indobufen / Pfizer - LARVOL DELTA

The Effect of Indobufen and Aspirin on Platelet Function in Acute Ischemic Stroke Patients with Early Neurological Deterioration. (PubMed, Eur J Pharmacol) - "Indobufen demonstrated superior platelet inhibition and more favorable neurological recovery compared to aspirin in acute ischemic stroke patients with early neurological deterioration. Indobufen also had a lower incidence of gastrointestinal side effects, while its overall safety profile was comparable to that of aspirin."

Journal • Cardiovascular • Gastrointestinal Disorder • Hematological Disorders • Ischemic stroke • Nephrology • Renal Disease

Comparative effectiveness and pharmacological fingerprints of indobufen versus rivaroxaban in patients with chronic kidney disease: a single-center, real-world study. (PubMed, Front Pharmacol) - "In this real-world CKD cohort, indobufen and rivaroxaban demonstrated comparable clinical effectiveness and safety. Combining machine learning with longitudinal models helps to statistically adjust for complex confounders like polypharmacy, thereby providing a more robust estimate of a drug's independent effect."

HEOR • Journal • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombosis

The Extended Safety and Efficacy of Indobufen in Conjunction With P2Y12 Receptor Inhibitors Among Patients Undergoing Revascularization: A Meta-Analysis and Overview. (PubMed, Cardiovasc Ther) - "Dual antiplatelet therapy (DAPT), which combines aspirin with a P2Y12 receptor inhibitor for platelets, is crucial for the prevention of cardiac and systemic ischemic events in patients with coronary artery disease who have undergone revascularization procedures. The final analysis included three randomized controlled trials, which yielded the following findings regarding major adverse cardiovascular and cerebrovascular events (MACCEs): The relative risk (RR) was 1.58 (95% CI, 0.72-3.38); for BARC Type 2, 3, or 5 bleeding events, the RR was 0.35 (95% CI, 0.18-0.67); and for gastrointestinal intolerance events, the RR was 0.06 (95% CI, 0.03-0.18). Indobufen-based DAPT may potentially increase the risk of ischemic events without compromising safety for revascularization, as its upper RR limit exceeds 1 for MACCEs."

Journal • Retrospective data • Review • Cardiovascular • Coronary Artery Disease

Pharmacokinetics and safety evaluation of indobufen tablets under fasting and fed conditions in healthy Chinese volunteers. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "As a result, for the two formulations, bioequivalence analysis showed that the 90% confidence intervals for the geometric mean ratios of the pharmacokinetic parameters were in the range of 80-125% in both fasting and fed groups. Therefore, the test and reference drugs of IDB were proved to be bioequivalent under the fasting and fed conditions, and they were safe and well tolerated after administration."

Journal • PK/PD data

Acute coronary syndrome with thrombocytopenia and megaloblastic anemia: A case report. (PubMed, Sci Prog) - "In recent years, the application of aspirin for coronary artery disease has become increasingly common, and aspirin-related enteropathy has gradually garnered more attention. Fortunately, after several months of follow-up, the patient's symptoms were alleviated, and his hemoglobin and platelet levels returned to normal. Indobufen might be a potential alternative medication for these patients in clinical practice in the future."

Journal • Acute Coronary Syndrome • Anemia • Cardiovascular • Coronary Artery Disease • Heart Failure • Hematological Disorders • Pain • Thrombocytopenia

Antiplatelet therapy trends in Chinese ischemic stroke patients 2019-2024. (PubMed, Sci Rep) - "Ticagrelor and indobufen showed rapid growth (both P < 0.001). Significant economic variations were observed: aspirin had the lowest DDC (¥0.57/DDD), while clopidogrel (¥3.60/DDD) and ticagrelor (¥6.61/DDD) decreased post-national centralized volume-based procurement policy (P < 0.001)...Cilostazol demonstrated 104% regional DDC variation (Shenyang ¥16.96/DDD vs. Harbin ¥8.29/DDD). Antiplatelet prescription counts in Chinese IS patients increased in the past five years, with aspirin remaining the most widely used and cost-effective option. The treatment landscape shows "traditional drug dominance with new drug growth", marked by significant economic and regional variations, necessitating guideline-aligned and policy-informed optimization of medication strategies."

