Document Detail


Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4,121 patients with focus on trial design: the CONVERGE report.
MedLine Citation:
PMID:  24038167     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: 30 mm Hg drops in office systolic blood pressure are reported in trials of renal denervation, but ambulatory reductions are much smaller. This disparity is assumed to have a physiological basis and also be present with antihypertensive drugs.
DESIGN: We examine this office-ambulatory discrepancy through meta-analysis of drug and denervation trials, categorising by trial design.
PATIENTS (STUDIES): 31 drug trials enrolling 4121 patients and 23 renal denervation trials enrolling 720 patients met the criteria.
RESULTS: In drug trials without randomisation or blinding, pressure reductions are 5.6 mm Hg (95% CI 2.98 to 8.22 mm Hg) larger on office measurements than ambulatory blood pressure monitoring (p<0.0001). By contrast, with randomisation and blinding, office reductions are identical to ambulatory reductions (difference -0.88 mm Hg, 95% CI -3.18 to 1.43, p=0.45). For renal denervation, there are no randomised blinded trial results. In unblinded trials, office pressure drops were 27.6 mm Hg versus pretreatment, and 26.6 mm Hg versus unintervened controls. By contrast, ambulatory pressure drops averaged 15.7 mm Hg across all trials. Among those where the baseline ambulatory pressure was not the deciding factor for enrolment (avoiding regression to the mean), ambulatory drops averaged only 11.9 mm Hg.
CONCLUSIONS: Discrepancies in drug trials between office and ambulatory blood pressure reductions disappear once double-blinded placebo control is implemented. Renal denervation trials may also undergo similar evolution. We predict that as denervation trial designs gradually improve in bias-resistance, office and ambulatory pressure drops will converge. We predict that it is the office drops that will move to match the ambulatory drops, that is, not 30, but nearer 13.
Authors:
James P Howard; Alexandra N Nowbar; Darrel P Francis
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't     Date:  2013-09-15
Journal Detail:
Title:  Heart (British Cardiac Society)     Volume:  99     ISSN:  1468-201X     ISO Abbreviation:  Heart     Publication Date:  2013 Nov 
Date Detail:
Created Date:  2013-10-08     Completed Date:  2013-12-02     Revised Date:  2014-02-20    
Medline Journal Info:
Nlm Unique ID:  9602087     Medline TA:  Heart     Country:  England    
Other Details:
Languages:  eng     Pagination:  1579-87     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Antihypertensive Agents / therapeutic use
Autonomic Denervation*
Blood Pressure* / drug effects
Blood Pressure Monitoring, Ambulatory
Clinical Trials as Topic / methods*
Double-Blind Method
Humans
Hypertension / diagnosis,  drug therapy,  physiopathology,  surgery*
Kidney / innervation*
Office Visits
Predictive Value of Tests
Research Design*
Treatment Outcome
Grant Support
ID/Acronym/Agency:
FS/10/038//British Heart Foundation; FS/10/38/28268//British Heart Foundation
Chemical
Reg. No./Substance:
0/Antihypertensive Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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