Efficacy and safety of lercanidipine/enalapril fixed combination in Lebanon: a prospective observational study

Abstract

Objective:

The DUAL study evaluated the effectiveness and safety of the fixed-dose combination of lercanidipine and enalapril in a real-practice scenario; the effects of this combination on a number of markers of cardiovascular risk have been also investigated.

Research design and methods:

This was a 2 month, phase IV, open-label, single-group, prospective observational study. Adult patients with untreated or uncontrolled hypertension (blood pressure [BP] >140/90 mmHg) were eligible for this study. All patients received lercanidipine/enalapril, in a once-daily fixed combination (10 mg/10 mg).

Main outcome measures:

The patients were evaluated at baseline, at 1 month and at 2 months. The following parameters were evaluated at all time points: systolic BP (SBP) and diastolic BP (DBP); heart rate (HR). A number of laboratory parameters were measured at baseline and at 2 months. Safety considerations were performed.

Results:

In total, 188 patients were enrolled (104 males; mean age 58 ± 12 years). At baseline, mean SBP was 159 ± 10 mmHg and mean DBP was 94 ± 7 mmHg. Treatment with lercanidipine/enalapril in fixed combination was associated with a reduction in both SBP and DBP already at 1 month; this reduction was sustained until month 2 (SBP: 131 ± 7 mmHg; DBP: 79 ± 5 mmHg; p < 0.05 vs baseline). At baseline HR was 78 ± 10 bpm; a significant reduction in this parameter was observed at month 2 (75 ± 7 bpm; p < 0.05 vs baseline).

A significant decrease in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and fasting glucose, and a significant increase in K⁺, and Ca²⁺ was observed at month 2 compared with baseline values. In total, two patients (1%) experienced dry cough. No other adverse effects were reported.

Conclusions:

Even with all the limitations of any observational study, these data show that a 2 month treatment with a fixed dose of lercanidipine/enalapril is associated with significant reductions in SBP and DBP, HR, and improvement in a number of laboratory parameters.

Keywords: :

• Combination therapy
• Enalapril
• Hypertension
• Lercanidipine

Transparency

Declaration of funding

Editorial support for this manuscript was funded by Recordati.

Declaration of financial/other relationships

S.A. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

Editorial assistance was provided by Luca Giacomelli PhD of Content Ed Net.

The DUAL Investigators Study Group: Fakhoury Robert, Middle East Institution Hospital; Mouawad Walid, Centre Hospitalier Du Nord; Dandashi Rabih, Haykal Hospital; El Samad Bassam, Nini Hospital; Khoury Walid, Haykal Hospital; Khoury Nabil, Hopital Libanais Geitaoui; Abi Rached Naji, Hopital Libanais Geitaoui; Abou Jaoude, Fady St-Georges Hospital; Sarkis Antoine, Hotel Dieu De France; Chammas Elie, Clemenceau Medical Center; Rahhal Malek, Middle East Hospital; Adhami Atika, Rafic Hariri University Hospital; Hamadeh Malek, Rassoul Hospital; Baydoun Ali, Bahman Hospital; Dirani Ali, Al-Sahel Hospital; Ghaddar Adel, Hammoud Hospital; Abou Zeinab, Hilal Hammoud Hospital; Jaber Khalil, Hammoud Hospital; Kouwayess Aii, Hammoud Hospital.