Cozaar

[Losartan]

COZAAR ® (Losartan Potassium Tablets) 9573524

Study 1 * HCTZ Losartan Lisinopril
Cough 25% 17% 69%

Study 2 ** Placebo Losartan Lisinopril
Cough 35% 29% 62%

Text Continues Below

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* Demographics = (89% caucasian, 64% female)
** Demographics = (90% caucasian, 51% female)

These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy. Cases of cough, including positive re-challenges, have been reported with the use of losartan in post-marketing experience. Hypertensive Patients with Left Ventricular Hypertrophy In the LIFE study, adverse events with COZAAR were similar to those reported previously for patients with hypertension.
Nephropathy in Type 2 Diabetic Patients
In the RENAAL study involving 1513 patients treated with COZAAR or placebo, the overall incidences of reported adverse experiences were similar for the two groups. COZAAR was generally well tolerated as evidenced by a similar incidence of discontinuations due to side effects compared to placebo (19% for COZAAR, 24% for placebo). The adverse experiences, regardless of drug relationship, reported with an incidence of 4% of patients treated with COZAAR and occurring more commonly than placebo, on a background of conventional antihypertensive therapy, are shown in the table below.

COZAAR ® (Losartan Potassium Tablets) 9573524

Losartan
and Conventional
Antihypertensive
Therapy
Incidence
%
(n= 751)

Placebo
and Conventional
Antihypertensive
Therapy
Incidence
%
(n= 762)

Body as a Whole
Asthenia/ Fatigue
Chest Pain
Fever
Infection
Influenza-like disease
Trauma

14
12
4
5
10
4

10
8
3
4
9
3 Cardiovascular

Hypotension
Orthostatic hypotension 7 4 3 1
Digestive
Diarrhea
Dyspepsia
Gastritis

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