title: Gender difference in the response to valsartan/amlodipine single-pill combination in essential hypertension (China Status II): An observational study.
abstract: BACKGROUND
  The China STATUS II is a prospective, multicentre, open-label, post-marketing, observational study including Chinese adults (aged ⩾ 18 years) with essential hypertension who were prescribed once-daily valsartan/amlodipine (Val/Aml 80/5 mg) single-pill combination. In order to examine gender differences in treatment response to Val/Aml, we further analysed data from the China STATUS II study.
  
  
  METHODS
  A total of 11,312 patients (6456 (57%) men and 4856 (43%) women) received the Val/Aml treatment for 8 weeks. After the treatment, we compared the proportion of patients not achieving the target systolic blood pressure (SBP: < 140 mm Hg) or diastolic blood pressure (DBP: < 90 mm Hg) in different age groups (by Fisher exact probability test) and estimated the changes in blood pressure (BP) according to age and gender, using a mixed model.
  
  
  RESULTS
  At enrolment, mean SBP was higher in the female versus the male patients (160.0 ± 12.71 versus 159.3 ± 12.31 mm Hg; p = 0.003), whereas the mean DBP was higher in the male versus the female patients (96.4 ± 10.65 versus 94.5 ± 10.72 mm Hg; p < 0.001). The overall proportion of women not achieving the target BP was less than that of men (57.41% versus 59.59%; p < 0.05) at 4 weeks and (22.22% versus 23.78%; p < 0.05) at 8 weeks after the Val/Aml treatment. Among both men and women, the proportion of patients not achieving the target SBP increased with age; however, the proportion not achieving the target DBP decreased with age. The mixed-model analysis showed that the changes in SBP were closely related to gender, indicating that the SBP-lowering effect after Val/Aml treatment might be better in women. In addition, the changes in DBP were closely related to age.
  
  
  CONCLUSIONS
  Gender might be a factor for consideration in the decision-making process of individualised antihypertensive therapy, in the future.
authors.affiliation: Fujian Provincial Cardiovascular Disease Institute, Fujian Medical University, Fuzhou, Fujian, China.
authors.forename: Huan
authors.initials: H
authors.lastname: Wang
authors.affiliation: Fujian Provincial Cardiovascular Disease Institute, Fujian Medical University, Fuzhou, Fujian, China chenhuiwyd@sina.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Chen
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002681:China; D003710:Demography; D003971:Diastole / Q000187:drug effects; D004359:Drug Therapy, Combination; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012727:Sex Characteristics; D013599:Systole / Q000187:drug effects; D000068756:Valsartan / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D017311:Amlodipine; D000068756:Valsartan
keywords: Amlodipine; STATUS II; essential hypertension; gender differences; renin angiotensin aldosterone system; single-pill combination; valsartan