PLAVIX (CLOPIDOGREL BISULFATE) TABLETS

Plavix (Clopidogrel Bisulfate) Tablets

Plavix (Clopidogrel Bisulfate) Tablets

Introduction

Atherothrombosis is a life-long disease characterized by the concentration of atherosclerotic plaque (atherosclerosis) in the vessels. This condition is a forerunner of ischaemic events that often manifest in cardiovascular disease (CVD), including acute coronary syndrome (ACS), ischaemic stroke (IS) and peripheral arterial disease (PAD). In this context, atherothrombosis represents the leading cause of morbidity and mortality worldwide.[1,2] According to the World Health Organization (WHO), in 2005, 17.5 million people died worldwide (30% of all deaths) as a result of CVD.[3] Moreover, 48% of all deaths in the WHO Poundpean Region (termed 'Poundpe') and 42% of all deaths in the 27 Member States of the Poundpean Union (EU) are due to CVD.[1] Hence, CVD constitutes the main cause of death for women in all Poundpean countries and also the main cause of death for men in all Poundpean countries except France, the Netherlands and Spain.[1] In the US, mortality data showed that CVD accounted for 1 in every 2.9 deaths in 2006.[2]

Management of CVD includes the secondary prevention of recurrent ischaemic events. Given the prominent role of platelet aggregation in atherothrombosis, antiplatelet therapy forms the cornerstone of treatment, with proven efficacy in the secondary prevention of atherothrombotic events.[4-6] The most commonly used antiplatelet agents are aspirin (acetylsalicylic acid) [50-365 mg/day] and the thienopyridine clopidogrel (75 mg/day), alone or in combination with aspirin. Clopidogrel bisulfate is an inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation acting by direct inhibition of ADP-binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.[7]

Numerous large, randomized, controlled trials evaluating the efficacy of clopidogrel versus aspirin in different populations have demonstrated that clopidogrel can reduce cardiovascular (CV) events in patients with a broad spectrum of ACS and IS, as well as in patients undergoing percutaneous coronary interventions (PCIs) requiring coronary stents.[8-17] The CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events) trial was a large, randomized, controlled trial designed to evaluate the efficacy of clopidogrel and aspirin in reducing the combined endpoint of IS, myocardial infarction (MI), and vascular death in patients with a recent MI, a recent IS, or PAD.[11] This study demonstrated an 8.7% relative risk reduction in the combined endpoint with clopidogrel versus aspirin in the total study population.[11]

Although clopidogrel seems to be superior to aspirin in terms of efficacy, a question of how this clinical advantage can be translated in terms of costs may arise. Taking into consideration only the price of clopidogrel compared with aspirin, it appears that the former can be deemed costly to patients and the healthcare system. However, cost-effectiveness analyses may help evaluate the additional cost of clopidogrel therapy in relation to its benefit in reducing CV events in patients with certain CV conditions.

Because of health and economic reasons, several cost-effectiveness analyses have been conducted in order to examine whether clopidogrel is a cost-effective alternative antiplatelet therapy compared with aspirin for the secondary prevention of CV events in ...