ahrq’s effective health care program: applying existing evidence to diabetes care
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AHRQ’s Effective Health Care Program: Applying Existing Evidence to Diabetes Care. Tuesday, December 14, 2010 CALL-IN TELEPHONE NUMBER: (888) 632-5065 ACCESS CODE: 25848872#. Questions. To submit a question: Press the “Ask Question” button located at the bottom of the screen. - PowerPoint PPT PresentationTRANSCRIPT
AHRQ’s Effective Health Care AHRQ’s Effective Health Care Program: Applying Existing Program: Applying Existing Evidence to Diabetes CareEvidence to Diabetes Care
Tuesday, December 14, 2010Tuesday, December 14, 2010
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(888) 632-5065(888) 632-5065
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25848872#25848872#
Questions Questions
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at the bottom of the screen. at the bottom of the screen.
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22CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872 ##
AgendaAgenda
Brief Overview of Patient-Centered Brief Overview of Patient-Centered Outcomes Research and AHRQ’s Outcomes Research and AHRQ’s Effective Health Care Program-Effective Health Care Program- Sonia Sonia Nagda, moderatorNagda, moderator
Comparative Effectiveness, Safety, and Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Indications of Insulin Analogues in Premixed Formulations for Adults With Premixed Formulations for Adults With Type 2 Diabetes- Type 2 Diabetes- Rehan Qayyum, Rehan Qayyum, M.D., M.H.S.M.D., M.H.S.
Q&A from Audience Q&A from Audience 33CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872 ##
Questions Questions
To submit a question: To submit a question: – Press the “Ask Question” button located Press the “Ask Question” button located
at the bottom of the screen. at the bottom of the screen.
– When you click on the button, a box will When you click on the button, a box will appear at the bottom of your screen appear at the bottom of your screen requesting that you enter your question. requesting that you enter your question.
– Once completed, press the “Submit” Once completed, press the “Submit” button. button.
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Patient-Centered Outcomes Patient-Centered Outcomes Research and AHRQ’s Effective Research and AHRQ’s Effective
Health Care ProgramHealth Care Program
Sonia Nagda, M.D., M.P.H.Sonia Nagda, M.D., M.P.H.
AHRQ’s Office of Communications and AHRQ’s Office of Communications and Knowledge TransferKnowledge Transfer
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Patient-Centered Patient-Centered Outcomes ResearchOutcomes Research
Benefits
Harms
Also known as comparative effectiveness researchAlso known as comparative effectiveness research
Unbiased and practical, evidence-based Unbiased and practical, evidence-based information information
Compares drugs, devices, tests and surgeries, and Compares drugs, devices, tests and surgeries, and approaches to health care approaches to health care – Benefits and harms Benefits and harms – What is known and what isn’tWhat is known and what isn’t
Descriptive, not prescriptiveDescriptive, not prescriptive 66
Horizon Horizon ScanningScanning
EvidenceEvidence NeedNeed
IdentificationIdentification
Evidence Evidence SynthesisSynthesis
EvidenceEvidence GenerationGeneration
StrategiesStrategiesInterventionsInterventionsConditionsConditionsPopulationsPopulations
DisseminationDisseminationTranslationTranslation
ImprovementsImprovements inin
Health CareHealth Care
Research PlatformResearch PlatformInfrastructure – Methods Development – Training Infrastructure – Methods Development – Training
A Framework for A Framework for Patient-Centered Outcomes Patient-Centered Outcomes
ResearchResearch
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Research Focus: Research Focus: 14 Priority Conditions14 Priority Conditions
Arthritis and nontraumatic joint Arthritis and nontraumatic joint disordersdisorders
CancerCancer
Cardiovascular disease, Cardiovascular disease, including stroke and including stroke and hypertensionhypertension
Dementia, including Dementia, including Alzheimer’s diseaseAlzheimer’s disease
Depression and other mental Depression and other mental health disordershealth disorders
Developmental delays, ADHD Developmental delays, ADHD and autismand autism
Diabetes mellitusDiabetes mellitus
Functional limitations and Functional limitations and disabilitydisability
Infectious diseases, Infectious diseases, including HIV/AIDSincluding HIV/AIDS
ObesityObesity
Peptic ulcer disease and Peptic ulcer disease and dyspepsiadyspepsia
Pregnancy including Pregnancy including preterm birthpreterm birth
Pulmonary disease/asthmaPulmonary disease/asthma
Substance abuseSubstance abuse
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Effective Health Care Program Effective Health Care Program Translation ProductsTranslation Products
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Executive Summary
Web Site
ClinicianGuide
ConsumerGuide Policymaker
Summary
Interactive Case Study
CE Modules
Faculty Slides
Patient Decision Aid(available soon)
Systematic Review Report
Diabetes ResourcesDiabetes Resources
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Public InvolvementPublic Involvement
Topic Topic GenerationGeneration
Topic Topic DevelopmentDevelopment
Topic Topic RefinementRefinement
Research Research ReviewReview
Research Research Needs Needs
DevelopmentDevelopment
Report Report Translation & Translation & DisseminationDissemination
During the Research ProcessDuring the Research Process
Web Web linkslinks
Newsletter Newsletter blurbsblurbs
Articles Articles or or
commentariescommentaries
Web Web conferencesconferences
Continuing Continuing EducationEducation
Disseminating the FindingsDisseminating the Findings
• Nominate topics using the online Nominate topics using the online formform• Participate in key question Participate in key question refinementrefinement• Comment via the web on draft key Comment via the web on draft key questions and reportsquestions and reports
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Comparative Effectiveness, Safety, and Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Indications of Insulin Analogues in
Premixed Formulations for Adults with Premixed Formulations for Adults with Type 2 DiabetesType 2 Diabetes
Rehan Qayyum, M.D., M.H.S.Rehan Qayyum, M.D., M.H.S.
