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. 2022 Feb 23:2022:6868143.
doi: 10.1155/2022/6868143. eCollection 2022.

A Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine

Jamshed Dalal  1 , J P Sawhney  2 , P B Jayagopal  3 , P K Hazra  4 , Mohammed Yunus Khan  5 , Kumar Gaurav  5 , Colette Pinto  5 , Amey Mane  5 , Sachin Rao  6 , Madhur Jain  7
Affiliations

A Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine

Jamshed Dalal et al. Int J Hypertens. .

Abstract

Introduction: Calcium channel blockers have pedal edema as one of the confining factors of treatment. A real-world study may help evident reality of the situation in regular Indian clinical practice. The aim of the study is to assess effectiveness and incidence of pedal edema in essential hypertensive patients treated with amlodipine or cilnidipine monotherapy.

Methods: Retrospective EMR data of adult essential hypertensive patients, prescribed amlodipine (n = 800) or cilnidipine (n = 800) as monotherapy, were analyzed. Incidence of pedal edema from baseline visit was analyzed in terms of dose and duration of treatment. The changes in systolic (SBP) and diastolic blood pressure (DBP) from baseline and proportion of patients achieving target BP goals were assessed.

Results: In amlodipine and cilnidipine groups, mean changes in SBP and DBP from baseline to end of the study period were 28.4 and 15.1 mmHg and 24.3 and 13.5 mmHg, respectively (p value <0.05). More than 50% of patients in both groups achieved BP goal at the end of the study (p value 0.266). In amlodipine group, total 23.9% reported pedal edema, while in cilnidipine, 27.6% (p value 0.0863). At the end of the study, 3.5% and 8.2% of patients remain with pedal edema, respectively, in both groups (pvalue <0.005).

Conclusion: Amlodipine demonstrated greater BP reduction at a lower average dose, better efficacy, and tolerability in terms of pedal edema count as a lesser number of patients reported edema at the end of the study and a higher percentage of patients continued the prescribed baseline dosage regimen as compared to cilnidipine. Thus, the study established amlodipine as an effective and well-tolerated antihypertensive for Indians.

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Conflict of interest statement

The authors, Dr. J. Dalal, Dr. J. P. Sawhney, Dr. P. B. Jayagopal, and Dr. P. K. Hazra, are the advisory board members for Dr. Reddy's Laboratories, Ltd. Dr. Md. Y. Khan, Dr. K. Gaurav, Colette Pinto, and Dr. A. Mane declare that they work in the Medical Affairs Department in Dr. Reddy's Laboratories, Ltd., Hyderabad, India. Dr. S. Rao and Dr. M. Jain declare that there are no conflicts of interest towards publishing the work as the manuscript.

Figures

Figure 1
Figure 1
Study sample selection flowchart.
Figure 2
Figure 2
(a) Average BP (mmHg) from baseline to follow-up visits. (b) Mean change in BP from baseline to end of the study.
Figure 3
Figure 3
Dose (mg) vs change in BP (mm Hg) from baseline to follow-up visits is given for amlodipine and cilnidipine.
Figure 4
Figure 4
(a) Overall pedal edema count (n) reported timelines during the study period. (b) Types of pedal edema count during follow-up visits. (c) Dose (mg) vs pedal edema incidences (n).
See this image and copyright information in PMC

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