FDA Approves New Hypertension Pill
The American Food and Drug Administration (FDA) recently approved “Tekamlo”, a single pill solution to high blood pressure that combines two different substances, namely, aliskiren and amlodipine, of which one is the only approved direct renin inhibitor and the other is the widely used calcium channel blocker respectively.
Tekamlo is a single pill therapy medication for patient with high blood pressure. It is an initial therapy for people who would usually need multiple medications to control their blood pressure.
The division head of Novartis Pharmaceuticals welcomed the FDA’s approval and said that high blood pressure treatment usually required multiple medications but by the approval of the Tekamlo it would become a whole lot easier. He also said that the medicine shows the dedication and commitment of Novartis Pharmaceuticals for the treatment of cardiovascular problems and for the development of effective and innovative treatments for people who have a high blood pressure problem.
The FDA approved Tekamlo after clinical trials involving some 5,000 patients with mild to moderate high blood pressure. An eight week randomized, double blind, placebo controlled study showed that this new combination of aliskiren and amlodipine led to a significant decrease in systolic/ diastolic blood pressure compared with aliskiren and amlodipine used separately.
In another double blind study on the same patterns involving people with moderate to severe high blood pressure, the new medication showed even better results lowering the blood pressure to a manageable limit.
The Tekamlo works in a multi pronged way for reducing blood pressure, the aliskiren portion of the medicine limits the activity of renin, which is an important part of the blood pressure mechanism produced by the kidney, and decreases its effects thereby reducing the narrowing down of the blood vessels. Amlodipine stops the effects of calcium on the blood vessels and relaxes them, enabling blood to flow more easily. Tekamlo works within one to two weeks.
Physicians say that single pill combination therapies provide convenient alternatives to medical practitioners in treating the different needs of patients in the treatment of high blood pressure as this single medication provided more effective and greater blood pressure reductions than the two ingredients, namely aliskiren and amlodipine, alone did. Nearly 75 million citizens in the US alone have hypertension, which if left untreated, could cause heart failure and strokes. But Tekamlo isn’t approved for treating strokes and heart failures. According to a study nearly 31% of the high blood pressure patients don’t have their blood pressures controlled to the normal limit of 140/90 mmHg.
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