There was a dose-dependent decrease in blood pressure for aliskiren 75 mg , 150 mg and 300 mg .
Aliskiren had no effect on blood pressure variability .
Due to very limited information available regarding change in heart rate and pulse pressure , it was not possible to meta-analyze these outcomes .Mortality and non-fatal serious adverse events were not increased .
AUTHORS ' CONCLUSIONS Compared to placebo , aliskiren lowered BP and this effect is dose-dependent .
This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme ( ACE ) inhibitors and angiotensin receptor blockers ( ARBs ) .
There is no difference in mortality , nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy .
BACKGROUND Hypertension is a chronic condition associated with an increased risk of mortality and morbidity .
Renin is the enzyme responsible for converting angiotensinogen to angiotensin I , which is then converted to angiotensin II .
Renin inhibitors are a new class of drugs that decrease blood pressure ( BP ) by preventing the formation of both angiotensin I and angiotensin II .
OBJECTIVES To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension .
To determine the change in BP variability , pulse pressure , and heart rate and to evaluate adverse events ( mortality , non-fatal serious adverse events , total adverse events , withdrawal due to adverse effects and specific adverse events such as dry cough , diarrhoea and angioedema ) .
Proceedings of the First International Conference on Stepped Wedge Trial Design
Table of contentsI1 Introduction Mona Kanaan , Noreen Dadirai Mdege , Ada KedingO1 The HiSTORIC trial : a hybrid before- and -after and stepped wedge design RA Parker , N Mills , A Shah , F Strachan , C Keerie , CJ WeirO2 Stepped wedge trials with non-uniform correlation structure And rew Forbes , Karla HemmingO3 Challenges and solutions for the operationalisation of the ENHANCE study : a pilot stepped wedge trial within a general practice setting Sarah A Lawton , Emma Healey , Martyn Lewis , Elaine Nicholls , Clare Jinks , Valerie Tan , And rew Finney , Christian D Mallen , on behalf of the ENHANCE Study TeamO4 Early lessons from the implementation of a stepped wedge trial design investigating the effectiveness of a training intervention in busy health care setting s : the Thistle study Erik Lenguerr and , Graeme MacLennan , John Norrie , Siladitya Bhattacharya , Tim Draycott , on behalf of the Thistle groupO5 Sample size calculation for longitudinal cluster r and omised trials : a unified framework for closed cohort and repeated cross-section design sRichard Hooper , Steven Teerenstra , Esther de Hoop , S and ra EldridgeO6 Restricted r and omisation schemes for stepped-wedge studies with a cluster-level covariateAlan Girling , Monica TaljaardO7 A flexible modelling of the time trend for the analysis of stepped wedge trials : results of a simulation study Gian Luca Di Tanna , Antonio GasparriniP1 Tackling acute kidney injury – a UK stepped wedge clinical trial of hospital-level quality improvement interventions Anna Casula , Fergus Caskey , Erik Lenguerr and , Shona Methven , Stephanie MacNeill , Margaret May , Nicholas SelbyP2 Sample size considerations for quantifying secondary bacterial transmission in a stepped wedge trial of influenza vaccineLeon Danon , Hannah Christensen , Adam Finn , Margaret MayP3 Sample size calculation for time-to-event data in stepped wedge cluster r and omised trialsFumihito Takanashi , Ada Keding , Simon Crouch , Mona KanaanP4 Sample size calculations for stepped-wedge cluster r and omised trials with unequal cluster sizesCaroline A. Kristunas , Karen L. Smith , Laura J. GrayP5 The design of stepped wedge trials with unequal cluster sizesJohn N.S. MatthewsP6 Promoting Recruitment using Information Management Efficiently ( PRIME ) : a stepped wedge SWAT ( study -within-a-trial)R Al-Shahi Salman , RA Parker , A Maxwell , M Dennis , A Rudd , CJ WeirP7 Implication s of misspecified mixed effect models in stepped wedge trial analysis : how wrong can it be?Jennifer A Thompson , Katherine L Fielding , Calum Davey , Alex and er M Aiken , James R Hargreaves , Richard J HayesS1 Stepped Wedge Design s with Multiple Interventions Vivian H Lyons , Lingyu Li , James Hughes , Ali Rowhani-RahbarS2 Analysis of the cross-sectional stepped wedge cluster r and omised trialKarla Hemming , Monica Taljaard , And rew
There was a dose-dependent decrease in blood pressure for aliskiren 75 mg , 150 mg and 300 mg .
Aliskiren had no effect on blood pressure variability .
Due to very limited information available regarding change in heart rate and pulse pressure , it was not possible to meta-analyze these outcomes .Mortality and non-fatal serious adverse events were not increased .
AUTHORS ' CONCLUSIONS Compared to placebo , aliskiren lowered BP and this effect is dose-dependent .
This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme ( ACE ) inhibitors and angiotensin receptor blockers ( ARBs ) .
There is no difference in mortality , nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy .
BACKGROUND Hypertension is a chronic condition associated with an increased risk of mortality and morbidity .
Renin is the enzyme responsible for converting angiotensinogen to angiotensin I , which is then converted to angiotensin II .
Renin inhibitors are a new class of drugs that decrease blood pressure ( BP ) by preventing the formation of both angiotensin I and angiotensin II .
OBJECTIVES To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension .
To determine the change in BP variability , pulse pressure , and heart rate and to evaluate adverse events ( mortality , non-fatal serious adverse events , total adverse events , withdrawal due to adverse effects and specific adverse events such as dry cough , diarrhoea and angioedema ) .