Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Cardiology/Vascular Diseases | Endocrinology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 1997 (capsules); July 2001 (tablets)
Treatment Area: Hypertension
Diovan, in both capsule and tablet formulations, has been
approved for the treatment of hypertension in adult subjects. It
offers blood pressure control comparable to current leading
antihypertensive therapies (lisinopril and enalapril) and an
outstanding side effect profile.
As with other drugs that affect the renin-angiotensin system,
Diovan can cause fetal and neonatal morbidity and death when
administered to pregnant women. Diovan therapy should be
discontinued as soon as pregnancy is detected.
Hypertension, the term used for abnormally high blood pressure,
is the most common health problem in the United States. Over 50
million Americans suffer from hypertension, but many are unaware of
the problem and remain untreated. Left untreated, it can lead to
serious and life-threatening events including stroke and heart
Diovan capsules were evaluated in seven placebo-controlled, four
to 12 week trials in adult subjects with baseline diastolic blood
pressures of 95-115. One trial included subjects over the age of
65. In total, over 2000 subjects were randomized to various doses
of the drug and about 800 were treated with placebo.
Results indicated that administration of Diovan to hypertensive
subjects led to a significant decrease in sitting, supine, and
standing systolic and diastolic blood pressure, usually with little
or no orthostatic change.
Adverse events associated with the use of Diovan capsules and
tablets may include (but are not limited to) the following:
- Viral infection
- Abdominal pain
Warning - Diovan should not be taken during pregnancy.
Mechanism of Action
Diovan (valsartan) blocks the vasoconstrictor and
aldosterone-secreting effects of angiotensin II by selectively
blocking the binding of angiotensin II to the AT1 receptor in many
tissues. Angiotensin II is the principal pressor agent of the
renin-angiotensin system, with effects including vasocantstriction,
stimulation of synthesis and release of aldosterone, cardiac
stimulation, and renal reabsorption of sodium.
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