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2016 Biomedtracker / Datamonitor Healthcare Post-ESC Report
September 26, 2016
The European Society of Cardiology Congress was held in Rome, Italy from 27–31 August 2016. Data were largely incremental, though
there were some interesting results supporting usage of PCSK9 inhibitors and novel oral anticoagulants (NOACs) in certain
settings, as well as pivotal data for AndexXa (PTLA). New European Society of Cardiology/European Atherosclerosis Society (ESC/EAS)
dyslipidemia guidelines were also released at the meeting, and there were interesting discussions about Entresto (NVS) for heart
failure.
Dyslipidemia
For our disclosures, please read the Biomedtracker Research Standards.
Dyslipidemia
- ODYSSEY ESCAPE found that Praluent (SNY, REGN) can reduce or even eliminate the need for high-cost lipoprotein apheresis
treatment in patients with heterozygous familial hypercholesterolemia. However, there are questions about the magnitude of the
reduction in
actual practice, due to differences in criteria for skipping apheresis.
- Soon after the conference, Repatha's (AMGN, Astellas) GLAGOV atherosclerosis imaging (using intravascular ultrasound) study was reported to be positive, bolstering confidence that the PCSK9 inhibitor’s cardiovascular outcome trials will be successful. Details from GLAGOV are to be presented at the American Heart Association Scientific Sessions in November.
- New ESC/EAS dyslipidemia guidelines, released during the conference, recommend an absolute low-density lipoprotein- cholesterol (LDL- C) target, but also call for at least a 50% reduction if baseline LDL-C is within certain levels closer to the targets.
- Data from AndexXa's single-arm study (ANNEXA-4) in patients with clinical bleeding from factor Xa inhibitors appeared
encouraging,
supporting approval of the drug, though the actual clinical benefit is difficult to fully assess without a control group.
- A rebound of anti-factor Xa activity after the end of the infusion could raise some questions about the dosing, but Portola
Pharmaceuticals believes anti-factor Xa activity just needs to be suppressed long enough for a definitive hemostatic plug to be formed.
- The ongoing study will include an amendment, requested by the US Food and Drug Administration (FDA), to allow physicians to readminister a second dose.
- There were concerns that the rate of thrombosis was somewhat high; this will need to be followed as the study accrues more patients.
- Company officials expect the recent complete response letter, much of which was due to manufacturing issues, to delay approval about a year, though they still need to meet with the FDA for more details on what is needed.
- A rebound of anti-factor Xa activity after the end of the infusion could raise some questions about the dosing, but Portola
Pharmaceuticals believes anti-factor Xa activity just needs to be suppressed long enough for a definitive hemostatic plug to be formed.
- Savaysa’s (Daiichi) ENSURE-AF trial results indicated that the drug was at least as safe and effective as vitamin K antagonist-based
anticoagulation in conjunction with cardioversion, helping to further bolster the case for preferential use of NOACs.
- While such trials cannot feasibly be large enough for statistical testing, Savaysa, like Xarelto (JNJ, BAYRY) in X-VeRT, showed a numerical benefit on the primary efficacy endpoint and major bleeding.
- ANTARCTIC was yet another in a series of negative trials evaluating platelet function monitoring to adjust antiplatelet therapy. In
this
study, Accriva's VerifyNow was used to monitor treatment with Effient (LLY, Daiichi).
- The trial reinforces the notion that routine platelet function monitoring is not warranted. However, critics noted that not many
patients in
the trial had to be uptitrated due to platelet function testing, and it is not clear if the 5mg dose used initially in the elderly study population
really
has a substantial advantage over clopidogrel, the drug used when platelet testing suggested de-escalation.
- Platelet function testing may still have a role in niche situations.
- The trial reinforces the notion that routine platelet function monitoring is not warranted. However, critics noted that not many
patients in
the trial had to be uptitrated due to platelet function testing, and it is not clear if the 5mg dose used initially in the elderly study population
really
has a substantial advantage over clopidogrel, the drug used when platelet testing suggested de-escalation.
- Panelists at had a number of interesting comments on how physicians may approach the use of Entresto (NVO), in the context of the recent ESC heart failure guidelines.
- Heart failure with mid-range ejection fraction is a new classification in the ESC heart failure guidelines that warrants further study.
- ARRY-797 (ARRY) demonstrated some interesting signals of efficacy in a study of an orphan cardiomyopathy indication, but
caution is
warranted as the study was quite small and without a control—and some of the data were more mixed.
- The company is not disclosing what the FDA has said about a path forward and is considering a range of options.
- Data for stem cell therapies Stemedyne-MSC (Stemedica, Phase IIa trial) and C-Cure (Celyad, Phase III trial) were mixed, with only
signals
for efficacy in some endpoints or subgroup analyses.
- Stemedica indicated it planned to further study its cells, which have the advantage of being delivered intravenously rather than injected into the heart muscle, but Celyad said it was looking for a partner for the US trial of its candidate.
- The studies just add to the mixed picture for stem cells in cardiovascular (CV) indications, with much frustration over the lack of a large definitive study.
For our disclosures, please read the Biomedtracker Research Standards.
Indications Covered: |
Acute Coronary Syndrome (ACS)
Atrial Fibrillation/Flutter Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF) Dyslipidemia / Hypercholesterolemia Percutaneous Coronary Interventions (PCIs) for Stable Angina Stroke Prevention in Atrial Fibrillation (SPAF) Venous Thromboembolism (VTE) |