Analysis of Risk Factors for Bleeding in Patients with Cardiovascular Disease Undergoing Warfarin Treatment at Rsud Kabupaten Tangerang

Q: What are the key findings of this study?

Herb use (aOR 25.33, p<0.001) and hypofibrinogenemia (aOR 19.10, p<0.001) were independently associated with increased bleeding risk in warfarin-treated cardiovascular patients.

Q: What is the clinical evidence from this study?

Study design: Case-Control. Population: Cardiovascular disease undergoing warfarin treatment (n=132). Intervention: Herb use vs. No herb use. Primary outcome: Hospitalization with bleeding events (OR 25.33, 95% CI 3.60-185.42, p=<0.001).

Q: What does this research mean for the field?

Concomitant herb use and hypofibrinogenemia are strong independent risk factors for bleeding complications in cardiovascular disease patients receiving warfarin therapy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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

To identify significant risk factors and evaluate their potential interaction regarding bleeding incidence among cardiovascular disease patients receiving warfarin therapy.

Muhamad Yqbal; Dian Ratih; M. Iqbal Julian R.P.P; Siti Elkana Nauli

doi:10.25077/jsfk.13.02.251-260.2026

October 3, 2026Jurnal Sains Farmasi & KlinisOpen Access

Analysis of Risk Factors for Bleeding in Patients with Cardiovascular Disease Undergoing Warfarin Treatment at Rsud Kabupaten Tangerang

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Key result

Herb use is linked to ~25.3-fold higher bleeding risk in warfarin-treated cardiovascular patients.

OR 25.33
95% CI 3.60-185.42
P<0.001
n=132

Why the study?

Although bleeding complications are a major contributor to hospitalization among cardiovascular patients on warfarin therapy, the causative risk factors and their potential interactions remained incompletely characterized.

Do concomitant herbal medicine use and hypofibrinogenemia increase the risk of hospitalization with bleeding events in cardiovascular disease patients undergoing warfarin therapy?

Key Points

To identify significant risk factors and evaluate their potential interaction regarding bleeding incidence among cardiovascular disease patients receiving warfarin therapy.
Retrospective case-control study of 132 cardiovascular disease patients on warfarin hospitalized between January 2023 and December 2024 at RSUD Kabupaten Tangerang (44 bleeding cases, 88 non-bleeding controls).
Evaluated clinical, demographic, and pharmacological variables using Fisher's exact test and multivariable Firth's penalized logistic regression to account for sparse data and quasi-complete separation.
Herb use was strongly and independently associated with bleeding (37 of 38 users experienced bleeding vs. 7 of 94 non-users; bivariate OR=460, p<0.001; multivariable aOR=25.33, 95% CI: 3.60–185.42, p<0.001).
Hypofibrinogenemia independently increased bleeding risk (38 of 41 with low levels bled vs. 6 of 91 with normal levels; bivariate OR=179, p<0.001; multivariable aOR=19.10, 95% CI: 3.19–114.29, p<0.001), whereas INR ≥3 was not statistically significant after adjustment (aOR=3.69, 95% CI: 0.33–41.30, p=0.321).
The synergistic interaction between herb use and hypofibrinogenemia was not statistically significant (χ²=2.78, p=0.095), within a multivariable model showing strong explanatory fit (Nagelkerke R²=0.854).

Study Design

Type

Case-Control (n=132)

Multicenter

No

Structured PICO

Do concomitant herbal medicine use and hypofibrinogenemia increase the risk of hospitalization with bleeding events in cardiovascular disease patients undergoing warfarin therapy?

P

Population

132 hospitalized cardiovascular disease patients receiving warfarin therapy at RSUD Kabupaten Tangerang (55.3% female; 34.8% aged >=60 years), comprising 44 cases with bleeding and 88 controls without bleeding.

