3 курс / Фармакология / Диссертация_Шаталова_О_В_Сравнительная_клинико_экономическая_оценка

221

234. Rodger, M.A. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy [Text] / Rodger M.A., Kahn S.R., Wells P.S., [et al.] // CMAJ. – 2008. – Vol. 179. –N.5. – P. 417 – 426.

235.Rodriguez, RA. Nonadherence to new oral anticoagulants: areason for concern during long–term anticoagulation? [Text] / Rodriguez RA, Carrier M, Wells PS. // J Thromb Haemost. – 2013. – Vol.11. – P. 390 – 394.

236.Romualdi, E. Oral rivaroxaban after symptomatic venous thromboembolism: the continued treatment study (EINSTEIN–extension study) [Text] / E. Romualdy, M.P. Donadini, W. Ageno // Expert Rev Cardiovasc Ther. – 2011 Jul. – Vol. 9. – N 7. – P. 841 – 844.

237.Frost C. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. / Frost C, Wang J, Nepal S, [et al.] // Br J Clin Pharmacol. – 2013. – Vol. 75. – P. 476 - 487.

238.Rose, AJ. Risk–adjusted percent time in therapeutic range as a quality indicator for outpatient oral anticoagulation results of the Veterans Affairs Study To Improve Anticoagulation (VARIA) [Text] / Rose AJ, [et al.] // Circ Cardiovasc Qual Outcomes. – 2011. – Vol. 4. – P. 22 – 29.

239.Chang M. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban. [Text] / Chang M, Yu Z, Shenker A, [et al.] // J Clin Pharmacol. – 2016. – Vol. 56. – P. 637 - 645.

240.Ruíz-Giménez, N. Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry. RIETE Investigators. [Text] / Ruíz-Giménez N, Suárez C, González R, [et al.] // Thromb Haemost. – 2008. Jul. – Vol. 100. – N.1. – P. 26 - 31.

241.Schulman, S. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. [Text] / Schulman S, Kakkar AK, Goldhaber SZ, [et al.] // Circulation. – 2014. – Vol.129. – P. 764 - 772.

242.Samantha, MacLean. /Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of CHEST Physicians Evidence–Based Clinical

222

Practice Guidelines / Samantha MacLean, Sohail Mulla, Elie A. Akl, [et al.] //

CHEST. – 2012. – P. 141.

243.Sandén, P. Bleeding complications and mortality in warfarin–treated VTE patients, dependence of INR variability and iTTR [Text] / Sandén P, Renlund H, Svensson PJ, [et al.] // Thromb Haemost. – 2017Jan. – Vol.117. – N.1. – P. 27 – 32.

244.Sandén, P. Bleeding complications in venous thrombosis patients on well– managed warfarin [Text] / Sandén P, Renlund H, Svensson PJ, [et al.] // Thromb Thrombolysis. – 2016. – Vol. 41. – N.2. – P. 351 – 358.

245.Sanderson, S. CYP2C9 gene variants, drug dose, and bleeding risk in warfarin–treated patients: a HuGEnet systematic review and metaanalysis [Text] / S. Sanderson, J. Emery, J. Higgins // Genet Med. – 2005. – Vol. 7. – N 2. – P. 97 – 104.

246.Sardar, P. Novel oral anticoagulants in patients with renal insufficiency: a meta–analysis of randomized trials [Text] / Sardar, P., Chatterjee, S., Herzog, E., [et al.] // Can. J. Cardiol. – 2014. – Vol.30. – P. 888 – 897.

247.Scaglione, F. New oral anticoagulants: comparative pharmacology with vitamin K antagonists [Text] / F. Scaglione // Clin Pharmacokinet. – 2013. – Vol. 52. – P. 69 – 82.

248.Schulman, S. Dabigatran versus warfarin in the treatment of acute venous thromboembolism [Text] / Schulman S, Kearon C, Kakkar AK, [et al.] // The New England Journal of Medicine. – 2009. – Vol. 361. – N.24. – P. 2342 – 2352.

249.Schulman, S. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch [Text] / Schulman S, Crowther M.A. // Blood. – 2012. – Vol.119. – P. 3016 – 3023.

