ABSTRACT
Background Acute kidney injury (AKI) is a common and serious condition affecting elderly patients. Despite its significance, comprehensive research focusing specifically on the clinical profile and short-term outcomes of AKI in this vulnerable population is lacking. Objective This study aimed to evaluate the clinical profile and short-term outcomes of AKI in elderly patients admitted to a tertiary care center. Methods A prospective observational study was conducted from December 2023 to March 2024, involving 75 elderly patients (aged ≥65 years) diagnosed with AKI. Baseline demographic data, clinical profiles, laboratory investigations, mortality rate among elderly patients diagnosed with AKI within 30 days of diagnosis, and short-term outcomes were recorded and analyzed. Descriptive statistics and appropriate statistical tests were used for the data analysis. Results The study cohort had a mean age of 72.6 years. Hypertension was present in 55 patients (73.3%), and diabetes mellitus was observed in 30 patients (40.0%). Prerenal causes of AKI were identified in 40 patients (53.3%), while acute tubular necrosis was found in 25 patients (33.3%). Stage 2 AKI was the most common, affecting 35 patients (46.7%). Out of the 75 patients, 15 patients (20.0%) succumbed to AKI within the study period. Deceased patients had longer hospital stays, with a median of 16 days compared to 10 days for survivors. ICU admission was required for 13 of the deceased patients (86.7%), compared to 32 of the surviving patients (53.3%). The need for renal replacement therapy was higher among the deceased patients, with 11 out of 15 patients (73.3%) requiring it, compared to 19 out of 60 surviving patients (31.7%). Renal function recovery was notably lower in the deceased patients. Conclusion AKI in elderly patients was associated with significant morbidity and mortality, highlighting the need for early recognition, appropriate management, and preventive strategies. A comprehensive evaluation of the clinical profile and short-term outcomes of AKI in the elderly population provides valuable insights for optimizing patient care and improving outcomes.
ABSTRACT
AIM: The present study compared the safety, efficacy, and tolerability of the new fixed-dose combination (FDC) of telmisartan 40 mg + bisoprolol 5 mg (TBP) tablets with the existing comparator FDC telmisartan 40 mg + metoprolol succinate ER 50 mg (TMS) tablets in patients with stage 1 and stage 2 hypertension. METHODOLOGY: The multicentric, double-blind, parallel-group, comparative, prospective, phase-III clinical study involved 264 subjects with stage 1 and stage 2 hypertension from 10 centres across India. The selected subjects were randomized into two groups: group A received the TMS and group B received the new FDC TBP. The primary endpoint was the mean change in seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) from baseline to week 12 in both the control and study arms. The secondary endpoint was achieving the target of SeSBP <140 mmHg and SeDBP <90 mmHg from baseline to week 12 in both groups. Safety and tolerability parameters were evaluated in both groups based on adverse effects (AEs) reported by the patients and the physician. RESULTS: Both treatment groups exhibited a reduction in BP after 2 weeks of treatment, which was sustained until 12 weeks. The mean change in SeSBP and SeDBP at weeks 2, 6, and 12 compared to the previous visit showed statistical significance (p < 0.001) in all cases for both groups A and B. The mean changes in SeSBP and SeDBP from baseline to study end were numerically higher in group B than in group A. The mean difference in SeSBP from baseline to study end was significantly higher in group B compared to group A (p = 0.029). By week 12, 88.28 % and 89.84 % of subjects in group B achieved SeSBP <140 mmHg and SeDBP <90 mmHg respectively, while 86.71 % and 91.40 % of subjects in group A achieved the same targets. Reported AEs were mostly mild to moderate in both treatment groups, and no serious AEs or deaths were reported. Tolerability was rated as 'excellent' by 93.75 % of subjects in group B and 91.40 % of subjects in group A. CONCLUSION: Both the new FDC TBP and the existing comparator TMS combination therapy have comparable efficacy, tolerability, and safety for the management of stage 1 and stage 2 hypertension. TRIAL REGISTRY NAME: Clinical Trials Registry of India (CTRI) TRIAL REGISTRATION NO: CTRI/2021/11/037,926 PROTOCOL NO: MLBTL/05/2021 PROTOCOL URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62069&EncHid=&userName=bisoprolol.
