Francisco Javier Martinez-Martin,Herminia Rodriguez-Rosas, Alicia Macias-Batista.Endocrinology Dpt., *Hypertension Clinic, Hospital Doctor Negrin, Las Palmas, Spain

Effects of a fixed Delapril/Manidipine combination on the Quality of Life in hypertensive type 2 diabetic patients:

The VITAL Study

Conflicts of Interest

This work was supported by an unrestricted grant from Chiesi Pharma, , manufacturers of VIVACE ® (fixed Delapril/Manidipine combination). The authors do not have any other conflict of interest relative to this work.

Chiesi Pharma had no participation in the design of the study, or in the collection, analysis and presentation of the data.

The VITAL Study was approved by the local Institutional Ethical Committee and conducted according to the Declaration of Helsinki and the Good Clinical Practice Guidelines.

All the patients gave their written informed consent for the study.

Ethical Guidelines

Introduction

• Most diabetic hypertensive patients need a combination of antihypertensives to reach blood pressure targets.

• The use of fixed combinations reduces the pill burden of the patients, may improve cost and long-term compliance, and is expected to result in better outcomes.

• However, the impact of most fixed combinations on Quality of Life (QoL) has not been sufficiently evaluated.

Objectives

• To evaluate the effect on QoL of switching to a fixed combination of delapril and manidipine, in hypertensive type 2 diabetic patients uncontrolled on monotherapy with a renin-angiotensin system blocker.

• To study the correlations of the variations in QoL with the reported side effects and with the changes in blood pressure and biochemical parameters.

Methods (I)

• We enrolled 90 patients aged 35-75 with type 2 diabetes mellitus and essential hypertension who had been treated for at least 6 months on monotherapy with a renin-angiotensin system blocker (ACEI or ARB) at maximal recommended doses but were uncontrolled (office BP > 140/90 mmHg).

• They were switched to a fixed combination of delapril 30 mg + manidipine 10 mg once a day, and were revaluated after 13 ± 2 weeks.

• QoL was assessed by the validated EuroQol 5D (EQ-5D-5L) questionnaire (Spanish version).

EuroQol 5D-5L Questionnaire (English)

x

x

x

x

x

M3-S2-U4-P3-A2 Table 0.486

.x

0.79

Methods (II)

• Blood pressure (BP), C-reactive protein (CRP) and urinary albumin excretion (UAE) were measured by standard clinical methods.

• Adverse effects (by questionnaire) and compliance (by pill counting) were assessed in the last visit.

• The Pearson’s R and the Spearman’s Rho were used for correlations of the variations in QoL with the changes in parametric and non-parametric variables, respectively.

Results (I)• 59% of the patients were female; the mean age was 54 ± 7 years.

• Baseline BP was 156 ± 13 mmHg; baseline HR was 87 ± 11 bpm.

• Baseline body mass index was 32.3 ± 6.3 kg/m2.

• Median baseline UAE was 36 mg/g (IQR 7 - 266).

• Mean baseline CRP was 2.8 ± 1.3 mg/L.

• Mean baseline Qol index (EQ-5D-5L) was 0.68 ± 0.11 (Scale 0 – 1).

Results (II)• The estimated compliance was 89%.

• BP was reduced by 16 ± 6/9 ± 5 mmHg (p < 0.001, t-test).

• 52 patients (58%) reached target BP (< 140/90 mmHg, t-test).

• UAE was reduced by 36% (CI 95%: 17 - 76%, p = 0.014, rank test).

• CRP was reduced by 29% (CI 95%: 13 - 65%, p = 0.032, t-test).

• QoL improved (> 0.05) in 69% of the patients, was unchanged in 21% and worsened (> 0.05) in 10%.

QoL after 13 weeks

ImprovedUnchangedWorsened

Results (III)• The EQ-5D index of QoL was significantly improved from 0.68 to

0.81 (+ 0.13; IC 95%: 0.11-0.16; p= 0.008, t-test) .

• 6 patients (6.7%) reported persistent cough, and 3 (3.3%) reported mild ankle oedema.

• No patient withdrew due to adverse effects, but 2 patients (2.2%) were lost to follow-up for unknown causes.

• Only the reduction in systolic BP and the presence of adverse effects correlated significantly with the changes in the QoL index (Pearson’s R: 0.216, p = 0.032; and Spearman’s Rho: -0.178, p = 0.043, respectively).

Baseline After 13 weeks0.5

0.6

0.7

0.8

0.9

1

*p = 0.008

QoL (EuroQol 5D-5L Index)

Conclusions

• The fixed combination of delapril and manidipine was effective and well tolerated, reduced CRP and albuminuria, and significantly improved QoL in hypertensive type 2 diabetic patients uncontrolled on monotherapy with a renin-angiotensin system blocker in this open, uncontrolled study.

• We hope that this approach can improve long-term patient compliance and result in better BP control.

Thanks for your attention, Merci beaucoup