Initial TherapyĪnalyzing the data described above specifically for initial therapy, it was observed that higher doses of Azor caused slightly more hypotension and orthostatic symptoms, but not at the recommended starting dose of Azor 5/20 mg.
#AZOR TABLETS PLUS#
The adverse event profile obtained from 44 weeks of open-label combination therapy with amlodipine plus olmesartan medoxomil was similar to that observed during the 8-week, double-blind, placebo-controlled period. These included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
Placebo-Subtracted Incidence of Edema During the Double-Blind Treatment PeriodĪcross all treatment groups, the frequency of edema was generally higher in women than men, as has been observed in previous studies of amlodipine.Īdverse reactions seen at lower rates during the double-blind period also occurred in the patients treated with Azor at about the same or greater incidence as in patients receiving placebo. The incidence was significantly reduced when 20 mg or 40 mg of olmesartan medoxomil was added to the 10 mg amlodipine dose. The placebo-subtracted incidence of edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. EdemaĮdema is a known, dose-dependent adverse effect of amlodipine but not of olmesartan medoxomil. The reported adverse reactions were generally mild and seldom led to discontinuation of treatment (2.6% for Azor and 6.8% for placebo). The overall incidence of adverse reactions on therapy with Azor was similar to that seen with corresponding doses of the individual components of Azor, and to placebo. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily. Seventy-one percent were Caucasian and 25% were Black. The population had a mean age of 54 years and included approximately 55% males. Azor was studied in one placebo-controlled factorial trial. The data described below reflect exposure to Azor in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Patients should be asked to report pregnancies to their physicians as soon as possible. Discuss treatment options with women planning to become pregnant. What are the side effects of Azor? WARNINGįemale patients of childbearing age should be told about the consequences of exposure to Azor during pregnancy.
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