Landmark Anti-dyslipidemic Trials Update - How Low Can You Go?

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Publication Date: 2004-06-23

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The Heart Protection Study showed that patients with normal LDL cholesterol, as defined by the NCEP guidelines, experienced equal benefit from LDL cholesterol reduction as those with high LDL cholesterol. These results have been confirmed by the REVERSAL, PROVE-IT and ALLIANCE trials, which have shown the benefit of intensive statin therapy to reduce LDL cholesterol below current targets.

Scope

Evaluation of recent data supporting the use of intensive statin therapy and lower LDL cholesterol target levels

Discussion of the current barriers to the therapeutic strategies proposed by recent trials

Report Highlights
Recent clinical trial data suggest that using intensive cholesterol-lowering therapy to reduce LDL cholesterol levels below current target levels is beneficial. On the basis of these results, current cholesterol targets may need to be revised as they may lead to patients being undertreated.

Reasons to Purchase

Understand the rationale behind the proposal to reduce LDL cholesterol targets

Identify the barriers to intensive cholesterol-lowering therapy using high dose statins

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Cardiovascular pharmaceutical analysis team - page 2
EXECUTIVE SUMMARY - page 4
- Introduction - page 4
- Scope and coverage of the Brief - page 4
- Key findings about the topic - page 5
  - Recent clinical trial data suggest that using intensive cholesterol-lowering therapy to reduce LDL cholesterol levels below current target levels is beneficial. - page 5
  - On the basis of these results current cholesterol targets may need to be revised as they may lead to patients being undertreated. Nevertheless a high proportion of patients do not reach existing cholesterol goals and therefore the priority may be to improve target attainment rates before any amendments are made to the existing treatment guidelines. - page 6
  - In addition, a number of barriers currently stand in the way of the intensive cholesterol-lowering therapy described in the REVERSAL, PROVE-IT and ALLIANCE trials. These include the continued underdiagnosis and undertreatment of dyslipidemics, the poor control of the condition with existing treatment strategies, concerns regarding the safety of high-dose statin therapy and the significant costs associated with high-dose statin use. - page 7
CURRENT TREATMENT GUIDELINES - page 8
HOW LOW SHOULD YOU GO? - page 12
CLINICAL TRIALS - page 15
DISCUSSION - page 28
APPENDIX - page 46
- Bibliography - page 46
  - Clinical trial data - page 46
  - Research methodology - page 47

List of Tables
Table 1: Shared features ATPII and ATP III - page 8
Table 2: New features of ATP III - page 10
Table 3: Patients eligible for lipid-lowering therapy in the US - page 11
Table 4: Comparison of results from landmark statin trials - page 13
Table 5: REVERSAL: final LDL cholesterol levels and percent change - page 16
Table 6: REVERSAL: major primary and secondary endpoint results - page 17
Table 7: REVERSAL: CRP reductions - page 17
Table 8: PROVE-IT: final LDL cholesterol level - page 21
Table 9: PROVE-IT: primary composite endpoint - page 21
Table 10: PROVE-IT: secondary endpoints - page 22
Table 11: LDL cholesterol reductions between study arms - page 25
Table 12: Proportion of drug-treated dyslipidemia patients in each sub-population failing to reach target cholesterol goals in the seven major markets, 2003 - page 33
Table 13: Statin doses available in the seven major markets, 2003 - page 36
Table 14: Percentage of statin prescribing by daily dose in the seven major markets, 2003 - page 37
Table 15: Number and frequency of rhabdomyolysis cases for all the statins in the US from launch to May 2001 - page 39
Table 16: Average rating of factors influencing the prescribing of anti-dyslipidemic therapy in the seven major markets, 2003 - page 44
Table 17: Yearly cost of treatment with atorvastatin 10mg versus atorvastatin 80mg - page 45

List of Figures
Figure 1: REVERSAL: clinical trial design - page 15
Figure 2: PROVE-IT: clinical trial design - page 20
Figure 3: ALLIANCE: clinical trial design - page 24
Figure 4: IDEAL: clinical trial design - page 26
Figure 5: TNT: clinical trial design - page 27
Figure 6: Limited absolute reductions in LDL cholesterol following increases in statin doses used - page 41
Figure 7: Comparison of LDL cholesterol reductions observed with the combination of ezetimbe and atorvastatin verus atorvastatin alone - page 43

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Landmark Anti-dyslipidemic Trials Update - How Low Can You Go?

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