A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .


Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .


Control parents received a standard brochure about safe driving .


Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .


The main outcome measure was a previously validated Risky Driving Score reported by teens .


Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .


Intervention teens ranked their parent 's success in talking about driving safety higher than control teens ( p = 0.035 ) and reported that their parents talked about more topics ( non-significant difference ) .


The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .


Interaction between communication quantity and the intervention was examined .


Intervention teens who reported more successful communication had a 42 % lower Risky Driving Score ( 95 % CI = 0.37 , 0.94 ) than control parents with less successful communication .


This program had a positive although not strong effect , and it may hold the most promise in partnership with other programs , such as Driver 's Education or Graduated Driver 's License policies .


ClinicalTrials.gov NCT01014923 .


Registered Nov. 16 , 2009 .


Deep molecular response ( MR ( 4.5 ) ) defines a subgroup of patients with chronic myeloid leukemia ( CML ) who may stay in unmaintained remission after treatment discontinuation .


It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .


Patients from the randomized CML-Study IV were analyzed for confirmed MR ( 4.5 ) which was defined as 4.5 log reduction of BCR-ABL on the international scale ( IS ) and determined by reverse transcriptase polymerase chain reaction in two consecutive analyses .


Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .


Of 1,551 randomly assigned patients , 1,524 were assessable .


After a median observation time of 67.5 months , 5-year overall survival ( OS ) was 90 % , 5-year progression-free-survival was 87.5 % , and 8-year OS was 86 % .


The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .


MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .


Independent of treatment approach , confirmed MR ( 4.5 ) at 4 years predicted significantly higher survival probabilities than 0.1 % to 1 % IS , which corresponds to complete cytogenetic remission ( 8-year OS , 92 % v 83 % ; P = .047 ) .


High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .


No patient with confirmed MR ( 4.5 ) has experienced progression .


MR ( 4.5 ) is a new molecular predictor of long-term outcome , is reached by a majority of patients treated with imatinib , and is achieved more quickly with optimized high-dose imatinib , which may provide an improved therapeutic basis for treatment discontinuation in CML .


To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .


Randomized controlled study with three parallel groups .


Level of evidence is 1b .


A total of 91 patients ( five bilateral ) with primary nasolacrimal duct obstruction ( NLDO ) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments : silicone , Prolene ( polypropylene ) , and otologic T-tube .


Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .


The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .


Complications were also noted .


The overall success rate of the En-DCR in the stent groups was 78.1 % ( 75/96 ) ; specifically , 87.5 % ( 28/32 ) with silicone , 84.4 % ( 27/32 ) with Prolene , and 62.5 % ( 20/32 ) with T-tube .


The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .


There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .


Prolene was found to be related with orbital complications .


Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .


The results of our study suggest that efficacy , defined as anatomic and functional success , is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR .


Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .


The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month , randomized , multi-site comparison of lithium - and quetiapine-based treatment .


Changes in clinical measures ( BISS total and subscales , CGI-BP , and CGI-Efficacy Index ) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up .


Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .


Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .


Benzodiazepine users ( at baseline or during follow-up ) experienced significantly less improvement in BISS total , BISS irritability , and CGI-BP scores than did benzodiazepine non-users .


There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .


There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .


This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .


Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over 6 months , after controlling for potential confounding factors .


Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .


Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .


GS-4997 is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase 1 ( ASK1 ) , which is a key mediator of the deleterious effects of oxidative stress .


We describe the rationale and design of a Phase 2 placebo-controlled clinical trial investigating the effects of GS-4997 in patients with T2DM and stage 3/4 DKD receiving standard of care therapy .


Approximately , 300 subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .


The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria .


Guided by the biology of oxidative stress signaling through ASK1 , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase 2 study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design .


Adherence to medication is often low .


Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .


Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .


A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups .


Each group consists of an intervention arm and an usual care arm .


The intervention arm in the first group is the usual care arm in the second group and vice versa .


One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .


The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription .


