Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function, arterial stiffness, vascular inflammation, oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk.
The largest population that suffers from cardiovascular events are subjects at moderate cardiovascular risk. However, no effective and safe preventive treatment is available for this population. This study aimed to investigate whether their arterial wall phenotype could be turned to a preventive direction by low-dose fluvastatin/valsartan combination (low-flu/val).
Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo). At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell adhesion molecule 1, total antioxidant status and expression of several protective genes (SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | received fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days |
|
| control group | Placebo Comparator | received placebo for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluvastatin 10 mg and valsartan 20 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| brachial flow-mediated dilatation (FMD) | FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia) | 30 days |
| reactive hyperaemia index (RHI) | RHI measured by Endopat device | 30 days |
| beta stiffness coefficient | assessed by ultrasound employing e-Tracking on right common carotid artery | 30 days |
| carotid pulse wave velocity (c-PWV) | assessed by ultrasound employing e-Tracking on right common carotid artery | 30 days |
| carotid-femoral PWV (cf-PWV) | cf-PWV measured by Sphygmocor device | 30 days |
| high-sensitivity C-reactive protein (hs-CRP) | inflammatory marker | 30 days |
| interleukin 6 (IL-6) | inflammatory marker | 30 days |
| vascular cell adhesion molecule 1 (VCAM1) | inflammatory marker | 30 days |
| total antioxidant status (TAS) |
| Measure | Description | Time Frame |
|---|---|---|
| brachial flow-mediated dilatation (FMD) | FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia) | 10 weeks after treatment completion |
| reactive hyperaemia index (RHI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27222591 | Background | Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available. | |
| 26567372 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
|
marker of oxidative stress |
| 30 days |
| gene SIRT1 | Hs01009006_m1 | 30 days |
| gene mTOR | Hs00234522_m1 | 30 days |
| gene NF-kB1 | Hs00765730_m1 | 30 days |
| gene Nrf2/NFE2L2 | Hs00975961_g1 | 30 days |
| gene AMPK/PRKAA1 | Hs01562315_m1 | 30 days |
RHI measured by Endopat device
| 10 weeks after treatment completion |
| beta stiffness coefficient | assessed by ultrasound employing e-Tracking on right common carotid artery | 10 weeks after treatment completion |
| carotid pulse wave velocity (c-PWV) | assessed by ultrasound employing e-Tracking on right common carotid artery | 10 weeks after treatment completion |
| carotid-femoral PWV (cf-PWV) | cf-PWV measured by Sphygmocor device | 10 weeks after treatment completion |
| Background |
| Matsuzawa Y, Kwon TG, Lennon RJ, Lerman LO, Lerman A. Prognostic Value of Flow-Mediated Vasodilation in Brachial Artery and Fingertip Artery for Cardiovascular Events: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2015 Nov 13;4(11):e002270. doi: 10.1161/JAHA.115.002270. |
| 20338492 | Background | Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061. |
| 28408026 | Background | Paneni F, Diaz Canestro C, Libby P, Luscher TF, Camici GG. The Aging Cardiovascular System: Understanding It at the Cellular and Clinical Levels. J Am Coll Cardiol. 2017 Apr 18;69(15):1952-1967. doi: 10.1016/j.jacc.2017.01.064. |
| 22385885 | Background | Lunder M, Janic M, Jug B, Sabovic M. The effects of low-dose fluvastatin and valsartan combination on arterial function: a randomized clinical trial. Eur J Intern Med. 2012 Apr;23(3):261-6. doi: 10.1016/j.ejim.2011.11.011. Epub 2011 Dec 12. |
| 28012835 | Background | Boncelj Svetek M, Erzen B, Kanc K, Sabovic M. Impaired endothelial function and arterial stiffness in patients with type 2 diabetes - The effect of a very low-dose combination of fluvastatin and valsartan. J Diabetes Complications. 2017 Mar;31(3):544-550. doi: 10.1016/j.jdiacomp.2016.12.002. Epub 2016 Dec 16. |
| 24263076 | Background | Janic M, Lunder M, Prezelj M, Sabovic M. A combination of low-dose fluvastatin and valsartan decreases inflammation and oxidative stress in apparently healthy middle-aged males. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):208-12. doi: 10.1097/HCR.0000000000000027. |
| 28870631 | Background | Sosnowska B, Mazidi M, Penson P, Gluba-Brzozka A, Rysz J, Banach M. The sirtuin family members SIRT1, SIRT3 and SIRT6: Their role in vascular biology and atherogenesis. Atherosclerosis. 2017 Oct;265:275-282. doi: 10.1016/j.atherosclerosis.2017.08.027. Epub 2017 Aug 26. |
| 27040132 | Background | Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, Lopez-Jaramillo P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M, Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G, McKelvie R, Pogue J, Jung H, Gao P, Diaz R, Lonn E; HOPE-3 Investigators. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2021-31. doi: 10.1056/NEJMoa1600176. Epub 2016 Apr 2. |
| 24814489 | Background | Robinson JG, Gidding SS. Curing atherosclerosis should be the next major cardiovascular prevention goal. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2779-85. doi: 10.1016/j.jacc.2014.04.009. Epub 2014 May 7. |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |