Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia

Jin, Xuan; Kim, Moo Hyun; Han, Ki Hoon; Hong, Soon Jun; Ahn, Jin‐Chul; Sung, Jung Hoon; Cho, Jin Man; Lee, Han Cheol; Choi, So Yeon; Lee, Kyounghoon; Kim, Woo Shik; Rhee, Moo Yong; Kim, Ju Han; Hong, Seung Pyo; Yoo, Byung Su; Cho, Eun Joo; Lee, Jae‐Hwan; Kim, Pum Joon; Park, Chang Gyu; Hyon, Min Su; Shin, Jinho; Lee, Sang Hyun; Sung, Ki Chul; Hwang, Jin‐Yong; Kwon, Kihwan; Chae, In Ho; Seo, Jeong-Sook; Kim, Hyungseop; Lee, Hana; Cho, Yoonhwa; Kim, Hyo Soo

doi:10.1111/jch.13893

Cited by 9 publications

(10 citation statements)

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“…To the best of our knowledge, this metanalysis also studies rosuvastatin's effect on BP variability based on newer randomized control trials which were not included in previously studied metanalyses. 40,42,47,70 Heterogeneity in our studies was found to be significant in terms of efficacy of statins on variability of SBP (I 2 = 93%; p < .00001) and DBP (I 2 = 81%; p < .00001). The possible reasons for this heterogeneity can be explained by the methodological differences of the different studies; the existence of a large number of studies; a large population size, where it was also observed that the population belonged to different ethnic backgrounds; and comorbidities such as diabetes, COPD, and so forth, were found in limited studies as well as in concomitant therapies F I G U R E 5 Meta-analysis of the impact of statins on DBP, studies were sub-grouped based on concomitant BP-lowering medications.…”

Section: Discussionmentioning

confidence: 73%

“…Along with other known statins, our analysis also studies rosuvastatin, which has been shown to significantly improve BP in patients with hypertension. To the best of our knowledge, this metanalysis also studies rosuvastatin's effect on BP variability based on newer randomized control trials which were not included in previously studied metanalyses 40,42,47,70 . Heterogeneity in our studies was found to be significant in terms of efficacy of statins on variability of SBP (I 2 = 93%; p < .00001) and DBP (I 2 = 81%; p < .00001).…”

Section: Discussionmentioning

confidence: 78%

“…As a result, the differences between placebo and control groups were minimized due to the fact that patients on placebo received slightly more antihypertensive study drugs (significantly and increasingly) as well as antihypertensive non‐study drugs 71 . Large RCT studies like Sever and colleagues 72 for (Atorvastatin), Yusuf and colleagues 48 (Rosuvastatin), Collins and colleagues 50 (Simvastatin), and Kushiro and colleagues 60 ; Tonelli and colleagues 64 (Pravastatin) showed significant SBP lowering effect of statins (Figure 3) while newer studies such as Fu and colleagues, 41 Jin and colleagues, 70 Kim and colleagues showed significant SBP lowering effect of Rosuvastatin. A metanalysis study by Lee and colleagues 73 from 2021 which included 507 patients stated that Rosuvastatin could be beneficial to control hypertension and, consequently, contribute toward reducing the risk of cardiovascular events in patients with hypertension and dyslipidemia.…”

Section: Discussionmentioning

confidence: 98%

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Statin's role on blood pressure levels: Meta‐analysis based on randomized controlled trials

Liu

Deng

et al. 2023

J of Clinical Hypertension

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Statins have been proven to be effective in minimizing the risk of cardiovascular adverse events, however, their effect on BP variability is debatable with respect to their significance and their use as a potential anti‐hypertensive. Using a meta‐analysis approach, the aim of this study was to explore whether certain statins have the potential to lower blood pressure (BP). For the period 2002–2022, Scopus, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials databases were searched for the studies that examined the effect of statins on blood pressure in normotensive or hypertensive individuals. Randomized controlled clinical trials that investigated this effect were included based on our inclusion criteria. Our primary outcomes were changes in systolic and diastolic blood pressure (DBP). The final analysis of the study included 49 RCTs involving 45 173 participants randomized to receive either statins or placebo. Among the two groups, the total weighted mean difference (WMD) for systolic blood pressure (ΔSBP) was –1.42 (95% CI: –2.38, –0.46; p = .004) and diastolic blood pressure (ΔDBP) was 0.82 (95% CI: –1.28, –0.36; p = .0005). Despite various studies suggesting the efficacy of statins in blood pressure lowering to be significant and non‐significant both, we observed a decrease in SBP and DBP both, although the change was not as large and could be considered significant. A large multicenter, multi‐ethnic, large sample pool size, and a long period follow‐up study is still required to assert these claims.

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Section: Discussionmentioning

confidence: 73%

Section: Discussionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 98%

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Statin's role on blood pressure levels: Meta‐analysis based on randomized controlled trials

Liu

Deng

et al. 2023

J of Clinical Hypertension

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“…Hypertension and dyslipidemia have become important factors affecting the life process of the elderly 10 . Previous cross-sectional studies have found a biological correlation between dyslipidemia and hypertension 11,12 ,and dyslipidemia can increase the incidence of hypertension in people with normal blood pressure 13,14 . A randomized controlled trial showed that patients with hypertension had higher lipid levels.…”

Section: Discussionmentioning

confidence: 95%

The correlation between LDL-C/HDL-C and Hypertension: a case control study

Zhang

2022

Preprint

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Dyslipidemia is a risk factor of hypertension, which can promote the occurrence and development of hypertension. In this study, we collect data of 362 elderly patients to explore the correlation between blood lipid indexes and hypertension in the elderly population. Patients were divided into two groups : hypertensive group and control group. Multivariate logistic regression analysis, Spearman correlation analysis and receiver operating characteristics (ROC) curve were used to analyze the correlation between blood lipid and hypertension and its predictive value for hypertension. We found that The levels of LDL-C/HDL-C in hypertensive group were higher than those in control group, and the levels of LDL-C/HDL-C in moderate and severe hypertension groups were higher than those in mild hypertension group (P < 0.05). Multivariate logistic regression analysis showed that LDL-C/HDL-C was an independent risk factor for hypertension. Correlation analysis showed that LDL-C/HDL-C was positively correlated with the severity of hypertension (r = 0.580, P < 0. 01). ROC curve analysis showed that area under the curve (AUC) of LDL-C/HDL-C in predicting hypertension was 0. 937 (95%CI: 0.914-0. 961, P < 0.01). When the cut-off value was 4.276, the specificity and sensitivity were 96.2% and 75. 20%. In conclusion, LDL-C/HDL-C is an independent risk factor for hypertension and has predictive value for hypertension.

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“…The present work described a validated reverse phase HPLC method for determination of TEL, ROS, and AML in synthetic mixture used in the management of hypertension with dyslipidemia. 14…”

Section: Aimmentioning

confidence: 99%

RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination

Mistry¹,

Shah²,

Jat³

2022

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Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients.  Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture.  Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min.  Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte.  Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.  

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Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 9 publications

References 24 publications

Statin's role on blood pressure levels: Meta‐analysis based on randomized controlled trials

Statin's role on blood pressure levels: Meta‐analysis based on randomized controlled trials

The correlation between LDL-C/HDL-C and Hypertension: a case control study

RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination

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