A random sample of pharmacies will send questionnaires 3 months after the first prescription .


This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .


The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention .


Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .


The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .


By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .


Finally the study will provide information on which patients are most likely to benefit from this intervention .


The trial is registered at http://www.trialregister.nl under the identifier NTR3237 .


The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )


We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators .


Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .


The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level .


Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .


Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .


Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .


No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .


We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .


The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .


Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .


The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .


Patients will be randomised to either group using a web-based system .


Both groups will receive pre and post-intervention physiotherapy review .


Patients will be followed-up to one year post-operation .


The primary outcome measure is the Oxford Knee Score .


Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .


Current Controlled Trials ISRCTN23357609 .


ClinicalTrials.gov NCT01849445 .


In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .


We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .


This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .


We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) .


Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations .


The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment .


Primary and safety analyses were by intention to treat .


We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board .


This trial is registered at ClinicalTrials.gov , number NCT01396759 .


Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited .


We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy .


Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy .


Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) .


No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) .


23 ( 10 % ) children died .


Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group .


Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) .


Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .


Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .


The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .


Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .


International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne .


Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 .


Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .


Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .


We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .


This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) .


Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .


Cluster randomisation will occur at the level of the primary health centres .


Outcome analyses will be conducted blinded to intervention allocation .


The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .


Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) .


Trial outcomes will be accompanied by detailed process and economic evaluations .


The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .


Clinical Trial Registry India CTRI/2013/06 / 003753 .


To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .


Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group .


All patients received WM therapy .


Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) .


The therapeutic course for all was 12 weeks .


The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment .


After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) .


There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) .


External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS .


High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .


In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .


Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .


Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .


The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .


No significant difference was seen in mean iFGF23 between groups at week 12 .


There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .


Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .


Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .


This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .


ClinicalTrials.gov NCT01128179 , 20 May 2010 .


This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .


Treatment of patients with ISR remains a challenge .


This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .


The primary endpoint was the minimal lumen diameter at 9 months ' follow-up .


A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) .


Procedural success was achieved in all patients .


At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 17 % vs. 25 20 % , p < 0.001 ) .


However , late loss ( 0.04 0.5 mm vs. 0.14 0.5 mm , p = 0.14 ) and binary restenosis rate ( 4.7 % vs. 9.5 % , p = 0.22 ) were very low and similar in both groups .


Clinical follow-up ( median 365 days ) was obtained in all ( 100 % ) patients .


Occurrences of the combined clinical outcome measure ( cardiac death , myocardial infarction , and target vessel revascularization ; 6 % vs. 8 % ; hazard ratio [ HR ] : 0.76 ; 95 % CI : 0.26 to 2.18 , p = 0.6 ) and the need for target vessel revascularization ( 2 % vs. 6 % ; HR : 0.32 : 95 % CI : 0.07 to 1.59 , p = 0.17 ) were similar in the 2 groups .


In patients with BMS-ISR , both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences .


However , compared with DEB , EES provide superior late angiographic findings .


( Restenosis Intra-stent of Bare Metal Stents : Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [ RIBS V ] ; NCT01239953 ) .


Irregularity measures have been suggested as risk indicators in patients with atrial fibrillation ( AF ) ; however , it is not known to what extent they are affected by commonly used rate-control drugs .


We aimed at evaluating the effect of metoprolol , carvedilol , diltiazem , and verapamil on the variability and irregularity of the ventricular response in patients with permanent AF .


Sixty patients with permanent AF were part of an investigator-blind cross-over study , comparing 4 rate-control drugs ( diltiazem , verapamil , metoprolol , and carvedilol ) .


We analyzed five 20-minute segments per patient : baseline and the 4 drug regimens .


On every segment , heart rate ( HR ) variability and irregularity of RR series were computed .


The variability was assessed as standard deviation , pNN20 , pNN50 , pNN80 , and rMSSD .


The irregularity was assessed by regularity index , approximate ( ApEn ) , and sample entropy .


A significantly lower HR was obtained with all drugs , the HR was lowest using the calcium channel blockers .


