Study 2: Use of a Polypill for the Prevention of Chronic Complications

1
Study 2 Use of a Polypill for the Prevention of
Chronic Complications

• HYPOTHESIS
• The addition of a polypill at the time of
  diagnosis of diabetes will reduce several of the
  chronic complications of diabetes

2
Rationale

• Lifestyle changes are difficult to achieve in
  practice and even more difficult to maintain
  long-term
• Several pharmacological therapies have been shown
  to reduce some of the chronic complications of
  diabetes
• Statins
• ACE inhibitors
• Aspirin
• Modeling studies suggest that tremendous cost
  savings in medical care can be achieved by the
  use of such a polypill

3
Questions

• Primary
• Will the use of the polypill reduce chronic
  complications of diabetes?
• Secondary
• Will the reduction of endpoints relate to the
  magnitude of lowering of risk factors?

4
Approach

• Add a polypill containing a statin, an ACE-I and
  ASA at the time of diagnosis of diabetes
• Follow patients for the development of
  complications for a period of 10 years
• Complications to evaluate
• CAD, CVD, PVD, nephropathy, retinopathy,
  neuropathy, dementia

5
Patient Groups

• Treatment group
• Receive polypill at diagnosis of diabetes
• Can have additional therapies added by the
  primary care doctor according to standard
  practice and guidelines of the particular country
• Polypill to contain low dose generic statin,
  ACE-I and ASA
• Control group
• Receive standard care by their primary care
  provider plus a placebo pill

6
Exclusion Criteria

• ASA allergy
• Statin intolerance
• Previous intolerable side effects with ACE-I

7
Ethical and Safety Issues

• All subject will receive standard care from their
  primary health care providers, but this is likely
  to be suboptimal in most cases, esp. in some
  parts of the world
• Because low doses of all 3 components will be
  used, toxicity unlikely even if primary providers
  add statins, ACE-I or ASA

8
Outcome Measures

• Assessment of complications every 2 years
• Standard measures of diabetes control
• Glycemic control
• Lipid control (probably should include LFTs)
• Blood pressure control
• Other measures
• Urine microalbumin

9
Budget and Other Considerations

• Will depend on sample size
• Need standardization of lab measures
• Cost of study likely to vary considerably from
  site to site