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Francisco Javier Martinez-Martin, Herminia Rodriguez-Rosas, Alicia Macias-Batista.

Effects of a fixed Delapril / Manidipine combination on the Quality of Life in hypertensive type 2 diabetic patients: The VITAL Study. Francisco Javier Martinez-Martin, Herminia Rodriguez-Rosas, Alicia Macias-Batista. Endocrinology Dpt., *Hypertension Clinic,

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Francisco Javier Martinez-Martin, Herminia Rodriguez-Rosas, Alicia Macias-Batista.

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  1. Effects of a fixed Delapril/Manidipine combination on the Quality of Life in hypertensive type 2 diabetic patients: The VITAL Study Francisco Javier Martinez-Martin, Herminia Rodriguez-Rosas, Alicia Macias-Batista. Endocrinology Dpt., *Hypertension Clinic, Hospital Doctor Negrin, Las Palmas, Spain

  2. Conflicts of Interest • ThisworkwassupportedbyanunrestrictedgrantfromChiesiPharma, , manufacturers of VIVACE ® (fixedDelapril/Manidipinecombination). Theauthors do nothaveanyotherconflictof interestrelativetothiswork. • ChiesiPharmahad no participation in thedesign of thestudy, or in thecollection, analysis and presentation of the data. • The VITAL Studywasapprovedbythe local InstitutionalEthicalCommittee and conductedaccordingtotheDeclaration of Helsinki and theGoodClinicalPracticeGuidelines. • Allthepatientsgavetheirwritteninformedconsentforthestudy. EthicalGuidelines

  3. 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.

  4. 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.

  5. 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).

  6. EuroQol 5D-5L Questionnaire (English) x .x x 0.79 x x x M3-S2-U4-P3-A2 Table 0.486

  7. 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.

  8. 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).

  9. 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%.

  10. 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).

  11. QoL (EuroQol 5D-5L Index) p = 0.008

  12. 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.

  13. Thanksforyourattention, Mercibeaucoup

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