Journal • Cardiovascular • Ischemic stroke

Computational Evaluation of Potential c-Abl Kinase Inhibitors for Parkinson's Disease: QSAR, Docking, Bioisosteric Replacement, ADMET, and MD Simulations. (PubMed, Appl Biochem Biotechnol) - "From 3605 drugs and 1456 bioisosteres, two bioisosteres of indobufen (indobufen 25 and 22) showed promising potential against c-Abl kinase. As the two bioisosteres returned the closest docking scores (14.880 and - 14.265 kcal mol-1, respectively) to the control drug (nilotinib, - 15.312 kcal mol-1), the Prime-MMGBSA calculations returned - 81.92 and - 84.07 kcal mol-1, respectively; MMPBSA calculations after a 200-ns MD simulation run returned - 48.20 ± 3.69 kcal mol-1 and - 49.94 ± 3.05 kcal mol-1, respectively...We present these bioisosteres as potential candidates for the treatment or management of PD targeting c-Abl kinase. However, in vitro and in vivo experiments to validate the findings are urgently required."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • ABL1

Indobufen alleviates apoptosis by the PI3K/Akt/eNOS pathway in myocardial ischemia‒reperfusion (I/R) injury. (PubMed, Sci Rep) - "In addition, indobufen increased the expression of p-Akt and p-eNOS in myocardial tissues and H9C2 cells, and LY294002, a specific inhibitor of the PI3K pathway, reversed these protective effects. In conclusion, indobufen reduced myocardial apoptosis and oxidative stress by the PI3K/Akt/eNOS pathway, thereby attenuating MI/R injury and improving cardiac function."

Journal • Cardiovascular • Myocardial Infarction • Myocardial Ischemia • Reperfusion Injury • NOS3

Efficacy and Safety of Indobufen in Patients with Coronary Artery Disease: A Systematic Review and Meta-Analysis. (PubMed, Clin Appl Thromb Hemost) - "The risk of ischemic stroke for secondary indicators was comparable (OR 0.98, 95%CI 0.63-1.52, p = 0.92, I2 = 3%). Similarly, the risk of myocardial infarction was comparable (OR 0.61, 95%CI 0.35-1.09, p = .10, I2 = 0%).ConclusionsAccording to the results of this meta-analysis, indobufen based treatment may reduce the bleeding risk with better efficacy than dual antiplatelet agents for the patients with coronary artery disease."

Clinical • Journal • Retrospective data • Review • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Ischemic stroke • Myocardial Infarction

Indobufen Versus Aspirin Plus Clopidogrel in Patients After Coronary Stenting in Patients With Diabetes: A Post Hoc Analysis of the OPTION Trial. (PubMed, J Diabetes) - "In patients receiving DES implantation, indobufen-based DAPT might be considered as a reasonable alternative to aspirin-based DAPT in the secondary prevention for those with diabetes, especially in patients at high bleeding risk."

Clinical • Journal • Retrospective data • Cardiovascular • Coronary Artery Disease • Diabetes • Hematological Disorders • Ischemic stroke • Metabolic Disorders • Myocardial Infarction • Thrombosis

Indobufen dual antiplatelet therapy (DAPT) vs aspirin dual antiplatelet therapy (DAPT) after Percutaneous Coronary Intervention (PCI) a systematic review and meta-analysis (ESC-WCC 2025) - "Our study found that indobufen-based (DAPT) therapy had a lower incidence of bleeding compared to aspirin-based (DAPT) therapy, and there was no difference between the two groups regarding myocardial infarction, cardiovascular death, ischemic stroke, stent thrombosis, and MACCE."

Retrospective data • Review • Cardiovascular • Ischemic stroke • Myocardial Infarction • Thrombosis

Indobufen-based dual antiplatelet therapy in patients with multivessel coronary disease undergoing drug-eluting stent implantation: insight from the OPTION trial (ESC-WCC 2025) - "In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI."

Clinical • Cardiovascular

Safety and Efficacy of Aspirin and Indobufen in the Treatment of Atherosclerotic Diseases: Systematic Review and Meta-Analysis. (PubMed, Interact J Med Res) - "Compared with aspirin, indobufen demonstrated better safety and was not inferior to aspirin in terms of efficacy, with superior results in some aspects (eg, fewer risks of adverse cardiovascular events and myocardial infarction). Further studies with larger sample sizes or longer follow-up periods may provide additional evidence."

Clinical • Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Hematological Disorders • Ischemic stroke • Myocardial Infarction • Thrombosis

INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT) (clinicaltrials.gov) - P=N/A | N=2500 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New trial • Cardiovascular • Vascular Neurology

Comparative effectiveness of Panax notoginseng saponins-related agents and antiplatelet agents in ischemic stroke: A systematic review and network meta-analysis. (PubMed, J Ethnopharmacol) - "Overall, our study indicates that initiating PNS plus aspirin therapy within 14 days of symptom onset, is associated with favorable functional outcomes in patients with IS compared with therapy comprising clopidogrel plus aspirin, indobufen, or aspirin alone. As such, PNS plus aspirin presents a potentially viable approach for the clinical treatment of IS, thereby contributing to a reduction in patient disability."

