Abstract Context Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence. Objective SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population. Design/setting The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide. Intervention Once-weekly semaglutide was prescribed at the physicians’ discretion. Main outcomes The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia. Results Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were –1.0%point (–10.9 mmol/mol; P <0.0001) and –4.5 kg (–4.2%; P <0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified. Conclusions In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. These results support the use of once-weekly semaglutide in routine clinical practice in adult patients with type 2 diabetes in Germany.

This article reviews the efficacy and safety data of tirzepatide, a once-weekly, novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 (GLP-1) receptor agonist approved in the United States, the European Union, and other regions for the treatment of type 2 diabetes. All doses of tirzepatide demonstrated superiority in reducing A1C and body weight from baseline versus placebo or active comparators. The safety profile of tirzepatide was consistent with that of the GLP-1 receptor agonist class, with mild to moderate and transient gastrointestinal side effects being the most common adverse events. With clinically and statistically significant reductions in A1C and body weight without increased risk of hypoglycemia in various populations, tirzepatide has demonstrated potential as a first-in-class treatment option for many people with type 2 diabetes.

Objectives: Herpes zoster (HZ) mainly affects elderly people and immunocompromised individuals. HZ is usually characterized by a unilateral painful skin rash. Its most common complication, postherpetic neuralgia (PHN), may cause chronic debilitating pain. This study aimed to estimate the HZ incidence in individuals aged >= 50 years in Germany, the proportion of PHN and the economic burden. Methods: From 2010 to 2014, HZ patients were recruited when consulting physicians in physician networks covering about 157,000 persons aged >= 50 years. PHN was defined as "worst pain" rated >= 3 on the zoster brief pain inventory persisting or appearing over 90 days after rash onset. Costs were calculated based on medical resource utilization and lost working time. Results: HZ incidence was estimated as 6.7/1000 person-years, increasing with age to 9.4/1000 in >= 80 year-olds. Among 513 HZ patients enrolled, the proportion of PHN was 11.9%, rising with age to 14.3% in HZ patients >= 80 years. Estimated total cost per HZ patient was (sic) 156 from the healthcare system perspective and (sic) 311 from the societal perspective. Conclusions: The study confirmed previous findings that HZ causes a substantial clinical and economic burden in older German adults. It also confirmed the age-related increasing risk of HZ and PHN. (C) 2018 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd on behalf of The British Infection Association.

Herpes zoster (HZ) is a painful dermatomal rash caused by reactivation of latent varicella zoster virus surviving in the patient’s sensory ganglia after a previous episode of varicella. The incidence of HZ increases markedly with age as does the proportion of HZ patients who develop postherpetic neuralgia (PHN) with often severe and debilitating pain persisting for months and even years.

To evaluate the impact of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) on the disease costs and quality of life (QoL) of adults ≥50 years of age in Germany. This prospective, cohort study used physician network covering three geographical areas (etrack number: 113206). Health-related QoL data were collected using the EuroQoL 5D (EQ-5D) and Zoster Brief Pain Inventory (ZBPI) questionnaires. PHN was defined as a score ≥3 in the ZBPI worst pain item appearing or persisting ≥90 days after HZ rash onset day. Data on resource utilization were gathered applying the official price and tariffs for Germany in 2014. 513 subjects were included in the analysis. 507 completed at least one evaluable QoL assessment. The mean age was 67.8 (Standard Deviation: 10.35) years and 63% were female. The completion rates of the QoL questionnaires were ≥85% at all time points up to day 90. The HZ diagnosis occurred approximately 4 days after rash onset. Mean ZBPI worst pain scores was 5.1 in all HZ subjects at day 0 and 4.4 in PHN subjects at day 90. The estimated EQ-5D disutility for the first 30 days was 0.148. PHN was experienced in 61 patients (11%); median time to PHN resolution was 276 days. Significant PHN predictors included the EQ-5D anxiety scores and Visual Analog Score (VAS) health state. HZ was accompanied by an increased use of healthcare resources. On average, 1.25 General Practitioner (GP) visits per patient were recorded (1.04 visits were chargeable to sickness funds). 91.6% of patients received ≥1 GP prescription, the mean drug cost per patient totaled €54.89 for sickness funds and €14.05 for out of pocket payments. HZ is associated with impaired QoL and increased health care resources use indicating a disease burden for the patient and health care system.