A randomised controlled trial of potential for pharmacologic prevention of new-onset albuminuria, hypertension and diabetes in a remote Aboriginal Australian community, 2008–2013

Wendy E. Hoy, Christopher M. Reid, Molla Huq, Beverly J. McLeod, Susan A. Mott

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Introduction: We conducted a double-blind randomised controlled trial in a remote-living Australian Aboriginal group at high risk for chronic disease to assess whether pharmacological treatment with angiotensin converting enzyme inhibitor (ACEi) could delay the onset of albuminuria, hypertension or diabetes in people currently free of those conditions.

Methods: Eligibility criteria in 2008 were age ≥18yr, blood pressure ≤140/90 mm/Hg, urinary albumin creatinine ratio (ACR) < 3.4 mg/mmol, normal levels of glycosylated haemoglobin, and, in females, infertility. A 2011 amendment allowed enrolment of fertile females using long-term contraception. “Treatment” was the ACEi perindopril arginine, or placebo, and participant events were ACR ≥3.4 mg/mmol and/or blood pressure >140/90 mm Hg and/or haemoglobin A1c >6.5%, and/or cardiovascular events. Results were analysed in 125 randomised participants who commenced treatment.

Results: Recruitment was low, especially of women, and dropout rates high: there were finally 60 and 65 people in the ACEi and placebo groups respectively. In females, there were no events among 10 in the ACEi group, versus 5 events among 17 in the placebo group, and longitudinal ACR, HbA1c and blood pressure levels supported probable benefit of ACEi. There was no benefit of ACEi in males, but a probable benefit on diabetes/hypertension events. With the genders combined, there was probable reduction of diabetes (zero vs 4 events, p = 0.068), and of diabetes or hypertension (zero vs 5 events, p = 0.037).

Discussion: In this high-risk population, ACEi probably delays development of albuminuria, diabetes and hypertension in females, and of non-ACR events overall. Repeat investigation with a larger sample size is warranted.

LanguageEnglish
Article number100323
Pages1-6
Number of pages6
JournalContemporary Clinical Trials Communications
Volume14
Issue numberJune
Early online date14 Jan 2019
DOIs
Publication statusE-pub ahead of print - 14 Jan 2019
Externally publishedYes

Fingerprint

Albuminuria
Angiotensin-Converting Enzyme Inhibitors
Randomized Controlled Trials
Hypertension
Creatinine
Albumins
Placebos
Blood Pressure
Sample Size
Hemoglobins
Chronic Disease
Pharmacology
Therapeutics
Population

Cite this

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title = "A randomised controlled trial of potential for pharmacologic prevention of new-onset albuminuria, hypertension and diabetes in a remote Aboriginal Australian community, 2008–2013",
abstract = "Introduction: We conducted a double-blind randomised controlled trial in a remote-living Australian Aboriginal group at high risk for chronic disease to assess whether pharmacological treatment with angiotensin converting enzyme inhibitor (ACEi) could delay the onset of albuminuria, hypertension or diabetes in people currently free of those conditions. Methods: Eligibility criteria in 2008 were age ≥18yr, blood pressure ≤140/90 mm/Hg, urinary albumin creatinine ratio (ACR) < 3.4 mg/mmol, normal levels of glycosylated haemoglobin, and, in females, infertility. A 2011 amendment allowed enrolment of fertile females using long-term contraception. “Treatment” was the ACEi perindopril arginine, or placebo, and participant events were ACR ≥3.4 mg/mmol and/or blood pressure >140/90 mm Hg and/or haemoglobin A1c >6.5{\%}, and/or cardiovascular events. Results were analysed in 125 randomised participants who commenced treatment. Results: Recruitment was low, especially of women, and dropout rates high: there were finally 60 and 65 people in the ACEi and placebo groups respectively. In females, there were no events among 10 in the ACEi group, versus 5 events among 17 in the placebo group, and longitudinal ACR, HbA1c and blood pressure levels supported probable benefit of ACEi. There was no benefit of ACEi in males, but a probable benefit on diabetes/hypertension events. With the genders combined, there was probable reduction of diabetes (zero vs 4 events, p = 0.068), and of diabetes or hypertension (zero vs 5 events, p = 0.037). Discussion: In this high-risk population, ACEi probably delays development of albuminuria, diabetes and hypertension in females, and of non-ACR events overall. Repeat investigation with a larger sample size is warranted.",
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A randomised controlled trial of potential for pharmacologic prevention of new-onset albuminuria, hypertension and diabetes in a remote Aboriginal Australian community, 2008–2013. / Hoy, Wendy E.; Reid, Christopher M.; Huq, Molla; McLeod, Beverly J.; Mott, Susan A.

In: Contemporary Clinical Trials Communications, Vol. 14, No. June, 100323, 01.06.2019, p. 1-6.

Research output: Contribution to journalArticleResearchpeer-review

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