gov Identifier: NCT00359879. RESULTS: 377 participants (55% female, age 54 +/- 10 years, weight 82 +/- 15 kg, BMI 31 +/- 4 kg/m(2), HbA(1c) 8.4 +/- 0.9%; mean +/- SD) from Brazil and Mexico were randomized to study treatment. HbA(1c) reduction with exenatide administration before BD was non-inferior to administration before LD (mean difference between (LD-BD) treatments: 0.14%; 95% CI -0.04 to 0.32%, p=0.120). Both treatments resulted in statistically significant HbA(1c) reductions at endpoint (BD -1.2% and LD -1.1%, respectively, p<0.001). In Brazil, the non-inferiority criteria were met for HbA(1c) reduction between treatment arms (-0.12%; CI -0.37 to 0.13%, p=0.344), whereas in Mexico, there was a difference favoring exenatide administration before BD (0.41%; CI 0.16 to 0.66%, p=0.002). At endpoint, there were no statistical significant differences between the BD and LD arms in mean change in FSG (0.50 mmol/L; CI -0.02 to 1.02 mmol/L, p=0.058) and daily mean change in SMBG (0.19 mmol/L; CI -0.17 to 0.54 mmol/L, p=0.295). The rates of symptomatic hypoglycemia (5.2 events/patient-year vs. 6.1 events/patient-year) and nausea (23% vs. 25%), were similar between the BD and LD arms, respectively. A limitation of the study design was that caloric intake of patients and meal times were not monitored. CONCLUSIONS: In T2DM patients who consume a small breakfast, exenatide administration before breakfast or lunch resulted in significant improvement in glycemic control.

Evidence for thyroid hormone as a positive regulator of serum thyrotropin bioactivity.

CONTEXT: The regulation of TSH bioactivity in humans is not completely understood. OBJECTIVE: The aim of the study was to investigate the role of serum thyroid hormones in regulating the bioactivity of TSH. DESIGN: We determined in vitro TSH bioactivity and glycosylation in nine patients (six females and three males, age 41.3 yr) with primary hypothyroidism before and after L-T(4) replacement, in 11 age- and sex-comparable controls (seven females and four males, age 37.6 yr), and in two thyroidectomized patients with TSH-secreting adenomas during and after L-T(4) withdrawal. METHODS: In vitro TSH bioactivity was measured by a sensitive and specific bioassay based on cAMP generation by Chinese hamster ovary cells transfected with human TSH receptor. TSH glycosylation was assessed by concanavalin A lectin and ricin column affinity chromatography. RESULTS: In vitro TSH bioactivity in hypothyroid patients was low as compared with controls (0.48 +/- 0.1 vs. 1.1 +/- 0.2; P = 0.004) and increased during L-T(4) (0.48 +/- 0.1 vs. 0.8 +/- 0.1; P = 0.01). A strong significant correlation (r = +0.80; P = 0.004, Spearman) was observed between the absolute increments of serum TSH bioactivity and T(3) during L-T(4) replacement. The degree of sialylation was elevated in hypothyroid patients before treatment (47 +/- 2.4% vs. 29 +/- 4.3%; P = 0.002) and decreased significantly after L-T(4) (47 +/- 2.4% vs. 33 +/- 4.3%; P = 0.02). The mannose content of serum TSH in hypothyroid patients was similar to controls and did not change during L-T(4). In vitro TSH bioactivity also decreased in patients with TSH-secreting adenomas during L-T(4) withdrawal. CONCLUSION: These data indicate that serum thyroid hormone level is a positive regulator of TSH bioactivity.

Custo da fratura osteoporótica de fêmur no sistema suplementar de saúde brasileiro / Cost of osteoporotic hip fracture in the Brazilian private health care system

OBJETIVO: Estimar custo direto durante hospitalização para fratura osteoporótica de fêmur no sistema privado de saúde brasileiro, pela perspectiva das empresas de planos de saúde. MÉTODOS: Estudo transversal e retrospectivo sobre custos hospitalares em pacientes acima de 50 anos com fratura osteoporótica de fêmur, entre julho 2003 e junho 2004. A amostra estudada foi extraída da base de dados de processamento eletrônico das faturas de pacientes beneficiários de planos de saúde. RESULTADOS: Houve 129.611 pacientes com diagnóstico de osteoporose. A incidência de fratura osteoporótica de fêmur foi 4,99 por cento (mulheres). A média de permanência hospitalar foi 9,21 dias (2,13 dias na UTI). O custo médio total da hospitalização foi de R$ 24.000. O maior componente de custo foi atribuído ao material médico (61 por cento). O impacto econômico da fratura osteoporótica de fêmur foi estimado em R$ 12 milhões. CONCLUSÃO: Os custos do tratamento da fratura osteoporótica de fêmur são consideráveis no sistema privado de saúde brasileiro. Este estudo destaca a minimização de custos para empresas de planos de saúde caso a fratura osteoporótica de fêmur possa ser evitada.

[Cost of osteoporotic hip fracture in the Brazilian private health care system]. / Custo da fratura osteoporótica de fêmur no sistema suplementar de saúde brasileiro.

OBJECTIVE: To assess the direct cost during hospitalization for an osteoporotic hip fracture in Brazilian private health care system, by health plan companies' perspective. METHODS: We conducted a cross-sectional and retrospective study on costs of medical resources in patients above 50 years with an osteoporotic hip fracture, under hospital treatment, between July 2003 and June 2004. The study sample was collected from electronic claims databases of patients enrolled in Brazilian health plans. RESULTS: There were 129,611 patients with osteoporosis diagnosis. The incidence of osteoporotic hip fracture was 4.99% (women). The mean length of hospital stay was 9.21 days (2.13 days in ICU). The total mean cost of hospitalization was R$ 24,000. The largest cost component was attributable to medical device (61%). The economic burden of osteoporotic hip fracture to health plan companies was estimated in R$ 12 million. CONCLUSION: The costs of treating osteoporotic hip fracture are substantial in Brazilian private health care system. This study highlights the savings to health plan companies if an osteoporotic hip fracture can be avoided.