Aims: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. Methods: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.0%)
Nag A, Bornheimer R, Oster G. Pharmacotherapy patterns in patients with chronic idiopathic constipation beginning treatment with linaclotide or lubiprostone in the United States. Drugs Context 2020;9:2020-5-10.
Background: Chronic idiopathic constipation (CIC) is a common gastrointestinal disorder in community settings. Limited information exists on its treatment with the prosecretory agents linaclotide and lubiprostone. This retrospective cohort study investigated real-world pharmacotherapy patterns of linaclotide and lubiprostone. Methods: Patients (≥18 years) with CIC who received linaclotide or lubiprostone between January 2013 and December 2015 were identified
Weycker D, Wygant GD, Guo JD, Lee T, Luo X, Rosenblatt L, Mardekian J, Atwood M, Hanau A, Cohen AT. Bleeding and recurrent VTE with apixaban vs warfarin as outpatient treatment: time-course and subgroup analyses. Blood Adv 2020;4(2):432-9.
In the phase 3 trial Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy, apixaban was noninferior to enoxaparin, overlapped and followed by warfarin, in the treatment of venous thromboembolism (VTE) with significantly less bleeding; in a real-world evaluation, risks for bleeding and recurrent VTE were lower with apixaban vs
Edelsberg J, Weycker D, Bensink M, Bowers C, Lyman GH. Prophylaxis of febrile neutropenia with colony-stimulating factors: the first 25 years. Curr Med Res Opin 2020;36(3):483-95.
Filgrastim prophylaxis, both primary and secondary, was rapidly incorporated into clinical practice in the 1990s. When pegfilgrastim became available in 2002, it quickly replaced filgrastim as the colony-stimulating factor (CSF) of choice for prophylaxis. Use of prophylaxis increased markedly in the first decade of this century and has stabilized during the present decade. Data concerning real-world CSF prophylactic practice
Weycker D, Hanau A, Hatfield M, Wu H, Sharma A, Bensink ME, Chandler D, Grossman A, Tarantino M. Primary immune thrombocytopenia in US clinical practice: incidence and healthcare burden in first 12 months following diagnosis. J Med Econ 2020;23(2):184-192.
Introduction: Primary immune thrombocytopenia (ITP), an autoimmune disorder characterized by low platelet count, can lead to serious bleeding events. Little is known about the current epidemiology of ITP in the US, and even less is known about the current healthcare burden of ITP, especially in the 12-month period following ITP diagnosis. Method: We used a retrospective cohort design and data from two US private healthcare claims databases (2010-2016) to identify persons
Hagiwara M, Panjabi S, Delea T, Yucel E, Fonseca R. Burden of disease progression in patients with multiple myeloma in the US. Leuk Lymphoma 2020;61(1):47-55.
Effects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) and without receipt of stem cell transplant were estimated using large US claims database. Disease progression was defined as advancement to the next LOT, bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, acute kidney failure, or death within 12 months of LOT initiation. Annual
Kreuter M, Lederer DJ, Cottin V, Kahn N, Ley B, Vancheri C, Weycker D, Atwood M, Kirchgaessler KU, Ryerson CJ. Concomitant medications and clinical outcomes in idiopathic pulmonary fibrosis. Eur Respir J 2019;54(6):1901188.
This post hoc exploratory analysis found no clear associations between frequently used concomitant medication combinations and disease progression in 1450 patients with IPF enrolled in phase III trials, but several combinations may require further study. Link to PubMed
Hannan MT, Weycker D, McLean RR, Sahni S, Bornheimer R, Barron R, Travison TG, Kiel DP. Predictors of imminent risk of nonvertebral fracture in older, high-risk women: The Framingham Osteoporosis Study. JBMR Plus 2019;3(6):310129.
Osteoporosis treatment decisions are often based solely on BMD or on 10-year fracture risk; little is known about factors increasing imminent fracture risk. Understanding factors contributing to imminent risk of fracture is potentially useful for personalizing therapy, especially among those at high risk. Our aim was to identify predictors of nonvertebral fracture for 1- and
Delea TE, Zhang X, Amdahl J, Boyko D, Dirnberger F, Campioni M, Cong Z. Cost effectiveness of blinatumomab versus inotuzumab ozogamicin in adult patients with relapsed or refractory B-Cell precursor acute lymphoblastic leukemia in the United States. Pharmacoeconomics 2019;37(9):1177-93.
Background and objective: The TOWER and INO-VATE-ALL trials demonstrated the efficacy and safety of blinatumomab and inotuzumab ozogamicin (inotuzumab), respectively, versus standard-of-care (SOC) chemotherapy in adults with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). The cost effectiveness of blinatumomab versus inotuzumab has not previously been examined. Methods: Cost effectiveness of blinatumomab versus inotuzumab in
Stellato D, Thabane M, Eichten C, Delea T. Preferences of Canadian patients and physicians for adjuvant treatments for melanoma. Curr Oncol 2019;26(6):e755-e65.
Background: Past research suggests that patients with early- and late-stage melanoma will endure adverse events and inconvenient treatment regimens for improved survival. Evidence about the preferences of Canadian patients and physicians for novel adjuvant treatments for melanoma is unavailable. Methods: Patient and physician preferences for adjuvant treatments for melanoma were assessed in an online discrete choice experiment (dce). Treatment alternatives were characterized by 8 attributes with respect to dosing regimen, efficacy, and toxicities, with levels corresponding to those
Weycker D, Doroff R, Hanau A, Bowers C, Belani R, Chandler D, Lonshteyn A, Bensink M, Lyman GH. Use and effectiveness of pegfilgrastim prophylaxis in US clinical practice: a retrospective observational study. BMC Cancer 2019;19(1):792.
Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy. Clinical practice guidelines recommend routine prophylactic coverage with granulocyte colony-stimulating factor (G-CSF)-such as pegfilgrastim-for most patients receiving chemotherapy with an intermediate to high risk for FN. Patterns of pegfilgrastim prophylaxis during the chemotherapy course and associated FN risks in US clinical practice have not been well characterized. Methods: A retrospective cohort design and data from two commercial