The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomized, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and either heart failure (signs, symptoms or radiological evidence) or left ventricular systolic dysfunction (ejection fraction ≤40% by radionuclide ventriculography or ≤35% by echocardiography or ventricular contrast angiography). Patients were randomized within 12 hours to 10 days after the onset of myocardial infarction symptoms to one of three treatment groups: valsartan (titrated from 20 or 40 mg twice daily to the highest tolerated dose up to a maximum of 160 mg twice daily), the ACE inhibitor, captopril (titrated from 6.25 mg three times daily to the highest tolerated dose up to a maximum of 50 mg three times daily), or the combination of valsartan plus captopril. In the combination group, the dose of valsartan was titrated from 20 mg twice daily to the highest tolerated dose up to a maximum of 80 mg twice daily; the dose of captopril was the same as for monotherapy. The population studied was 69% male, 94% Caucasian, and 53% were 65 years of age or older. Baseline therapy included aspirin (91%), beta-blockers (70%), ACE inhibitors (40%), thrombolytics (35%) and statins (34%). The mean treatment duration was 2 years. The mean daily dose of Valsartan in the monotherapy group was 217 mg. The primary endpoint was time to all-cause mortality. Secondary endpoints included (1) time to cardiovascular (CV) mortality, and (2) time to the first event of cardiovascular mortality, reinfarction, or hospitalization for heart failure. The results are summarized in the following table.
|Valsartan vs Captopril (N=4,909) (N=4,909)||Valsartan + Captopril vs. Captopril (N=4,885) (N=4,909)|
|No. of Deaths Valsartan/Captopril||Hazard Ratio CI||p-value||No. of Deaths Comb/Captopril||Hazard Ratio CI||p-value|
|All-cause mortality||979 (19.9%) /958 (19.5%)||1.001 (0.902, 1.111)||0.98||941 (19.3%) /958 (19.5%)||0.984 (0.886, 1.093)||0.73|
|CV mortality||827 (16.8%) /830 (16.9%)||0.976 (0.875, 1.090)|
|CV mortality, hospitalization for HF, and recurrent non-fatal MI||1,529 (31.1%) /1,567 (31.9%)||0.955 (0.881, 1.035)|
There was no difference in overall mortality among the three treatment groups. There was thus no evidence that combining the ACE inhibitor captopril and the angiotensin II blocker valsartan was of value.
The data were assessed to see whether the effectiveness of valsartan could be demonstrated by showing in a non-inferiority analysis that it preserved a fraction of the effect of captopril, a drug with a demonstrated survival effect in this setting. A conservative estimate of the effect of captopril (based on a pooled analysis of 3 post-infarction studies of captopril and 2 other ACE inhibitors) was a 14% to 16% reduction in mortality compared to placebo. Valsartan would be considered effective if it preserved a meaningful fraction of that effect and unequivocally preserved some of that effect. As shown in the table, the upper bound of the CI for the hazard ratio (valsartan/captopril) for overall or CV mortality is 1.09 to 1.11, a difference of about 9% to 11%, thus making it unlikely that valsartan has less than about half of the estimated effect of captopril and clearly demonstrating an effect of valsartan. The other secondary endpoints were consistent with this conclusion.
Effects on Mortality Amongst Subgroups in VALIANT
There were no clear differences in all-cause mortality based on age, gender, race, or baseline therapies, as shown in the figure above.
NDC: 50090-4130-0 30 TABLET, FILM COATED in a BOTTLE
NDC: 50090-4130-1 90 TABLET, FILM COATED in a BOTTLE, PLASTIC
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy: Advise female patients of childbearing age about the consequences of exposure to valsartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their healthcare provider as soon as possible [see Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].
Lactation: Advise women not to breastfeed during treatment with valsartan tablets [see Use in Specific Populations (8.2)].
Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue valsartan tablets until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.2)].
Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions ( 7.1)].
What is the most important information I should know about valsartan tablets?
Valsartan tablets can cause harm or death to an unborn baby.
• Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant.
• If you become pregnant during treatment with valsartan tablets, stop taking valsartan tablets and tell your healthcare provider right away.
What is valsartan tablets?
Valsartan tablets is a prescription medicine used in:
• adults and children 1 year of age and older to lower high blood pressure (hypertension). valsartan tablets may be used alone or in combination with other blood pressure medicines.
• adults to treat heart failure. valsartan tablets may help decrease your need for hospitalization that happens with heart failure.
• adults with certain types of heart failure, to increase the chance of living longer after a heart attack (myocardial infarction).
Valsartan tablets should not be used to treat high blood pressure in children less than 1 year of age.
It is not known if valsartan tablets is safe and effective in children with certain kidney problems.
Do not take valsartan tablets if you:
• are allergic to any of the ingredients in valsartan tablets. See the end of this leaflet for a complete list of ingredients in valsartan tablets.