250.Schulman, S. RE–COVER II Trial Investigators.Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis / Schulman, S., Kakkar AK, Goldhaber SZ, [et al.]. // Circulation. – 2014. – Vol. 129. – N.7. – P. 764 – 772.

251.Schweikert, В Demographics, clinical characteristics, health resource utilization and cost of chronic thromboembolic pulmonary hypertension patients: retrospective results fromВ, PittrowsixEuropeanD, countries [Text] / Schweikert

223

Carmine Dario Vizza [et al.] // BMC Health Services Research. – 2014. – Vol.

14.– P. 246.

252.Sébastien, Gaertnera, , Rivaroxaban versus standard anticoagulation for symptomatic venous thromboembolism (REMOTEV observational study): Analysis of 6–month outcomes [Text] / Sébastien Gaertnera, Elena–Mihaela Cordeanua, Salah Nouria, [et al.] // International Journal of Cardiology. – 2017. – Vol. 226. – P. 103 –

253.Shalansky, SJ. Self–reported Morisky Score for identifying nonadherence with cardiovascular medications [Text] / Shalansky SJ, Levy AR, Ignaszewski AP. // The Annals of Pharmacotherapy. – 2004. – Vol. 38. – P. 1363 – 1368.

254.Sharifi, M. Low incidence of post–thrombotic syndrome in patients treated with new oral anticoagulants and percutaneous endovenous intervention for lower extremity deep venous thrombosis [Text] / M. Sharifi, W. Freeman, C. Bay [et al.] // Vasc Med. – 2015 Apr. – Vol. 20. – N 2. – P. 112 – 116.

255.Simpson, SH. A meta–analysis of the association between adherence to drug therapy and mortality [Text] / Simpson SH, Eurich DT, Majumdar SR. [et al.] // BMJ. – 2006. – Vol. 333. – P. 15 – 20.

256.Siragusa, S. Low–molecular–weight heparins and unfractionated heparin in the treatment of patients with acute venous thromboembolism: results of a meta– analysis [Text] / S. Siragusa, B. Cosmi, F. Piovella [et al.] // Am J Med. – 1996. – Vol.

100.– N 3. – P. 269 – 277.

257.Smith, ML. Weight based heparin protocol using antifactor Xa monitoring [Text] / Smith ML., Wheeler KE. // Am J Health–Syst Pharm. – 2010. – Vol. 67. – P.

371– 374.

258.Smith, S. Early anticoagulation is associated with reduced mortality for acute pulmonary embolism [Text] / S. Smith, J. Geske, J. Maguire [et al.] // CHEST. – 2010. – Vol. 137. – N 6. – P. 1382 – 1390.

259.Sogaard, K.K. 30–Year mortality after venous thromboembolism: a population–based cohort study [Text] / Sogaard K.K., Schmidt M., Pedersen L., [et al.] // Circulation. – 2014. –Vol. 130. – P. 829 – 836.

224

260. Sokol, MG. Impact of medication adherence on hospitalization risk and healthcare cost [Text] / Sokol MG, McGuigan KA, Verbrugge R. [et. al.] // Med Care. – 2005. Vol. 43. – N.6. – P. 521 – 530.

261.Song, X. Patterns and predictors of use of warfarin and other common long–term medications in patients with atrial fibrillation [Text] / Song X, Sander SD, Varker H, [et al.] // Am J Cardiovasc Drugs. – 2012. Vol.12. – P. 245 – 53.

262.Spencer, F. The Worcester Venous Thromboembolism study: a population– based study of the clinical epidemiology of venous thromboembolism [Text] / F.Spenser, C. Emery, D. Lessard [et al.] // J. Gen. Intern. Med. – 2006. – N 21. – P. 722

–727.

263.Spyropoulos, AC. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: An administrative claims analysis from 30 managed care organizations [Text] / Spyropoulos AC., Lin J. // J Manag Care. Pharm. – 2007. – Vol.13. – N.6 – P.475–486.

264.Stergiopoulos, K. Genotype–guided vs clinical dosing of warfarin and its analogues: meta–analysis of randomized clinical trials [Text] / K. Stergiopoulos, D.L. Brown // JAMA Intern Med. – 2014 Aug. – Vol. 174. – N 8. – P. 1330 – 1338.

