Opthalmic Antibiotic‐Steroid Combination Agents

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OpthalmicAntibiotic-SteroidCombinationAgents

Month/YearofReview:November2012

DateofLastReview:March2010

PDLClass:OpthalmicAntibiotics-steroidscombination

SourceDocument:ProviderSynergies(PS)

CurrentPreferredAgents

CurrentNon-PreferredAgents

Neo/polymyxBsulf/dexamethasonedrops

Fluometholone/sulfacetamide(FML-SLiquifilm?)drops

Neomysulf/bacitrac/poly/HCointment

Gentamicin/prednisolone(Pred-G?)0.3%/1%dropsand0.3%/0.6%ointment

SulfacetmNA/prednisolAC(BelphamideS.O.P?)ointment

Loprednol/tobromycin(Zylert?)drops

SulfacetmNA/prednisolAC(Blephamide?)drops

Tobramycinsulf/dexamethasonedrops

Tobramycinsulf/dexamethasone(Tobradex?)Ointment

PreviousRecommendations:

1. Thereisnodifferenceinefficacy/effectivenessorinsafetybetweenagents.(Strengthofrecommendation:C)

2. Thereisinsufficientevidencetomakeaspecificrecommendation.

PACriteria/QL:None

Recommendations: Nofurtherresearchorreviewneededatthistime. Background: Theuseofacombinationdrugwithanti-infectivecomponentisindicatedwheretheriskofsuperficialocularinfectionishighorwherethereisanexpectation thatpotentiallydangerousnumbersofbacteriawillpresentintheeye.

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Methods:

AMEDLINEOVIDsearchwasconductedusingallophthalmicantibiotics-steroidcombinationagentslimitedtorandomizedcontrolledtrialsandmeta-analysis,

Englishlanguage,andconductedinhumanssincetheliteraturesearchconductedforthepreviousPSreview.TheAgencyforHealthcareResearchandQuality

(AHRQ),CochraneCollection,andtheCanadianAgencyforDrugsandTechnologiesinHealth(CADTH)resourcesweresearchedforhighqualitysystematic

reviews.TheFDAwebsitewassearchedfornewdrugs,indications,andsafetyalerts,andtheAHRQNationalGuidelineClearinghouse(NGC)wassearchedfor

updatedandrecentevidence-basedguidelines.

NewTrials:

Atotalof36citationsresultedandafterreviewforinclusions,twopotentiallyrelevantclinicaltrialswereidentified(Appendix1).Thesetrialsarebriefly

describedinTable1.

Table1:PotentialRelevantNewTrials

Study BlairJ1,2011

Comparison Dexamethasone+

Population Overtheageof12years

PrimaryOutcome

Results

Residualulcersizeat10weeks Allsubjects(n=30)demonstrateda

RCT

gatifloxacincomparedwith withbacterialcornealulcer basedondigitalphotographs. reductioninulcersizeoverthestudy

gatifloxacin+Placebo

confirmedbyculture.

period.Therewasnosignificantdifference

betweenthe2groupsintermsofthe

TorkildsenGL2,

Tobramycin/dexamethasone Patientswithmoderateto Seven-itemglobalscore

primaryoutcome. Astatisticallysignificantlowermeanglobal

2011 RCT,MC, investigator-

(ST)comparedto azithromycin

severeblepharitis/ blepharoconjunctivitis.

definedasthetotalscoreoflid score(p=0.0002)wasobservedin

marginredness,bulbar

subjectstreatedwithSTcomparedto

conjunctivalredness,palpebral subjectstreatedwithazithromycinatDay

masked

conjunctivalredness,ocular discharge(0-3scale),andlid swelling,itchyeyelids,and grittyeyes(0-4scale).

8.Noseriousadverseeventswere reportedduringthecourseofthestudyin eithergroup.

RCT=Randomizedcontroltrial;MC=multi-center

Newdrugs:

Noneidentified.

NewFDAIndications:

Noneidentified.

NewFDAsafetyalerts:

Noneidentified.

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 NewSystematicReviews: Noneidentified. Guidelines:

Noneidentified.

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 References:

1.BlairJ,HodgeW,Al-GhamdiS,parisonofantibiotic-onlyandantibiotic-steroidcombinationtreatmentincornealulcerpatients:double-blindedrandomizedclinical trial.Can.J.Ophthalmol.2011;46(1):40?45. 2.TorkildsenGL,CockrumP,MeierE,etal.Evaluationofclinicalefficacyandsafetyoftobramycin/dexamethasoneophthalmicsuspension0.3%/0.05%comparedto azithromycinophthalmicsolution1%inthetreatmentofmoderatetosevereacuteblepharitis/blepharoconjunctivitis.CurrMedResOpin.2011;27(1):171?178.

