News in brief: Timing of anticoagulant resumption post-GI bleed; Remote monitoring of chemo side effects reduces symptom burden; Industry wants improved access to cell and gene therapies;

Thursday, 29 Jul 2021

Timing of anticoagulant resumption not a factor in recurrent bleeding post-GI bleed

Anticoagulant treatment after GI bleeding is associated with a higher risk of recurrent clinically relevant bleeding (HR 1.55) but lower risk of thromboembolism (HR 0.34) and death (HR 0.50).

However the timing of resumption of anticoagulation after the index bleed does not appear to be a factor, according to the ISTH SSC Subcommittee on Control of Anticoagulation.

A retrospective international study included 948 adults hospitalised for GI bleeding during treatment with vitamin K antagonists or DOACs and followed for two years.

Anticoagulants were resumed in 66.4% of patients after a median time of 6 days from the index GI bleed although there was a wide range from 1 to 447 days.

Significant predictors of recurrent clinically relevant bleeding were previous bleeding (prior to the index event), index major bleeding, and lower glomerular filtration rate.

“Thus, if confirmed in future studies, our findings may help physicians to identify patient subgroups with heightened risk of recurrent bleeding, who could benefit from closer clinical monitoring,” the study said.

The optimal timing of anticoagulant treatment resumption remains unclear.

Journal of Thrombosis and Haemostasis

Industry lobbies for access to cell and gene therapies

A pharmaceutical industry-sponsored paper has called on government to introduce a range of regulatory and funding reforms to improve Australian patients’ access to a pipeline of more 1000 cell and gene therapies (CGTs).

The paper, sponsored by CAR T-cell provider Novartis, says the current drug approval and reimbursement assessment systems in Australia are not set up to deal with high cost products for rare diseases. It calls on government to look at system in other jurisdictions such as Europe, and provides recommendations such as setting up an Office for Rare Diseases within the Department of Health and a CGT expert advisory group to provide input and advice to TGA, PBAC and MSAC.

It also calls on Minister for Health to establish a cross-functional working group rethink  current Health Technology Assessment (HTA) processes for CGTs.

“These recommendations will allow Australia to deliver on the promise of CGTs as a future of care for many Australians living with currently incurable cancers, viruses, and rare debilitating conditions,” it concludes.

Remote monitoring of chemo side effects reduces symptom burden

Remote monitoring of symptoms associated with chemotherapy toxicities appears to reduce the symptom burden in blood cancer patients by facilitating timely access to care.

A European study across five countries randomised 829 adult cancer patients with conditions including Hodgkin’s disease or non-Hodgkin’s lymphoma to either remote monitoring via the Advanced Symptom Management System (ASyMS) or usual care.

Patients using ASyMS upload a Daily Chemotherapy Toxicity Self-Assessment Questionnaire (DCTAQ) and body temperature to the server which applies an algorithm for symptom alerts to clinicians and a symptom management protocol.

The study found symptom burden as measured on the Memorial Symptom Assessment Scale (MSAS) remained at pre-chemotherapy treatment levels in the intervention group but increased with treatment in the usual care group.

Health-related quality of life was also higher in the intervention group than the control group across six cycles of chemotherapy.

“Our findings suggest that benefits of remote monitoring begin within the first three cycles of treatment and are sustained over time, indicating that systems such as ASyMS should be implemented at the start of treatment,” the study said.

“The ultimate vision is to have a multimodal seamless system of remote symptom monitoring used from the start of treatment and through survivorship.”


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