concentration. There was no significant difference in the incidence of the composite endpoint of cardiovascular morbidity and mortality.
The favorable effects of losartan potassium were seen in patients also taking other anti-hypertensive medications (angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors were not allowed), oral hypoglycemic agents and lipid-lowering agents.
For the primary endpoint and ESRD, the effects of losartan potassium in patient subgroups defined by age, gender and race are shown in Table 5 below. Subgroup analyses can be difficult to interpret and it is not known whether these represent true differences or chance effects.
Table 5Efficacy Outcomes within Demographic Subgroups
No. of Patients
Primary Composite Endpoint
ESRD
Losartan potassium Event Rate %
Placebo Event Rate %
Hazard Ratio (95% CI)
Losartan potassium Event Rate %
Placebo Event Rate %
Hazard Ratio (95% CI)
Overall Results
1513
43.5
47.1
0.84 (0.72, 0.98)
19.6
25.5
0.71 (0.58, 0.89)
Age
<65 years
1005
44.1
49.0
0.78 (0.65, 0.94)
21.1
28.5
0.67 (0.52, 0.86)
≥65 years
508
42.3
43.5
0.98 (0.75, 1.28)
16.5
19.6
0.85 (0.56, 1.28)
Gender
Female
557
47.8
54.1
0.76 (0.60, 0.96)
22.8
32.8
0.60 (0.44, 0.83)
Male
956
40.9
43.3
0.89 (0.73, 1.09)
17.5
21.5
0.81 (0.60, 1.08)
Race
Asian
252
41.9
54.8
0.66 (0.45, 0.95)
18.8
27.4
0.63 (0.37, 1.07)
Black
230
40.0
39.0
0.98 (0.65, 1.50)
17.6
21.0
0.83 (0.46, 1.52)
Hispanic
277
55.0
54.0
1.00 (0.73, 1.38)
30.0
28.5
1.02 (0.66, 1.59)
White
735
40.5
43.2
0.81 (0.65, 1.01)
16.2
23.9
0.60 (0.43, 0.83)
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC:70786-0135-1 30 TABLET, FILM COATED in a BOTTLE
17 PATIENT COUNSELING INFORMATION
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 losartan potassium during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
Potassium Supplements
Advise patients receiving losartan potassium not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)].
SPL UNCLASSIFIED SECTION
Manufactured by:
Cadila Healthcare Ltd.
India
Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Rev.: 12/15
MEDICATION GUIDE
Patient Information
Losartan Potassium (loe |
