Antihypertensive Management in Patients With T2DM
Details of the methods used in the randomized controlled trial were registered before patient recruitment (ISRCTN97121854); results of the main trial and changes to the predicted 10-year risk of cardiovascular diseases have been reported previously. This prespecified substudy is a secondary analysis of data collected during the main study.
All 260 patients enrolled in the main study were eligible for inclusion in both analyses of this substudy. Patients were included in the treatment change analysis if their pharmacy dispensing records were available. Patients were included in the adherence analysis if they had sufficient information to calculate a medication possession ratio (MPR).
Our first objective was to examine the effect of pharmacist intervention on changes to antihypertensive medication management. Patients' dispensing records during the 6-month period before enrollment in the main study were reviewed to establish a baseline antihypertensive medication regimen. Any changes to the baseline regimen during the final 6 months of the main study followup were identified and categorized as addition, dosage increase, or switching of antihypertensive medications. The primary outcome for this objective was a composite binary outcome of any of these treatment changes. Individuals with more than one treatment change were counted only once for the primary outcome analysis. We also evaluated each component of the primary composite outcome separately.
We compared the proportions of patients in each group with at least one treatment change using the chisquare test. We also calculated the relative risk (RR) and 95% confidence interval (95% CI) to measure the association between treatment groups and treatment changes and to measure the association between treatment changes and achievement of clinically important reductions in blood pressure (defined as a 10% or more reduction in systolic blood pressure during the 1-year study period). Similar analyses were conducted for each component of the primary outcome.
Our second objective was to evaluate the effect of pharmacist intervention on adherence to antihypertensive medications. Medication adherence was measured using the MPR, which was calculated using a standard formula. The mean MPR for all antihypertensive medications was then calculated for the 6-month period before enrollment in the main study and for the final 6 months of the main study follow-up period. We used a paired t test to examine the changes in MPR from baseline to follow-up for intervention and control groups. A Student's t test was used to test for between-group differences in the MRP change.
Methods
Details of the methods used in the randomized controlled trial were registered before patient recruitment (ISRCTN97121854); results of the main trial and changes to the predicted 10-year risk of cardiovascular diseases have been reported previously. This prespecified substudy is a secondary analysis of data collected during the main study.
Inclusion Criteria
All 260 patients enrolled in the main study were eligible for inclusion in both analyses of this substudy. Patients were included in the treatment change analysis if their pharmacy dispensing records were available. Patients were included in the adherence analysis if they had sufficient information to calculate a medication possession ratio (MPR).
Antihypertensive Treatment Change Analysis
Our first objective was to examine the effect of pharmacist intervention on changes to antihypertensive medication management. Patients' dispensing records during the 6-month period before enrollment in the main study were reviewed to establish a baseline antihypertensive medication regimen. Any changes to the baseline regimen during the final 6 months of the main study followup were identified and categorized as addition, dosage increase, or switching of antihypertensive medications. The primary outcome for this objective was a composite binary outcome of any of these treatment changes. Individuals with more than one treatment change were counted only once for the primary outcome analysis. We also evaluated each component of the primary composite outcome separately.
We compared the proportions of patients in each group with at least one treatment change using the chisquare test. We also calculated the relative risk (RR) and 95% confidence interval (95% CI) to measure the association between treatment groups and treatment changes and to measure the association between treatment changes and achievement of clinically important reductions in blood pressure (defined as a 10% or more reduction in systolic blood pressure during the 1-year study period). Similar analyses were conducted for each component of the primary outcome.
Medication Adherence Analysis
Our second objective was to evaluate the effect of pharmacist intervention on adherence to antihypertensive medications. Medication adherence was measured using the MPR, which was calculated using a standard formula. The mean MPR for all antihypertensive medications was then calculated for the 6-month period before enrollment in the main study and for the final 6 months of the main study follow-up period. We used a paired t test to examine the changes in MPR from baseline to follow-up for intervention and control groups. A Student's t test was used to test for between-group differences in the MRP change.
SHARE