HEOR • Journal • Retrospective data • Review • Cardiovascular • Ischemic stroke

Effect of Stroke Severity on Efficacy and Safety of Indobufen versus Aspirin in Patients with Moderate to Severe Stroke: Results from the INSURE Randomized Clinical Trial. (PubMed, J Atheroscler Thromb) - "This exploratory analysis indicates that the benefit of indobufen in reducing new strokes within 3 months may vary across stroke severity. The potential non-inferiority of indobufen relative to aspirin in patients with NIHSS scores of ≥ 7, with no significant difference in safety, requires further study."

Clinical • Journal • Cardiovascular • Hematological Disorders • Ischemic stroke

Indobufen versus aspirin after percutaneous coronary intervention in elderly patients with acute coronary syndrome. (PubMed, BMC Cardiovasc Disord) - "Indobufen, as an alternative to aspirin, demonstrates comparable efficacy and safety in elderly ACS patients after PCI, with a potential reduction in gastrointestinal symptoms. These findings support the use of indobufen as a viable alternative for elderly ACS patients who are intolerant to aspirin."

Clinical • Journal • Retrospective data • Acute Coronary Syndrome • Allergy • Cardiovascular • Myocardial Infarction

A randomized controlled trial comparing the efficacy and safety of indobufen versus aspirin in reducing target vessel restenosis after drug-eluting balloon angioplasty in patients with coronary artery disease. (PubMed, Clinics (Sao Paulo)) - "Indobufen demonstrated non-inferior efficacy to aspirin in preventing TVR and MACE after DEB angioplasty in patients with CAD, with comparable safety profiles and no significant difference in gastrointestinal bleeding rates. However, indobufen is relatively more expensive than aspirin. While the present results suggest that indobufen may be a viable alternative to aspirin, particularly in patients at higher risk of gastrointestinal adverse reactions, this conclusion should be interpreted with caution due to the study's limitations, including its single-blind design and relatively small sample size."

Journal • Cardiovascular • Coronary Artery Disease • Gastroenterology

Meta-analysis of Indobufen Combined With Clopidogrel in the Treatment of Ischemic Stroke Patients. (PubMed, Clin Neuropharmacol) - "The dual antiplatelet therapy regimen using indobufen and clopidogrel is suitable for the treatment of ischemic stroke, which can effectively alleviate neurological damage and inhibit cerebral thrombogenesis."

Journal • Retrospective data • Cardiovascular • Ischemic stroke

Efficacy and Safety of Indobufen Combined with Clopidogrel in the Treatment of Intracranial Artery Stenting (ChiCTR) - P4 | N=198 | Not yet recruiting | Sponsor: Beijing Hospital; Beijing Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Vascular Neurology

Indobufen and Aspirin Hypersensitivity: A Promising Alternative or a Limited Option? (PubMed, J Cardiovasc Pharmacol) - No abstract available

Journal • Immunology

Role of Indobufen in coronary artery disease: the story of a neglected drug. A systematic review. (PubMed, J Cardiovasc Pharmacol) - "After years of empirical use, recent clinical studies have shed some light on the efficacy/safety profile of indobufen when compared to aspirin in low-risk CAD patients. However, also encouraged by promising pharmacodynamic data on platelet inhibition, further clinical investigations are strongly advocated."

Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease

Indobufen versus aspirin in patients with indication for antiplatelet therapy: A systematic review and meta-analysis. (PubMed, Vascul Pharmacol) - "The efficacy and safety of antiplatelet therapy with indobufen were comparable to those of aspirin alone. Therefore, indobufen can be considered as a suitable alternative for patients who are intolerant or hypersensitive to aspirin. Nevertheless, additional trials involving larger populations are required to establish their clinical applicability."

Journal • Retrospective data • Review • Cardiovascular • Ischemic stroke • Myocardial Infarction

The efficacy and safety of indobufen in patients with ischemic cardiovascular or cerebrovascular diseases: systematic review and meta-analysis. (PubMed, Front Cardiovasc Med) - "However, compared to anticoagulants such as aspirin and clopidogrel, indobufen has a shorter history of use, and its evidence base is relatively limited, highlighting the need for further research. However, due to the potential risks in MACE, stroke, and other events, further clinical trials are needed to assess the clinical applicability of indobufen. https://www.crd.york.ac.uk/, identifier (CRD42024587938)."

Journal • Retrospective data • Review • Cardiovascular • CNS Disorders • Gastrointestinal Disorder • Hematological Disorders • Myocardial Infarction • Thrombosis • Vascular Neurology

Indobufen-based Dual Antiplatelet Therapy in Patients with Multivessel Coronary Disease Undergoing Drug-eluting Stent Implantation Insight From the OPTION Trial. (PubMed, Am Heart J) - P4 | "In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI."

Journal • Cardiovascular