Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews

Emanuel Raschi1, Matteo Bianchin2, Milo Gatti2

  • 1Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy. emanuel.raschi@unibo.it.

Drug Safety
|September 26, 2019
PubMed

Insights

Direct oral anticoagulants (DOACs) are recommended for stroke prevention and venous thromboembolism. This review synthesizes evidence on DOAC comparative effectiveness and safety, highlighting research gaps.

Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Evidence-Based Practice

Background:

  • Direct oral anticoagulants (DOACs) are guideline-recommended for stroke prevention in non-valvular atrial fibrillation and venous thromboembolism (VTE) in non-cancer patients.
  • No head-to-head trials exist, but indirect comparisons suggest distinct risk profiles for individual DOACs.
  • Understanding these nuanced risk profiles is crucial for optimal patient management.

Purpose of the Study:

  • To critically assess the latest comparative effectiveness and safety evidence for DOACs in their primary indications.
  • To identify and highlight underexplored research areas and challenges in DOAC comparative research.
  • To evaluate current evidence against existing guidelines and inform future DOAC implementation.

Main Methods:

  • Overview of systematic reviews synthesizing evidence from indirect comparisons and observational studies.
  • Critical appraisal of existing literature on DOAC comparative effectiveness and safety.
  • Consideration of ongoing and unpublished studies to identify research gaps.

Main Results:

  • Evidence suggests that different DOACs may possess specific risk profiles, impacting their comparative effectiveness and safety.
  • Existing research provides a foundation for understanding DOACs, but significant knowledge gaps remain.
  • The current evidence base requires careful appraisal in light of established clinical guidelines.

Conclusions:

  • DOACs represent a significant advancement, but their distinct risk profiles necessitate careful consideration in clinical practice.
  • Further research is needed to address underexplored areas and refine the comparative understanding of DOACs.
  • Evidence synthesis supports informed decision-making regarding DOAC use and future research directions.

Related Concept Videos

Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants01:18

Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants

Oral anticoagulants are vital tools in preventing and treating blood clotting disorders. This diverse class of medications can be categorized as vitamin K antagonists, exemplified by warfarin, and direct thrombin inhibitors (DTIs), such as dabigatran, as well as factor Xa inhibitors, including rivaroxaban.
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
2.1K
Anticoagulant Drugs: Low-Molecular-Weight Heparins01:30

Anticoagulant Drugs: Low-Molecular-Weight Heparins

Hemostasis is a crucial process that prevents excessive blood loss from damaged blood vessels. It involves various mechanisms such as vasoconstriction, platelet adhesion and activation, and fibrin formation. The importance of each mechanism depends on the type of vessel injury. In contrast, thrombosis is the abnormal formation of a blood clot within the blood vessels, leading to potential complications if the clot obstructs blood flow. Thrombosis can be caused by increased coagulability of the...
1.7K
Venous Thrombosis III: Interprofessional Care01:29

Venous Thrombosis III: Interprofessional Care

Venous thrombosis requires effective prevention and treatment strategies to improve patient outcomes and reduce potential complications.Prevention StrategiesHealthcare providers must prioritize preventing venous thromboembolism (VTE) for all adult patients upon admission. Interventions depend on bleeding and thrombosis risk, medical history, current medications, diagnoses, planned procedures, and patient preferences. Patients on bed rest should change positions every two hours and, if not...
280
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors01:20

Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors

Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
1.1K
Antihypertensive Drugs: Direct Renin Inhibitors01:25

Antihypertensive Drugs: Direct Renin Inhibitors

The renin-angiotensin-aldosterone system (RAAS) is an intricate physiological pathway involving numerous enzymes and hormones, including renin, angiotensin-converting enzyme (ACE), angiotensin I and II, and aldosterone. Imbalances within this system increase the production of angiotensin II and aldosterone. Increased angiotensin II levels promote vasoconstriction and blood pressure elevation. Concurrently, higher aldosterone levels stimulate sodium and water reabsorption in the kidneys,...
1.3K
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
151