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

Communautés culturelles et ethniques et réseaux de communications

Il ne s’est pratiquement construit qu’un seul grand édifice public en Haïti depuis un quart de siècle, c’est celui imposant de la TELECO, la compagnie de téléphone, en plein quartier résidentiel au Piémont du Canapé-Vert. Il n’y a pratiquement qu’une seule administration à bien marcher en Haïti, beau temps mauvais temps, embargo ou pas, tout en rapportant beaucoup d’argent et de devises, c’est la TELECO. Quand vient le temps d’atterrir à Port-au-Prince, du hublot, on voit la masse blanche de ..

Rules, Risks, and Rifts in the Transition to Democracy in Haiti

As the title of this introduction implies, there are few traces of hope and optimism to be found in Haiti\u27s current situation. If the unavoidable problems of rural communities in a nation of peasants such as Haiti are left unaddressed, and if the nation continues to rely on the standards of the old police state as a model for the new national police, Haiti\u27s transition toward democracy will be off to a bad start. There must be the immediate desire to straighten out this tangled web if Haiti is not to miss this window of opportunity. This Article analyzes this transition, charting the narrow path to democracy and development from which Haiti may still benefit

Chronique

Picavet C.-G., Anglade Joseph. Chronique. In: Annales du Midi : revue archéologique, historique et philologique de la France méridionale, Tome 38, N°151-152, 1926. pp. 473-484

Chronique

Picavet C.-G., Anglade Joseph. Chronique. In: Annales du Midi : revue archéologique, historique et philologique de la France méridionale, Tome 38, N°151-152, 1926. pp. 473-484