265.Strom, B.L. Textbook of Pharmacoepidemiology [Text] / Strom B.L. , Kimmel S.E., Hennessy S // 2nd edition: Wiley–Blackwell. – 2013.

266.Tagalakis, V. Incidence of and mortality from venous thromboembolism in a real–world population: the Q–VTE Study Cohort [Text] / Tagalakis V, Patenaude V, Kahn SR, [et al.] // The American Journal of Medicine. – 2013. Vol.126. – N.9. – spp. 832. – P. 13 – 21.

267.Tajiri, K. Impact of rivaroxaban compared with warfarin on the coagulation status in Japanese patients with non–valvular atrial fibrillation: a preliminary analysis of the prothrombin fragment 1+2 levels [Text] / K. Tajiri, F. Sato, T. Harunari [et al.] // J Cardiol. – 2015 Mar. – Vol. 65. – N 3. – P. 191 – 196.

268.The AMCP Format for Formulary Submissions [Version 3.1.] Academy of

http://www.amcp.org/practice–resources/amcp–format–formulary–submisions.pdf

225

269.The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism [Text] // N Engl J Med. – 2010. – Vol. 363. – P. 2499 – 2510.

270.The Ninth ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence–Based Guidelines [Text] // CHEST. – 2012. Vol. 141. – N.2. – spp. 7S–801S.

271.Tosetto, A. Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH) [Text] / Tosetto A., Iorio A., Marcucci M., [et al.] // J Thrombol Haemost. – 2012. Vol. 10. N.6.

–P. 1019 – 1025.

272.U.S. Food & DRUG [Электронныйресурс] Режим//доступа:

http://www.fda.gov/Food/default.htm (д атаобращения10.01.2016);

273.Ho, WK. Risk of recurrent venous thromboembolism in patients with common thrombophilia: a systematic review [Text] / Ho WK, Hankey GJ, Quinlan DJ, [et al.] // Arch Intern Med. – 2006. – Vol.166. – P. 729 – 36.

274.Van Dongen, C.J. Relation between quality of anticoagulant treatment and the development of the postthrombotic syndrome [Text] / C.J. Van Dongen, P. Prandoni, M. Frulla [et al.] // J Thromb Haemost. - 2005. - Vol. 3. - P. 939 - 942

275.Van Den Belt, AG. Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism [Text] / van Den Belt AG, Prins MH, Lensing AW, [et al.] // Cochrane Database Syst Rev. – 2000. Vol. 2. – CD001100.

276.Van der Hulle, T. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta–analysis [Text] / van der Hulle T, Kooiman J, den Exter PL, [et al.] // J Thromb Haemost. – 2014. Vol. 12. – P. 320 – 328

277.Van Dongen, C.J. Relation between quality of anticoagulant treatment and the development of the postthrombotic syndrome [Text] / C.J. Van Dongen, P. Prandoni, M. Frulla [et al.] // J Thromb Haemost. – 2005. – Vol. 3. – P. 939 – 942.

226

thromboembolic diseases and the role of thrombophilia testing. NICE clinical guideline

144.Guidance.nice.org.uk/cg144. – 2014.

279.Venous Thromboembolism: morbidity // GlobalData: [electronic resource] / Analytics company. – Last update November 2016.

280.Verhovsek, M. Systematic review: D–dimer to predict recurrent disease after stopping anticoagulant therapy for unprovoked venous thromboembolism [Text] / Verhovsek M., Douketis J.D., Yi Q., Shrivastava S., [et al.] // Ann Intern Med. – 2008. Vol. 149. N. 7. – P. 481 – 490.

281.Vienna predictionЭлектронныйресурс]. Memodel for recurrent VTE [

Univ Vienna Cent Med Stat Informatics Intell Syst Режим доступа:

http://cemsiis.meduniwien.ac.at/en/kb/science–research/software/clinical–

software/recurrent–vte/#calc–params.

282.Weitz, J.I. EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study [Text] / Weitz J.I., Bauersachs R., Beyer– Westendorf J., [et al.] // Thromb Haemost. – 2015. Vol.114. – P. 645 – 650.

