3 research outputs found
The Vehicle, 1967, Vol. 9 no. 2
Table of Contents
Commentarypage 3
SketchAnn Butlerpage 4
I Take A Long-Out-of-Use BookAnthony Griggspage 5
The Leaf StemDianne Cochranpage 6
The Four MusketeersJim Courterpage 7
Status QuoAdrian Beardpage 7
SketchAnn Butlerpage 8
NocturneMike Baldwinpage 9
Oh Impatient HeartK. H. Shariffpage 9
Letter to a FianceeMaurice Snivelypage 10
Listen!Bonnie Blackpage 11
The Water\u27s EdgeStephen W. Gibbspage 12
TogetherDavid Reifpage 13
SketchAnn Butlerpage 14
Evening TimeSharon Nelsonpage 15
Japanese HaikuBev Hensonpage 15
Of Love and WarBruce Czeluscinskipage 16
Always AloneKib Voorheespage 17
the end of loveJackie Bratcherpage 18
1-20-66Sharon Nelsonpage 19
Blessed Are WeBonnie Marie Beckpage 19
The Time To LiveNeil Tracypage 20
Imminent AwakeningHelen Coxpage 21
The Dead Panther LairMolly J. Evanspage 21
Good SheepMike Tilfordpage 22
The Flame of LifeJacki Jacquespage 23
Then Arrives The Day Of DarkMolly J. Evanspage 23
Sketch: To love is to rememberAnn Butlerpage 24
Hidden RiversCharles J. Mertzpage 25
SilenceLinda G. Phillipspage 26
December - 1964Bonnie Blackpage 26
LoveHazel Thomaspage 27
To Praise A Good Man Neil Tracypage 28
Definitions \u2767Sharon Nelsonpage 29
To Wish Is a CrimeBonnie Marie Beckpage 30
College MadhatterMaurice Snivelypage 31
No. 8Sharon Nelsonpage 32
The Open FireSusan Williamspage 32https://thekeep.eiu.edu/vehicle/1017/thumbnail.jp
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
The Vehicle, 1967, Vol. 9 no. 2
Table of Contents
Commentarypage 3
SketchAnn Butlerpage 4
I Take A Long-Out-of-Use BookAnthony Griggspage 5
The Leaf StemDianne Cochranpage 6
The Four MusketeersJim Courterpage 7
Status QuoAdrian Beardpage 7
SketchAnn Butlerpage 8
NocturneMike Baldwinpage 9
Oh Impatient HeartK. H. Shariffpage 9
Letter to a FianceeMaurice Snivelypage 10
Listen!Bonnie Blackpage 11
The Water\u27s EdgeStephen W. Gibbspage 12
TogetherDavid Reifpage 13
SketchAnn Butlerpage 14
Evening TimeSharon Nelsonpage 15
Japanese HaikuBev Hensonpage 15
Of Love and WarBruce Czeluscinskipage 16
Always AloneKib Voorheespage 17
the end of loveJackie Bratcherpage 18
1-20-66Sharon Nelsonpage 19
Blessed Are WeBonnie Marie Beckpage 19
The Time To LiveNeil Tracypage 20
Imminent AwakeningHelen Coxpage 21
The Dead Panther LairMolly J. Evanspage 21
Good SheepMike Tilfordpage 22
The Flame of LifeJacki Jacquespage 23
Then Arrives The Day Of DarkMolly J. Evanspage 23
Sketch: To love is to rememberAnn Butlerpage 24
Hidden RiversCharles J. Mertzpage 25
SilenceLinda G. Phillipspage 26
December - 1964Bonnie Blackpage 26
LoveHazel Thomaspage 27
To Praise A Good Man Neil Tracypage 28
Definitions \u2767Sharon Nelsonpage 29
To Wish Is a CrimeBonnie Marie Beckpage 30
College MadhatterMaurice Snivelypage 31
No. 8Sharon Nelsonpage 32
The Open FireSusan Williamspage 32https://thekeep.eiu.edu/vehicle/1017/thumbnail.jp