What is the clinical evidence from this study?

Study design: RCT. Population: heart disease at risk for cardiogenic embolism (n=196). Intervention: indobufen vs. placebo. Primary outcome: cerebral ischemic attack (stroke and transient ischemic attack), systemic embolism, pulmonary embolism, and fatal myocardial infarction (RR 0.35, 95% CI 0.14-0.89, p=< 0.05).

What does this research mean for the field?

Indobufen significantly reduces the risk of thromboembolic complications by 65% in patients with heart disease who are at risk for cardiogenic embolism. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study aims to assess the efficacy of indobufen in preventing thromboembolic complications in patients with heart disease.

January 1, 1993Circulation

Indobufen in the prevention of thromboembolic complications in patients with heart disease. A randomized, placebo-controlled, double-blind study.

Q: What are the key findings of this study?

Indobufen significantly reduced the risk of primary embolic events compared to placebo (6.1% vs 17.3%; RR 0.35; 95% CI 0.14-0.89; p<0.05) in patients with heart disease at risk for embolism.

Q: What does this research mean for the field?

Indobufen significantly reduces the risk of thromboembolic complications by 65% in patients with heart disease who are at risk for cardiogenic embolism. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

This study aims to assess the efficacy of indobufen in preventing thromboembolic complications in patients with heart disease.

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Key result

Indobufen significantly reduced the risk of primary embolic events compared to placebo (6.1% vs 17.3%; RR 0.35; 95% CI 0.14-0.89; p<0.05) in patients with heart disease at risk for embolism.

Why the study?

Does indobufen reduce the risk of embolic events in patients with heart disease at risk for cardiogenic embolism?

Population

196 patients with heart disease and at risk for cardiogenic embolism

Comparison

Indobufen 100 mg b.i.d. vs Placebo

Design

RCT, randomly assigned, double-blind

Follow-up

median 854 days (indobufen) and 865 days (placebo)

Authors

GFG FornaroAzienda Ospedaliera Citta' della Salute e della Scienza di Torino PRP RossiUniversity of Rome Tor Vergata PMP G ManticaNovamont (Italy)

Discussion

Member takes

Implication

Indobufen warrants consideration for embolic prevention in heart disease; confirms benefit versus placebo in this RCT.

Key Points

This study aims to assess the efficacy of indobufen in preventing thromboembolic complications in patients with heart disease.
Randomized, double-blind, placebo-controlled design
196 patients with heart disease, including 90 with atrial fibrillation
Patients received either indobufen (100 mg b.i.d.) or placebo, with evaluations every 3 months for approximately 854-865 days.
Indobufen group experienced a 6.1% primary event rate compared to 17.3% in the placebo group (p < 0.05)
Indobufen reduced the risk of primary events by 65% (relative risk 0.35; 95% CI 0.14-0.89)
Adverse reactions in 9.2% of indobufen patients, primarily gastrointestinal or hemostatic issues.

Study Design

Type

RCT (n=196)

Blinding

double-blind

Randomization

randomly assigned

Structured PICO

Does indobufen reduce the risk of embolic events in patients with heart disease at risk for cardiogenic embolism?

Population

196 patients with heart disease and at risk for cardiogenic embolism (90 with atrial fibrillation and 106 in sinus rhythm)

Intervention

Indobufen 100 mg b.i.d.

Comparator

Placebo

Outcome

Composite of cerebral ischemic attack (stroke and transient ischemic attack), systemic embolism, pulmonary embolism, and fatal myocardial infarctioncomposite

Main Result

Effect estimate: RR 0.35 (95% CI 0.14-0.89)

Absolute Event Rate: 6.1% vs 17.3%

p-value: p=< 0.05

Indobufen significantly reduces the risk of thromboembolic events in patients with heart disease at risk for cardiogenic embolism compared to placebo.

Cite This Study

Fornaro et al. (1993) conducted an RCT in heart disease at risk for cardiogenic embolism (n=196). indobufen vs. placebo was evaluated on cerebral ischemic attack (stroke and transient ischemic attack), systemic embolism, pulmonary embolism, and fatal myocardial infarction (RR 0.35, 95% CI 0.14-0.89, p=< 0.05). Indobufen significantly reduced the risk of primary embolic events compared to placebo (6.1% vs 17.3%; RR 0.35; 95% CI 0.14-0.89; p<0.05) in patients with heart disease at risk for embolism.

synapsesocial.com/papers/6a0848281e8b9db648ddfd74 https://doi.org/10.1161/01.cir.87.1.162

Topics

Dual antiplatelet therapy

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Indobufen in the prevention of thromboembolic complications in patients with heart disease. A randomized, placebo-controlled, double-blind study.

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Indobufen in the prevention of thromboembolic complications in patients with heart disease. A randomized, placebo-controlled, double-blind study.

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider