A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension

Lee, Hae Young; Kim, Yong Jin; Ahn, Taehoon; Youn, Ho Joong; Chae, Shung Chull; Seo, Hong Seog; Kim, Ki Sik; Rhee, Moo Yong; Choi, Dong Ju; Kim, Jae Joong; Chun, Kook Jin; Yoo, Byung Su; Park, Jong Seon; Oh, Seok Kyu; Kim, Dong Soo; Kwan, Jun; Ahn, Youngkeun; Park, Jeong Bae; Jeong, Jin Ok; Hyon, Min Soo; Cho, Eun Joo; Han, Kyoo Rok; Kim, Doo Il; Joo, Seung Jae; Shin, Jinho; Sung, Ki Chul; Jeon, Eun Seok

doi:10.1016/j.clinthera.2015.02.019

Cited by 13 publications

(8 citation statements)

References 27 publications

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“…30 Recently, SPCs of calcium channel blockers with angiotensin receptor blockers have been widely used. 18,31,32 Amlodipine is the most reasonable choice when considering a calcium channel blocker for combination with other drugs, mostly because of its long half-life of 35 hours. 33 Clinical trials have shown that, in addition to exerting a direct antihypertensive effect via vasodilation, amlodipine reduces the incidence of cardiovascular events.…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

Lee

Kim

Choi

et al. 2017

Clinical Therapeutics

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Section: Discussionmentioning

confidence: 99%

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

Lee

Kim

Choi

et al. 2017

Clinical Therapeutics

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“…It is used as a medication alone or in combination with other antihypertensive drugs [13, 14]. Its safety and efficacy have been proven [15, 17].…”

Section: Discussionmentioning

confidence: 99%

“…The difference in the mean and the standard deviation between the two treatment groups were estimated using weighted mean and pooled standard deviation based on the results of previous studies [14, 15]. The mean siSBP was lowered −17.41 mmHg by FMS treatment and −7.34 mmHg by placebo.…”

Section: Methodsmentioning

confidence: 99%

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

Rhee

Ahn

Chang

et al. 2017

BMC Pharmacol Toxicol

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BackgroundHypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia.MethodsWe conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups.1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks.ResultsOf 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments.ConclusionThis study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.Trial registrationClinicalTrials.gov Identifier: NCT02166814. 16 June 2014Electronic supplementary materialThe online version of this article (doi:10.1186/s40360-016-0112-7) contains supplementary material, which is available to authorized users.

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“…Not much information regarding the formulations is available as the studies are more clinically oriented and the combinations have been discussed with respect to their clinical outcomes only in majority of the cases. The drugs most commonly employed in combination with AD (i.e., single drug + AD combination) include aliskiren [39–41], atorvastatin [42–52], azilsartan [53], benazepril [54, 55], fimasartan [56], indapamide [57, 58], irbesartan [59], olmesartan (olmesartan medoxomil) [39, 60–67], perindopril [68–72], telmisartan [73–77], and valsartan [70, 71, 78–97]. …”

Section: Formulations Of Admentioning

confidence: 99%

Formulations of Amlodipine: A Review

Sheraz

Ahsan

Khan

et al. 2016

Journal of Pharmaceutics

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Amlodipine (AD) is a calcium channel blocker that is mainly used in the treatment of hypertension and angina. However, latest findings have revealed that its efficacy is not only limited to the treatment of cardiovascular diseases as it has shown to possess antioxidant activity and plays an important role in apoptosis. Therefore, it is also employed in the treatment of cerebrovascular stroke, neurodegenerative diseases, leukemia, breast cancer, and so forth either alone or in combination with other drugs. AD is a photosensitive drug and requires protection from light. A number of workers have tried to formulate various conventional and nonconventional dosage forms of AD. This review highlights all the formulations that have been developed to achieve maximum stability with the desired therapeutic action for the delivery of AD such as fast dissolving tablets, floating tablets, layered tablets, single-pill combinations, capsules, oral and transdermal films, suspensions, emulsions, mucoadhesive microspheres, gels, transdermal patches, and liposomal formulations.

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A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension

Cited by 13 publications

References 27 publications

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

Formulations of Amlodipine: A Review

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