• have diabetes and are also taking aliskiren. Talk to your healthcare provider if you are not sure.
Before taking valsartan tablets, tell your healthcare provider about all of your medical conditions including, if you:
• have heart problems
• have kidney problems
• are pregnant or plan to become pregnant. See “What is the most important information I should know about Valsartan tablets?
• are breastfeeding or plan to breastfeed. It is not known if valsartan passes into your breast milk. You should not breastfeed during treatment with valsartan tablets. Talk with your healthcare provider about the best way to feed your baby during your treatment with valsartan tablets.
Tell your healthcare provider about all the medicines you take including prescription and over- the-counter medicines, vitamins and herbal supplements. Valsartan tablets may affect the way other medicines work.
Especially tell your healthcare provider if you take:
• other medicines for high blood pressure or a heart problem
• water pills (also called “diuretics”)
• potassium-containing medicines, potassium supplements or salt substitutes containing potassium. Your healthcare provider may check the amount of potassium in your blood regularly.
• nonsteroidal anti-inflammatory drugs (NSAIDs)
• Lithium. Your healthcare provider will check the amount of lithium in your blood regularly.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when a new medicine is prescribed. Talk to your healthcare provider or pharmacist before you start taking any new medicine.
How should I take valsartan tablets ?
• Take valsartan tablets exactly as prescribed by your healthcare provider.
• For treatment of high blood pressure, take valsartan tablets 1 time each day
• For children: Your pharmacist will mix valsartan tablets as a liquid suspension for your child, if:
o your child is 1 to 5 years of age, or
o your child is older than 5 years of age and cannot swallow tablets, or
o if tablets are not available in the prescribed strength needed for your child
• If your child switches between taking the tablet and the suspension, your healthcare provider will adjust the dose as needed.
o Shake the bottle of suspension well for at least 10 seconds before pouring the dose of medicine to give to your child.
• For adults with heart failure or who have had a heart attack, take valsartan tablets 2 times each day. Your healthcare provider may start you on a low dose of valsartan tablets and may increase the dose during your treatment.
• Valsartan tablets can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
If you take too much valsartan tablets, call your healthcare provider, or go to the nearest hospital emergency room.
What are the possible side effects of valsartan tablets?
• Valsartan tablets can cause serious side effects, including: See “What is the most important information I should know about valsartan tablets?” • Low blood pressure (hypotension). Low blood pressure can happen with valsartan tablets, especially when you first start taking it and can cause you to feel lightheaded. Feeling lightheaded is most likely to happen if you:
|o take water pills||o are dehydrated (decreased body fluids) due to vomiting and diarrhea|
|o are on a low-salt diet||o you sweat excessively|
|o get dialysis treatments||o have heart problems|
|o do not drink enough liquids|
Lie down, if you feel lightheaded, dizzy or faint. Call your healthcare provider right away.
• Kidney problems. Kidney problems may get worse in people that already have kidney disease or heart problems. Your doctor may do blood tests to check for this.
• Increased potassium in your blood. Some people may develop increased potassium in the blood during treatment with valsartan tablets. Your doctor may do a blood test to check your potassium levels as needed.
The most common side effects of valsartan tablets when used to treat people with high blood pressure include:
• flu symptoms
• stomach (abdominal) pain
The most common side effects of valsartan tablets when used to treat people with heart failure include:
• low blood pressure
• joint and back pain
• high blood potassium
The most common side effects of valsartan tablets when used to treat people after a heart attack that cause them to stop taking valsartan tablets include:
• low blood pressure
• high blood creatinine (decreased kidney function)
You should not stop taking valsartan tablets without talking to your healthcare provider. These are not all of the possible side effects of valsartan tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA¬1088.
How should I store valsartan tablets?
• Store valsartan tablets at room temperature between 68ºF to 77ºF (20ºC to 25 ºC).
• Keep valsartan tablets container tightly closed and in a dry place to protect from moisture.
• Valsartan suspension is provided in a glass bottle with a child-resistant screw-cap closure.
• Store bottles of valsartan suspension at room temperature less than 86ºF (30ºC) for up to 30 days, or refrigerate between 35ºF to 46ºF (2ºC to 8ºC) for up to 75 days.
Keep valsartan tablets and all medicines out of the reach of children.
General information about the safe and effective use of valsartan tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use valsartan tablets for a condition for which it was not prescribed. Do not give valsartan tablets to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about valsartan tablets that is written for health professionals.
What are the ingredients in valsartan tablets?
Active ingredient: valsartan
Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxides (yellow, black and/or red), microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc and titanium dioxide.
Manufactured for :
Macleods Pharma USA, Inc.
Plainsboro, NJ 08536
Manufactured by :
Macleods Pharmaceuticals Ltd.
Daman (U.T.) INDIA
For more information, call 1-888-943-3210 or 1-855-926-3384.
Revised : May 2021
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 5/2021
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