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2 results on '"N. Novikovs"'

1. Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study

Author

P.W. Kamphuisen, A.Y.Y. Lee, G. Meyer, R. Bauersachs, M.S. Janas, M.F. Jarner, A.A. Khorana, R. Bella Santiago, S. Cerana, J.J. Zarbá, J. Andel, C.H. Barrios, A. Borba Reiriz, F. Cesario, S. de Azevedo, A.F. Ferreira Filho, F.A. Franke, S. Padilha, R. Paiva Queiroz, A. Pimenta, J. Rerin, R. Rigo, S.B. van Eyll Rocha, G. Santos Borges, G. Vacaro, V. Anastasov, T. Dragneva, G. Georgiev, P. Champion, P. Kuruvilla, C. Gonzalez, P. Ditl, J. Förster, B. Lubomir, J. Vydra, R.A. El Hassan, S. Sabri, N. Allahloubi, A. Elzawawy, S.S. Ezzat, M.S. El Kady, L. Bacchus, J. Beyer‐Westendorf, U. Kamphausen, D. Niederwieser, H. Ostermann, M. Sosada, N. Anagnostopoulos, G. Fountzilas, C. Ioannou, C. Liapis, J.F.B. Schaeffer, S. Atilli, S. Balsubramanian, S. Bondarde, S.C. Desai, C. Deshmukh, D.P. Singh, F. Gharami, L. Goyal, S. Gupta, S. Gupte, K.K. Mukherjee, S. Krishnan, K. Kumar, A. Mehta, K. Mishra, R. Naik, S. Pawar, R.V. Nagarkar, N. Warrier, B. Brenner, I. Gavish, G. Lugassy, M. Kolin, B. Enrico, M.G. Mazzucconi, G. Visani, A. Awidi, N. Novikovs, J. Miscuks, D. Abigerges, F. Farhat, P. Khoueiry, J. Makarem, O. Alvarez Ordorica, E. Anaya Santacruz, G. Calderillo Ruiz, J.H. de la Concha Ureta, W.S.R. Pantigoso, M. Philco, A.R. Pineda, E.A.V. Queszada, K. Gawrychowski, W. Witkiewicz, E. Macias, E. Teixeira, T.‐E. Ciuleanu, C.C. Ligia, D. Lungulescu, I.G. Manolescu, A. Rodica, C. Volovat, Y. Burov, I. Katelnitsky, D. Svistov, K. Ahmad, F. Algahtani, H. Al‐Zahrani, M. Qari, D. Jovanovic, N. Milanovic, B. Perin, V. Stojanovic, L. Tomasic, J. Chovanec, O. Herman, V. Kissova, F. Sasvary, S. Špánik, M. Szentivanyi, F. Barón, E. Gallardo, D. Jiménez, O. Remedios, A. Sanchez, J. Engelbrecht, N. Jonas, G. McAdam, M. Patel, B. Rapoport, B. Robertson, D. Oh, H. Kim, H.‐K. Kim, H.J. Kim, H.S. Kim, J.S. Ahn, J. Chung, J. Jang, K.U. Park, S.‐W. Shin, S.H. Kim, S‐S. Yoon, Y.‐K. Kim, C.‐F. Chiu, C.‐S. Chang, J.‐H. Liu, K.‐M. Rau, S.‐W. Chen, S. Chittima, T. Ekkapong, K. Nonglak, A. Pantep, M. Pramook, S. Thanakrit, S. Patrapim, T. Sumitra, C. Udomluck, I. Kobza, O. Nykonenko, V. Prasol, I. Vladychuk, and Cardiovascular Centre (CVC)

Subjects
Male, medicine.medical_specialty, anticoagulants, Time Factors, INTRACRANIAL HEMORRHAGE, venous thromboembolism, neoplasms, BRAIN METASTASES, Hemorrhage, 030204 cardiovascular system & hematology, Malignancy, Risk Assessment, ANTICOAGULANT TREATMENT, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Medicine, Humans, Prospective Studies, THERAPEUTIC RANGE, Aged, COMPLICATIONS, tinzaparin, business.industry, Incidence, Hazard ratio, RIETE REGISTRY, Warfarin, Cancer, Hematology, Tinzaparin, MOLECULAR-WEIGHT HEPARIN, Middle Aged, medicine.disease, bleeding, Thrombosis, Confidence interval, Exact test, WARFARIN PATIENTS, Treatment Outcome, 030220 oncology & carcinogenesis, INTERNATIONAL NORMALIZED RATIO, ATRIAL-FIBRILLATION, Female, Drug Monitoring, business, medicine.drug
Abstract

Essentials Cancer patients receiving anticoagulants for venous thromboembolism have an elevated bleeding risk. This secondary analysis of CATCH assessed characteristics of clinically relevant bleeding (CRB). CRB occurs in 15% of cancer patients with thrombosis using therapeutic doses of anticoagulation. After multivariate analysis, risk factors for CRB were age >75 years and intracranial malignancy. Summary Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg-1 once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of 75 years and intracranial malignancy.

Published
2018

2. Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections.

Author

Solomkin JS, Ramesh MK, Cesnauskas G, Novikovs N, Stefanova P, Sutcliffe JA, Walpole SM, and Horn PT

Subjects
Adolescent, Adult, Aged, Community-Acquired Infections microbiology, Double-Blind Method, Ertapenem, Female, Humans, Intraabdominal Infections microbiology, Male, Middle Aged, Young Adult, Anti-Bacterial Agents therapeutic use, Community-Acquired Infections drug therapy, Intraabdominal Infections drug therapy, beta-Lactams therapeutic use
Abstract

Eravacycline is a novel fluorocycline, highly active against Gram-positive and Gram-negative pathogens in vitro, including those with tetracycline and multidrug resistance. This phase 2, randomized, double-blind study was conducted to evaluate the efficacy and safety of two dose regimens of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs). Patients with confirmed cIAI requiring surgical or percutaneous intervention and antibacterial therapy were randomized (2:2:1) to receive eravacycline at 1.5 mg/kg of body weight every 24 h (q24h), eravacycline at 1.0 mg/kg every 12 h (q12h), or ertapenem at 1 g (q24h) for a minimum of 4 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 10 to 14 days after the last dose of study drug therapy. Overall, 53 patients received eravacycline at 1.5 mg/kg q24h, 56 received eravacycline at 1.0 mg/kg q12h, and 30 received ertapenem. For the ME population, the clinical success rate at the TOC visit was 92.9% (39/42) in the group receiving eravacycline at 1.5 mg/kg q24h, 100% (41/41) in the group receiving eravacycline at 1.0 mg/kg q12h, and 92.3% (24/26) in the ertapenem group. The incidences of treatment-emergent adverse events were 35.8%, 28.6%, and 26.7%, respectively. Incidence rates of nausea and vomiting were low in both eravacycline groups. Both dose regimens of eravacycline were as efficacious as the comparator, ertapenem, in patients with cIAI and were well tolerated. These results support the continued development of eravacycline for the treatment of serious infections, including those caused by drug-resistant Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under registration no. NCT01265784.).

Published
2014
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