Persistent dry cough (with an incidence of a few percent) has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown below.

*
Demographics = (89% caucasian, 64% female)
†
Demographics = (90% caucasian, 51% female) 
Study 1* HCTZ Losartan Lisinopril
Cough 25% 17% 69%
       
Study 2† Placebo Losartan Lisinopril
Cough 35% 29% 62%

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.

Pediatric Patients: No relevant differences between the adverse experience profile for pediatric patients and that previously reported for adult patients were identified.

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.

 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
15
4
5
10
3
4
Endocrine
   Diabetic neuropathy
   Diabetic vascular disease
4
10
3
9
Eyes, Ears, Nose and Throat