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Appendix1

1. BlairJ,HodgeW,Al-GhamdiS,parisonofantibiotic-onlyandantibiotic-steroidcombinationtreatmentincornealulcerpatients:double-blindedrandomized clinicaltrial.Can.J.Ophthalmol.2011;46(1):40?45.

Objective:Todeterminethebenefitofearlyadditionofcorticosteroidstoantibioticsinthetreatmentofcornealulcers.

Participants:Thirtyeyesof30patients,overtheageof12years,withbacterialcornealulcerconfirmedbyculture.

Methods:Patientswererandomizedbeforeenrollment;15weretreatedwithgatifloxacin(Zymar)andamaskedplaceboandtheother15weretreatedwithgatifloxacin andmaskeddexamethasone0.1%(Maxidex).Primaryoutcomewasresidualulcersizeat10weeksbasedondigitalphotographs.Secondaryoutcomesincludedresidual ulcerareabyclinicianestimate,visualacuity,VF-14score,andtimetohealing.

Results:Allsubjects(n=30)demonstratedareductioninulcersizeoverthestudyperiod.Therewasnosignificantdifferencebetweenthe2groupsintermsoftheprimary outcome.Therewasasignificantdifferencebetweenthe2groupsin1ofthesecondaryoutcomes.Themeanresidualulcersizecomparedwiththebaselinebyclinician estimate(slit-lamp)was-0.789mm2fortheantibiotic-onlygroupand-4.206mm2fortheantibiotic-steroidgroup(p=0.05).Amongtheothersecondaryoutcomesthere werenosignificantdifferencesbetweenthe2groups.

Conclusions:Nobenefitwasdemonstratedinourprimaryoutcomeforusingsteroidsincombinationwithantibiotictherapyintreatmentofcornealulcers.Thisstudy suggeststhattheearlyadditionofsteroidstotheantibiotictreatmentofcornealulcersdoesnotseemtobeharmfulwhenemployedinacloselymonitoredclinicalsetting.

2. TorkildsenGL,CockrumP,MeierE,etal.Evaluationofclinicalefficacyandsafetyoftobramycin/dexamethasoneophthalmicsuspension0.3%/0.05%comparedto azithromycinophthalmicsolution1%inthetreatmentofmoderatetosevereacuteblepharitis/blepharoconjunctivitis.CurrMedResOpin.2011;27(1):171?178.

Objective:Toevaluatetheclinicalefficacyandsafetyoftobramycin/dexamethasone(TobraDexST;'ST')ophthalmicsuspension0.3%/0.05%comparedtoazithromycin (Azasite?)ophthalmicsolution(1%)inthetreatmentofmoderatetosevereblepharitis/blepharoconjunctivitis.

Researchdesignandmethods:Thestudywasamulticenter,randomized,investigator-masked,andactive-controlled,15-daystudy.Enrolledinthestudywere122adult subjects(atleast18yearsofage)diagnosedwithmoderatetosevereblepharitis/blepharoconjunctivitis,definedbyaminimumscoreofatleast'1'foroneofthelidsigns, oneoftheconjunctivalsigns,andoneofthesymptomsinatleastoneeyeandaminimumglobalscore(totalsignsandsymptomsscore)of'5'inthesameeye.Onegroupof 61subjectsreceivedSTwithinstructionstodose1dropfourtimesdaily(QID)for14days.Theothergroupof61subjectsreceivedazithromycinanddosedwith1drop twicedaily(BID)for2daysfollowedbyoncedaily(QD)dosingfor12days.VisitswereconductedatDay1(baseline),Day8andDay15.Theaprioriprimaryoutcome parameterofthestudywastheseven-itemglobalscoredefinedasthetotalscoreoflidmarginredness,bulbarconjunctivalredness,palpebralconjunctivalredness,ocular discharge(0-3scale),andlidswelling,itchyeyelids,andgrittyeyes(0-4scale).Thestudyutilizedstandardized,validatedphotographcontrolscalesdevelopedbyOra,Inc. (Andover,MA).Clinicaltrialregistration:undertheregistrynumberNCT01102244.

Results:Astatisticallysignificantlowermeanglobalscore(p=0.0002)wasobservedinsubjectstreatedwithSTcomparedtosubjectstreatedwithazithromycinatDay8. Noseriousadverseeventswerereportedduringthecourseofthestudyineithergroup.

Conclusion:STprovidesafastandeffectivetreatmentofacuteblepharitiscomparedtoazithromycin.Initialtherapywiththecombinationoftobramycin/dexamethasone providesfasterinflammationreliefthanazithromycinformoderatetosevereblepharitis/blepharoconjunctivitis.

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