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Articles

Antiplatelet formulations suggested for adults with swallowing difficulties

1 July 2021A range of antiplatelets are suitable for use in adults with swallowing difficulties.

Safety in Lactation: Drugs for thromboembolic disorders

18 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral anticoagulants The coumarin anticoagulants, warfarin…
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Medicine Compliance Aid Stability

BriliqueAstraZeneca UK Ltd

AstraZeneca UK Ltd
Brilique
Tablets f/c 90mg
G1 · Green 1Stability 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.
9 November 2015

Lactation Safety Information

Clopidogrel, Dipyridamole
Normally administered orally with aspirin
No published evidence of safety
Amount in milk likely to be small due to the drug's properties
Absorption from the infant’s gastro-intestinal tract likely to be small due to low oral bioavailability
Monitor the infant for signs of bruising or bleeding
12 July 2021

New Medicines

Brilique (EU), Brilinta (US), PossiaAcute ischaemic stroke or transient ischaemic attack - secondary prevention

Information

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

Development and Regulatory status

None
Pre-registration (Filed)
Launched
Dec 20Is currently pre-registration in EU. Has been filed using the centralised procedure [10].
Nov 20FDA grants approval [9].
Jul 20Filed in US with priority review [8].
Mar 20Filings planned for H1 20 [7].
Sep 18Filings based on THALES study planned for 2020 or later [4].

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

Trial or other data

Jul 21 Sub-group analysis of PIII THALES RCT (n= 9983) found ticagrelor plus aspirin showed similar efficacy and safety vs aspirin alone in patients presenting with moderate acute ischemic stroke and those presenting with less severe ischemic cerebrovascular events [11].
Jan 20Topline data from PIII THALES study showed that 90mg of ticagrelor BD with aspirin for 30 days, provided a statistically significant and clinically meaningful decrease in the risk of stroke and death vs. aspirin alone in >11,000 pts who had a minor acute ischemic stroke or high-risk TIA 24 hours before beginning treatment.[6]
Dec 19PIII THALES (NCT03354429) trial completed [5].
Mar 18PIII 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), PossiaSickle 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 20According 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 20PIII HESTIA3 terminated on the recommendation of an independent data monitoring committee (DMC) and accepted by AstraZeneca [6].

Brilique (EU), Brilinta (US), PossiaPrevention 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

Discontinued
Discontinued
Launched
Apr 21Removed from company pipeline; assume EU/UK development discontinued [19].
Mar 21EU filing withdrawn by company. At the time of withdrawal, there were unresolved issues and the company has withdrawn the application. Based on the review of the information and the company’s response to the Agency’s questions, the Agency had concerns and its provisional conclusion was that ticagrelor with aspirin could not have been authorised for this indication. The Agency considered that the benefit seen in prevention of atherosclerotic events did not outweigh the risks, especially bleeding [18].
Jun 20Approved in US [17].
Sep 19EU and US filings based on THEMIS data accepted [16].
Sep 18Filings planned H2 19 [12].
Nov 17Estimated EU and US filings now planned for 2019 [11]
Nov 16Estimated EU filing remains 2018 [8]
Dec 15Filings now planned for 2018 in US & EU [6].
Apr 14Estimated 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

Trial or other data

Sep 19THEMIS-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 19PIII 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 19Astra 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 17Data from THEMIS expected 2019 [10].
Nov 16The PIII THEMIS study (NCT01991795) is ongoing, but no longer recruiting patients [9]
Jan 16The 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 13THEMIS = NCT01991795. The study starts Feb 14 and is due to complete Dec 16 [2].
Nov 13AstraZeneca 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