What is the clinical evidence from this study?

Study design: RCT. Population: adriamycin-induced cardiomyopathy (n=54). Intervention: carvedilol vs. control. Primary outcome: left ventricular ejection fraction (null, 95% CI null, p=0.003).

November 1, 2016Open Access

Preventive role of carvedilol in adriamycin-induced cardiomyopathy

Q: What does this research mean for the field?

Carvedilol maintains left ventricular ejection fraction at 63.88%, while control significantly decreased to 60.82% (P=0.003) in patients receiving adriamycin chemotherapy. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Key Result

Carvedilol maintained left ventricular ejection fraction at 63.88%, while control significantly decreased to 60.82% (P=0.003) in patients receiving adriamycin chemotherapy.

Study Design

Type

RCT (n=54)

Blinding

null

Randomization

null

Multicenter

Structured PICO

Does prophylactic carvedilol prevent adriamycin-induced left ventricular systolic dysfunction in patients with haematological malignancies?

Population

54 newly diagnosed patients with haematological malignancy (lymphoreticular malignancy) planned for adriamycin (ADR) chemotherapy, mean age 43.89 (carvedilol) and 38.74 (control), predominantly male. Key exclusions: prior chemotherapy or thoracic radiotherapy, coronary arterial disease, established dilated or restrictive cardiomyopathy, moderate-to-severe valvular dysfunction, pericardial effusion, diabetes mellitus, renal dysfunction, and thyroid disorder.

Intervention

Carvedilol 12.5 mg oral once daily, started before chemotherapy and maintained for 6 months during chemotherapy.

Comparator

Control group receiving standard chemotherapy without carvedilol or placebo.

Outcome

Systolic functions (left ventricular ejection fraction) and death at 6 months follow-up.surrogate

Prophylactic use of low-dose carvedilol preserves left ventricular systolic function in patients receiving anthracycline chemotherapy.

Main Result

Effect estimate: null (95% CI null)

Absolute Event Rate: 63.88% vs 60.82%

p-value: p=0.003

Limitations

Limited sample size
Not placebo controlled
Different baseline ejection fractions between groups

Abstract

Background P < 0.05). Interpretation & conclusions: Prophylactic use of carvedilol in patients receiving anthracycline protected systolic functions of the left ventricle. Carvedilol can be a potential drug which can ameliorate ADR-induced CMP.

KI fragen

Bookmark

View Full Paper