Fixed‐dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia

Lin, Chia‐Pin; Tung, Ying-Chang; Hsiao, Fu-Chih; Yang, Chia‐Hung; Kao, Yi-Wei; Lin, Yu‐Sheng; Chu, You-Chia; Chu, Pao‐Hsien

doi:10.1111/jch.14016

Cited by 6 publications

(10 citation statements)

References 40 publications

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“…Adequate BP and LDL-C control are recommended by clinical guidelines both in primary and secondary CVD prevention [29,35,36]. In our previous study, we only demonstrated the bene cial effect of reducing major adverse cardiovascular events with FDC of amlodipine/atorvastatin in the primary prevention setting [23]. In the present study, we further analyzed the differences in e cacy among three study groups with regards to primary and secondary CVD prevention, and the results were comparable in composite CV outcome.…”

Section: Discussionmentioning

confidence: 67%

“…In our previous study, we demonstrated that FDC regimen of amlodipine and atorvastatin improved composite CV outcomes compared to FEC of the same medications in patients with newly diagnosed hypertension and dyslipidemia during a 5-year follow-up period [23]. In that study, the medication adherence as assessed by PDC was better in the FDC than in the FEC group (0.49 ± 0.26 versus 0.32 ± 0.3, P < 0.001), and this may explain the results.…”

Section: Discussionmentioning

confidence: 97%

“…Medication adherence was assessed by using the proportion of days covered (PDC) according to the EMRs, which was de ned as the total number of days covered by the study drugs divided by the total number of follow-up days [7,9,13,23,26]. The follow-up period started from the index date of the rst prescription of the study drug until the date of an outcome, death, the date of switching among the studies drugs, the last visit date in the CGRD, or the end of the study period (September 30th, 2019), whichever occurred rst.…”

Section: Discussionmentioning

confidence: 99%

“…Among these studies, the follow-up periods ranged from only 6 weeks to 6 months [13][14][15][16][17][18][19][20][21][22]. In our previous work, we demonstrated improved clinical outcomes with the use of FDC of amlodipine and atorvastatin in patients with concomitant hypertension and dyslipidemia compared to a free-equivalent combination (FEC), including major adverse cardiovascular events, hospitalization for coronary artery disease and newly initiating hemodialysis [23]. However, these results were generated from the National Health Insurance Research Database (NHIRD) of Taiwan, which is a large administrative database that does not contain personal data such as smoking, body weight, blood pressure (BP) records or laboratory data.…”

Section: Introductionmentioning

confidence: 99%

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Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

Lin

Hsiao

et al. 2021

Preprint

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Background Blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) are important risk factors for cardiovascular (CV) diseases and treating these factors simultaneously is recommended by current guidelines but only short-term clinical results were available. The objective of this study was to examine the longer-term efficacy and safety of fixed-dose combination (FDC) versus free combination of amlodipine and atorvastatin in patients with concomitant hypertension and hypercholesterolemia. Methods Patients with hypertension and hypercholesterolemia were stratified into three groups (FDC of amlodipine 5 mg/atorvastatin 10 mg [Fixed 5/10], FDC of amlodipine 5 mg/atorvastatin 20 mg [Fixed 5/20], and free combination of amlodipine 5 mg/atorvastatin 10 mg [Free 5/10]). After inverse probability of treatment weighting, the composite CV outcome, liver function, BP, LDL-C and glycated hemoglobin (HbA1c) changes were compared. Results A total of 1,788 patients were eligible for analysis and the mean follow-up period was 1.7 year. There was no significant difference in the composite CV outcome among the three groups during the 30-month follow-up period (Fixed 5/10 6.1%, Fixed 5/20 6.3% and Free 5/10 6.0%). The LDL-C level was significantly reduced in the Fixed 5/20 group (-35.7 mg/dL) compared to the Fixed 5/10 (-23.6 mg/dL) and Free 5/10 (-10.3 mg/dL) groups (P=0.001 and <0.001, respectively). The changes in HbA1c were similar among the three groups. Conclusions FDC of amlodipine and atorvastatin, especially the regimen with higher dosage of statin, significantly reduced the mid-term LDL-C level compared to free combination in patients with concomitant hypertension and hypercholesterolemia. Blood sugar level during the follow-up period was not significantly changed by this aggressive treatment strategy.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

Lin

Hsiao

et al. 2021

Preprint

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“…Fixed-dose combinations (FDC) contribute to a better clinical outcome with increased compliance over monotherapy [ 1 - 3 ]. In this context, many pharmaceutical companies are interested in the development of FDC.…”

Section: Introductionmentioning

confidence: 99%

An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug

Hong

Jeon²,

Choi

et al. 2021

Korean J Physiol Pharmacol

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Fixed-dose combinations development requires pharmacokinetic drugdrug interaction (DDI) studies between active ingredients. For some drugs, pharmacokinetic properties such as long half-life or delayed distribution, make it difficult to conduct such clinical trials and to estimate the exact magnitude of DDI. In this study, the conventional (non-compartmental analysis and bioequivalence [BE]) and modelbased analyses were compared for their performance to evaluate DDI using amlodipine as an example. Raw data without DDI or simulated data using pharmacokinetic models were compared to the data obtained after concomitant administration. Regardless of the methodology, all the results fell within the classical BE limit. It was shown that the model-based approach may be valid as the conventional approach and reduce the possibility of DDI overestimation. Several advantages (i.e., quantitative changes in parameters and precision of confidence interval) of the model-based approach were demonstrated, and possible application methods were proposed. Therefore, it is expected that the model-based analysis is appropriately utilized according to the situation and purpose.

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Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia

Jung

Kim

Hong

et al. 2023

J of Clinical Hypertension

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The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL‐C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: −7.08%, 95% CI: −11.79 to −2.38, p = .0034, per‐protocol analysis set [PPS]: −6.97%, 95% CI: −11.76 to −2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: −10.13%, 95% CI: −15.41 to −4.84, p = .0002, PPS: −10.96%, 95% CI: −15.98 to −5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL‐C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).

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Fixed‐dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia

Cited by 6 publications

References 40 publications

Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug

Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia

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