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Abstract

The aim of this study was to compare the effects of fosinopril and amlodipine alone or in combination on urinary albumin excretion (UAE) in NIDDM hypertensives with microalbuminuria

We studied 311 microalbuminuric hypertensive patients (DBP>90 mmHg) with well controlled NIDDM. After a 4-week placebo (P) period they were treated with amlodipine 5 to 15 mg o.d. (n =102) or with fosinopril 10 to 30 mg o.d. (n = 106) or with amlodipine fosinopril combination (5/10 to 15/30 mg) (n = 103) for 4 years. The aim was to achieve a DBP < 90 mmHg with the 2 monotherapies and < 85 mmHg with the combination. The patients non responders or complaining side effects at the 3rd month of titration were discontinued. Every 6 months BP, UAE and creatinine clearance (CrCl) were evaluated.

The main results are as follows: (See Table)

PlaceboAmlodipineFosinoprilCombination
6 m48 m6 m48 m6 m48 m
SBP mmHg161141**143**142**145**129**128**
DBP mmHg10185**84**86**88**81**80**
UAE mg/24h1069765*51**41**40**33**
CrCl ml/min90979188898492
PlaceboAmlodipineFosinoprilCombination
6 m48 m6 m48 m6 m48 m
SBP mmHg161141**143**142**145**129**128**
DBP mmHg10185**84**86**88**81**80**
UAE mg/24h1069765*51**41**40**33**
CrCl ml/min90979188898492
*

p < 0.05

**

p < 0.01 vs placebo.

PlaceboAmlodipineFosinoprilCombination
6 m48 m6 m48 m6 m48 m
SBP mmHg161141**143**142**145**129**128**
DBP mmHg10185**84**86**88**81**80**
UAE mg/24h1069765*51**41**40**33**
CrCl ml/min90979188898492
PlaceboAmlodipineFosinoprilCombination
6 m48 m6 m48 m6 m48 m
SBP mmHg161141**143**142**145**129**128**
DBP mmHg10185**84**86**88**81**80**
UAE mg/24h1069765*51**41**40**33**
CrCl ml/min90979188898492
*

p < 0.05

**

p < 0.01 vs placebo.

After 4 years the percentage of patients with UAE < 30 mg/24 h was 34% with amlodipine, 56% with fosinopril and 74% with the combination.

These data suggest that both drugs are effective in reducing UAE; however fosinopril leads to a greater and earlier improvement in UAE. The combination induces a greater response than the single drugs; it is difficult to understand wether it is due to pharmacospecific effects or to the greater antihypertensive effect.

Microalbuminuria, Fosinopril, Amlodipine
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© American Journal of Hypertension, Ltd. 2001
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