Holly Chong Statin Presentation 141107 (ppt)


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Holly Chong Statin Presentation 141107 (ppt)

  1. 1. Cholesterol and Statins Holly Chong Cardiology Pharmacist Bromley Hospitals NHS Trust
  2. 2. The Background <ul><li>Statins represent the largest drug cost to the NHS (£738 million in 2004) </li></ul><ul><li>Statin use is increasing by 30% a year in England </li></ul><ul><li>Most statin prescriptions in England are for simvastatin and atorvastatin, usually at moderate or low doses </li></ul><ul><li>Simvastatin 40mg is now available at very low cost </li></ul><ul><ul><li>£3.40 per month compared to atorvastatin 10-20mg (18.03-£24.64 per month) </li></ul></ul>
  3. 3. High Cost Statin Prescribing <ul><li>Lipid management guidance </li></ul><ul><ul><li>NHS policy: </li></ul></ul><ul><ul><ul><li>NSF – cholesterol targets 5 / 3 </li></ul></ul></ul><ul><ul><ul><li>NICE TA 94 – defining risk </li></ul></ul></ul><ul><ul><li>DOH strategy </li></ul></ul><ul><ul><ul><li> cost-effective Rx </li></ul></ul></ul><ul><ul><ul><li>Implement NICE Tag 94 </li></ul></ul></ul><ul><ul><li>JBS-2 (2005) </li></ul></ul><ul><ul><ul><li>?New targets 4 / 2 </li></ul></ul></ul><ul><ul><ul><li>Audit standard 5 / 3 </li></ul></ul></ul><ul><ul><ul><li>‘ aspirational’ </li></ul></ul></ul>
  4. 4. National Context <ul><li>Increasing statin use 20-30% per year </li></ul><ul><ul><li>Huge variation in use 19.2%-85% simvastatin! </li></ul></ul><ul><ul><li>Atorvastatin accounts for 2/3 of expenditure </li></ul></ul><ul><li>Implementation of NICE TA 94 </li></ul><ul><ul><li>5.2 million population require tx </li></ul></ul><ul><ul><li>Cost = £230 million pa using simvastatin </li></ul></ul><ul><ul><li>Cost = £1,068 million pa using 50% atorva / 50% simva </li></ul></ul><ul><ul><li>Difference = £839 million per year </li></ul></ul>
  5. 5. Key Issues for the CPF Statins <ul><li>Increasing ‘cost-effective’ statin prescribing: </li></ul><ul><ul><li>Consensus on first-line agent </li></ul></ul><ul><ul><li>Statin-switching polices </li></ul></ul><ul><ul><li>Addressing implementation issues </li></ul></ul><ul><li>What about JBS-2? </li></ul><ul><li>Can we ‘future-proof’ our guidance? </li></ul>
  6. 6. The following guidance represents the consensus view of the SELCN Prescribing Forum But does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer
  7. 7. Key Messages <ul><li>1. Statins should be considered for patients </li></ul><ul><ul><li>With cardiovascular disease (CVD) </li></ul></ul><ul><ul><li>At high risk of developing CVD </li></ul></ul><ul><ul><ul><li>Non diabetics, CVD risk > 20% over next 10 yrs </li></ul></ul></ul><ul><ul><ul><li>All diabetics >40 yrs old </li></ul></ul></ul><ul><li>2. A statin with lowest acquisition cost to be used first line ie., simvastatin </li></ul>
  8. 8. <ul><li>3. Simvastatin starting dose should be 40mg with evening meal. </li></ul><ul><li>4. National cholesterol treatment targets </li></ul><ul><ul><li>Total cholesterol <5.0mmol/L or  20% </li></ul></ul><ul><ul><li>LDL cholesterol <3.0mmol/L or  30% </li></ul></ul><ul><li>5. Cholesterol levels rechecked within 3 months of initiation. Liver function tests (ALT and AST) checked within first year of therapy. </li></ul>
  9. 9. Frequently Asked Questions <ul><li>26 questions and answers </li></ul><ul><li>Calculation of CVD risk </li></ul><ul><ul><li>www.bhsoc.org/resources/prediction_chart.htm </li></ul></ul><ul><ul><li>http://cvrisk.mvm.ed.ac.uk/calculator/bnf.htm </li></ul></ul><ul><ul><li>Type I diabetics excluded due to under-estimation (NICE guidance 15) </li></ul></ul>
  10. 10. CVD risk prevention charts Cardiovascular Disease Risk Prediction Chart reproduced with permission from The University of Manchester Department of Medical Illustration, Manchester Infirmary. © University of Manchester. Wood D, Wray R, Poulter N et al. Heart 2005;91(Suppl V):1-52
  11. 11. Simvastatin 40mg daily <ul><li>First-line </li></ul><ul><li>Average reduction in LDL-cholesterol 41% </li></ul><ul><li>Equivalent to atorvastatin 10mg daily </li></ul><ul><li>Majority of patients will achieve treatment target (TC<5mmol/L, LDL<3mmol/L) </li></ul><ul><li>Heart Protection study showed it can reduce mortality and CVS events </li></ul><ul><li>Using simvastatin 40mg instead of atorvastatin 10mg will save PCT £ 176 per patient per yr </li></ul>
  12. 12. Can cholesterol be too low for initiating lipid lowering therapy? Wood D, Wray R, Poulter N et al. Heart 2005;91(Suppl V):1-52.
