Randomised controlled trialindependent cross-checkabstract only checked★ key study I-ODD-07 in-depth review

Semaglutide heart safety trial

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Overview

Marso SP et al.. N Engl J Med 2016 · PMID 27633186 · DOI 10.1056/NEJMoa1607141

Fewer heart attacks/strokes, but more diabetic eye complications and stomach side effects.

Does the study support the specific claim? No · Methodological quality: high

Study explained simply

What did the researchers want to find out?: CV safety of semaglutide
How was the study done?: Double-blind placebo-controlled RCT (SUSTAIN-6)
How many people, animals or samples were studied?: 3,297; Type 2 diabetes, 83% with CVD/CKD
What was actually found?: Primary 6.
How large was the observed effect?: HR 0.74
What do the results mean in everyday life?: This drug class protects heart and/or kidneys in the studied patients.
What are the study's limitations?: Industry funded; Selected high-risk population
What does it say about Elawady's specific claim?: Contradicts C-ODD-06; GI and retinopathy harms relevant to C-ODD-05.
Do the results apply to Germany and Europe?: Multinational trial including European sites or directly applicable to EU practice.
What can explicitly not be concluded from this study?: Benefit in low-risk people; absence of side effects.

CV safety of semaglutide

Study design: Randomised controlled trial – Double-blind placebo-controlled RCT (SUSTAIN-6)
Population: Type 2 diabetes, 83% with CVD/CKD
Country: International
Period: 104 weeks
Sample size: 3,297
Inclusion and exclusion criteria: As described in the abstract; details not available in abstract.

Results: Primary 6.6% vs 8.9% (HR 0.74, 0.58-0.95); stroke HR 0.61; retinopathy complications higher (HR 1.76, 1.11-2.78); more GI discontinuations.
Absolute risks: Primary -2.3 percentage points.
Authors' conclusion: Lower CV events; noninferiority confirmed.

Clinically relevant reductions with adequate precision.

Contradicts C-ODD-06; GI and retinopathy harms relevant to C-ODD-05.

Adverse effects listed in archive studies.

Multinational trial including European sites or directly applicable to EU practice.

High-quality evidence of benefit.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	high
Risk of bias	low
Precision of results	high
Directness	direct
Reproducibility	replicated
Consistency with the overall evidence	consistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

None beyond those stated.