Losartan Gains First Approval In Sweden

Merck & Co's angiotensin II antagonist Cozaar (losartan), which is being developed jointly with DuPont Pharma, has gained its first approval in Sweden for the treatment of hypertension. A New Drug Application has been filed in the USA and most other major markets, says Merck.

According to the company, controlled clinical trials in 2,500 patients have demonstrated that losartan, as monotherapy and also in combination with the diuretic hydrochlorothiazide, has a good safety and tolerability profile. In documented trials, the overall adverse reaction profile of the drug was shown to be comparable with that of placebo. The most common adverse reaction was dizziness (2.5% with losartan and 3.5% with losartan and HCTZ compared to 1.3% with placebo). The reported rate of patients discontinuing treatment with losartan and losartan plus HCTZ was 2.4% and 2.8% respectively.

In addition, the results of a study into the occurrence of dry cough, which is commonly associated with administration of ACE inhibitors, showed significantly lower rates with losartan than in the ACE inhibitor lisinopril group. The researchers attributed the lower incidence of dry cough to the inability of the drug to enhance the action of bradykinin. Unlike ACE inhibitors, which cause the accumulation of bradykinin, losartan allows for the natural breakdown of the molecule, added the company.