All drugs increased the variability of ventricular response in respect to baseline ( as an example , rMSSD : baseline 171 47 milliseconds , carvedilol 229 58 milliseconds ; P < 0.05 vs. baseline , metoprolol 226 66 milliseconds ; P < 0.05 vs. baseline , verapamil 228 84 ; P < 0.05 vs. baseline , diltiazem 256 87 milliseconds ; P < 0.05 vs. baseline and all other drugs ) .


Only - blockers significantly increased the irregularity of the RR series ( as an example , ApEn : baseline 1.86 0.13 , carvedilol 1.92 0.09 ; P < 0.05 vs. baseline , metoprolol 1.93 0.08 ; P < 0.05 vs. baseline , verapamil 1.86 0.22 ns , diltiazem 1.88 0.16 ns ) .


Modification of AV node conduction by rate-control drugs increase RR variability , while only - blockers affect irregularity .


Among patients with quiescent ulcerative colitis ( UC ) , lower fecal concentrations of calprotectin are associated with lower rates of relapse .


We performed an open-label , randomized controlled trial to investigate whether increasing doses of mesalamine reduce concentrations of fecal calprotectin ( FC ) in patients with quiescent UC .


We screened 119 patients with UC in remission on the basis of Simple Clinical Colitis Activity Index scores , FC > 50 g/g , and intake of no more than 3 g/day mesalamine .


Participants taking mesalamine formulations other than multimatrix mesalamine were switched to multimatrix mesalamine ( 2.4 g/day ) for 6 weeks ; 52 participants were then randomly assigned ( 1:1 ) to a group that continued its current dose of mesalamine ( controls , n = 26 ) or a group that increased its dose by 2.4 g/day for 6 weeks ( n = 26 ) .


The primary outcome was continued remission with FC < 50 g/g .


Secondary outcomes were continued remission with FC < 100 g/g or < 200 g/g ( among patients with pre-randomization values above these levels ) .


The primary outcome was achieved by 3.8 % of controls and 26.9 % of the dose escalation group ( P = .0496 ) .


More patients in the dose escalation group reduced FC to below 100 g/g ( P = .04 ) and 200 g/g ( P = .005 ) .


Among the patients who were still in remission after the randomization phase , clinical relapse occurred sooner in patients with FC > 200 g/g compared with those with FC < 200 g/g ( P = .01 ) .


Among patients with quiescent UC and increased levels of FC , increasing the dose of mesalamine by 2.4 g/day reduced fecal concentrations of calprotectin to those associated with lower rates of relapse .


Clinicaltrials.gov number : NCT00652145 .


Despite standard statin therapy , a majority of patients retain a high `` residual risk '' of cardiovascular events .


The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention ( PCI ) .


This trial was a prospective , randomized , controlled , multicenter study .


Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe ( 10 mg ) daily .


Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol ( LDL-C ) < 70 mg/dl .


Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients .


The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy ( 63.2 16.3 mg/dl vs. 73.3 20.3 mg/dl ; p < 0.001 ) .


For the absolute change in percent atheroma volume ( PAV ) , themean difference between the 2 groups ( -1.538 % ; 95 % confidence interval [ CI ] : -3.079 % to 0.003 % ) did not exceedthe pre-defined noninferiority margin of 3 % , but the absolute change in PAV did show superiority for the dual lipid-lowering strategy ( -1.4 % ; 95 % CI : -3.4 % to -0.1 % vs. -0.3 % ; 95 % CI : -1.9 % to 0.9 % with atorvastatin alone ; p = 0.001 ) .


For PAV , a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression ( 78 % vs. 58 % ; p = 0.004 ) .


Both strategies had acceptable side effect profiles , with a low incidence oflaboratory abnormalities and cardiovascular events .


Compared with standard statin monotherapy , the combination of statin plus ezetimibe showed greater coronary plaque regression , which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering .


( Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [ PRECISE-IVUS ] ; NCT01043380 ) .