Prepared for: Agency for Healthcare Research Prepared for: Agency for Healthcare Research
and Qualityand QualityContract No. #290-02-0018Contract No. #290-02-0018Prepared by: Evidence-based Practice Center, Prepared by: Evidence-based Practice Center,
The Johns Hopkins UniversityThe Johns Hopkins University 1212
Insulin AnaloguesInsulin Analogues
Insulin analoguesInsulin analogues are altered forms of are altered forms of human insulin with minor structural human insulin with minor structural changes without affecting glycemic changes without affecting glycemic controlcontrol
These structural changes impart These structural changes impart pharmacokinetic properties that allow pharmacokinetic properties that allow better control of the onset and duration of better control of the onset and duration of insulinlike activity. insulinlike activity.
These analogues are produced using These analogues are produced using recombinant DNA technology.recombinant DNA technology.
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Insulin AnaloguesInsulin Analogues
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Premixed Insulin AnaloguesPremixed Insulin Analogues
Mixture of rapid-acting and intermediate-Mixture of rapid-acting and intermediate-acting insulin analoguesacting insulin analogues
Intermediate-acting insulin is prepared Intermediate-acting insulin is prepared by mixing insulin analogues with by mixing insulin analogues with protamine sulfateprotamine sulfate
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Key Questions
1.1. In adults (age ≥ 18 years) with type 2 diabetes, what is the In adults (age ≥ 18 years) with type 2 diabetes, what is the effectivenesseffectiveness of of premixed insulin analogues (insulin aspart 70/30, insulin lispro 75/25, insulin premixed insulin analogues (insulin aspart 70/30, insulin lispro 75/25, insulin lispro 50/50) in achieving optimal glycemic control, as compared to insulin lispro 50/50) in achieving optimal glycemic control, as compared to insulin regimens including, but not necessarily limited to, the following preparations?regimens including, but not necessarily limited to, the following preparations? Premixed human insulin preparations (neutral protamine Hagedorn Premixed human insulin preparations (neutral protamine Hagedorn
[NPH]/regular 70/30, NPH/regular 50/50)[NPH]/regular 70/30, NPH/regular 50/50) Long-acting insulin analogues (insulin detemir, insulin glargine) Long-acting insulin analogues (insulin detemir, insulin glargine)
administered aloneadministered alone Intermediate-acting human insulin (NPH insulin) administered aloneIntermediate-acting human insulin (NPH insulin) administered alone Short-acting human insulin (regular insulin) administered prandiallyShort-acting human insulin (regular insulin) administered prandially Rapid-acting insulin analogues (insulin aspart, insulin glulisine, insulin Rapid-acting insulin analogues (insulin aspart, insulin glulisine, insulin
lispro) administered separately (prandially) with a long-acting insulin lispro) administered separately (prandially) with a long-acting insulin analogue (insulin detemir, insulin glargine)analogue (insulin detemir, insulin glargine)
2.2. For adults with type 2 diabetes, do premixed insulin analogues differ from other For adults with type 2 diabetes, do premixed insulin analogues differ from other commonly used insulin preparations with regard to commonly used insulin preparations with regard to safety, adverse effects, or safety, adverse effects, or adherenceadherence? The adverse effects of interest include, but are not limited to, ? The adverse effects of interest include, but are not limited to, hypoglycemia (nocturnal and daytime), weight gain, and interactions with other hypoglycemia (nocturnal and daytime), weight gain, and interactions with other medications.medications. 1616
Key Questions (cont.)Key Questions (cont.)
