Valsartan (Page 6 of 8)

14.2 Heart Failure

The Valsartan Heart Failure Trial (Val-HeFT) was a multinational, double-blind study in which 5,010 patients with NYHA class II (62%) to IV (2%) heart failure and LVEF <40%, on baseline therapy chosen by their physicians, were randomized to placebo or valsartan (titrated from 40 mg twice daily to the highest tolerated dose or 160 mg twice daily) and followed for a mean of about 2 years. Although Val-HeFT’s primary goal was to examine the effect of valsartan when added to an ACE inhibitor, about 7% were not receiving an ACE inhibitor. Other background therapy included diuretics (86%), digoxin (67%), and beta-blockers (36%). The population studied was 80% male, 46% 65 years or older and 89% Caucasian. At the end of the trial, patients in the valsartan group had a blood pressure that was 4 mmHg systolic and 2 mmHg diastolic lower than the placebo group. There were two primary end points, both assessed as time to first event: all-cause mortality and heart failure morbidity, the latter defined as all-cause mortality, sudden death with resuscitation, hospitalization for heart failure, and the need for intravenous inotropic or vasodilatory drugs for at least 4 hours. These results are summarized in the following table.

Placebo (N=2,499) Valsartan (N=2,511) Hazard Ratio (95% CI *) Nominal p-value
All-cause mortality 484 (19.4%) 495 (19.7%) 1.02 (0.90-1.15) 0.8
HF morbidity 801 (32.1%) 723 (28.8%) 0.87 (0.79-0.97) 0.009
* Cl = Confidence Interval

Although the overall morbidity result favored valsartan, this result was largely driven by the 7% of patients not receiving an ACE inhibitor, as shown in the following table.

Without ACE Inhibitor With ACE Inhibitor
Placebo (N=181) Valsartan (N=185) Placebo (N=2,318) Valsartan (N=2,326
Events (%) 77 (42.5%) 46 (24.9%) 724 (31.2%) 677 (29.1%)
Hazard ratio (95% CI) 0.51 (0.35, 0.73) 0.92 (0.82, 1.02)
p-value 0.0002 0.0965

The modest favorable trend in the group receiving an ACE inhibitor was largely driven by the patients receiving less than the recommended dose of ACE inhibitor. Thus, there is little evidence of further clinical benefit when valsartan is added to an adequate dose of ACE inhibitor. Secondary end points in the subgroup not receiving ACE inhibitors were as follows.

Placebo (N=181) Valsartan (N=185) Hazard Ratio (95% CI)
Components of HF morbidity
All-cause mortality 49 (27.1%) 32 (17.3%) 0.59 (0.37, 0.91)
Sudden death with resuscitation 2 (1.1%) 1 (0.5%) 0.47 (0.04, 5.20)
CHF therapy 1 (0.6%) 0 (0.0%)
CHF hospitalization 48 (26.5%) 24 (13.0%) 0.43 (0.27, 0.71)
Cardiovascular mortality 40 (22.1%) 29 (15.7%) 0.65 (0.40, 1.05)
Non-fatal morbidity 49 (27.1%) 24 (13.0%) 0.42 (0.26, 0.69)

In patients not receiving an ACE inhibitor, valsartan-treated patients had an increase in ejection fraction and reduction in left ventricular internal diastolic diameter (LVIDD).
Effects were generally consistent across subgroups defined by age and gender for the population of patients not receiving an ACE inhibitor. The number of black patients was small and does not permit a meaningful assessment in this subset of patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

Valsartan, USP is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in unit dose blister packages as described below.
Valsartan Tablets USP, 40 mg are yellow coloured, capsule shaped, biconvex, film coated tablets, debossed with ‘H’ on one side and ‘182’ on the other side, 18 and 2 separated by a score line.
NDC 50268-783-15
10 tablets per card, 5 cards per carton
Valsartan Tablets USP, 80 mg are pink coloured, round shaped, biconvex, film coated tablets, debossed with ‘183’ on one side and ‘H’ on the other side.
NDC 50268-784-15
10 tablets per card, 5 cards per carton
Valsartan Tablets USP, 160 mg are yellowish brown coloured, oval shaped, biconvex, film coated tablets, debossed with ‘184’ on one side and ‘H’ on the other side.
NDC 50268-785-15
10 tablets per card, 5 cards per carton
Valsartan Tablets USP, 320 mg are dark grey-violet colored, capsule shaped, biconvex, film coated tablets, debossed with ‘185’ on one side and ‘H’ on the other side.
NDC 50268-786-13
10 tablets per card, 3 cards per carton
Dispensed in Unit Dose package. For Institutional Use Only.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
Dispense in tight container (USP).

17 PATIENT COUNSELING INFORMATION

Information for Patients
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to valsartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 08/15

AV 04/16 (P)

AvPAK

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