A randomized, double-blind, controlled, parallel-group comparison of perindopril and candesartan in hypertensive patients with type 2 diabetes mellitus

Giuseppe Derosa, Arrigo F G Cicero, Leonardina Ciccarelli, Roberto Fogari

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: When choosing an antihypertensive drug for patients with hypertension and diabetes mellitus (DM), the metabolic side effects, possibility of improving some metabolic parameters, and need for adequate blood pressure control must all be considered. Objective: The goal of this study was to compare the impacts of perindopril and candesartan on blood pressure, glucose metabolism, serum lipid profile, and metabolic parameters in patients with mild hypertension and type 2 DM during therapy and after a 1-month washout period. Methods: Type 2 DM patients with mild hypertension and good glucose control who were not taking hypercholesterolemic drugs were enrolled. Perindopril 4 mg QD or candesartan 16 mg QD was administered for 12 months in this randomized, double-blind, controlled, parallel-group clinical trial. Fasting plasma glucose (FPG), fasting plasma insulin (FPI), glycosylated hemoglobin, homeostasis model assessment (HOMA) index, systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglycerides, lipoprotein(a) (Lp[a]), plasminogen activator inhibitor 1 (PAI-1), homocysteine, body mass index (BMI), and albumin excretion rate (AER) were assessed. Results: Ninety-six patients (49 women and 47 men; mean [SD] ages, 53 [10] years [perindopril] and 55 [9] years [candesartan]) were enrolled. Mean (SD) body weight, height, and BMI were 78.2 (9.4) kg, 1.69 (0.05) m, and 27.2 (2.0) kg/m2 in the perindopril group and 77.5 (8.6) kg, 1.70 (0.06) m, and 26.8 (2.5) kg/m2 in the candesartan group. A significant change occurred from baseline to month 12 during treatment with perindopril in SBP and DBP (both P <0.01), FPG (P <0.05), FPI (P <0.05), TC (P <0.05), LDL-C (P <0.05), Lp(a) (P <0.05), PAI-1 (P <0.05), and AER (P <0.05). Significant changes from baseline to month 12 occurred with candesartan in SBP and DBP (both P <0.01) and AER (P <0.05). The HOMA index was significantly lower at month 12 in the perindopril group than in the candesartan group (P <0.05). When we interrupted perindopril and candesartan therapy for a 1-month washout period, changes in SBP and DBP values were significant compared with month 12 in both groups (all P <0.05). Changes in TC and LDL-C from month 12 to the end of washout were significant only in the perindopril group (both P <0.05). Conclusions: Perindopril and candesartan both effectively lowered blood pressure in this group of patients with mild hypertension and type 2 DM. Perindopril showed an improvement on some metabolic parameters compared with candesartan. However, the inclusion/exclusion criteria could limit the ability to extrapolate the results to a general population.

Original languageEnglish
Pages (from-to)2006-2021
Number of pages16
JournalClinical Therapeutics
Volume25
Issue number7
DOIs
Publication statusPublished - Jul 1 2003

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Perindopril
Type 2 Diabetes Mellitus
Blood Pressure
Fasting
LDL Cholesterol
candesartan
Hypertension
Albumins
Plasminogen Activator Inhibitor 1
Cholesterol
Glucose
Body Mass Index
Homeostasis
Insulin

Keywords

  • Candesartan
  • Diabetes mellitus
  • Hypertension
  • Insulin sensitivity
  • Perindopril

ASJC Scopus subject areas

  • Pharmacology

Cite this

A randomized, double-blind, controlled, parallel-group comparison of perindopril and candesartan in hypertensive patients with type 2 diabetes mellitus. / Derosa, Giuseppe; Cicero, Arrigo F G; Ciccarelli, Leonardina; Fogari, Roberto.

In: Clinical Therapeutics, Vol. 25, No. 7, 01.07.2003, p. 2006-2021.

Research output: Contribution to journalArticle

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T1 - A randomized, double-blind, controlled, parallel-group comparison of perindopril and candesartan in hypertensive patients with type 2 diabetes mellitus

