Results of a Russian multicenter open prospective study of the efficacy and safety of Telmista® and Telmista® H in patients with arterial hypertension 1 and 2 degrees
https://doi.org/10.38109/2075-082X-2022-2-17-26
Abstract
Relevance. The proportion of angiotensin receptor blockers has increased significantly among prescribed antihypertensive agents. To a large extent, this is facilitated by the emergence of new high-quality generic drugs available to the widest range of patients.
Study objectives. Evaluation of effectiveness and safety of Telmista® (Telmisartan 40 mg, 80 mg, tablets, JSC Krka, d.d., Novo Mesto, Slovenia) and Telmista® H (hydrochlorothiazide + telmisartan 12.5 mg + 40 mg , 12.5 mg + 80 mg, 25 mg + 80 mg, tablets, JSC «Krka, dd, Novo Mesto», Slovenia) in patients with arterial hypertension of 1 and 2 degrees.
Materials and methods. The study included 50 patients, 25 men and 25 women with arterial hypertension of 1–2 degrees. All patients underwent office blood pressure assessment, 24-hour blood pressure monitoring (ABPM), total cholesterol, HDL cholesterol, LDL cholesterol, TG, creatinine, glucose, insulin and glycated hemoglobin levels, HOMA index was calculated, urine microalbumin was determined, LV myocardial mass and LVMI were assessed according to ECHOCG at baseline and throughout the study. BP was re-measured after 4, 8, 12, 16, 20, 24 weeks of therapy, ABPM - after 16 weeks, the rest of the listed examinations - after 24 weeks.
Results. During therapy with Telmista® and Telmista® H, 89% of patients with grade 1–2 AH achieved the target BP level, which was accompanied by an improvement in the metabolic profile, a decrease in LVMI and urinary microalbumin (in 50% of patients), alongside with an improvement in the quality of life after 24 weeks treatment. Thus, due to high antihypertensive and organoprotective efficacy, excellent tolerability and availability, Telmista® and Telmista® can be the drugs of choice in hypertensive patients, especially those with metabolic disorders, to maximize the reduction of cardiovascular risk in this category of patients.
About the Authors
I. E. ChazovaRussian Federation
Irina E. Chazova, Prof., Dr. of Sci. (Med.), Academician of RAS, Deputy General Director for Scientific and Expert Work, Head of Hypertension Department
3rd Cherepkovskaya str., 15 a, Moscow 121552
Yu. V. Zhernakova
Russian Federation
Yuliya V. Zhernakova, Prof., Dr. of Sci. (Med.), Scientific Secretary of the Institute of Clinical Cardiology named after A.L. Myasnikov, National Medical Research Center of Cardiology
3rd Cherepkovskaya str., 15 a, Moscow 121552
N. E. Zvartau
Russian Federation
Nadezhda E. Zvartau, Cand. of Sci. (Med.), Associate Professor, Deputy General Director for Work with the Regions, Head of the Department for the Implementation of Federal Projects
st. Akkuratova, 2, St. Petersburg 197341
N. Sh. Zagidullin
Russian Federation
Naufal' Sh. Zagidullin, Prof., Dr. of Sci. (Med.), prof., cardiologist, head of the department of propaedeutics of internal diseases
st. Zaki Validi, 47, Ufa 450008
S. I. Kseneva
Russian Federation
Svetlana I. Kseneva, Dr. of Sci. (Med.)
Lenin Ave., 3, Tomsk 634028
O. Yu. Trifonova
Russian Federation
Olga Yu. Trifonova, Dr. of Sci. (Med.)
