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Nocturnal antihypertensive treatment in patients with type 1 diabetes with autonomic neuropathy and non-dipping: a randomised, placebo-controlled, double-blind cross-over trial.
- Source :
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BMJ open [BMJ Open] 2016 Dec 05; Vol. 6 (12), pp. e012307. Date of Electronic Publication: 2016 Dec 05. - Publication Year :
- 2016
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Abstract
- Objectives: Cardiovascular autonomic neuropathy (CAN) and abnormal circadian blood pressure (BP) rhythm are independent cardiovascular risk factors in patients with diabetes and associations between CAN, non-dipping of nocturnal BP and coronary artery disease have been demonstrated. We aimed to test if bedtime dosing (BD) versus morning dosing (MD) of the ACE inhibitor enalapril would affect the 24-hour BP profile in patients with type 1 diabetes (T1D), CAN and non-dipping.<br />Setting: Secondary healthcare unit in Copenhagen, Denmark.<br />Participants: 24 normoalbuminuric patients with T1D with CAN and non-dipping were included, consisting of mixed gender and Caucasian origin. Mean±SD age, glycosylated haemoglobin and diabetes duration were 60±7 years, 7.9±0.7% (62±7 mmol/mol) and 36±11 years.<br />Interventions: In this randomised, placebo-controlled, double-blind cross-over study, the patients were treated for 12 weeks with either MD (20 mg enalapril in the morning and placebo at bedtime) or BD (placebo in the morning and 20 mg enalapril at bedtime), followed by 12 weeks of switched treatment regimen.<br />Primary and Secondary Outcome Measures: Primary outcome was altered dipping of nocturnal BP. Secondary outcomes included a measurable effect on other cardiovascular risk factors than BP, including left ventricular function (LVF).<br />Results: Systolic BP dipping increased 2.4% (0.03-4.9%; p=0.048) with BD compared to MD of enalapril. There was no increase in mean arterial pressure dipping (2.2% (-0.1% to 4.5%; p=0.07)). No difference was found on measures of LVF (p≥0.15). No adverse events were registered during the study.<br />Conclusions: We demonstrated that patients with T1D with CAN and non-dipping can be treated with an ACE inhibitor at night as BD as opposed to MD increased BP dipping, thereby diminishing the abnormal BP profile. The potentially beneficial effect on long-term cardiovascular risk remains to be determined.<br />Trial Registration Number: EudraCT2012-002136-90; Post-results.<br />Competing Interests: Conflicts of Interest: None declared.<br /> (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)
- Subjects :
- Aged
Angiotensin-Converting Enzyme Inhibitors administration & dosage
Angiotensin-Converting Enzyme Inhibitors therapeutic use
Antihypertensive Agents therapeutic use
Autonomic Nervous System
Autonomic Nervous System Diseases etiology
Autonomic Nervous System Diseases physiopathology
Blood Pressure Monitoring, Ambulatory
Cardiovascular Diseases etiology
Circadian Rhythm
Cross-Over Studies
Double-Blind Method
Drug Administration Schedule
Enalapril therapeutic use
Female
Humans
Hypertension etiology
Hypertension physiopathology
Male
Middle Aged
Risk Factors
Antihypertensive Agents administration & dosage
Autonomic Nervous System Diseases drug therapy
Blood Pressure physiology
Cardiovascular Diseases drug therapy
Diabetes Mellitus, Type 1 complications
Enalapril administration & dosage
Hypertension drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 6
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 27920083
- Full Text :
- https://doi.org/10.1136/bmjopen-2016-012307