E

Exposure

Warfarin therapy with evaluated risk exposures including concomitant herbal medicine use (garlic, ginger, turmeric, green tea, or combinations), hypofibrinogenemia (fibrinogen <200 mg/dL), INR ≥3, duration of warfarin use ≥1 year, weekly warfarin dose ≥23 mg, and major drug interactions

C

Comparator

Warfarin therapy without concomitant herbal medicine use, with normal fibrinogen levels, INR <3, duration of warfarin use <1 year, weekly warfarin dose <23 mg, and no major drug interactions (analyzed across 44 cases with bleeding and 88 controls without bleeding)

O

Outcome

Hospitalization with bleeding events among warfarin-treated cardiovascular disease patients between January 2023 and December 2024safety

Main Result

Odds Ratio: 25.33 (95% CI 3.6–185.42)

Absolute Event Rate: 97.4% vs 7.4%

p-value: p=<0.001

In hospitalized cardiovascular patients treated with warfarin, concomitant herbal medicine use and hypofibrinogenemia were strong independent risk factors for bleeding, highlighting the clinical need to screen for herbal supplement use and monitor fibrinogen levels alongside INR.

Limitations

Relatively small sample size (n=132) and limited number of bleeding events (n=44) resulting in wide confidence intervals and reduced precision
Retrospective design and reliance on electronic medical records introducing potential information bias
Patient-reported herb use may introduce recall bias
Single-center setting limits the generalizability of the findings
Potential circularity from the role of INR as both a marker of anticoagulation intensity and a bleeding risk factor
Herb use analyzed as a composite binary variable due to small sample sizes for subtypes, obscuring heterogeneity across individual herbal products
Relatively small sample size (n = 132) and limited number of bleeding events (n = 44) resulted in wide confidence intervals and reduced precision
Retrospective design and reliance on electronic medical records introduce potential for information bias, and patient-reported herb use may introduce recall bias
Role of INR as both a marker of anticoagulation intensity and a potential bleeding risk factor may introduce circularity
Herb use was analyzed as a composite binary variable due to limited sample size for each herb subtype, which may obscure heterogeneity across individual herbal products

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Herb use and hypofibrinogenemia were associated with bleeding; leaves open whether screening improves outcomes in warfarin-treated patients.

Abstract

Bleeding complications are a major contributor to hospitalization among cardiovascular patients on warfarin therapy, yet the causative factors remain incompletely characterized. This retrospective case-control study aimed to identify significant risk factors and their potential interaction in bleeding incidence among cardiovascular disease (CVD) patients at RSUD Kabupaten Tangerang. Medical-record data from CVD patients on warfarin hospitalized with or without bleeding between January 2023 and December 2024 were analyzed using JAMOVI, encompassing bivariate, multivariate, and interaction analyses. A total of 132 patients were enrolled, comprising 44 (33.3%) cases with bleeding and 88 (66.7%) controls without bleeding. Fisher's exact test, employed due to sparse and unbalanced data, identified significant associations with herb use (p<0.001, OR=460), INR ≥3 (p<0.001, OR=8.33), and hypofibrinogenemia (p<0.001, OR=179). Firth's penalized logistic regression confirmed herb use (aOR=25.33, p<0.001) and hypofibrinogenemia (aOR=19.10, p<0.001) as independently and strongly associated with bleeding, with a strong model fit (Nagelkerke R²=0.854). However, the likelihood ratio test for the synergistic interaction between these two factors was not statistically significant (χ²=2.78, p=0.095). Overall, herb use and hypofibrinogenemia are independently risk factors for bleeding in warfarin-treated cardiovascular patients; the interaction between them was not statistically significant, so clinicians should screen for herb use and monitor fibrinogen levels.

Discussion

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Cite This Study

Yqbal et al. (2026) conducted a case-control in Cardiovascular disease undergoing warfarin treatment (n=132). Herb use vs. No herb use was evaluated on Hospitalization with bleeding events (OR 25.33, 95% CI 3.60-185.42, p=<0.001). Herb use (aOR 25.33, p<0.001) and hypofibrinogenemia (aOR 19.10, p<0.001) were independently associated with increased bleeding risk in warfarin-treated cardiovascular patients.

synapsesocial.com/papers/6ae28e75cbadf70daf6c42cf https://doi.org/10.25077/jsfk.13.02.251-260.2026

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Analysis of Risk Factors for Bleeding in Patients with Cardiovascular Disease Undergoing Warfarin Treatment at Rsud Kabupaten Tangerang

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Analysis of Risk Factors for Bleeding in Patients with Cardiovascular Disease Undergoing Warfarin Treatment at Rsud Kabupaten Tangerang

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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