ATC kod: C08CA01, C09DB01
Kliniska studier har visat motsägande resultat om huruvida det finns könsskillnader eller inte i blodtryckssänkning av amlodipin.
En vanlig biverkan av amlodipin är ödem, främst perifert ödem, och förekommer oftare hos kvinnor.
In a single-dose bioequivalence study comparing two forms of amlodipine in healthy volunteers (18 men, 18 women), women had a slightly higher bioavailability compared with men. The difference disappeared after adjusting for weight [7]. The clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested [8].
Studies analyzing sex differences in blood pressure reduction (BP) after amlodipine treatment report contradictory results. Clinical trials have reported a greater BP reduction with amlodipine in women compared with men [9-12]. 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 [9]. Also in the bioequivalence study mentioned earlier [8], 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 men and women, although decreases in systolic BP were more pronounced in men [5, 13]. Also, another clinical trial found a slightly less BP reduction in women compared with men [14].
Clinical trials have report similar incidence of adverse events in men and women [7, 11]. In the Amlodipine Cardiovascular Community Trial [9], the most common adverse event was edema (mainly peripheral edema) which occurred in 24% of treated patients and was more common in women. Mainly peripheral edema is associated with amlodipine treatment [15]. A few cases, most men, of gingival overgrowth have been reported [16], but no significant difference between men and women has been shown [17].There are conflicting results from studies reporting that calcium channel blockers could be associated with cancer [1-5]. One case-control study has reported suspected increase in breast cancer in women taking calcium channel blockers [6], however the study was criticized due to methodological problems.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (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 [11].
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 [18].
Uppdaterat: 2020-10-13
Litteratursökningsdatum: 2019-04-25
Faktagranskat av: Diana Rydberg, Carl-Olav Stiller
Godkänt av: Karin Schenck-Gustafsson