REAL-WORLD EFFECTIVENESS OF AZILSARTAN, AZILSARTAN/CHLORTHALIDONE AND DILTIAZEM EXTENDED RELEASE IN THE TREATMENT OF HYPERTENSION IN A CANADIAN ROUTINE-CARE SETTING: RESULTS FROM THE CV-CARE REGISTRY

Abstract

Azilsartan (AZ), azilsartan/chlorthalidone (AZ/CLD) and diltiazem-extended release (TXC) have been shown to significantly decrease blood pressure (BP) in randomized controlled trials. Effectiveness in the real-world setting has not been extensively reported. This analysis describes the effectiveness of AZ, AZ/CLD and TXC in hypertension management in a Canadian community-care setting. CV-CARE is a multi-center, community-based registry enrolling patients with cardio metabolic disorders including hypertension, treated with AZ, AZ/CLD and/or TXC. We assessed changes in systolic (SBP) and diastolic BP (DBP) over 12 months. Achieved BPs were stratified into three groups: SBP/DBP: A: <140/90 mmHg; B: <130/80 mmHg; and C: <120/80 mmHg. A total of 1,656 patients have been enrolled to date (AZ: n=1,087; AZ/CLD: n=423; TXC: n=146) of which 530 have 12-month follow-ups. TXC patients had the longest mean disease duration (9.0±9.94 years) when compared to AZ/CLD (5.8±6.61 years) and AZ (4.0±6.47 years) patients (p<0.001). Although the majority of patients entered into the study were medicated for their hypertension, mean baseline BP was above 150/90 mm Hg. The results from Table 1 show that baseline parameters were similar for the three treatments. At month 12, clinically and statistically significant SBP and DBP reductions were observed for AZ (-21.9/-11.2 mmHg), AZ/CLD (-23.1/-11.4 mmHg) and TXC (-15.9/-6.8 mmHg). Across all three medications, 59-76% achieved strata A, 17-29% achieved strata B, but only 6-15% achieved strata C at month 12. At month 12, only 13% had changes in study drug, with 2.2% switching to a new drug and 3.8% discontinuing, suggesting a good efficacy and tolerability. The most frequent reason for treatment change was inadequate BP control (AZ: 73.7%; AZ/CLD: 71.4%; p=0.747). Both monotherapy and combination therapy patients had significant (p<0.001) reductions in BP and pulse (monotherapy; combination: -2.7 bpm; -2.5 bpm) over 12 months of treatment. The most commonly reported baseline comorbidity was type 2 diabetes among patients treated with AZ (18.3%) and AZ/CLD (22.7%) while dyslipidemia was most frequent among TXC patients (50.7%). In a real-world setting, treatment of hypertension is sub-optimal. This study shows that AZ, AZ/CLD and TXC fulfill an unmet medical need, as these treatments were effective in reducing BP and achieving conventional BP targets.