Drug products: Amlarrow, Amlobesyl, Amlodipin Accord, Amlodipin Actavis, Amlodipin Aurobindo, Amlodipin Bluefish, Amlodipin BMM Pharma, Amlodipin Hexal, Amlodipin Jubilant, Amlodipin Krka, Amlodipin Orifarm, Amlodipin ratiopharm, Amlodipin Sandoz, Amlodipin STADA®, Amlodipin/Valsartan Ebb, Amlodipin/Valsartan Krka, Amlodipin/Valsartan STADA, Amlodipine, Amlodipine Teva, Amlodipine Vitabalans, Amlodistad, Amloratio, Amlori, Exforge®, Milodimyl, Norvasc, Norvasc®
ATC code: C08CA01, C09DB01
Substances: amlodipine, amlodipine besylate, amlodipine maleate, amlodipine mesilate, amlodipine mesylate monohydrate
Clinical studies have shown contradictory results if women or men have a greater effect of blood pressure reduction by amlodipine.
A common adverse effect to amlodipine is edema, mainly bone edema, and occurs more often among women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
In a single-dose bioequivalence study comparing two forms of amlodipine in healthy volunteers (18 men, 18 women), women had a slightly higher bioavailability of amlodipine compared with men. The difference disappeared after adjusting for weight . The clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested .
There are conflicting results whether men or women have more blood pressure (BP) reduction with amlodipine therapy. Clinical trials have reported a greater BP reduction with amlodipine in women compared with men [4-6]. The Amlodipine Community Trial (702 men, 382 women) observed that women had a greater absolute decrease in BP compared with men following amlodipine therapy (5-10 mg/day for 12 weeks). The percentage of patients achieving goal BP was higher in women than in men (91.4% vs. 83.0%). Reasons for these sex differences could be due to several mechanisms . Also in the study by Abad-Santos et al. , women demonstrated a more pronounced reduction in systolic BP than men. The clinical significance of the sex difference remains to be determined.Contrary to these findings, the large randomized double-blind ALLHAT study (17 719 men, 15 638 women) reported that the achieved BP reductions from amlodipine therapy (20 mg/day) were comparable in both sexes, although decreases in systolic BP were more pronounced in men . Also, another clinical trial found a slightly less BP reduction in women compared with men .
Clinical trials have report similar incidence of adverse events in men and women [2,6]. In the Amlodipine Cardiovascular Community Trial , the most common adverse event was edema which occurred in 24% of treated patients, and was more common in women. A few cases, most men, of gingival overgrowth have been reported , but no statistically significant difference between the sexes has been shown .There are conflicting results from studies reporting that calcium channel blockers could be associated with cancer. One study reported suspected increase in breast cancer in women taking calcium channel blockers; however the study was criticised due to methodological problems of the study .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
A randomized clinical trial (76 men, 61 women) found that BP response to amlodipine among African-American men and women with early hypertensive nephrosclerosis appears to be determined by CYP4A4 genotypes and sex specificity may be an important consideration .
Date of litterature search: 2014-02-04
Reviewed by: Karin Schenck-Gustafsson, Mia von Euler
Approved by: Karin Schenck-Gustafsson