Efficacy and tolerability of the single-pill combination of aliskiren 300 mg/amlodipine 10 mg in hypertensive patients not controlled by olmesartan 40 mg/amlodipine 10 mg

Axthelm, Christoph; Sieder, Christian; Meister, Franziska; Kaiser, E.

doi:10.1185/03007995.2011.637914

Cited by 6 publications

(5 citation statements)

References 41 publications

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“…Changes in laboratory values generally were infrequent, in accordance with the known profiles of the drugs. Details have been reported elsewhere 27 . AE were not analyzed by subgroups in view of the low patient numbers.…”

Section: Resultsmentioning

confidence: 99%

“…The aliskiren/amlodipine and aliskiren/amlodipine/HCT combinations were investigational formulations manufactured by Novartis for this study, whereas the olmesartan/amlodipine film tablets used were marketed products. The first 60 patients who were eligible and agreed to participate were included in the extension (results reported previously) 27 . Study drugs were to be taken orally in the morning.…”

Section: Methodsmentioning

confidence: 99%

“…In the present post-hoc analysis of a previously published prospective non-randomized study 27 we aimed to investigate the BP lowering effect of the SPC aliskiren/amlodipine in special patient groups with hypertension that typically present in everyday practice and may pose a particular challenge to treating physicians owing to comorbidity, comedication or complexity of the disease: patients of advanced age, high body mass index (BMI) (overweight, obesity), with metabolic risk factors and/or with DM.…”

Section: Introductionmentioning

confidence: 99%

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Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index

Axthelm¹,

Sieder

Meister

et al. 2012

Journal of Drug Assessment

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AimsBlood pressure (BP) reduction in hypertensive patients is more difficult to achieve in the elderly or in the presence of comorbidities. We aimed to investigate the efficacy of the single-pill combination (SPC) aliskiren/amlodipine in hypertensive elderly patients, patients with high body mass index (BMI), with at least one metabolic risk factor, and/or type 2 diabetes mellitus (DM).MethodsIn an open-label non-randomized study, patients not adequately controlled by previous treatment with the SPC olmesarten 40/amlodipine 10 (phase 1) were switched to the SPC aliskiren 300/amlodipine 10 (phase 2). The present post-hoc analysis investigated BP reduction in phase 2 in the named subgroups. The EudraCT identifier was 2009-016693-33, ClinicalTrials.gov identifier NCT01113047.ResultsOf the 187 patients not adequately controlled in phase 1 and thus treated with the SPC aliskiren 300/amlodipine 10 in phase 2, 69 were of advanced age (≥65 years), 74 or 89 were overweight or obese (BMI 25.0–29.9 kg/m2 or ≥30 kg/m2, respectively), 91 had metabolic risk factors (without DM) and 41 had DM. At the beginning of phase 2, depending on the subgroup, baseline SBP was 168–169 mmHg and DBP 103–104 mmHg. After 4 weeks of treatment with aliskiren 300/amlodipine 10, SBP/DBP was lowered by −5.1/−4.8 mmHg in the total cohort, by −5.5/−5.1 mmHg in elderly patients, by −6.7/−5.5 in overweight and by −4.2/−4.5 mmHg in obese patients, by −6.4/−4.7 mmHg in patients with metabolic risk factors without DM, and by −3.3/−5.0 mmHg in DM patients. Limitations include low sample size, limited treatment duration and the fact that the post-hoc defined groups were not mutually exclusive.ConclusionsIn this study reflecting clinical practice, the aliskiren/amlodipine combination achieved effective BP reduction in elderly patients or with metabolic comorbidities, including DM that might be more difficult to treat. This consistent BP lowering pattern facilitates everyday care of patients who receive aliskiren/amlodipine.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index

Axthelm¹,

Sieder

Meister

et al. 2012

Journal of Drug Assessment

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“…Axthelm et al designed a study to investigate the efficacy of aliskiren and amlodipine combination therapy in hypertensive patients whose BP is not adequately controlled by the combination of olmesartan and amlodipine [72]. This study had two 4-week phases, which were noted as phase 1 and phase 2.…”

Section: Methodsmentioning

confidence: 99%

Management of Hypertension Using Olmesartan Alone or in Combination

Zhang

et al. 2017

Cardiol Ther

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Hypertension is one of the most significant and consistent risk factors for many cardiovascular diseases. The global prevalence of hypertension has dramatically increased over recent years. Life-style and genetic factors are generally considered to be primarily responsible for the incidence of hypertension. Concerning the high morbidity rate, setting up an updated standard for hypertensive patients becomes indispensable. According to the widely accepted standard treatments for hypertension, these four basic principles should be taken into account: low dosage; medication should provide long term-control; combination therapies are becoming common; personalized treatments are a newer approach. In most patients with hypertension, adequate control of BP can be achieved with combined therapy. Therefore, antihypertensive agents with complementary mechanisms are now recommended. In this review, we focus on the pharmacology, antihypertensive efficacy, and adverse events (AEs) of olmesartan medoxomil, either alone or in combination with other antihypertensive medications. In conclusion, olmesartan medoxomil, is an angiotensin II receptor blocker with an excellent efficacy in the reduction and stabilization of blood pressure. When combined with calcium channel blockers (CCBs) and diuretics, olmesartan medoxomil has a better effect on controlling BP and reducing AEs in patients.

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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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Efficacy and tolerability of the single-pill combination of aliskiren 300 mg/amlodipine 10 mg in hypertensive patients not controlled by olmesartan 40 mg/amlodipine 10 mg

Cited by 6 publications

References 41 publications

Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index

Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index

Management of Hypertension Using Olmesartan Alone or in Combination

Formulations of Amlodipine: A Review

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