db2 - efficacy and safety of human insulin versus animal

Comments

Transcription

db2 - efficacy and safety of human insulin versus animal
EFFICACY AND SAFETY OF HUMAN INSULIN
VERSUS ANIMAL INSULIN AMONG PATIENTS WITH
DIABETES IN CHINA: A META-ANALYSIS
Zhang Hena1, Wang Ke1, Yang Jun1
1. Lilly Suzhou Pharmaceutical Co., Ltd Shanghai Branch,
Shanghai, China
Presented at ISPOR 6th Asia Pacific,
Beijing, China, Sep 6-9, 2014
Background
Diabetes in China
 Increasing prevalence of diabetes in China1,2,3
15.00%
11.60%
9.70%
10.00%
5.00%
0.67%
1.04%
1980
1986
2.28%
2.60%
1994
2002
0.00%
2007
 High burden of diabetes in China
•
4% of national health expenditure in 2002
Company Confidential
Copyright© 2006 Eli Lilly and Company
4
2010
Insulin Use in China
17.14%
5.73%
7.94%
8.07%
37.75%
79%
Other
insulin
23.37%
Insulin
Repaglinide
Glimepiride
21%
Animal
insulin
Acarbose
Metformin
Others
 Insulin is the most prescribed medication for diabetes. 4
 Animal insulin is still used in China although it’s rarely
used in western countries now.5
Company Confidential
Copyright© 2006 Eli Lilly and Company
Insulin Studies in China

Many studies have compared human insulin and animal
insulin in their safety and efficacy.

However, these studies don’t have sufficient power because
of small sample sizes.


Only systematic reviews for Caucasian are available.
A systematic review is needed in China.
Company Confidential
Copyright© 2006 Eli Lilly and Company
Methods
Why Systematic Review? 6
Systematic
Reviews
Randomized
Controlled Trials
Cohort studies
Case-Control Studies
Case Series, Case Reports
Expert Opinion
Company Confidential
Copyright© 2006 Eli Lilly and Company
Search Strategy
human insulin + Humulin + Novolin +
Gansulin





CNKI
CBM
VIP
Wanfang
MEDLINE
animal insulin + porcine insulin + pork
insulin + beef insulin + sheep insulin
China + Chinese + Taiwan + Taiwanese +
Hong Kong
Company Confidential
Copyright© 2006 Eli Lilly and Company
Study Selection
Inclusion Criteria
Exclusion Criteria
RCT, NRCT, SW
Duplicate publications
human insulin vs. animal insulin
Animal studies
≥1 clinical outcome
Not final report
Case studies, editorials, letters to
the editor, conference articles and
abstracts.
RCT: randomized controlled trial
NRCT: non-randomized controlled trial
SW: switch study where patients switched from animal insulin to human insulin
Company Confidential
Copyright© 2006 Eli Lilly and Company
Data Extraction
1
2
3
• Title and abstracts screened
• Full text screened
• Data extracted into spreadsheet
General
information
title; author;
publish date
Study
design
randomization;
blinding;
withdraw;
control; sample
size
Company Confidential
Copyright© 2006 Eli Lilly and Company
Clinical
outcomes
HbA1c; daily
dose; allergy;
hypoglycemia;
local reaction
Data Analysis
≥3 studies
• The arm with switch in RCTs/
NRCTs was included into SWs
Heterogeneity • Yes: random-effect model
?
• No: fixed-effect model
• Continuous measurements:
Synthesis
MD
• Count measurements: RR
 R version 2.15.1
Company Confidential
Copyright© 2006 Eli Lilly and Company
Results
Publication Flow
CNKI
VIP
Wanfang
CBM
MEDLINE
N=254
N=159
N=99
N=82
N=3
Total
N=597
Title and abstract screened
N=76
Full text screened
N=23
RCTs
NRCTs
SWs
N=7
N=6
N=10
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin was associated with significantly less daily
dose
RCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin was associated with significantly less daily
dose (cont’d)
NRCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin was associated with significantly less daily
dose (cont’d)
SW
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin induced less hypoglycemia compared with
animal insulin
RCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin induced less hypoglycemia compared with
animal insulin (cont’d)
NRCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin induced less hypoglycemia compared with
animal insulin (cont’d)
SW
Company Confidential
Copyright© 2006 Eli Lilly and Company
Patients had significantly larger decrease in HbA1c when
switching from animal insulin to human insulin
SW
Company Confidential
Copyright© 2006 Eli Lilly and Company
Human insulin caused less incidence of local swelling
and induration compared with animal insulin
RCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
There is a numeric difference in the incidence of allergy
although it’s not statistically significant
RCT
Company Confidential
Copyright© 2006 Eli Lilly and Company
Strengths & Limitation
Strengths
Limitations
First meta-analysis
comparing human insulin
and animal insulin in
Chinese populations
Incomplete report of
related information
Broad range of literatures
Not all study types are
sufficient for each clinical
outcome
Company Confidential
Copyright© 2006 Eli Lilly and Company
Conclusion
This meta-analysis may provide some evidence that human
insulin is superior to animal insulin among Chinese patients in
terms of daily dose, HbA1c, hypoglycemia as well as local
swelling and induration.
Company Confidential
Copyright© 2006 Eli Lilly and Company
Reference
1. China Guideline for Prevention and Treatment of type 2 Diabetes (2010)
2. Li LM, Rao KQ, Kong LZ, et al. A description on the Chinese national
nutrition and health survey in 2002[J]. Chin J Epidemiol, 2005, 26(7): 478484.
3. Xu, Y., L. Wang, J. He, et al. Prevalence and control of diabetes in
Chinese adults[J]. JAMA, 2013. 310(9): p. 948-59.
4. Research Report of Anti-diabetes Market (2011)
5. Research Report of Insulin Market (2010)
6. OCEBM Levels of Evidence Working Group. Levels of Evidence (March
2009). Available at: http://www.cebm.net/?o=1025. Accessed 22 April 2014.
Company Confidential
Copyright© 2006 Eli Lilly and Company
Contact information:
Tel: (86 21) 2302 1120
Mobile: (86) 13818817606
Email: [email protected]
Company Confidential
Copyright© 2006 Eli Lilly and Company

Similar documents