How is it used?

Exforge HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning. The dose of Exforge HCT to be used is the same as the doses of three individual active substances that the patient was taking before. The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.

How does it work?

The three active substances in Exforge HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Amlodipine is a ‘calcium channel blocker’. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and helps the blood vessel walls to relax and widen, thereby reducing blood pressure.
Valsartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a body hormone called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce. Hydrochlorothiazide is a diuretic. It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.

The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has it been studied?

Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). Patients received either Exforge HCT or one of the three combinations containing only two of the active substances for eight weeks. The main measure of effectiveness was the average change in the blood pressure.

What benefits has it shown during the studies?

Treatment with the highest strength of Exforge HCT was more effective at treating hypertension than dual combinations containing any of the two active substances. The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Exforge HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.

What is the risk associated?

The most common side effects with Exforge HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally freq