Shalini Kumar
Medical Affair Ajanta Pharma Ltd, IndiaPresentation Title:
An Open-Label, Single-Arm, Non-Randomized, Prospective, Observational Multi-Center PMS Study to Assess the Efficacy and Safety of Cilnidipine in the Management of Essential Hypertension in a Franco-African Population
Abstract
Introduction: Hypertension is a global concern, particularly affecting the African continent. Despite available treatments, hypertension persists in many patients. Cilnidipine, a new-generation calcium channel blocker, offers potential benefits and has demonstrated efficacy and safety in the treatment of hypertension. This prospective, multicentre observational study was conducted from June 2022 to May 2023 in Côte d'Ivoire and Mali to evaluate the efficacy and safety of cilnidipine in the management of essential hypertension.
Methods: Sixty-three newly diagnosed individuals with hypertension, aged 18 to 65 years, were included in the study. The primary objectives included assessing efficacy by the mean change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) from baseline to 12 weeks. Cilnidipine was administered orally (5 or 10 mg) according to patient characteristics and the judgment of the treating physician. Adverse events were monitored.
Results: In this study involving 76.2% women (N=48) and 23.8% men (N=15), cilnidipine treatment demonstrated significant reductions in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate over 12 weeks. Patients' mean SBP decreased from 166.84 mmHg at baseline to 126.63 mmHg at week 12 (p <0.05), while their mean DBP decreased from 88.81 mmHg to 73.32 mmHg (p <0.05). Heart rate decreased from 83.31 bpm to 70.93 bpm (p <0.05). Adverse events were mild, with dizziness, headache, vomiting, and flushing reported by 14.29% of patients. No peripheral edema or rash was observed.
Conclusion: Cilnidipine effectively reduces SBP, DBP, and HR in hypertensive patients with minimal adverse effects.
Biography
To be updated