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November 10, 2003Archives of Internal Medicine

Comparison of Oral vs Intravenous Phytonadione (Vitamin K1) in Patients With Excessive Anticoagulation

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Why the study?

Does oral phytonadione correct excessive anticoagulation as effectively and safely as intravenous phytonadione in patients without major bleeding?

Population

61 consecutive patients presenting with excessive anticoagulation without major bleeding.

Comparison

Oral phytonadione vs Intravenous phytonadione

Design

RCT, Randomized

Follow-up

24 hours

Key result

Oral phytonadione achieved similar mean INR values at 24 hours compared to intravenous administration (2.6 vs 2.9) for excessive anticoagulation, despite a slower initial response.

Authors

ALAharon LubetskyHYHagith YonathDODavid Olchovsky

Discussion

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Overview

Supports oral phytonadione as alternative to IV for excessive anticoagulation without bleeding; confirms similar 24-hour INR correction in RCT.

Key Points

  • To compare the efficacy and safety of intravenous versus oral phytonadione (vitamin K1) in patients presenting with excessive anticoagulation without major bleeding.
  • Prospective randomized controlled trial evaluating 66 episodes of excessive anticoagulation without major bleeding across two baseline international normalized ratio (INR) tiers: 6 to 10 (n=44 patients, 47 episodes) and >10 (n=17 patients, 19 episodes).
  • Patients with baseline INR 6 to 10 received intravenous (0.5 mg) or oral (2.5 mg) phytonadione, while those with INR >10 received intravenous (1.0 mg) or oral (5.0 mg) phytonadione, with sequential tracking of INR correction.
  • For baseline INR 6 to 10, intravenous phytonadione achieved therapeutic INR (2.0–4.0) more rapidly at 6 hours (11/24 vs 0/23) and 12 hours (16/24 vs 8/23), but mean ± SD INR values equalized by 24 hours (2.9 ± 0.8 vs 2.6 ± 0.8).
  • Patients receiving intravenous phytonadione experienced higher rates of overcorrection (INR <2.0) than those receiving oral dosing (7/24 vs 2/23) in the INR 6 to 10 cohort, while efficacy and safety were comparable between routes for baseline INR >10.

Study Design

Type

RCT (n=61)

Randomization

randomized

Structured PICO

Does oral phytonadione correct excessive anticoagulation as effectively and safely as intravenous phytonadione in patients without major bleeding?

P
Population
61 consecutive patients (66 episodes) presenting with excessive anticoagulation without major bleeding (n=44 with baseline INR 6-10; n=17 with baseline INR >10).
I
Intervention
Oral phytonadione (2.5 mg for baseline INR 6-10, 5 mg for baseline INR >10)
C
Comparator
Intravenous phytonadione (0.5 mg for baseline INR 6-10, 1 mg for baseline INR >10)
O
Outcome
Sequential INR changes and the proportion of patients achieving therapeutic range (INR 2-4), overcorrection (INR<2.0), or undercorrection (INR>4.0)surrogate

Main Result

Absolute Event Rate: 34.8% vs 66.7%

Oral phytonadione is an effective and safe alternative to intravenous administration for correcting excessive anticoagulation without bleeding, achieving similar INR levels at 24 hours with potentially less overcorrection.

Cite This Study

Lubetsky et al. (2003) conducted an RCT in Excessive anticoagulation without bleeding (n=61). Oral phytonadione vs. Intravenous phytonadione (0.5 mg or 1 mg) was evaluated on Proportion of patients achieving therapeutic range (INR 2-4) at 12 hours (baseline INR 6-10). Oral phytonadione achieved similar mean INR values at 24 hours compared to intravenous administration (2.6 vs 2.9) for excessive anticoagulation, despite a slower initial response.

synapsesocial.com/papers/6a0a584597b2cd656859160ahttps://doi.org/10.1001/archinte.163.20.2469
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