27 research outputs found

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

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    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

    Water Pollution: A Menace All Around

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    Carpal tunnel syndrome: Ultrasonographic evaluation of median nerve diameter

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    Background: Carpal tunnel syndrome is the most frequently encountered peripheral compression neuropathy. Diagnosis of carpal tunnel syndrome involves physical examination, nerve conduction studies and electromyography. Ultrasonography (USG) examination of median nerve in carpal tunnel has been proposed as a useful alternative in diagnosing carpal tunnel syndrome. Materials and Methods: Patients were selected from those undergoing diagnostic workup for carpal tunnel syndrome in pre-treatment period. USG was performed using 11 MHz linear array transducer. Cross-sectional area at each level, major and minor axes were measured. Results: In our study, the mean median nerve cross sectional area at proximal part of carpal tunnel by direct method was 12.33 mm 2 in patients and 7.33 mm 2 in controls. By indirect method it was 12.01 mm 2 and 6.633 mm 2 in cases and controls respectively. In this study we found significant difference in flattening ratio between cases and controls. The mean flattening ratio in distal part of tunnel (at the level of hook of hamate) was 2.97 and 2.38 in cases and controls respectively. The sensitivity and specificity for cut-off value ≥2.5 was 76% and 63% respectively. Conclusion: We found that best discriminatory criterion for diagnosis of carpal tunnel syndrome are median nerve cross sectional area in the proximal part of carpal tunnel ≥9 mm 2 (Direct method) and ≥8.5 mm 2 (Indirect method). With our experience, we found it easier to evaluate the median nerve in the carpal tunnel in the disto proximal sequence by identifying the flexor pollicislongus (FPL) first with dynamic evaluation. As the percentage of space occupying lesions causing symptoms in unilateral (atypical) carpal tunnel syndrome is 35%, we highly recommend this pre-operative investigation in all carpal tunnel syndrome patients
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