COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

Cohen, Alexander T.; Maraveyas, Anthony; Beyer‐Westendorf, Jan; Lee, Agnes Y.Y.; Mantovani, Lorenzo Giovanni; Bach, Miriam

doi:10.1186/s12959-018-0176-2

Cited by 21 publications

(20 citation statements)

References 51 publications

(56 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…COSIMO registry will include DDI as a secondary outcome. 42 A prospective, observational, and hypothesis-generating international registry from the Internal Society of Thrombosis and Hemostasis (ISTH) 43 was designed to assess the safety and efficacy of 200 patients with cancer followed for 6 months on concomitant use of DOACs and antineoplastic and supportive care drugs. Targeted therapies include ibrutinib, acalabrutinib, imatinib, nilotinib, osimertinib, alectinib, sunitinib, cabozantinib, lapatinib, palbocyclib, vemurafenib, or everolimus.…”

Section: Discussionmentioning

confidence: 99%

Drug–Drug Interactions of 257 Antineoplastic and Supportive Care Agents With 7 Anticoagulants: A Comprehensive Review of Interactions and Mechanisms

Miranda¹,

Takahashi²,

Iwamoto³

et al. 2020

Clin Appl Thromb Hemost

View full text Add to dashboard Cite

Data on drug–drug interactions (DDI) of antineoplastic drugs with anticoagulants is scarce. We aim to evaluate factors associated with DDI of antineoplastic and supportive care drugs with anticoagulants resulting in modification of pharmacokinetics of these last mentioned. A literature review on DDI databases and summaries of products characteristics (SmPC) was done. Drug–drug interactions of 257 antineoplastic and supportive care drugs with direct oral anticoagulants (DOACs), warfarin, enoxaparin, or fondaparinux were categorized as no clinically significant expected DDI, potentially weak DDI, potentially clinically significant DDI, and recommendation against coadministration. Logistic regression models were performed to analyze the association between the dependent variable potentially clinically significant interaction/recommendation against coadministration and the mechanisms of DDI. Of the 1799 associations, 84.4% were absence of DDI, 3.6% potentially weak DDI, 10.2% potentially clinically relevant DDI, and 2.0% recommendation against coadministration. Warfarin has higher DDI potential than other anticoagulants. Enoxaparin and fondaparinux have fewer DDI than others. There was no difference between DOACs. Drug–drug interactions with apixaban and rivaroxaban was independently associated with the absence of CYP3A4 competition, P-glycoprotein inhibition, CYP3A4 induction, and drug class of tyrosine kinase inhibitors. Drug–drug interactions with dabigatran and edoxaban was associated with inhibition of P-glycoprotein and tyrosine kinase inhibitors. Warfarin, induction of CYP3A4, and inhibition of CYP2C9. Enoxaparin and fondaparinux, only tyrosine kinase inhibitors. Direct oral anticoagulants did not differ regarding DDI with antineoplastic agents. Warfarin presented more DDI than other anticoagulants. P-glycoprotein inhibition and CYP3A4 induction were independently associated with DDI of antineoplastic agents with DOACs.

show abstract

Section: Discussionmentioning

confidence: 99%

Drug–Drug Interactions of 257 Antineoplastic and Supportive Care Agents With 7 Anticoagulants: A Comprehensive Review of Interactions and Mechanisms

Miranda¹,

Takahashi²,

Iwamoto³

et al. 2020

Clin Appl Thromb Hemost

View full text Add to dashboard Cite

show abstract

“…However, real‐world evidence on patient satisfaction with, or preferences for, DOACs in patients with CAT were lacking. The CALLISTO program was developed with an RCT (COSIMO) and a real‐world study (CONKO‐011) to collect data on patient‐reported treatment satisfaction as a primary objective . The recent results from COSIMO were mentioned in section 3.…”

Section: Ongoing Studies In the Callisto Programmentioning

confidence: 99%

“…The recent results from COSIMO were mentioned in section 3. The phase III clinical trial CONKO‐011 will compare patient‐reported treatment satisfaction in patients after randomization to rivaroxaban or LMWH therapy . Quality of life will be measured using the Spitzer index, ACTS, and the treatment satisfaction questionnaire for medication.…”

