Tekamlo (Aliskiren Hemifumarate / Amlodipine Besylate) - Summary

TEKAMLO SUMMARY

Tekamlo is a single tablet of aliskiren hemifumarate (an orally active, nonpeptide, potent direct renin inhibitor) and amlodipine besylate (a dihydropyridine calcium channel blocker).

Tekamlo (ALISKIREN/AMLODIPINE) is indicated for the following:

Tekamlo is a combination of aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension:

• As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1)
  
• In patients not adequately controlled with monotherapy.
  
• As a substitute for its titrated components.

NEWS HIGHLIGHTS

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Published Studies Related to Tekamlo (Aliskiren / Amlodipine)

Effect of aliskiren addition to amlodipine on ankle edema in hypertensive patients: a three-way crossover study. [2011.06]
CONCLUSIONS: Direct renin inhibition by aliskiren partially counteracts the microcirculatory changes responsible for calcium-channel-induced edema formation, possibly through preferential vasodilation of venous capacitance vessels.

Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. [2011.03]
Minority patients with hypertension generally require combination therapy to reach blood pressure (BP) goals. We examined the BP-lowering efficacy and safety of combination aliskiren/amlodipine therapy in self-identified minority patients in the United States with stage 2 hypertension and the impact of adding hydrochlorothiazide (HCTZ) to this combination...

Differential effects of aliskiren/amlodipine combination and high-dose amlodipine monotherapy on endothelial function in elderly hypertensive patients. [2014]
amlodipine monotherapy on endothelial function in elderly hypertensive patients... CONCLUSION: Addition of aliskiren improved endothelial function in elderly

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. [2011.11]
The renin-angiotensin system (RAS) is a common link between hypertension and comorbidities of obesity and metabolic syndrome (MetS). We evaluated the antihypertensive efficacy and safety of the combination direct renin inhibitor, aliskiren, with amlodipine versus amlodipine alone in self-identified African Americans with stage 2 hypertension in a subgroup of patients with obesity or MetS participating in the Aliskiren Amlodipine Combination in African AmEricans with Stage 2 HypertenSion (AACESS) trial.

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension. [2011.08]
Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension...

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Clinical Trials Related to Tekamlo (Aliskiren / Amlodipine)

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension [Terminated]
Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma. Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.

Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome [Completed]
The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients [Completed]
To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine [Completed]
This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine. Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension [Completed]

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Reports of Suspected Tekamlo (Aliskiren / Amlodipine) Side Effects

Diabetes Mellitus (6),  Osteoporosis (6),  Poor Quality Sleep (6),  Blood Uric Acid Increased (6),  Vasodilatation (6),  Breast Cancer (6),  Hypoaesthesia (6),  Alopecia (6),  Hypothyroidism (6),  Oedema Peripheral (3), more >>