283.Wells, PS. Long–term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit–Risk Analysis of EINSTEIN–Extension [Text] / Wells PS, Prins MH, Levitan B, [et al.] // CHEST. – 2016.Nov. Vol.150. N. 5. – P. 1059 – 1068.

284.Wells, PS. Treatment of venous thromboembolism [Text] / Wells PS, [et al.] // JAMA. – 2014. Vol. 311. N.7. – P. 717 – 728.

285.Werth, S. Bleeding risk, management and outcome in patients receiving non–VKA oral anticoagulants (NOACs) [Text] / S. Werth, T. Breslin, F. NiAinle [et al.]

//Am J Cardiovasc Drugs. – 2015 Aug. – Vol. 15. – N 4. – P. 235 – 242.

286.White, R.H. Major bleeding after hospitalization for deep–venous thrombosis [Text] / R.H. White, R.J. Beyth, H. Zhou [et al.] // Am J Med. – 1999. – Vol 107. – N 5. – P. 414 – 424.

227

287. White, RH. Effect of ethnicity and gender on the incidence of venous thromboembolism in a diverse population in California in 1996 [Text] / White RH, Zhou H, Murin S, [et al.] // Thromb Haemost. – 2005. Vol. 93. – P. 298 – 305.

288.Whitlock, RP. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic therapy and prevention of thrombosis, 9th ed: [Text] / Whitlock RP, Sun JC, Fremes SE, [et al.] // American College of CHEST Physicians evidence based clinical practice guidelines. CHEST – 2012. Vol. 141. P. 576s – 600s.

289.Wittkowsky, AK. New oral anticoagulants: a practical guide for clinicians [Text] / Wittkowsky AK. // J Thromb Thrombolysis. – 2010. Vol. 29. – P. 182 – 191.

290.World Health Organization: Adherence to long–term therapies, evidence for action. / Geneva. – 2003. – [Электронный ресурс] // Режим доступа:

http://apps.who.int/medicinedocs/pdf/s4883e/s4883e.pdf

291.Young VL. The need for venous thromboembolism (VTE) prophylaxis in plastic surgery [Text] / Young VL, Watson ME. // Aesthet Surg J. – 2006. – Vol. 26. – N.2. – P. 157 - 175.

292.Morgan, C.L. Warfarin treatment in patients with atrial fibrillation: observing outcomes associated with varying levels of INR control. [Text] / Morgan, C.L., McEwan, P., Tukiendorf, A., [et al.] // Thromb Res. – 2009. – Vol. 124. – P. 37 – 41.

293.Yusuf, H.R. Hospitalizations of adults ≥60 years of age with venous thromboembolism [Text] / Yusuf H.R., Reyes N., Zhang Q.C., [et al.] // Clin Appl Thromb Hemost. – 2014. – Vol. 20. – P. 136 – 142.

294.Yusuf, H.R. Venous thromboembolism in adult hospitalizations United States, 2007 – 2009 [Text] / H.R. Yusuf, J. Tsai, H.K. Atrash [et al.] // MMWR Morb Mortal Wkly Rep. – 2012. – Vol. 61. – P. 401 – 404.

295.Simon, J. Evaluation of prescribing and patient use of target-specific oral anticoagulants in the outpatient setting [Text] / Simon J, Hawes E, Deyo Z, [et al.] // J Clin Pharm Ther. – 2015. – Vol. 40. – P. 525 - 530.

apixaban in subjects with end-stage renal disease on hemodialysis. [Text] / Wang X, Tirucherai G, Marbury TC, [et al.] // J Clin Pharmacol. – 2016. – Vol. 56. – P. 628 - 636.

229

230

Приложение2 . Схемаисследования

Визит 0 (скрининг)

День -2...-1

Подписание информированного согласия Включение пациента в исследование

!

Визит 1

День 1

Рандомизация больных, стратификация по риску развития кровотечений

!

!

Визит 2

Неделя 1 (Оценка состояния пациента)

!

Визит 3

Неделя 4 (Оценка состояния пациента)

!

Визит 4

Неделя 12 (Оценка состояния пациента)

!

Визит 5

Неделя 24 (Окончание терапии) Заключительный осмотр

!