OTC Statins - The UK Experience
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Cardiovascular pharmaceutical analysis team - page 2
- EXECUTIVE SUMMARY - page 5
- Introduction - page 5
- Scope and coverage of the Brief - page 5
- Key findings about the the topic - page 5
- UK STATIN MARKET - page 7
- POM statin market - page 7
- OTC statin market - page 9
- Who is eligible for treatment with Zocor Heart-Pro? - page 9
- Potential market size - page 12
- Evidence/lack of evidence for OTC statin - page 12
- Clinical evidence of efficacy at this dose of simvastatin - page 12
- Who would benefit from this dose of statin? - page 13
- Cost benefit analysis: who should pay? - page 14
- Alternative means of reducing risk in this target population - page 15
- Smoking - page 15
- Weight reduction - page 15
- Exercise - page 16
- Salt restriction - page 16
- Fruit and vegetable intake - page 16
- Fish oils - page 16
- Balanced message - page 17
- Compliance - page 17
- Safety - page 19
- LAUNCH OF ZOCOR HEART-PRO - page 20
- Consultation process - page 20
- Key stakeholder concerns/views on POM to P switch - page 20
- British Heart Foundation view - page 20
- UK Secretary of State, John Reid's view - page 22
- Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff's view - page 22
- Lancet editorial, May 22, 2004 - page 22
- UK healthcare professionals - page 23
- Research on key practice points and training requirements - page 26
- Attitudes towards OTC simvastatin - page 26
- Practical aspects of the supply of OTC statins - page 26
- Training requirements - page 27
- Key stakeholder concerns/views on POM to P switch - page 20
- Promotion - page 27
- Pharmacy - page 27
- Pharmacist and Counter Assistant campaign - page 29
- Pharmacy partnerships - page 35
- Problems with pharmacy roll-out - page 38
- Patients: cholesterol awareness; cholesterol testing - page 38
- Patient knowledge - page 38
- Patient focus - page 39
- Cholesterol testing - page 40
- Pharmacy - page 27
- Consultation process - page 20
- UPTAKE OF OTC STATINS - page 43
- Pharmacists report moderate consumer interest - page 43
- Pharmacist personal perspectives - page 43
- Difficulty of making money - page 43
- POTENTIAL FOR OTHER STATINS AND OTHER MARKETS - page 46
- Potential for other statins - page 46
- Statin studies - page 46
- Less potential for interaction - page 49
- Potential in other markets - page 49
- Potential for other statins - page 46
- APPENDIX - page 52
- Bibliography - page 52
- Epidemiology - page 52
- Clinical trials and non-epidemiological Government publications - page 52
- Regulatory documentation - page 54
- Research methodology - page 54
- Calculating eligible population for OTC statins in UK - page 54
- Overweight - page 55
- Smoking - page 55
- South Asian family origin - page 56
- People with a family history of early heart disease - page 56
- Patients not suitable for OTC treatment due to excess risk - page 56
- Disclaimer - page 59
- Bibliography - page 52
- List of Tables
- Table 1: UK POM statin market, 2003 (12 months) and H1 2004 (6 months) - page 7
- Table 2: Overveiw of trials that have studied effects of statin intervention in moderate risk primary prevention groups - page 13
- Table 3: Trial outcomes - page 13
- Table 4: INTERHEART: Risk of acute MI associated with risk factors in the overall population - page 16
- Table 5: CURVES study comparison of LDL reductions with different statins - page 47
- Table 6: Reported rates of statin-associated muscle complaints in controlled studies, Thompson et al., 2003. - page 48
- Table 7: Maximum estimated population eligible for OTC statin therapy before excluding people whose 10-year risk exceeds 15% - page 55
- Table 8: Quantifying eligibility criteria for men aged 45-55 and women aged 55-70 - page 55
- Table 9: Men and women excluded from maximum eligible due to diabetes, angina or peripheral vascular disease, UK - page 57
- List of Figures
- Figure 1: UK prescription-only simvastatin sales (standard units), 2001-04 - page 8
- Figure 2: UK prescription-only simvastatin sales ($USD), 2001-04 - page 9
- Figure 3: Patient eligibility for statin therapy based on 10-year CHD risk - page 10
- Figure 4: Pharmacist-focused advertising for Zocor Heart-Pro - page 28
- Figure 5: Zocor Heart-Pro Pharmacist training guide - page 31
- Figure 6: Zocor Heart-Pro customer questionnaire - page 32
- Figure 7: Zocor Heart-Pro recommendation guide for counter use - page 34
- Figure 8: Boots simvastatin in-store patient leaflet (front) - page 36
- Figure 9: Boots simvastatin leaflet (back) with cut-out patient record card - page 37
- Figure 10: Treatment algorithm in Zocor Heart-Pro patient leaflet - page 39
- Figure 11: Heart-Pro Cholesterol Test - page 42
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