Atorvastatin is Widely Prescribed

1
Atorvastatin is Widely Prescribed

• Atorvastatin has been approved in over 50
  countries
• More than 5.9 million patient years of
  cholesterol-reducing therapy with atorvastatin
  have been supplied worldwide since launch

IMS Jan 97Mar 99
2
Adverse Event Profile for Atorvastatin
Atorvastatin (n2502)
Other statins combined (n742)
Atorvastatin adverse events experienced by ?2 of
patients
Includes 93 patients who received placebo for 16
weeks and then atorvastatin for 36
weeks. Simvastatin, lovastatin and
pravastatin. Includes 67 patients who received
placebo for 16 weeks and then lovastatin for 36
weeks. Black DM et al. Arch Intern Med
1998158577584.
3
Atorvastatin vs Simvastatin

• Data from a 1-year comparative study showed that
• Atorvastatin was well-tolerated, with a safety
  profile similar to that of simvastatin
• 12 of atorvastatin patients had an adverse event
  considered associated with treatment compared
  with 16 of simvastatin patients
• Most common adverse events with
• ? atorvastatin myalgia (3)
• ? simvastatin athralgia (7) and chest pain (4)

Data from a 1-year study comparing atorvastatin
1020 mg to simvastatin 1020 mg in 177
hypercholesterolemic patients. Dart A et al. Am J
Cardiol 1997803944.
4
Atorvastatin vs Pravastatin

• Data from a 1-year comparative study

Atorvastatin is an efficacious HMG-CoA
reductase inhibitor that lowers LDL-C more
effectively than pravastatin within a similar
overall safety profile
Data from a 1-year study comparing atorvastatin
1020 mg to pravastatin 2040 mg in 305
hypercholesterolemic patients. Bertolini S et al.
Atherosclerosis 1997130191197.
5
Atorvastatin vs Lovastatin

• Data from a 1-year comparative study

The overall safety profile of atorvastatin was
similar to that of lovastatin. Both compounds
were well tolerated
A 1-year study comparing atorvastatin 1020 mg to
lovastatin 2040 mg in 1049 hypercholesterolemic
patients Davidson M et al. Am J Cardiol
19977914751481.
6
Atorvastatin vs Cerivastatin

• Data from a 6-week comparative study

Data from a 6-week study comparing atorvastatin
10 mg to cerivastatin 300 µg in 215
hypercholesterolemic patients. Hunninghake D et
al. Presented at the 71st European
Atherosclerosis Society Congress, 2629 May 1999,
Athens, Greece.
7
Atorvastatin Safety Profile

• Review of 21 controlled clinical studies showed
  that
• ? ALT elevations gt3x ULN less than 1 of cases
• ? CPK gt10x ULN less than 0.1 of cases
• Controlled clinical trial data indicate that
  atorvastatinhas no significant effect on
  fibrinogen or Lp(a)

Black DM et al. Arch Intern Med
1998158577584. Davidson M et al. Am J Cardiol
19977914751481. Jones P et al. Am J Cardiol
199881582587.
8
Safety in Special Populations

• Review of 21 clinical studies showed that the
  safety profile of atorvastatin was comparable in
• ? elderly vs non-elderly
• ? men vs women
• ? diabetics vs non-diabetics

Black DM et al. Arch Intern Med 1998158577574.
9
Safety and Tolerability Conclusions

• Atorvastatin is well tolerated
• The safety profile of atorvastatin is similar to
  that ofother statins
• The safety profile of atorvastatin is similar
  over a broadrange of patients