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Background: Thromboprophylaxis in bariatric surgery is widely debated; however, few large articles evaluate treatment plans and their efficacy. Herein, we make the first large-scale report of the safety and efficacy of apixaban (Eliquis) for thrombus prevention following bariatric surgery. Purpose: To evaluate the safety and efficacy of apixaban following bariatric surgery. Setting: Three private institutes, USA. Materials and Methods: Data from 5017 consecutive bariatric patients that were placed on postoperative apixaban for thromboprophylaxis were used for retrospective analysis. The dose prescribed to patients was 2.5 mg PO BID for a total of 30 days starting on day 3 postoperatively. Results: In total, of the 5017 patients, 59.7%, 31.2%, 4.4%, 2.5%, 1.8%, and 0.1% of the patients had undergone sleeve gastrectomy (SG), single-anastomosis duodeno-ileal bypass with SG (SADI-S), Roux-en-Y gastric bypass (RYGB), conversion from SG to SADI, small bowel reconstruction, and RYGB reversal, respectively. The 30-day follow-up rate was 95.3%. In total, 1.7% of patients experienced apixaban-related side effects. The most common side effects were menorrhagia and rash. Two (0.03%) side effects developed into Clavien-Dindo grade II complications. Overall, 10 (0.1%) patients experienced thromboembolic complications (five (0.09%) PVTs and five (0.09%) PEs). In each case, the protocol was not followed for extenuating circumstances. There were no deaths or thromboembolic events in cases where the protocol was able to be fully followed. Conclusions: In conclusion, 30 days of postoperative apixaban appears to be safe and effective with minimal side effects while preventing thromboembolic events. [ABSTRACT FROM AUTHOR]

Over the past few decades, drug discovery directed at the treatment and prevention of thromboembolic diseases has been challenged by the need to balance robust efficacy with improved safety relative to the standard of care. To this end, the most impactful advance to date has been the discovery and development of oral factor Xa inhibitors. In this essay, a brief account of the program that culminated in the discovery of Eliquis (apixaban) and the commitment to identify a compound with an optimal profile are described. [ABSTRACT FROM AUTHOR]

Purpose: To describe a case of a young woman who presented for fertility preservation and underwent ovarian stimulation with an etonogestrel implant in place. Methods: A 24-year old, gravida 0, with an etonogestrel implant and newly diagnosed lower extremity sarcoma and DVT desiring oocyte cryopreservation prior to adjuvant chemotherapy and radiation. To avoid delay in her oncologic care and allow for continued use of contraception post-retrieval, the patient underwent controlled ovarian hyperstimulation (COH) without removal of the etonogestrel implant. Results: Baseline labs included follicle-stimulating hormone 9 mIU/mL, luteinizing hormone 4.9 mIU/mL, estradiol 42 pg/mL, anti-Müllerian hormone 5.1 ng/mL, and antral follicle count greater than 40. The patient was placed on an antagonist protocol and stimulated with 125 IU Gonal-F and 75 IU Menopur. She received a total of 12 days of gonadotropin stimulation. On the day of trigger, her estradiol was 1472 pg/mL, lead follicle 21.5 mm with a total of 25 follicles measured > 12 mm. She was triggered with 5000 U hCG. She had a total of 23 oocytes retrieved, 17 of which were metaphase II and vitrified. Conclusions: COH and successful oocyte cryopreservation can be achieved in patients with an etonogestrel implant in situ without apparent detrimental effects to oocyte yield or maturity. Due to the etonogestrel implant's inhibitory effects on LH, it is recommended to use an hCG trigger for final oocyte maturation. [ABSTRACT FROM AUTHOR]

Purpose: This double-blind, placebo-controlled, intra-subject, dose-escalation study assessed single-dose safety, pharmacokinetics, and pharmacodynamics of apixaban in healthy Japanese and Caucasian subjects. Subjects and methods: Sixteen healthy male Japanese and sixteen healthy male Caucasian subjects, matched for age, weight, and smoking status were randomized to receive four sequential single oral doses of either apixaban (2.5, 10, 25, and 50 mg) or matched placebo. Doses were separated by a ≥5-day washout. Blood samples were collected for the determination of apixaban plasma concentration, clotting times (international normalized ratio [INR], activated partial thromboplastin time, and modified prothrombin time [mPT]), and ex vivo thrombin generation (TG). Urine samples were collected for the analysis of apixaban concentration. Results: Ascending single doses of apixaban 2.5–50 mg were safe and well tolerated by all subjects. Apixaban exposure increased the dose proportionally up to 10 mg. Apixaban reached maximum concentrations (Cmax) 3–4 h postdose, with mean Cmax ranging from 52.5–485.0 to 44.8–494.3 ng/mL in Japanese and Caucasian subjects. The mean half-life was ~8 and ~13 h and the renal clearance was 1.1 and 0.8 L/h in Japanese and Caucasian subjects, respectively. Pharmacodynamic assessments were similar between ethnic groups, with comparable dose-related prolongation of INR and mPT and inhibition of TG. Conclusion: Ascending single doses of apixaban over a 20-fold dose range were safe and well tolerated in Japanese and Caucasian subjects in this study. The consistency between pharmacokinetic and pharmacodynamic measures in Japanese and Caucasian subjects indicates that apixaban may be administered as a fixed dose with no need for adjustment in Japanese patients. [ABSTRACT FROM AUTHOR]