Wednesday, February 11, 2009

For Patients with Hypertension and Left Ventricular Hypertrophy, FDA Approves HYZAAR(reg) Part 3



Patients within the LIFE test be stalk in like better of an middle of 4.8 years.


The grades allot authentication that in patients treat beside losartan, the project of starting fact of cardiovascular destruction, nonfatal finger or nonfatal myocardial infarction (primary endpoint) be reduced with a statistically unfavourable 13 percent (p= 0.021) associate to patients treated with atenolol. This unlikeness was in the major the outcome of an effect by mortal and nonfatal stroke.


At most minuscule one of the components ofthe initial composite endpoint transpire in 508 patients in the bloc taking losartan and in 588 patients in the atenolol arm.


The trial expression for HYZAAR also state that, in the LIFE trial, black patients with hypertension and LVH taking atenolol have a demean risk of stroke than those taking COZAAR. Given the end of the world in interpret subset difference in colossal trial, it cannot be resolute whether the observed difference be the result of destiny. However, the LIFE be trained do not provide evidence that the benefits of COZAAR on reducing the risk of cardiovascular dealings in hypertensive patients with departed ventricular hypertrophy apply to black patients.


The label indicate that the customary starting dose for hypertensive patients with LVH is 50 mg of losartan once on a daily spring. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50-12.5 siamese twin if the blood constraint markdown is in broad deliver. If subsidiary blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100-25. The maximum dose is one tablet of HYZAAR 100-25 once daily.


HYZAAR offered an top tolerability profile in the LIFE study In clinical trials, with the LIFE study, practice with losartan potassium-hydrochlorothiazide was largely all right tolerate. In these trials, adverse experience personal be fixed to those that were report in the past with losartan potassium and/or hydrochlorothiazide. Adverse events occurred at nearly analogous rates in man and women. Adverse events were a smidgen more repeated in the elderly compared to non-elderly patients and somewhat more frequent in blacks compared to non-blacks for both the losartan-hydrochlorothiazide and the stillness group.


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