Notes

Slide Show

Outline

1	PROactive Study
2	PRESIDENT OF THE EASD
3	PROactive Study
4	Duality of Interest Declaration
5	Programme
6	RATIONALE
7	Global Projections for the Diabetes Epidemic: 2003-2025 (millions)
8	Reduction in Life Expectancy of Patients with Type 2 Diabetes by Age at Diagnosis
9	Fatal and Non-fatal Myocardial Infarction and Stroke in Patients with Type 2 Diabetes (adjusted to age 60)
10	Cardiovascular Events in Patients with Type 2 Diabetes Compared to General Population
11	Annual Macrovascular Event Rates
12	Summary
13	Current glucose-lowering agents
14	Pioglitazone
15	Pioglitazone
16	PROactive Study Objectives
17	Participating Countries
18	Committees
19	National Principal Investigators
20	Committees
21	Role of NCRL and ICON
22	STUDY DESIGN
23	PROactive Study Design
24	PROactive Study Design
25	Allocation to Treatment
26	Inclusion Criteria (1)
27	Inclusion Criteria (2)
28	Principal Exclusion Criteria
29	Titration of Study Medication
30	Primary Endpoint
31	Principal Secondary Endpoint
32	Secondary Endpoints Pre-Defined in Statistical Analysis Plan
33	Secondary Endpoints Pre-Defined in Statistical Analysis Plan
34	Secondary Endpoints Pre-Defined in Statistical Analysis Plan
35	BASELINE CHARACTERISTICS
36	PROactive Study
37	Recruitment
38	Recruitment
39	Baseline (1)
40	Baseline (2)
41	Entry Criteria: Evidence of Macrovascular Disease
42	Overlap of Previous Macrovascular Events
43	Overlap of Previous Macrovascular Events
44	Overlap of Previous Macrovascular Events
45	Other History
46	Glucose-Lowering Medication at Baseline
47	Cardiovascular Medication at Baseline (1)
48	Cardiovascular Medication at Baseline (2)
49	Baseline Laboratory Values
50	Summary: Baseline Characteristics
51	CARDIOVASCULAR RESULTS
52	5602 patients screened(a)
53	5602 patients screened(b)
54	5602 patients screened(c)
55	5602 patients screened(d)
56	5602 patients screened(e)
57	Study Quality
58	Pattern of Dose Titration
59	Primary Endpoint
60	Time to Primary Composite Endpoint
61	Principal Secondary Endpoint
62	Time to Death, MI (Excluding Silent) or Stroke
63	Summary of Results
64	Numbers of First Events Contributing to the Primary Composite Endpoint
65	Numbers of First Events Contributing to the Principal Secondary Endpoint
66	Numbers of First Events Contributing to the Primary Composite and Principal Secondary Endpoints
67	Numbers of First Events Contributing to the Primary Composite and Principal Secondary Endpoints
68	Numbers of First Events Contributing to the Primary Composite and Principal Secondary Endpoints
69	Total Numbers of Events for each Component of the Primary Endpoint
70	Demographic Subgroups
71	Entry Criteria Subgroups
72	Metabolic Subgroups
73	Baseline Medication Subgroups
74	Other Variables with p >0.05
75	Multivariate Analysis (Significance p < 0.05)
76	Summary: PROactive Cardiovascular Results
77	METABOLIC RESULTS
78	Change in Concomitant Medication Use to Final Visit
79	Time to Permanent Insulin Use
80	Time Course of HbA1c
81	Time Course of Triglycerides
82	Time Course of HDL Cholesterol
83	Time Course of LDL/HDL
84	Change in Laboratory Data from Baseline to Final Visit
85	Blood Pressure
86	Factors Possibly Contributing to the Beneficial Effect of Pioglitazone
87	Summary of PROactive Metabolic Results
88	SAFETY
89	Safety Data Collected
90	Definition of a Serious Adverse Event
91	Summary of Serious Adverse Events
92	Serious Adverse Events Occurring in >1% of Patients (Excluding Endpoints)
93	Heart Failure
94	Malignant Neoplasms
95	Bladder Cancer
96	Other Pre-defined Adverse Events of Interest
97	Time Course of ALT
98	Summary: PROactive Safety Conclusions
99	STUDY CONCLUSIONS
100	Summary of Results
101	Summary of Results
102	PROactive Study Conclusions