Ticagrelor

Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·
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Articles

Safety in Lactation: Drugs for thromboembolic disorders

Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral anticoagulants The coumarin anticoagulants, warfarin… Abciximab Acenocoumarol Alteplase Apixaban Argatroban Aspirin Cardiovascular system disorders Clopidogrel Dabigatran etexilate Dalteparin Dipyridamole Edoxaban Enoxaparin Epoprostenol Eptifibatide Fondaparinux Heparin Phenindione Prasugrel Rivaroxaban Safety in Lactation Ticagrelor Tinzaparin Urokinase Warfarin

Medicine Compliance Aid Stability

Brilique · AstraZeneca UK Ltd

AstraZeneca UK Ltd
Brilique
Tablets f/c 90mg
G1 · Green 1 · Stability data indicates that the drug is suitable for CAs and there are no theoretical concerns with the product.
No special precautions for storage
May be stored for up to 14 days in an MCA.
9th November 2015

Lactation Safety Information

Clopidogrel, Dipyridamole
Normally administered orally with aspirin
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties
21st October 2016

New Medicines

Brilique (EU), Brilinta (US), Possia · Prevention of cardiovascular events in patients with coronary artery disease and type 2 diabetes

Information

Brilique (EU), Brilinta (US), Possia
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Launched
Jun 20 · Approved in US [17].
Sep 19 · EU and US filings based on THEMIS data accepted [16].
Sep 18 · Filings planned H2 19 [12].
Nov 17 · Estimated EU and US filings now planned for 2019 [11]
Nov 16 · Estimated EU filing remains 2018 [8]
Dec 15 · Filings now planned for 2018 in US & EU [6].
Apr 14 · Estimated EU filing 2017 [4]

Category

P2Y12 adenosine diphosphate receptor antagonist
Mar 14: Estimated UK prevalence of diagnosed diabetes was 2.9 million people in 2011; 85% have T2DM and about 72% are receiving medication. It is thought a further 850,000 are undiagnosed. [3]
Prevention of cardiovascular events in patients with coronary artery disease and type 2 diabetes
Oral

Further information

Yes
To be confirmed

Trial or other data

Sep 19 · THEMIS-PCI, a sub-group analysis of THEMIS is published; it enrolled 11,154 participants with a history of PCI (58% of the overall THEMIS trial) reported that addition of ticagrelor to aspirin reduced cardiovascular death, MI, and stroke vs placebo for a median of 3.3 years (7.3 vs 8.6% in the PCI group; HR 0.85; 95% CI 0.74–0.97; p=0.013), although with increased risk of major bleeding [15].
Sep 19 · PIII THEMIS (n=19,220; median follow-up 39.9 months) is published; the authors reported lower incidence of ischaemic cardiovascular events with ticagrelor + aspirin vs aspirin (7.7 vs. 8.5%; HR, 0.90; 95% CI, 0.81 to 0.99; P=0.04) but higher incidence of major bleeding (2.2 vs. 1.0%; 2.32; 1.82 to 2.94; P<0.001) [14].
Feb 19 · Astra Zeneca reported the PIII THEMIS trial met its primary endpoint and demonstrated that ticagrelor taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) vs aspirin alone. Full data will be presented at a forthcoming medical meeting [13]
Mar 17 · Data from THEMIS expected 2019 [10].
Nov 16 · The PIII THEMIS study (NCT01991795) is ongoing, but no longer recruiting patients [9]
Jan 16 · The PIII THEMIS study (NCT01991795) is currently recruiting pts, with an estimated final data collection date for the primary outcome measure of Jan 2018 [7].
Nov 13 · THEMIS = NCT01991795. The study starts Feb 14 and is due to complete Dec 16 [2].
Nov 13 · AstraZeneca plans to start a new PIII study as part of the PARTHENON clinical trial programme. THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study), is a global clinical trial involving 17,000 patients with Type 2 diabetes without a history of previous MI or stroke but with documented coronary atherosclerosis. The event-driven, randomized study will evaluate the efficacy of long-term treatment with ticagrelor vs placebo for the prevention of major CV events – the composite of CV death, MI or stroke [1].

Evidence based evaluations

Brilique (EU), Brilinta (US), Possia · Acute ischaemic stroke or transient ischaemic attack - secondary prevention

Information

Brilique (EU), Brilinta (US), Possia
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Pre-registration (Filed)
Jul 20 · Filed in US with priority review [8].

Category

P2Y12 adenosine diphosphate receptor antagonist.
There are more than 100,000 strokes in the UK each year; Age standardised stroke incidence is 115 per 100,000 people. Around 1 in 4 stroke survivors will experience another stroke within five years [1].
Acute ischaemic stroke or transient ischaemic attack - secondary prevention
Oral

Further information

Yes
To be confirmed

Trial or other data

Dec 19 · PIII THALES (NCT03354429) trial completed [5].
Mar 18 · PIII THALES trial to evaluate the safety and efficacy of 30-day treatment with ticagrelor vs. placebo, on a background therapy of aspirin (ASA), for reducing recurrent stroke and death in patients who have already suffered an acute ischaemic stroke or high-risk transient ischaemic attack (TIA) in the previous 24 hours starts (NCT03354429). The global trial intends to enrol approximately 13,000 patients in 28 countries. Primary endpoint is prevention of composite of subsequent stroke or death at 30 days; data are expected 2020 [2,3].

Evidence based evaluations

Brilique (EU), Brilinta (US), Possia · Sickle cell disease in children aged 2-18 years

Information

Brilique (EU), Brilinta (US), Possia
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Sep 20 · According to company H1 2020 results update, HESTIA3 has been discontinued and there are no plans for filing [5].

Category

P2Y12 adenosine diphosphate receptor antagonist.
Sickle cell disease is thought to be the most common severe genetic disease in the UK and France, with 10,000-15,000 people affected. The sickle beta globin gene is spread widely throughout Africa, the Middle East, the Mediterranean and India (eg, sickle genes are present in 1 in every 50 Asians and 1 in every 100 Northern Greeks). The gene has spread through population movement to the Caribbean, North America and Northern Europe [1].
Sickle cell disease in children aged 2-18 years
Oral

Trial or other data

Sep 20 · PIII HESTIA3 terminated on the recommendation of an independent data monitoring committee (DMC) and accepted by AstraZeneca [6].