warfarin and Dyspepsia

Topics: Chamomile; Colic; Conjunctivitis; Cyclosporine; Dermatitis; Dermatitis, Contact; Diarrhea; Dyspepsia; Female; Flowers; Herb-Drug Interactions; Humans; Infant; Lactation; Morning Sickness; Phytotherapy; Plant Extracts; Plant Preparations; Pregnancy; Warfarin

Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.. In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism.. Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051).. In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)

Topics: Aged; Anticoagulants; Atrial Fibrillation; Benzimidazoles; Chi-Square Distribution; Dabigatran; Double-Blind Method; Dyspepsia; Embolism; Female; Follow-Up Studies; Hemorrhage; Humans; Liver; Male; Middle Aged; Myocardial Infarction; Prodrugs; Proportional Hazards Models; Pyridines; Stroke; Warfarin

Atrial fibrillation (AF) is a common cardiac arrhythmia. Dabigatran etixalate (DE) is one of the new oral anticoagulant drugs being used in nonvalvular AF (NVAF). There is no adequate real world data in different populations about DE. The aim of this registry was to evaluate the efficacy and safety of DE Consecutive NVAF patients treated with warfarin or both DE doses were enrolled during 18 months study period. The patients were re-evaluated at regular 6-month intervals during the follow-up period. During the follow-up period outcomes were documented according to RELY methodology A total of 555 patients were analyzed. There was no significant difference in ischemic stroke rates (p = 0.73), death rates (p = 0.15) and MI rates (p = 0.56) between groups. The rate of major bleeding was significantly higher in warfarin and dabigatran 150 mg group than dabigatran 110 mg (p < 0.001). Intracranial bleeding rate and relative risk were significantly lower in dabigatran 110 mg group than warfarin group (p = 0.004). Dyspepsia was significantly higher in both DE doses than warfarin (p = 0.004) Both DE doses are as effective as warfarin in reducing stroke rates in NVAF patients, without increasing MI rates. Intracranial bleeding rates are significantly lower in warfarin than both doses of DE and gastrointestinal bleeding risk increases with increased DE doses.

Topics: Aged; Anticoagulants; Atrial Fibrillation; Dabigatran; Dyspepsia; Female; Follow-Up Studies; Gastrointestinal Hemorrhage; Humans; Intracranial Hemorrhages; Male; Myocardial Infarction; Registries; Stroke; Warfarin

Although dyspepsia is common among nonvalvular atrial fibrillation (NVAF) patients, its impact on patient health and cost has not been adequately studied.. To evaluate the incremental health care burden associated with dyspepsia among NVAF patients and its impact on warfarin treatment.. NVAF patients ≥ 18 years of age with continuous insurance coverage were identified (January 1, 2007, to December 31, 2009) from the MarketScan Commercial and Medicare Research databases. Patients with 1 inpatient or 2 outpatient dyspepsia diagnoses within 12 months following any NVAF diagnosis were grouped into the dyspeptic cohort, and patients without any dyspepsia diagnosis were grouped into the nondyspeptic cohort. Of the overall cohorts, patients were matched by key patient characteristics. Dyspepsia was further categorized as having a prior history of dyspepsia (chronic) or no dyspepsia (nonchronic) during the baseline period. Health care resource utilization, associated costs, and warfarin use were evaluated during a 12-month follow-up period.. Of NVAF patients included in the study (N = 142,322), 10.4% were diagnosed with dyspepsia. After matching for key characteristics, NVAF patients with dyspepsia had significantly greater inpatient, outpatient, and prescription claims per patient year than those without dyspepsia (1.24 ± 1.21 vs. 0.36 ± 0.68, P < 0.0001; 110.18 ± 101.03 vs. 66.98 ± 72.43, P < 0.0001; and 52.13 ± 35.30 vs. 44.29 ± 32.41, P < 0.0001, respectively). This greater number of claims was reflected in higher annual inpatient, outpatient, and prescription payments ($23,610 ± $54,748 vs. $5,509 ± $19,142, P < 0.0001; $18,182 ± $28,790 vs. $9,765 ± $22,009, P < 0.0001; and $4,661 ± $5,628 vs. $3,897 ± $4,586, P < 0.0001, respectively). NVAF patients with chronic dyspepsia were the least likely to take warfarin for stroke prevention.. NVAF patients with dyspepsia experienced more all-cause hospitalizations and required more outpatient medical services, all associated with greater expenditures than NVAF patients without dyspepsia. Additionally, dyspepsia may be a barrier to warfarin use among NVAF patients.

Topics: Adolescent; Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Cost of Illness; Databases, Factual; Dyspepsia; Female; Follow-Up Studies; Health Care Costs; Hospitalization; Humans; Male; Middle Aged; Prescription Drugs; Retrospective Studies; Stroke; Warfarin; Young Adult

Topics: Anticoagulants; Atrial Fibrillation; Benzimidazoles; Dabigatran; Dyspepsia; Hemorrhage; Humans; Multicenter Studies as Topic; Prospective Studies; Pyridines; Randomized Controlled Trials as Topic; Warfarin