Lenin Ave., 3, Tomsk 634028
S. B. Erofeeva
Russian Federation
Svetlana B. Erofeeva, Cand. of Sci. (Med.), Clinical Pharmacologist, Head of the Department of Experimental and Clinical Research
st. Shchepkina, 61/2, Moscow 129110
References
1. Olsen MH, Angell SY, Asma S, et al. A call to action and a life course strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet 2016; 388:2665-2712. https://doi.org/10.1016/s0140-6736(16)31134-5
2. Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol 2021; published online May 28. 2021 Nov;18(11):785-802; https://doi.org/10.1038/s41569-021-00559-8
3. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980. https://doi.org/10.1016/S0140-6736(21)01330-1
4. Boytsov S.A. et al. Arterial hypertension among individuals of 25–64 years old: prevalence, awareness, treatment and control. By the data from ECCD. Cardiovasc Ther Prev. 2014;13(4):4-14]. https://doi.org/10.15829/1728-8800-2014-4-4-14
5. Yusuf S, Lonn E, Pais P, Bosch J, Lopez-Jaramillo P, Zhu J, Xavier D, Avezum A, Leiter LA, Piegas LS, Parkhomenko A, Keltai M, Keltai K, Sliwa K, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Accini JL, McKelvie R, Pogue J, Jung H, Liu L, Diaz R, Dans A, Dagenais G, HOPE-3 Investigators. Blood-pressure and cholesterol lowering in persons without cardiovascular disease. N Engl J Med 2016;374:2032-2043. https://doi.org/10.1056/nejmoa1600177
6. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. Eur Heart J. 2018 Sep 1;39(33):3021-3104. https://doi.org/10.1093/eurheartj/ehy339
7. Chazova I.E., Zhernakova Yu.V. on behalf of the experts. Clinical guidelines. Diagnosis and treatment of arterial hypertension. Systemic Hypertension. 2019;16(1):6-31]. https://doi.org/10.26442/2075082X.2019.1.190179
8. Appel GB, Appel AS. Angiotensin II Receptor Antagonists: Role in Hypertension, Cardiovascular Disease, and Renoprotection. Prog Cardiovasc Dis. 2004;47:105-115. https://doi.org/10.1016/j.pcad.2004.04.005
9. Weir MR, Dzau VJ. The renin-angiotensin-aldosterone system: a specific target for hypertension management. Am J Hypertens. 1999;12(12 Pt 3):205S-213S. https://doi.org/10.1016/s0895-7061(99)00103-x
10. Burnier M. Angiotensin II Type 1 Receptor Blockers. Circulation. 2001;103:904–912. https://doi.org/10.1161/01.cir.103.6.904
11. Lauer D, Slavic S, Sommerfeld M, et al. Angiotensin type 2 receptor stimulation ameliorates left ventricular fibrosis and dysfunction via regulation of tissue inhibitor of matrix metalloproteinase 1/matrix metalloproteinase 9 axis and transforming growth factor β1 in the rat heart. Hypertension. 2014;63:e60-7. https://doi.org/10.1161/hypertensionaha.113.02522
12. Kakuta H, Sudoh K, Sasamata M, et al. Telmisartan has the strongest binding affinity to angiotensin II type 1 receptor: Comparison with other angiotensin II type 1 receptor blockers Int. J Clin Pharmacol Res. 2005;25(1):41-6. PMID: 15864875
13. Stangier J, Su CA, Roth W. Pharmacokinetics of Orally and Intravenously Administered Telmisartan in Healthy Young and Elderly Volunteers and in Hypertensive Patients. J Int Med Res. 2000;28(4):149-67. https://doi.org/10.1177/14732300000280040
14. Zhu JR, Bai J, Cai NS, Tang B, Fan WH, Guo JZ, Ke YN, Guo JX, Sheng LH, Lu ZY, Cheng NN. Efficacy and safety of telmisartan vs. losartan in control of mild-to-moderate hypertension: a multicentre, randomised, double-blind study. Int J Clin Pract Suppl. 2004;(145):46-9. https://doi.org/10.1111/j.1742-1241.2004.00410.x, PMID: 15617459.
15. Lacourcière Y, Krzesinski JM, White WB, et al. Sustained antihypertensive activity of telmisartan compared with valsartan. Blood Press Monit 2004;9(4):203-10. https://doi.org/10.1097/00126097-200408000-00005
16. Yusuf S, Teo K, Anderson C, et al. Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008;372(9644):1174-83. https://doi.org/10.1016/S0140-6736(08)61242-8
17. Diener HC, Sacco RL, Yusuf S, et al. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008;7(10):875-84. https:// doi.org/10.1016/S1474-4422(08)70198-4
18. Taguchi I, Inoue T, Kikuchi M, et al. Pleiotropic effects of ARB on dyslipidemia. Curr Vasc Pharmacol. 2011;9(2):129-35. https://doi.org/10.2174/157016111794519336
19. Choi GJ, Kim HM, Kang H, Kim J. Effects of telmisartan on fat distribution: a meta-analysis of randomized controlled trials. Curr Med Res Opin. 2016; 32(7):1303-9. https://doi.org/10.1185/03007995.2016.1171204
20. K. Kinouchi, A. Ichihara, M. Sakoda, A. Kurauchi-Mito, K. Murohashi-Bokuda, and H. Itoh. Effects of telmisartan on arterial stiffness assessed by the cardio-ankle vascular index in hypertensive patients. Kidney Blood Press. Res. 2010;33(4):304–312. https://doi.org/10.1159/000316724
21. K. Yamaguchi et al. Effects of telmisartan on inflammatory cytokines and coronary plaque component as assessed on integrated backscatter intravascular ultrasound in hypertensive patients. Circ. J. 2014; 78(1): 240–247. https://doi.org/10.1253/circj.CJ-13-0741
