ASPRE trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and medical and obstetrical history
Tsokaki, T.
ASPRE trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and medical and obstetrical history - 2017
NMUH Staff Publications
<h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">OBJECTIVE:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">We sought to examine whether there are differences in the effect of aspirin on the incidence of preterm preeclampsia in the ASPRE trial in subgroups defined according to maternal characteristics and medical and obstetrical history.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">STUDY DESIGN:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">This was a secondary analysis of data from the ASPRE trial. In ASPRE, women with singleton pregnancies were screened by means of an algorithm that combines maternal factors and biomarkers at 11-13 weeks' gestation. Those with an estimated risk for preterm preeclampsia of >1 in 100 were invited to participate in a double-blind trial of aspirin (150 mg/d) vs placebo from 11-14 weeks' until 36 weeks' gestation. Aspirin was associated with a significant reduction in the incidence of preterm preeclampsia with delivery at <37 weeks' gestation, which was the primary outcome (odds ratio, 0.38; 95% confidence interval, 0.20-0.74; P = .004). Subgroup analysis was performed to assess evidence of differences in the effect of aspirin on incidence of preterm preeclampsia in subgroups defined by maternal age (<30 and ≥30 years), body mass index (<25 and ≥25 kg/m<sup style="line-height: 1.6363em; position: relative; vertical-align: baseline; top: -0.5em;">2</sup>), racial origin (Afro-Caribbean, Caucasian, and other), method of conception (natural and assisted), cigarette smoking (smoker and nonsmoker), family history of preeclampsia (present and absent), obstetrical history (nulliparous, multiparous with previous preeclampsia, and multiparous without previous preeclampsia), and history of chronic hypertension (present and absent). Interaction tests were performed on the full data set of patients in the intention-to-treat population and on the data set of patients who took ≥90% of the prescribed medication. Results are presented as forest plot with P values for the interaction effects, group sizes, event counts, and estimated odds ratios. We examined whether the test of interaction was significant at the 5% level with a Bonferroni adjustment for multiple comparisons.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">RESULTS:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history. In participants with chronic hypertension preterm preeclampsia occurred in 10.2% (5/49) in the aspirin group and 8.2% (5/61) in the placebo group (adjusted odds ratio, 1.29; 95% confidence interval, 0.33-5.12). The respective values in those without chronic hypertension were 1.1% (8/749) in the aspirin group and 3.9% (30/761) in the placebo group (adjusted odds ratio, 0.27; 95% confidence interval, 0.12-0.60). In all participants with adherence of ≥90% the adjusted odds ratio in the aspirin group was 0.24 (95% confidence interval, 0.09-0.65); in the subgroup with chronic hypertension it was 2.06 (95% confidence interval, 0.40-10.71); and in those without chronic hypertension it was 0.05 (95% confidence interval, 0.01-0.41). For the complete data set the test of interaction was not significant at the 5% level (P = .055), but in those with adherence ≥90%, after adjustment for multiple comparisons, the interaction was significant at the 5% level (P = .0019).</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">CONCLUSION:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">The beneficial effect of aspirin in the prevention of preterm preeclampsia may not apply in pregnancies with chronic hypertension. There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history.</span></p>
ASPRE trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and medical and obstetrical history - 2017
NMUH Staff Publications
<h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">OBJECTIVE:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">We sought to examine whether there are differences in the effect of aspirin on the incidence of preterm preeclampsia in the ASPRE trial in subgroups defined according to maternal characteristics and medical and obstetrical history.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">STUDY DESIGN:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">This was a secondary analysis of data from the ASPRE trial. In ASPRE, women with singleton pregnancies were screened by means of an algorithm that combines maternal factors and biomarkers at 11-13 weeks' gestation. Those with an estimated risk for preterm preeclampsia of >1 in 100 were invited to participate in a double-blind trial of aspirin (150 mg/d) vs placebo from 11-14 weeks' until 36 weeks' gestation. Aspirin was associated with a significant reduction in the incidence of preterm preeclampsia with delivery at <37 weeks' gestation, which was the primary outcome (odds ratio, 0.38; 95% confidence interval, 0.20-0.74; P = .004). Subgroup analysis was performed to assess evidence of differences in the effect of aspirin on incidence of preterm preeclampsia in subgroups defined by maternal age (<30 and ≥30 years), body mass index (<25 and ≥25 kg/m<sup style="line-height: 1.6363em; position: relative; vertical-align: baseline; top: -0.5em;">2</sup>), racial origin (Afro-Caribbean, Caucasian, and other), method of conception (natural and assisted), cigarette smoking (smoker and nonsmoker), family history of preeclampsia (present and absent), obstetrical history (nulliparous, multiparous with previous preeclampsia, and multiparous without previous preeclampsia), and history of chronic hypertension (present and absent). Interaction tests were performed on the full data set of patients in the intention-to-treat population and on the data set of patients who took ≥90% of the prescribed medication. Results are presented as forest plot with P values for the interaction effects, group sizes, event counts, and estimated odds ratios. We examined whether the test of interaction was significant at the 5% level with a Bonferroni adjustment for multiple comparisons.</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">RESULTS:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history. In participants with chronic hypertension preterm preeclampsia occurred in 10.2% (5/49) in the aspirin group and 8.2% (5/61) in the placebo group (adjusted odds ratio, 1.29; 95% confidence interval, 0.33-5.12). The respective values in those without chronic hypertension were 1.1% (8/749) in the aspirin group and 3.9% (30/761) in the placebo group (adjusted odds ratio, 0.27; 95% confidence interval, 0.12-0.60). In all participants with adherence of ≥90% the adjusted odds ratio in the aspirin group was 0.24 (95% confidence interval, 0.09-0.65); in the subgroup with chronic hypertension it was 2.06 (95% confidence interval, 0.40-10.71); and in those without chronic hypertension it was 0.05 (95% confidence interval, 0.01-0.41). For the complete data set the test of interaction was not significant at the 5% level (P = .055), but in those with adherence ≥90%, after adjustment for multiple comparisons, the interaction was significant at the 5% level (P = .0019).</span></p><h4 style="font-size: 13px; margin: 0px 0.25em 0px 0px; text-transform: uppercase; float: left; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">CONCLUSION:</span></h4><p style="margin: 0px 0px 0.5em; font-size: 1.04em; font-family: arial, helvetica, clean, sans-serif; text-align: left;"><span style="font-size: 10pt;">The beneficial effect of aspirin in the prevention of preterm preeclampsia may not apply in pregnancies with chronic hypertension. There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history.</span></p>