1. European drug statistics What is the reason for the differences between the various EU countries Ulrich Schwabe Pharmakologisches Institut der Ruprecht-Karls-Universität Heidelberg Perspectives and Achievements with Rational Pharmacotherapy 6. November 2002, Copenhagen

2. Drug expenditures in 15 EU countries in 1999 Sales per inhabitants per year in € EU average 252 € Rosian I. et al.: Drug expenditures, strategies for cost containement in the European Union. Austrian Federal Institute of Health Service (ÖBIG), Vienna 2001.

3. Drug markets in 15 EU countries in 1999 Rosian I. et al.: Drug expenditures, strategies for cost containement in the European Union. Austrian Federal Institute of Health Service (ÖBIG), Vienna 2001.

4. Drug utilization as defined daily doses (DDD) DenmarkGermanyNorway Sales (€) or DDD per inhabitant per year Sales in 1999 € DDD in 1999 Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Prescription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

6. The ATC/DDD System Anatomical therapeutic chemical (ATC) classification system Classification by 14 main groups at 5 different levels 1. Level: A Alimentary tract and metabolism Anatomical main group 2. Level: A10 Drugs used in diabetes Therapeutic main group 3. Level: A10B Oral blood glucose lowering drugs Therapeutic subgroup 4. Level: A10B A Biguanides Pharmacological subgroup 5. Level: A10B A02 Metformin (INN) Chemical substance subgroup Definition of the defined daily dose (DDD) The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. DDD of metformin: 2000 mg Presentation of data: DDDs per 1000 inhabitants per day

7. Drug utilization data in EU countries

8. Prescription of statins 1993–2001 DDD per 1000 inhabitants per day Denmark Germany Norway Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Prescription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

9. Prescription of statins in 2000 Denmark Norway England Germany Simvastatin Lovastatin Pravastatin Fluvatatin Atorvastatin Cerivastatin DDD per 1000 inhabitants per day 15.4 23.9 26.5 59.6

10. Prescription of the two leading statins 2000 7.5 4.6 9.7 9.4 5.5 11.5 29.8 21.0 0 5 10 15 20 25 30 35 DenmarkEngland Germany Norway Simvastatin Atorvastatin DDD per 1000 inhabitants per day

11. Evidence for statines from clinical trials

12. DDD costs of statins in several European countries 1.25 1.07 1.28 0.92 1.47 1.05 1.16 0.93 0 0.5 1 1.5 2 Treatment costs (€ per DDD) DenmarkEngland Germany Norway Simvastatin Atorvastatin

13. Prescriptions in millions Sales in billion € Prescriptions Sales Schwabe U., Paffrath D. (eds.): Arzneiverordnungs-Report 2002. Springer-Verlag, Berlin Heidelberg (2002), p. 816. Prescriptions of therapeutically disputed drugs in Germany

14. Expecto- rants Antineuro- pathic drugs Antidementia drugs Vaso- dilators Topical antirheu- matic drugs Antivaricose therapy Sales (million €) 2000 2001 –7.6% –3.6% –3.4% –7.8% +4.4% –6.3% Sales of therapeutically disputed drugs in Germany

15. Sales in million € Pentoxifylline Naftidrofuryl Buflomedil Ginkgo biloba Moxaverine Prescription of peripheral vasodilators 2001 in Germany

16. Prescription of peripheral vasodilators 2001 in 3 European countries 0.1 0.53 2.58 0 0.5 1.0 1.5 2.0 2.5 3.0 Denmark Norway Germany DDD per 1000 inhabitants per day

17. Pentoxifylline trials in patients with intermittent claudication

18. Exercise training in claudicatio intermittens

19. Walking distance 400 m 300 m 200 m 100 m 0 m 68 m 82 m 64 m 318 m 16 Studies 9 Studies 10 Studies 10 Studies PentoxifyllineNaftidrofuryl Ginkgo biloba Exercise Comparison of treatment in claudicatio intermittens

20. E. Housley Clinic for Peripheral Vascular Diseases Royal Infirmary of Edinburgh Brit. Med. J. 296: 1483–1484 (1988)

21. Prescription of pentoxifylline DDD per 1000 inhabitants per day Denmark Germany Norway Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Presription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

22. Drug utilization studies as health care indicator

23. Secondary prevention of coronary heart disease in 1996 EUROASPIRE Study Group: Eur. Heart J. 18: 1569-1582 (1997) Smoking Obesity BMI >30 kg/m 2 Hypertension >140/90 mm Hg Hyperchol- esterolemia Hyperchol- esterolemia >212 mg/dl 100% 80% 60% 40% 20% 0% before after Patients Diabetes Retrospective survey of 3569 patients with CHD in 9 European countries 6–48 month after hospital discharge

24. Prescription of lipid lowering agents in Germany Statins Fibrates 32.8 Treatment for 2.4 mio. patients Schwabe U., Paffrath D. (eds.): Arzneiverordnungs-Report 2002. Springer-Verlag, Berlin Heidelberg (2002), p. 521 DDD per 1000 inhabitants per day

25. Prevalence of coronary heart disease in Germany

26. Number of statin-treated patients in Germany Treated patients according to DDD utilization (mio.) treated patients Total number of coronary patients 2,84 83% 66% 22%

27. Objectives of drug utilization studies Report on the volume and structure of drug prescriptions by physisians Annual information on drug utilization for – physicians – sick funds – pharmacists Transparency of the drug market – market share of generic drugs – role of "me-too" drugs – drugs of disputed therapeutic efficacy Evaluation of market changes – introduction of new drugs – withdrawal of drugs to due adverse effects