22. Williams B, Gosse P, Lowe L, PRISMA I Study Group. The prospective, randomized investigation of the safety and efficacy of telmisartan versus ramipril using ambulatory blood pressure monitoring (PRISMA I). J Hypertens 2006; 24:193-200. https://doi.org/10.1097/01.hjh.0000194364.11516.ab
23. Williams B, Lacourcire Y, Schumacher H et al. Antihypertensive efficacy of telmisartan vs ramipril over the 24-h dosing period, including the critical early morning hours: a pooled analysis of the PRISMA I and II randomized trials. J Hum Hypertens 2009; 23 (9): 610–9. https://doi.org/10.1038/jhh.2009.4
24. Neldam S, Edwards C, ATHOS Study Group. Telmisartan plus hydrochlorothiazide compared with amlodipine plus hydrochlorothiazide in older patients with systolic hypertension: Results from a large ABPM study. Am J Geriat Cardiol 2006; 15(3):151-60. https://doi.org/10.1111/J.1076-7460.2006.05219.X
25. Neutel JM, Littlejohn TW, Chrysant SG, et al. Telmisartan/hydrochlorothiazide in comparison with losartan/hydrochlorothiazide in managing patients with mild-to-moderate hypertension. Hypertens Res. 2005;28:555-563. https://doi.org/10.1291/hypres.28.555
26. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension.Eur Heart J. 2018;39(33):3021-104. https://10.1093/eurheartj/ehy339
27. Wakino S., Ronald E. L., Hsueh W.A. Vascular protective effects by activation of nuclear receptor PPARγ. Journal of Diabetes and its Complications. 2002;16(1):46-9. https://10.1016/S1056-8727(01)00197-0
28. Hsueh W.A., Law R. The central role of fat and effect of peroxisome proliferator-activated receptorgamma on progression of insulin resistance and cardiovascular disease. Am J Cardiol. 2003;92(4A):3J-9J. https://10.1016/S0002-9149(03)00610-6
29. Schiffrin E.L., Amiri F., Benkirane K., et al. Peroxisome proliferator-activated receptors. Hypertension. 2003;42(4):664-668. https://10.1161/01.HYP.0000084370.74777.B6
30. Takagi H, Niwa M, Mizuno Y, et al. ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Telmisartan as a metabolic sartan: the first meta-analysis of randomized controlled trials in metabolic syndrome. J Am Soc Hypertens. 2013;7(3):229-35. https://10.1016/j.jash.2013.02.006
31. Derosa, G., Cicero, A., D'angelo, A. et al. Telmisartan and Irbesartan Therapy in Type 2 Diabetic Patients Treated with Rosiglitazone: Effects on Insulin-Resistance, Leptin and Tumor Necrosis Factor-α. Hypertens Res 29, 849-856. https://doi.org/10.1291/hypres.29.849
32. Mann JFE, Schmieder RE, McQueen M et al.; on behalf of the ONTARGET investigators. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet 2008;372 (9638):547-553. https://doi.org/10.1016/s0140-6736(08)61236-2
33. Makino H et al. Prevention of transition from incipient to overt nephropathy with telmisartan in patients with type 2 diabetes. Diabetes Care 2007;30:1577-8. https://doi.org/10.2337/dc06-1998
34. Barnett A et al. Angiotensin-receptor blockade versus convertingenzyme inhibition in type 2 diabetes and nephropathy. N Engl J Med 2004;351:1952-61. https://doi.org/10.1056/nejmoa042274
35. Barnett AH. Preventing renal complications in diabetic patients: the Diabetics Exposed to Telmisartan And enalaprIL (DETAIL) study. Acta Diabetol 2005; 42(Suppl. 1):S42-9. https://doi.org/10.1007/s00592-005-0180-4
36. Galle J, Schwedhelm E, Pinnetti S et al. Antiproteinuric effects of telmisartan versus valsartan in patients with type 2 diabetes and overt nephropathy. Nephrology Dialysis Transplantation 2008; 23(10):3174-83. https://doi.org/10.1093/ndt/gfn230
37. Bakris G, Burgess E, Weir M et al. on behalf of the AMADEO Study Investigators. Telmisartan is more effective than losartan in reducing proteinuria in patients with diabetic nephropathy. Kidney Int 2008; 74(3):364–9. https://doi.org/10.1038/ki.2008.204
38. Stehouwer CD. Microalbuminuria is associated with impaired brachial artery, flow-mediated vasodilation in elderly individuals without and with diabetes: further evidence for a link between microalbuminuria and endothelial dysfunction–the Hoorn Study. Kidney Int Suppl 2004; 66:S42-4. https://doi.org/10.1111/j.1523-1755.2004.09211.x
39. Schmieder RE, Delles C, Mimran A et al. Impact of telmisartan versus ramipril on renal endothelial function in patients with hypertension and type 2 diabetes. Diabetes Care 2007; 30(6):1351-6. https:// doi.org/10.2337/dc06-1551
Review
For citations:
Chazova I.E., Zhernakova Yu.V., Zvartau N.E., Zagidullin N.Sh., Kseneva S.I., Trifonova O.Yu., Erofeeva S.B. Results of a Russian multicenter open prospective study of the efficacy and safety of Telmista® and Telmista® H in patients with arterial hypertension 1 and 2 degrees. Systemic Hypertension. 2022;19(2):17-26. (In Russ.) https://doi.org/10.38109/2075-082X-2022-2-17-26