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Real-World Effectiveness and Safety of Ramipril/Indapamide Combination Therapy in Essential Hypertension: A
Mariusz Mogielnicki1, Marian Płaszczyca2, Andrew Leary3
1Clinical Study Excellence Team, Medical Department, Zakłady Farmaceutyczne Polpharma S.A., Gdańsk, Poland.
Objective:
This study aimed to evaluate the patient characteristics, effectiveness, safety, adherence, and persistence of ramipril/indapamide (R/I) free combination therapy in patients with essential hypertension inadequately controlled with monotherapy.
Methods:
This retrospective observational cohort study used anonymized UK primary care electronic health records from IQVIA's Medical Research Database (IMRD), incorporating "The Health Improvement Network" (THIN), a Cegedim Database. Adults with essential hypertension who switched from ramipril or indapamide monotherapy to R/I between database inception and January 1, 2021, were enrolled. Outcomes included changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), proportions achieving BP < 140/90 mmHg or SBP ≥ 20 mmHg/DBP ≥ 10 mmHg decrease, proportion of days covered (PDC), persistence, and adverse events (AEs) over 12 months.
Results:
A total of 1089 patients met inclusion criteria (mean age 63.5 years; 55.6% female). Mean baseline BP on monotherapy was 156.0/89.1 mmHg. Over 12 months, mean SBP decreased by 18.7 mmHg and DBP by 8.9 mmHg (both p < 0.001); 54.3% of patients achieved BP < 140/90 mmHg, and 61.6% met the predefined BP decrease threshold. A dose-response relationship was observed for BP outcomes. Mean PDC was 92.4% at 3 months and 86.2% at 12 months; persistence was 87.7% and 81.5%, respectively. The most frequent AE was cough (10.38%); gout occurred in 0.73%, exclusively in indapamide-naïve patients. The outcomes remained consistent across sensitivity and subgroup analyses.
Conclusion:
Switching from ramipril or indapamide monotherapy to their free combination was associated with clinically meaningful BP decreases, high adherence and persistence, and a favorable safety profile in routine practice. These findings are consistent with current therapeutic guidelines that endorse its use in essential hypertension management.
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