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

Media Articles Related to Tekamlo (Aliskiren / Amlodipine)

Deaths from pulmonary hypertension have increased, say CDC
Source: Hypertension News From Medical News Today [2014.04.04]
A study from the CDC finds that deaths from pulmonary hypertension - high blood pressure in the arteries leading from the heart to the lungs - have increased over the past decade.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Source: MedicineNet Brain Aneurysm Specialty [2014.04.02]
Title: Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Category: Diseases and Conditions
Created: 11/8/1998 8:47:00 PM
Last Editorial Review: 4/2/2014 12:00:00 AM

Children with glomerular kidney disease more likely to have hypertension as adults
Source: Hypertension News From Medical News Today [2014.03.20]
Men who as children had glomerular disease, a disorder of the portion of the kidney that filters blood and one that usually resolves with time, were more likely than men without childhood...

Guidelines on the management of pulmonary hypertension of sickle cell disease
Source: Hypertension News From Medical News Today [2014.03.18]
The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from...

Pulmonary Hypertension
Source: MedicineNet Congestive Heart Failure Specialty [2013.11.25]
Title: Pulmonary Hypertension
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/25/2013 12:00:00 AM

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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...

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...

Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension. [2011]
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 [Recruiting]
Part 1 investigated aliskiren, amlodipine and angiotensin II levels in interstitial fluid of fat and skeletal muscle; aliskiren concentration, angiotensin II levels, and renin activity and concentration in fat and skeletal muscle tissues; aliskiren and amlodipine concentrations, angiotensin II levels, and renin activity and concentrations in plasma.

Part 2 investigates 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.

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People [Recruiting]
This study will provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a CCB) in elderly individuals (≥ 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.

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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 >>