Fixed-Dose Combination Antihypertensives and Reduction in Target Organ Damage

Smith, David H.G.

doi:10.2165/00129784-200707060-00004

Cited by 20 publications

(8 citation statements)

References 98 publications

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“…1,6,8 Clinical studies have generally supported the increased effi cacy of combination therapy compared with monotherapy with respect to achievement of BP target levels. [8][9][10] A range of combination-therapy approaches have been recommended and employed in the treatment of HTN, typically involving medications with differing mechanisms of action administered separately or as single-pill combinations. 1 These agents include diuretics, β-blockers, α-blockers, calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and aldosterone antagonists.…”

Section: Introductionmentioning

confidence: 99%

Review: A Single-Pill Combination of Telmisartan plus Amlodipine for the Treatment of Hypertension

Guthrie

2011

Postgraduate Medicine

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Despite an increased proportion of patients with hypertension achieving recommended blood pressure (BP) targets, BP control remains suboptimal in many patients. A range of combination therapies utilizing medications with differing mechanisms of action have been shown to provide superior BP-lowering efficacy than monotherapy with individual components. Single-pill combinations deliver improved convenience and may help to improve patient compliance. A single-pill combination of the angiotensin receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine has recently been approved in 4 different doses (telmisartan/amlodipine 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg) for antihypertensive use in the United States. In an 8-week clinical study (N = 1461), these combinations were superior to monotherapy with telmisartan or with amlodipine with respect to the primary endpoint, change in diastolic BP (DBP) from baseline (mean baseline BP, 153.2 [± 12.1]/101.7 [± 4.3] mm Hg) to study end (placebo-corrected reductions of 10.3, 14.0, 12.0, and 13.9 mm Hg, respectively), as well as in multiple secondary endpoints, including change in systolic BP (SBP), DBP response, SBP response, BP control (< 140/< 90 mm Hg), and DBP control (< 90 mm Hg). The telmisartan plus amlodipine combinations were well tolerated, with the incidence of adverse events similar to placebo; the incidence of peripheral edema was lower with the 40 mg/10 mg and 80 mg/10 mg combinations than with amlodipine 10 mg alone. In another study (N = 858), the highest-dose combination (80 mg/10 mg) demonstrated superior BP-lowering efficacy than same-dose monotherapy with either telmisartan or amlodipine in patients with severe hypertension (SBP ≥ 180 and DBP ≥ 95 mm Hg). Single-pill telmisartan plus amlodipine combination therapy appears to be an effective and well-tolerated treatment as initial therapy for patients likely to require > 1 antihypertensive agent to reach BP targets.

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Section: Introductionmentioning

confidence: 99%

Review: A Single-Pill Combination of Telmisartan plus Amlodipine for the Treatment of Hypertension

Guthrie

2011

Postgraduate Medicine

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“…6,7 The combination of a long-acting calcium channel blocker (CCB) and an angiotensin receptor blocker (ARB) is effective and well tolerated. 8 Agents from these 2 classes have complementary mechanisms of action, which result in additional lowering of blood pressure, and nonoverlapping adverse event profiles. 9 The CCB amlodipine besylate and the ARB olmesartan medoxomil are well suited for combination therapy of hypertension.…”

mentioning

confidence: 99%

Pharmacokinetics of Amlodipine and Olmesartan After Administration of Amlodipine Besylate and Olmesartan Medoxomil in Separate Dosage Forms and as a Fixed‐Dose Combination

Rohatagi

Lee

Shenouda³

et al. 2008

The Journal of Clinical Pharma

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The pharmacokinetics of amlodipine and olmesartan in healthy volunteers after coadministration of amlodipine besylate and olmesartan medoxomil concomitantly as separate dosage forms and together in a fixed-dose combination tablet were characterized in 5 phase I, randomized, crossover studies. The mean steady-state pharmacokinetics of amlodipine and olmesartan were similar when olmesartan medoxomil 40 mg/day and amlodipine 10 mg/day were administered separately or concomitantly for 10 days. The total and maximum exposure to amlodipine and olmesartan after administration of fixed-dose combination amlodipine/olmesartan medoxomil 10 mg/40 mg was bioequivalent to amlodipine 10 mg plus olmesartan medoxomil 40 mg. The ratio of least squares mean and 90% confidence intervals for the area under the drug concentration-time curve from time zero to time t, from time zero to infinity, and the maximum observed plasma drug concentration of amlodipine and olmesartan fell within the prespecified range for bioequivalence (80.0% - 125.0%). The area under the drug concentration-time curve from time zero to time t, from time zero to infinity, and the maximum observed plasma drug concentration of both drugs also met the prespecified criterion for bioequivalence when the fixed-dose combination tablet was taken 30 minutes after a high-fat breakfast. Total exposure to amlodipine and olmesartan was dose-proportional after administration of olmesartan medoxomil 10 mg to 40 mg in the fixed-dose combination formulation with amlodipine 5 mg to 10 mg. From a pharmacokinetic perspective, the 2 drugs are well suited to coadministration in a fixed-dose combination.

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“…In these groups, a large BP reduction is needed, which is difficult to achieve with one-drug regimens. Advantages of combination therapy also include: in low-dose, side effects are less common; reducing frustration of repetitively changing drugs in monotherapy; single-pill combinations are available, allowing lower pill intake per day and increasing patient compliance; and there may be drug synergy, allowing BP targets to be reached earlier [7,9].…”

Section: Combination Therapymentioning

confidence: 99%

“…Thiazides have synergistic action with other classes of drugs, especially with ACEis and ARBs [10]. Previous guidelines recommended that, when using two or more drugs, one of them should be a thiazide diuretic [9]. Moreover, guidelines worldwide have assumed that the amount of BP reduction is the major determinant of reduction in cardiovascular risk, not the choice of antihypertensive drug [7,[10][11][12].…”

Section: Which Drugs To Combinementioning

confidence: 99%

Combination of telmisartan plus amlodipine in the treatment of hypertension: review of results

Oigman¹,

Neves²,

Gismondi³

2010

Expert Review of Cardiovascular Therapy

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The rate of control of hypertension remains suboptimal despite widespread educational programs and an increasing number of novel medications. The combination of drugs with different mechanisms of action has become an alternative to improve blood pressure reduction and control, enhance adherence to the treatment and reduce adverse events. Telmisartan and amlodipine in monotherapy provide effective blood pressure lowering at all clinically relevant doses, but less than 50% of stage 1 and 2 achieve the target blood pressure. This article presents most of the relevant results of combinations of telmisartan plus amlodipine, at different doses, in hypertensive patients and a post hoc analysis of subgroups including the elderly, Type 2 diabetics, those with systolic hypertension and obese patients.

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Fixed-Dose Combination Antihypertensives and Reduction in Target Organ Damage

Cited by 20 publications

References 98 publications

Review: A Single-Pill Combination of Telmisartan plus Amlodipine for the Treatment of Hypertension

Review: A Single-Pill Combination of Telmisartan plus Amlodipine for the Treatment of Hypertension

Pharmacokinetics of Amlodipine and Olmesartan After Administration of Amlodipine Besylate and Olmesartan Medoxomil in Separate Dosage Forms and as a Fixed‐Dose Combination

Combination of telmisartan plus amlodipine in the treatment of hypertension: review of results

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