FDA Approves Higher Dose Formulations of High Blood Pressure Medication Diovan HCT

Strategic Insights -

The US Food and Drug Administration (FDA) has approved two new, higher dose formulations of the high blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide): 320/12.5 mg and 320/25 mg. These new formulations provide more options for physicians to effectively manage their patients' high blood pressure. The approval is a significant milestone for the treatment of high blood pressure, which affects millions of Americans. Diovan HCT is a combination of the efficacious blood pressure medicine Diovan (valsartan) and the diuretic hydrochlorothiazide (HCTZ). With the approval of the higher doses, patients who require more than either medication alone can now benefit from the combination therapy.

Key Takeaways:

  • The FDA has approved two new, higher dose formulations of Diovan HCT: 320/12.5 mg and 320/25 mg.
  • The new formulations are expected to be commercially available by early June 2006.
  • Diovan HCT is a combination of Diovan (valsartan) and hydrochlorothiazide (HCTZ), which provides greater blood pressure-lowering benefits to patients who require more than either medication alone.
  • The approval of the higher doses of Diovan HCT provides more options for physicians to manage their patients' high blood pressure.
  • The blood-pressure lowering effect of the high doses of Diovan HCT was maintained throughout long-term follow-up studies lasting up to one year.
  • The overall incidence of adverse events with Diovan HCT was comparable to placebo.
  • Diovan HCT lowered the incidence of hypokalemia (low blood potassium) associated with HCTZ.
  • Diovan and Diovan HCT should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child.
  • The most serious side effects with both Diovan and Diovan HCT are low blood pressure (hypotension) and kidney problems, and additionally with Diovan HCT, skin rash.

Statistics:

  • Diovan HCT lowered systolic/diastolic blood pressure by 25/17 mmHg compared to 6/7 mmHg with placebo alone.
  • The blood-pressure lowering effect of the high doses of Diovan HCT was maintained throughout long-term follow-up studies lasting up to one year without placebo control.
  • The overall incidence of adverse events with Diovan HCT was comparable to placebo (2.4% nasopharyngitis vs 1% with placebo).

Sources:

  • U.S. Food and Drug Administration (FDA)
  • American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition in New York, NY
  • World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.