Prestalia (perindopril arginine and amlodipine besylate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved January 2015

Specific Treatments:

hypertension

Therapeutic Areas

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General Information

Prestalia is a combination of perindopril, an angiotensin converting enzyme (ACE) inhibitor, and amlodipine, a dihydropyridine calcium channel blocker.

Prestalia is specifically indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Prestalia is supplied as a tablet for oral administration.  The recommended starting oral dose of Prestalia is 3.5/2.5 mg once daily. The dose may be adjusted according to blood pressure goals waiting 1 to 2 weeks between titration steps. The maximum recommended dose is 14/10 mg once daily.

Clinical Results

FDA Approval

The FDA approval of Prestalia was based on a phase III trial, PATH (Perindopril Amlodipine for the Treatment of Hypertension), conducted in 837 subjects. The subjects received Prestalia 14/10 mg, perindopril erbumine 16 mg, or amlodipine 10 mg once daily for 6 weeks. The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. Prestalia was also studied in 1,581 patients randomized to Prestalia 3.5/2.5 mg, perindopril arginine 3.5 mg, perindopril arginine 5 mg, amlodipine 2.5 mg, amlodipine 5 mg, or placebo. At week 8, Prestalia 3.5/2.5 mg produced statistically significantly greater reductions in blood pressure than perindopril arginine 3.5 mg and amlodipine 2.5 mg. 

Side Effects

Adverse effects associated with the use of Prestalia may include, but are not limited to, the following:

  • edema
  • cough
  • headache
  • dizziness

Prestalia comes with a boxed warning for fetal toxicity. Prestalia is pregnancy category D.

Mechanism of Action

Prestalia is a combination of perindopril, an angiotensin converting enzyme (ACE) inhibitor, and amlodipine, a dihydropyridine calcium channel blocker.

Additional Information

For additional information regarding Prestalia or hypertension, please visit http://www.symplmed.com/