Abstract
Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-weight heparin. It inhibits factor Xa, preventing blood clot formation. To date, its use in clinical practice as thromboprophylaxis agent is still limited. In addition, the efficacy and safety profile of this agent was not robustly reported globally, especially for countries with major Muslim population. We hypothesized that Na-PPS was equally effective as the standard thromboprophylaxis. We aim to compare the efficacy and safety of Na-PPS against standard agent (fondaparinux or enoxaparin). Methods: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding. Results: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001). Conclusion: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a standard thromboprophylactic agent.
| Original language | English |
|---|---|
| Pages (from-to) | 1458-1465 |
| Number of pages | 8 |
| Journal | Journal of Obstetrics and Gynaecology Research |
| Volume | 44 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 1 Aug 2018 |
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Keywords
- embolism
- enoxaparin
- fondaparinux
- pentosan
- thrombosis
ASJC Scopus subject areas
- Obstetrics and Gynaecology
Cite this
Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery. / Indirayani, Ima; Kalok, Aida; Nik Ismail, Nik A.; Shah, Shamsul A.; Lim, Pei S.; Mohamed Ismail, Nor A.; Nur Azurah, Abdul G.; Omar, Mohd Hashim; Shafiee, Mohamad N.
In: Journal of Obstetrics and Gynaecology Research, Vol. 44, No. 8, 01.08.2018, p. 1458-1465.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery
AU - Indirayani, Ima
AU - Kalok, Aida
AU - Nik Ismail, Nik A.
AU - Shah, Shamsul A.
AU - Lim, Pei S.
AU - Mohamed Ismail, Nor A.
AU - Nur Azurah, Abdul G.
AU - Omar, Mohd Hashim
AU - Shafiee, Mohamad N.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-weight heparin. It inhibits factor Xa, preventing blood clot formation. To date, its use in clinical practice as thromboprophylaxis agent is still limited. In addition, the efficacy and safety profile of this agent was not robustly reported globally, especially for countries with major Muslim population. We hypothesized that Na-PPS was equally effective as the standard thromboprophylaxis. We aim to compare the efficacy and safety of Na-PPS against standard agent (fondaparinux or enoxaparin). Methods: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding. Results: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001). Conclusion: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a standard thromboprophylactic agent.
AB - Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-weight heparin. It inhibits factor Xa, preventing blood clot formation. To date, its use in clinical practice as thromboprophylaxis agent is still limited. In addition, the efficacy and safety profile of this agent was not robustly reported globally, especially for countries with major Muslim population. We hypothesized that Na-PPS was equally effective as the standard thromboprophylaxis. We aim to compare the efficacy and safety of Na-PPS against standard agent (fondaparinux or enoxaparin). Methods: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding. Results: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001). Conclusion: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a standard thromboprophylactic agent.
KW - embolism
KW - enoxaparin
KW - fondaparinux
KW - pentosan
KW - thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85051272090&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85051272090&partnerID=8YFLogxK
U2 - 10.1111/jog.13686
DO - 10.1111/jog.13686
M3 - Article
C2 - 29845672
AN - SCOPUS:85051272090
VL - 44
SP - 1458
EP - 1465
JO - Asia-Oceania Journal of Obstetrics and Gynaecology
JF - Asia-Oceania Journal of Obstetrics and Gynaecology
SN - 1341-8076
IS - 8
ER -