3. Does the effectiveness or safety of the new premixed insulin 3. Does the effectiveness or safety of the new premixed insulin analogue regimens vary across the following analogue regimens vary across the following subpopulationssubpopulations of of patients with type 2 diabetespatients with type 2 diabetes The elderly (≥ 65 years), very elderly (≥ 85 years)The elderly (≥ 65 years), very elderly (≥ 85 years) Other demographic groups (ethnic or racial groups, genders)Other demographic groups (ethnic or racial groups, genders) Individuals with comorbid medical conditionsIndividuals with comorbid medical conditions Individuals with limited life expectancyIndividuals with limited life expectancy Individuals with disabilitiesIndividuals with disabilities
4. What is the 4. What is the effectiveness and safetyeffectiveness and safety of the new premixed of the new premixed insulin analogue regimens in individuals insulin analogue regimens in individuals on oral antidiabetic on oral antidiabetic agents agents and individuals with and individuals with different blood glucose patterns different blood glucose patterns (such as fasting hyperglycemia or postprandial hyperglycemia) (such as fasting hyperglycemia or postprandial hyperglycemia) or or types of control types of control (such as tight control, usual control, good (such as tight control, usual control, good fasting or postprandial control)? fasting or postprandial control)? 1717
MethodsMethods
Search StrategySearch Strategy– Electronic database (February 2008)Electronic database (February 2008)
– Hand search of literature and Web sitesHand search of literature and Web sites
– Scientific information submitted by the pharmacy Scientific information submitted by the pharmacy industryindustry
Study Inclusion CriteriaStudy Inclusion Criteria– Clinical trials and observational studies Clinical trials and observational studies
Two reviewers independently selected studiesTwo reviewers independently selected studies
Data AbstractionData Abstraction– For relevant outcomesFor relevant outcomes
– Crossover studies excluded from progressive Crossover studies excluded from progressive outcomesoutcomes
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Statistical MethodsStatistical Methods
Intermediate outcomes Intermediate outcomes (Fasting and postprandial glucose, A1c)(Fasting and postprandial glucose, A1c)
– Random effects modelRandom effects model Adverse Effects Adverse Effects (Hypoglycemia, weight change)(Hypoglycemia, weight change)
– Random effects modelRandom effects model Clinical Outcomes Clinical Outcomes (rare-event data)(rare-event data)
– Fixed effects model (Mantel-Haenszel)Fixed effects model (Mantel-Haenszel)– Sensitivity analysis with Peto’s method and Bayesian Sensitivity analysis with Peto’s method and Bayesian
random-effects modelrandom-effects model
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ResultsResults
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2020
ResultsResults- Fasting Glucose -- Fasting Glucose -
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2121
ResultsResults- Postprandial Glucose -- Postprandial Glucose -
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2222
ResultsResults - Hemoglobin A1C -- Hemoglobin A1C -
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2323
ResultsResults- Hypoglycemia -- Hypoglycemia -
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2424
ResultsResults- Weight Change -- Weight Change -
Mean 95%CI P-value
Long-acting insulin analogues vs.
All premixed insulin analogues
1.97 1.22 to 2.73 < 0.001
Insulin Aspart 70/30 2.5 1.6 to 3.4 < 0.001
Insulin Lispro 75/25 No data
Insulin Lispro 50/50 1.58 0.99 to 2.18 < 0.001
Non-insulin antidiabetic agents vs.
All premixed insulin analogues
2.35 0.84 to 3.86 0.002
Insulin Aspart 70/30 2.82 0.61 to 5.02 0.012
Insulin Lispro 75/25 1.88 1.35 to 2.41 < 0.001
Insulin Lispro 50/50 No data
Premixed Human insulin vs.
All premixed insulin analogues
Not enough data
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ResultsResults- Other Comparisons -- Other Comparisons -
No or scant data for other comparisonsNo or scant data for other comparisons
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ResultsResults- Clinical Outcomes -- Clinical Outcomes -
Qayyum et al. Ann Intern Med. 2008; 21:549-559 2727
ResultsResults- Quality of Life -- Quality of Life -
Six studies evaluated this outcome.Six studies evaluated this outcome. In four studies using validated measurement In four studies using validated measurement
tools, only one of six quality of life outcomes tools, only one of six quality of life outcomes (psychological distress) showed a statistically (psychological distress) showed a statistically significant difference, in favor of premixed significant difference, in favor of premixed insulin analogues over other antidiabetic insulin analogues over other antidiabetic agents.agents.
