Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Successful Market Coverage Strategy- the Path to Retailers : A Study of the Bulgarian Office Products Retailers

Recently many academic researchers have become interested in the retailers as part of the distribution channel. Today retailers have grown so influential, that sometimes they take the functions of the wholesalers. The retailers constitute the road for manufacturers to the end market. Therefore, knowing retailers’ decision variables and assortment considerations is important for manufacturers when designing upon their marketing strategies. The study is conducted with focus on the Bulgarian office products retail industry. The purpose of the present research is to get a deeper understanding of retailers’ assortment criteria and analyze how the latter relates to market coverage strategy. Retailers’ assortment criteria concern decision variables such as profitability and sales, economic conditions, assortment considerations, consumer evaluation, marketing, supplier characteristics, competitive considerations, distributive factors, tactical considerations. The meaning underlying the assortment criteria is applied for arguing what market coverage strategy would best serve the Bulgarian retailers of office products. The research is performed employing qualitative method, in particular, in-depth semi- structured interviews providing the possibility for a broad discussion. The results of the study revealed some common patterns pertaining to four main inductive categories including product, brand positioning, promotion and distributor’s attributes. The patterns corresponding to the categories were further related to the market coverage strategy alternatives, namely, intensive, selective and exclusive coverage strategy. The results of the study showed that the nature of the product requires considerable effort from the distributors’ side to persuade the retailers to become customers who are aware of the products’ attributes. In other words, the nature of the office products calls for certain knowledge and skills that the retailers have to gain in order to be successful as traders to their own customers and that can be best achieved if selective coverage strategy is employed. Further, the results of the study reveal that manufacturers of office products that would like to position their brands on the high quality dimension should pursue highly selective distribution as this creates a superior product image. The results of the study also show that greater selectivity is suitable since it guarantees that the retailers’ requirements related to promotion are met. Last, the authors suggest that higher degrees of selectivity is the most appropriate way for a manufacturer to follow the performance of distributors and thus, to ensure that the desired by the retailers distributor’s attributes are present

Bulgarian General Practitioners’ Communication Styles about Child Vaccinations, Mainly Focused on Parental Decision Making in the Context of a Mandatory Immunization Schedule

The communication practices of general practitioners in relation with vaccines have not been a topic of wide scientific interest. In this article, we outline them in the context of Bulgaria. A representative, cross-sectional, quantitative, face-to-face survey was conducted among 358 Bulgarian general practitioners in 2022 using simple random sampling. We conducted an exploratory factor analysis using questions about the role of the GPs, which measure models of communication. Based on the factor analysis, we distinguished four communication styles. They were called: active communicator, restrictive communicator, informing communicator, and strained communicator. One-way ANOVA and the T-test were carried out to explore the connections between factor scores (communication styles) and other variables. One of the most important results in the study was that the informing physician (emphasizing the choice of the parents) was the most common model in Bulgaria. This is somewhat contradictory, because of the mandatory status of most vaccines. We found connections between the communication styles and other variables—such as the type of settlement, having a hesitant parent in the practice, recommendations of non-mandatory vaccines, and experience with vaccine-preventable diseases. On the basis of the factor analysis and analysis of relationships with other variables, we reached the conclusion that in Bulgaria, hesitant parents are not sufficiently involved in active, effective communication about vaccines by GPs