Section: Ongoing Studies In the Callisto Programmentioning

confidence: 99%

See 1 more Smart Citation

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Bauersachs¹,

Khorana

Lee

et al. 2020

Research and Practice in Thrombosis and Haemostasis

Self Cite

View full text Add to dashboard Cite

Cancer‐associated venous thromboembolism (VTE) is a frequent, potentially life‐threatening event that complicates cancer management. Anticoagulants are the cornerstone of therapy for the treatment and prevention of cancer‐associated thrombosis (CAT); factor Xa–inhibiting direct oral anticoagulants (DOACs; apixaban, edoxaban, and rivaroxaban), which have long been recommended for the treatment of VTE in patients without cancer, have been investigated in this setting. The first randomized comparisons of DOACs against low‐molecular‐weight heparin for the treatment of CAT indicated that DOACs are efficacious in this setting, with findings reflected in recent updates to published guidance on CAT treatment. However, the higher risk of bleeding events (particularly in the gastrointestinal tract) with DOACs highlights the need for appropriate patient selection. Further insights will be gained from additional studies that are ongoing or awaiting publication. The efficacy and safety of DOAC thromboprophylaxis in ambulatory patients with cancer at a high risk of VTE have also been assessed in placebo‐controlled randomized controlled trials of apixaban and rivaroxaban. Both studies showed efficacy benefits with DOACs, but both studies also showed a nonsignificant increase in major bleeding events while on treatment. This review summarizes the evidence base for rivaroxaban use in CAT, the patient profile potentially most suited to DOAC use, and ongoing controversies under investigation. We also describe ongoing studies from the CALLISTO (Cancer Associated thrombosis—expLoring soLutions for patients through Treatment and Prevention with RivarOxaban) program, which comprises several randomized clinical trials and real‐world evidence studies, including investigator‐initiated research.

show abstract

“…In addition, compared with LMWH, rivaroxaban was associated with significantly lower rates of recurrent VTE (11.9 versus 14.7% at 12 months; hazard ratio 0.83; 95% CI 0.73–0.96; P = 0.01) and similar rates of major bleeding (the latter of which was identified using the Cunningham algorithm) [60]. COSIMO, an ongoing noninterventional, observational study that is part of the CALLISTO programme, will provide data on patient-reported outcomes and treatment satisfaction in patients with cancer-associated thrombosis switching to rivaroxaban therapy after at least 4 weeks’ treatment with standard anticoagulation (LMWH/VKA) [61].…”

Section: Rivaroxaban For the Treatment Of Venous Thromboembolism In Amentioning

confidence: 99%

Rivaroxaban and the EINSTEIN clinical trial programme

Cohen

Bauersachs

2019

Blood Coagulation &Amp; Fibrinolysis

Self Cite

View full text Add to dashboard Cite

Rivaroxaban, a direct oral anticoagulant, is widely used for the treatment of venous thromboembolism (VTE) in adult patients. The approval of rivaroxaban for the treatment of deep vein thrombosis and pulmonary embolism and the extended secondary prevention of recurrent VTE is based on the results of the EINSTEIN DVT and EINSTEIN PE trials, and the EINSTEIN EXT and EINSTEIN CHOICE trials, respectively. This review provides an updated overview of these completed EINSTEIN studies in adult patients, including results of subanalyses in patients at high risk of recurrent VTE, and discusses the emerging data from the EINSTEIN Junior programme, which is evaluating the use of rivaroxaban for the treatment of paediatric VTE. In the EINSTEIN DVT and EINSTEIN PE trials, rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily thereafter) was shown to be an effective and safe alternative to standard anticoagulation for the treatment of deep vein thrombosis and pulmonary embolism in a broad range of adult patients. These results are supported by increasing amounts of real-world data from patients treated with rivaroxaban in routine clinical practice worldwide. In the EINSTEIN EXT and EINSTEIN CHOICE trials, rivaroxaban was superior to placebo and acetylsalicylic acid, respectively, for the extended treatment of VTE – physicians can now choose between two doses of rivaroxaban (20 mg once daily or 10 mg once daily) for the extended prevention of recurrent VTE, based on a patient's risk of recurrence, bleeding and personal preferences.

show abstract

COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

Cited by 21 publications

References 51 publications

Drug–Drug Interactions of 257 Antineoplastic and Supportive Care Agents With 7 Anticoagulants: A Comprehensive Review of Interactions and Mechanisms

Drug–Drug Interactions of 257 Antineoplastic and Supportive Care Agents With 7 Anticoagulants: A Comprehensive Review of Interactions and Mechanisms

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Rivaroxaban and the EINSTEIN clinical trial programme

Contact Info

Product

Resources

About