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ResultsResults- in combination with oral agents -- in combination with oral agents -
Fasting glucose, Postprandial glucose, and Fasting glucose, Postprandial glucose, and HypoglycemiaHypoglycemia– 3 studies; no significant difference3 studies; no significant difference
Hemoglobin A1cHemoglobin A1c– 3 studies, combination better than premixed analogues alone 3 studies, combination better than premixed analogues alone
Weight change and Clinical outcomesWeight change and Clinical outcomes– 2 studies, no significant difference2 studies, no significant difference
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ResultsResults
No evidence forNo evidence for– adherence to treatment regimenadherence to treatment regimen– effectiveness and safety in subpopulations of effectiveness and safety in subpopulations of
interestinterest– different intensity of glucose controldifferent intensity of glucose control– targeting fasting versus postprandial glucose targeting fasting versus postprandial glucose
controlcontrol
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Case Study 1Case Study 1
50-year-old obese diabetic male comes 50-year-old obese diabetic male comes in for his regular clinic visitin for his regular clinic visit– HbA1C = 8.7HbA1C = 8.7
– Fasting glucose = 160-190Fasting glucose = 160-190
– On glipizide 10 mg twice daily and On glipizide 10 mg twice daily and metformin XL 1000mg twice dailymetformin XL 1000mg twice daily
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Case Study 2Case Study 2
56-year-old diabetic female comes in for her 56-year-old diabetic female comes in for her regular clinic visitregular clinic visit– HbA1C = 7.4HbA1C = 7.4
– Fasting glucose = 120-140Fasting glucose = 120-140
– Postprandial glucose = 180-220Postprandial glucose = 180-220
– On glyburide/metformin 5/500 BID and sitagliptin On glyburide/metformin 5/500 BID and sitagliptin 100mg QD100mg QD
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SummarySummary
Long Long actingacting
Rapid Rapid ActingActing
Long + Long + RapidRapid
NPH + NPH + RapidRapid PremixedPremixed NPHNPH Noninsulin Noninsulin
antidiabeticantidiabetic
FBGFBG
IA70/30IA70/30 ↔↔ ↓↓ ↔↔ XX ↑↑ ↔↔ ↓↓IL 75/25IL 75/25 ↑↑ XX XX XX ↔↔ XX ↓↓IL 50/50IL 50/50 ↑↑ ↔↔ ↑↑ XX ↑↑ XX XX
PPBGPPBG
IA70/30IA70/30 ↓↓ ↑↑ ↔↔ XX ↓↓ ↔↔ ↓↓IL 75/25IL 75/25 ↓↓ XX XX XX ↓↓ XX ↓↓IL 50/50IL 50/50 ↓↓ ↔↔ ↑↑ XX ↓↓ XX XX
HbA1cHbA1c
IA70/30IA70/30 ↓↓ ↔↔§§ ↓↓* * ↔↔ ↔↔ ↔↔ ↓↓IL 75/25IL 75/25 ↓↓ XX XX XX ↔↔ XX ↔↔IL 50/50IL 50/50 ↓↓ ↔↔ ↑↑ XX ↔↔ XX XX
Hypogly-Hypogly-cemiacemia
IA70/30IA70/30 ↑↑ ↔↔ ↓↓* * ↔↔ ↔↔ ↔↔ ↑↑IL 75/25IL 75/25 ↑↑** XX XX XX ↔↔ XX ↔↔IL 50/50IL 50/50 ↑↑ ↔↔ ↔↔ XX ↔↔ XX XX
Weight Weight ChangeChange
IA70/30IA70/30 ↑↑ ↓↓ ↔↔ ↑↑ ↔↔ ↔↔ ↑↑IL 75/25IL 75/25 XX XX XX XX ↔↔ XX ↑↑IL 50/50IL 50/50 ↑↑* * ↓↓** ↔↔ XX ↔↔ XX XX
↑ = variable increases with premixed analogue versus comparator↓ = variable decreases with premixed analogue versus comparator↔ = premixed analgoue and comparator has same effect on variableX = No studies have looked at the comparison* = Overall evidence is not of sufficient strength§ = benefit with premixed insulin analogue almost reached statistical significance
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Questions Questions
To submit a question: To submit a question: – Press the “Ask Question” button located Press the “Ask Question” button located
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– Once completed, press the “Submit” Once completed, press the “Submit” button. button.
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