Real-World Evaluation of the Efficacy and Tolerability of a Fixed-Dose Combination of Amlodipine and Indapamide in Patients Over 55 Years

BACKGROUND: Isolated systolic hypertension (ISH) is a major cardiovascular risk factor in older adults, yet blood pressure (BP) control remains suboptimal. This study assessed the real-world effectiveness and tolerability of a FDC of indapamide and amlodipine in Bangladeshi patients aged 55 years and older. METHODS: The COMBINE (COMBination of Indapamide and amlodipiNE) study was an open-label, multicenter, prospective observational study conducted across 10 tertiary centers in Bangladesh from June to October 2022. A total of 185 patients with ISH, defined as systolic BP (SBP) between 140 and 179 mmHg (millimeters of mercury), received indapamide 1.5 mg and amlodipine 5 mg once daily. Primary endpoints included the mean SBP change and the proportion achieving SBP targets (<140 mmHg, <130 mmHg). BP, adverse events, and patient-reported well-being were assessed using the visual analogue scale (VAS). RESULTS: The mean SBP decreased by 20.9, 24.7, and 29.3 mmHg (p < 0.001); mean diastolic BP (DBP) declined by 8.1, 10.4, and 12.9 mmHg (p < 0.001) at two, four, and 12 weeks, respectively. At 12 weeks, most patients (164, 88.6%) achieved SBP <140 mmHg, and over half (115, 62.2%) of patients reached SBP <130 mmHg. Pulse pressure also improved significantly. The treatment was well tolerated, with mild adverse events including leg edema in three (1.6%) and hypokalemia in four (2.2%). VAS scores improved significantly, reflecting enhanced patient-perceived health status. CONCLUSIONS: In his real-world study, therapy was associated with substantial BP reductions, target SBP achievement, good tolerability, and improved patient-reported well-being in older adults with ISH.