Gender, blood pressure, and cardiovascular and renal outcomes in adults with hypertension from the Systolic Blood Pressure Intervention Trial

Abstract

Background: To determine if the effects of intensive lowering of systolic blood pressure (goal of less than 120 mmHg) versus standard lowering (goal of less than 140 mmHg) upon cardiovascular, renal, and safety outcomes differed by gender.

Methods: Nine thousand three hundred and sixty-one men and women aged 50 years or older with systolic blood pressure of 130 mmHg or greater, taking 0-4 antihypertensive medications, and with increased risk of cardiovascular disease, but free of diabetes, were randomly assigned to either a systolic blood pressure target of less than 120 mmHg (intensive treatment) or a target of less than 140 mmHg (standard treatment). The primary composite outcome encompassed incident myocardial infarction, heart failure, other acute coronary syndromes, stroke, or cardiovascular-related death. All-cause mortality, renal outcomes, and serious adverse events were also assessed.

Results: Compared with the standard treatment group, the primary composite outcome in the intensive treatment group was reduced by 16% [hazard ratio 0.84 (0.61-1.13)] in women, and by 27% in men [hazard ratio 0.73 (0.59-0.89), P value for interaction between treatment and gender is 0.45]. Similarly, the effect of the intensive treatment on individual components of the primary composite outcome, renal outcomes, and overall serious adverse events was not significantly different according to gender.

Conclusion: In adults with hypertension but not with diabetes, treatment to a systolic blood pressure goal of less than 120 mmHg, compared with a goal of less than 140 mmHg, resulted in no heterogeneity of effect between men and women on cardiovascular or renal outcomes, or on rates of serious adverse events.ClinicalTrials.gov number, NCT01206062.

Conflict of interest statement

Conflicts of interest

There are no conflicts of interest.

Figures

FIGURE 1

Mean systolic blood pressure in (a) women and (b) men in the two treatment arms over the course of the trial. In both (a) and (b) the mean number of medications is the number of blood pressure medications administered at the exit of each visit and the bars represent 95% confidence intervals.

FIGURE 2

Forest plot of primary and secondary cardiovascular disease outcomes according to treatment group and gender. The primary outcome was the first occurrence of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from cardiovascular causes. ACS, acute coronary syndrome; HF, heart failure; MI, myocardial infarction.

FIGURE 3

Forest plot of renal outcomes according to treatment group and gender. The composite renal outcome for participants with CKD at baseline was the first occurrence of a reduction in the estimated GFR of 50% or more, long-term dialysis, or kidney transplantation. CKD, chronic kidney disease, defined as estimated glomerular filtration rate of less than 60 ml/min/1.73 m2 using the Modification of Diet in Renal Disease equation. Incident albuminuria is defined as a doubling of the ratio of urinary albumin (in milligrams) to creatinine (in grams) from less than 10 at baseline to greater than 10 during follow-up. The denominators for number of patients represent those without albuminuria at baseline.