First Real-World Results From the Independent Study: Blood Pressure Control With a Novel Single-Pill of Angiotensin Ii Receptor Blocker and Indapamide in European Clinical Practice

Objective: This study evaluates the efficacy and safety of a new single pill combination of valsartan or telmisartan with indapamide in achieving the 2023 ESH first target office blood pressure (<140/80 mmHg) in routine clinical practice. Design and method: The interim results of ongoing international, noninterventional, prospective, multicentre study include 715 hypertensive patients from Bulgaria, North Macedonia, Hungary and Croatia, observed for 10–16 weeks, data collected at baseline and two follow up visits. This interim analysis covers only the valsartan and indapamide 160/1.5 mg combination. Results: Among 715 patients (53.3% female; mean age 61.9±11.9 years), 96.5% had uncontrolled hypertension. At baseline, 60.3% had at least one comorbidity. Hypertension grades: 43.1% Grade 1, 44.7% Grade 2, and 12.2% Grade 3. 52.7% had prior additional antihypertensive therapy. The mean body mass index was 28.6±4.86 kg/m2. Cardiovascular family history was reported in 47.1%. Diabetes was present in 20.8%, hyperlipidaemia in 52.7%, chronic kidney disease in 2.1%, and metabolic syndrome in 9.5%. Office blood pressure showed substantial improvement. Mean systolic /diastolic values decreased from 158±16.9 / 94.4±9.91 mmHg at baseline to 127±10.4 / 79.3±6.4 mmHg at the third visit (p<0.001). The largest reductions occurred between the first and second visits (29.8±16.8 mmHg systolic; 14.1±10.7 mmHg diastolic). Changes from second to third visit were less pronounced, indicating early blood pressure improvement, followed by stabilization. Overall, 87% achieved the previous <140/90 mmHg first target, while 38.8% met the newer <140/80 mmHg first target, with the diastolic threshold being the limiting factor. Treatment choice reflected adherence expectations and good physician experience with angiotensin II receptor blockers and indapamide regimens. Safety was favourable: 98.9% reported no adverse events. Adverse events occurred in 1.1%, with 0.84% treatment related and all non serious. These results support valsartan/indapamide SPC as an effective and safe option for achieving guideline recommended blood pressure control in routine practice.Conclusions: These interim findings show that the valsartan and indapamide single pill combination effectively and safely lowers blood pressure in routine practice. Strong reductions and high achievement rates of guideline defined targets highlight its value for improving adherence and simplifying hypertension management.