An increase in clopidogrel prescriptions could be seen in the US and Europe for secondary ischaemic stroke prevention as a result of the outcomes of the Phase III POINT trial, according to data and analytics company, GlobalData.
Stroke
The standard of care (SoC) for patients with non-cardioembolic acute ischaemic stroke (AIS) and transient ischaemic attack (TIA) to reduce the risk of recurrence in the US is aspirin. However, in China it is routine practice to prescribe aspirin with another antiplatelet drug, clopidogrel, which is sold by Sanofi under the brand name Plavix.
“Trials have unquestionably demonstrated that aspirin can reduce the risk of recurrent stroke by approximately 20%, but the same cannot be said for clopidogrel,” explained Edit Kovalcsik, PhD, pharma analyst at GlobalData. “As such, the drug has not been recommended a SoC by the US and EU guidelines, except for the UK, where clopidogrel monotherapy is recommended by the National Institute for Health and Care Excellence (NICE) as an option to prevent occlusive vascular events for patients who have had an AIS event.”
Both aspirin and clopidogrel are platelet inhibitors, which, according to the authors of the POINT study, act synergistically with aspirin in platelet-aggregation assays. The combination of aspirin and clopidogrel has been used for many years by cardiologists in patients with acute coronary syndrome (ACS) to reduce the risk of ischaemic events. However, clopidogrel is prescribed only sparingly in secondary stroke prevention, mainly in patients who are allergic to aspirin or in those who have had a recent heart attack or coronary artery stenting.
“The efficacy results of the POINT trial are encouraging since the trial showed a significantly lower risk of major ischaemic events occurring in patients with minor AIS or high-risk TIA who received clopidogrel + aspirin (5.0%), compared to those who received aspirin alone (6.5%),” continued Kovalcsik. “However, unlike the CHANCE trial, the POINT trial also reported a higher risk of major haemorrhage at 90 days in patients receiving the combination compared to those who received aspirin monotherapy.”
For antithrombotic therapies the big safety issue is that of the associated increased risk of bleeding. Previously, the MATCH trial demonstrated a higher risk of life-threatening bleeding in patients with recent AIS and TIA when adding aspirin to clopidogrel. Yet, this trial did not show a significant improvement in stroke prevention when comparing clopidogrel to SoC aspirin monotherapy.
“Whether or not the recommendations by the AHA/ASA and EU guidelines about the use of clopidogrel + aspirin will be reconsidered based on the POINT trial results remains to be seen,” added Kovalcsik. “Nevertheless, we expect that the encouraging efficacy data demonstrated by the POINT trial will increase the use of the dual therapy in AIS and TIA; however, physicians will still have to carefully select which patients should be prescribed the combination.”