AU - Derosa, Giuseppe

AU - Cicero, Arrigo F G

AU - Ciccarelli, Leonardina

AU - Fogari, Roberto

PY - 2003/7/1

Y1 - 2003/7/1

N2 - Background: When choosing an antihypertensive drug for patients with hypertension and diabetes mellitus (DM), the metabolic side effects, possibility of improving some metabolic parameters, and need for adequate blood pressure control must all be considered. Objective: The goal of this study was to compare the impacts of perindopril and candesartan on blood pressure, glucose metabolism, serum lipid profile, and metabolic parameters in patients with mild hypertension and type 2 DM during therapy and after a 1-month washout period. Methods: Type 2 DM patients with mild hypertension and good glucose control who were not taking hypercholesterolemic drugs were enrolled. Perindopril 4 mg QD or candesartan 16 mg QD was administered for 12 months in this randomized, double-blind, controlled, parallel-group clinical trial. Fasting plasma glucose (FPG), fasting plasma insulin (FPI), glycosylated hemoglobin, homeostasis model assessment (HOMA) index, systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglycerides, lipoprotein(a) (Lp[a]), plasminogen activator inhibitor 1 (PAI-1), homocysteine, body mass index (BMI), and albumin excretion rate (AER) were assessed. Results: Ninety-six patients (49 women and 47 men; mean [SD] ages, 53 [10] years [perindopril] and 55 [9] years [candesartan]) were enrolled. Mean (SD) body weight, height, and BMI were 78.2 (9.4) kg, 1.69 (0.05) m, and 27.2 (2.0) kg/m2 in the perindopril group and 77.5 (8.6) kg, 1.70 (0.06) m, and 26.8 (2.5) kg/m2 in the candesartan group. A significant change occurred from baseline to month 12 during treatment with perindopril in SBP and DBP (both P <0.01), FPG (P <0.05), FPI (P <0.05), TC (P <0.05), LDL-C (P <0.05), Lp(a) (P <0.05), PAI-1 (P <0.05), and AER (P <0.05). Significant changes from baseline to month 12 occurred with candesartan in SBP and DBP (both P <0.01) and AER (P <0.05). The HOMA index was significantly lower at month 12 in the perindopril group than in the candesartan group (P <0.05). When we interrupted perindopril and candesartan therapy for a 1-month washout period, changes in SBP and DBP values were significant compared with month 12 in both groups (all P <0.05). Changes in TC and LDL-C from month 12 to the end of washout were significant only in the perindopril group (both P <0.05). Conclusions: Perindopril and candesartan both effectively lowered blood pressure in this group of patients with mild hypertension and type 2 DM. Perindopril showed an improvement on some metabolic parameters compared with candesartan. However, the inclusion/exclusion criteria could limit the ability to extrapolate the results to a general population.

AB - Background: When choosing an antihypertensive drug for patients with hypertension and diabetes mellitus (DM), the metabolic side effects, possibility of improving some metabolic parameters, and need for adequate blood pressure control must all be considered. Objective: The goal of this study was to compare the impacts of perindopril and candesartan on blood pressure, glucose metabolism, serum lipid profile, and metabolic parameters in patients with mild hypertension and type 2 DM during therapy and after a 1-month washout period. Methods: Type 2 DM patients with mild hypertension and good glucose control who were not taking hypercholesterolemic drugs were enrolled. Perindopril 4 mg QD or candesartan 16 mg QD was administered for 12 months in this randomized, double-blind, controlled, parallel-group clinical trial. Fasting plasma glucose (FPG), fasting plasma insulin (FPI), glycosylated hemoglobin, homeostasis model assessment (HOMA) index, systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglycerides, lipoprotein(a) (Lp[a]), plasminogen activator inhibitor 1 (PAI-1), homocysteine, body mass index (BMI), and albumin excretion rate (AER) were assessed. Results: Ninety-six patients (49 women and 47 men; mean [SD] ages, 53 [10] years [perindopril] and 55 [9] years [candesartan]) were enrolled. Mean (SD) body weight, height, and BMI were 78.2 (9.4) kg, 1.69 (0.05) m, and 27.2 (2.0) kg/m2 in the perindopril group and 77.5 (8.6) kg, 1.70 (0.06) m, and 26.8 (2.5) kg/m2 in the candesartan group. A significant change occurred from baseline to month 12 during treatment with perindopril in SBP and DBP (both P <0.01), FPG (P <0.05), FPI (P <0.05), TC (P <0.05), LDL-C (P <0.05), Lp(a) (P <0.05), PAI-1 (P <0.05), and AER (P <0.05). Significant changes from baseline to month 12 occurred with candesartan in SBP and DBP (both P <0.01) and AER (P <0.05). The HOMA index was significantly lower at month 12 in the perindopril group than in the candesartan group (P <0.05). When we interrupted perindopril and candesartan therapy for a 1-month washout period, changes in SBP and DBP values were significant compared with month 12 in both groups (all P <0.05). Changes in TC and LDL-C from month 12 to the end of washout were significant only in the perindopril group (both P <0.05). Conclusions: Perindopril and candesartan both effectively lowered blood pressure in this group of patients with mild hypertension and type 2 DM. Perindopril showed an improvement on some metabolic parameters compared with candesartan. However, the inclusion/exclusion criteria could limit the ability to extrapolate the results to a general population.

KW - Candesartan

KW - Diabetes mellitus

KW - Hypertension

KW - Insulin sensitivity

KW - Perindopril

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U2 - 10.1016/S0149-2918(03)80201-1

DO - 10.1016/S0149-2918(03)80201-1

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VL - 25

SP - 2006

EP - 2021

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

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