  13. 13. High dose statins in acute coronary syndrome (ACS) <ul><li>PROVE-IT trial (atorvastatin 80mg vs pravastatin 40mg) </li></ul><ul><ul><li>Statistically significant reduction in composite CV mortality and morbidity </li></ul></ul><ul><li>A to Z trial (simvastatin 40mg then 80mg vs placebo then 20mg) </li></ul><ul><li>Beneficial in early stages of ACS </li></ul><ul><li>NICE guidance expected in January 2008 </li></ul>
  14. 14. Raised triglycerides <ul><li>Most elevations of TG are secondary to other causes such as excess alcohol intake, diabetes, renal or liver disease </li></ul><ul><li>Statins have a triglyceride lowering effect </li></ul><ul><li>There are few outcomes studies with other lipid lowering drug classes </li></ul><ul><li>Statins should still be first-line </li></ul><ul><li>If TG>10 risk of pancreatitis – seek specialist advice </li></ul>
  15. 15. <ul><li>Age is not the deciding factor for initiating statins </li></ul><ul><li>Cessation of statins in certain patient groups </li></ul><ul><ul><li>Coexisting life-threatening condition (<2 years lifespan) </li></ul></ul><ul><ul><li>Active liver disease (2 consecutive measurements of serum transaminases with  3x ULN) </li></ul></ul><ul><ul><li>Inflammatory muscle disease (polymyositis) or CK>5x ULN </li></ul></ul><ul><ul><li>Pregnant or breast-feeding </li></ul></ul><ul><li>Diet is important in cholesterol lowering </li></ul><ul><ul><li>BMI>29 have 4x increased risk of CHD </li></ul></ul><ul><ul><li>Every reduction in 10kg reduces TC by 0.5mmol/l </li></ul></ul>
  16. 16. Are Statins Safe? <ul><li>Serious adverse effects are rare </li></ul><ul><li>Meta-analysis compared statin and placebo </li></ul><ul><ul><li>Statins increased S/E by 39% (NNH = 197) </li></ul></ul><ul><ul><li>Statins reduced CV events by 26% (NNT = 27) </li></ul></ul><ul><ul><li>For 1000 patients, prevent 37 CV events and observe 5 adverse effects </li></ul></ul><ul><li>Atovastatin associated greatest risk of adverse events </li></ul>
  17. 17. Liver enzymes <ul><li>Measure LFTs </li></ul><ul><ul><li>before statin therapy, 12 weeks after initiation or change of dose and at 12 monthly intervals thereafter </li></ul></ul><ul><li>Hepatotoxicity - dose related </li></ul><ul><li>Counsel patients </li></ul><ul><li>Most LFT elevations seen within the first 12 weeks of initiation and transient </li></ul><ul><li>IF transaminases increase to more than 3x ULN, discontinue statin </li></ul><ul><li>Pravastatin (water-soluble) may be suitable alternative </li></ul>
  18. 18. Drug interactions with simvastatin <ul><li>Metabolised by cytochrome P450 enzyme system </li></ul>Current problems in pharmacovigilance. MHRA. Vol. 30. Oct 2004 . Do not exceed 40mg simvastatin Diltiazem Effect of anticoagulant (warfarin) increased, monitor INR and adjust accordingly Anticoagulants Reduces plasma levels of simvastatin so may need to increase dose Rifampicin Do not exceed 20mg simvastatin Verapamil Amiodarone Do not exceed 10mg simvastatin Ciclosporin Niacin >1g daily Avoid simvastatin Potent CYP3A4 inhibitors: Protease inhibitors Azole antifungals Macrolides Prescribing advice Interacting drug
  19. 19. Grapefruits and Pomegranates <ul><li>Avoid eating grapefruit/pomegranate or drinking grapefruit/pomegranate juice </li></ul><ul><li>Both are potent inhibitor of CYP450 3A4 </li></ul><ul><li>Interaction leads to 9-fold increase in peak serum drug level – increase risk of rhabdomyolysis </li></ul><ul><li>If patient wants to continue eating grapefruits/pomegranate, pravastatin or rosuvastatin are alternatives </li></ul>
  20. 20. Muscle aches on a statin <ul><li>Rule out common causes (exercise) </li></ul><ul><li>Check thyroid function tests </li></ul><ul><li>Measure CK </li></ul><ul><ul><li>If elevated >5 x ULN – stop </li></ul></ul><ul><ul><li>If elevated <5 x ULN – monitor and repeat in 1 month </li></ul></ul><ul><ul><li>If still elevated, reduce dose and recheck in 1 month </li></ul></ul><ul><ul><li>If continue to be elevated – seek advice. </li></ul></ul><ul><li>Patients to be counselled to seek urgent medical advice if experience unexplained muscular ache </li></ul>
  21. 21. Will simvastatin work if taken in the morning? <ul><li>Simvastatin marginally less effective at lowering cholesterol when taken in morning </li></ul><ul><li>One study showed a difference: </li></ul><ul><ul><li>TC 0.38mmol/L </li></ul></ul><ul><ul><li>LDL cholesterol 0.25mmol/L </li></ul></ul><ul><li>Still substantial reduction in cholesterol from baseline so should be used first-line </li></ul>
  22. 22. Simvastatin side effects <ul><li>Gastrointestinal side effects and insomnia common </li></ul><ul><li>Avoid taking on an empty stomach at night </li></ul><ul><li>Best taken with of after evening meals at 6pm </li></ul><ul><li>If continued GI effects and insomnia, consider taking simvastatin in the morning or lunchtime </li></ul><ul><li>Recheck cholesterol levels if dose permanently move to morning </li></ul>
  23. 23. Improving concordance <ul><li>Estimated 50% stop within 1 year and 75% stop within 5 years </li></ul><ul><li>Important as healthcare professionals to explain: </li></ul><ul><ul><li>regular treatment is required to reduce CV risk and treatment is for life, otherwise benefit lost </li></ul></ul><ul><ul><li>Likelihood of serious side effects is low but to seek medical attention if muscular pain with malaise, fever or dark urine </li></ul></ul><ul><li>Check concordance and reinforce importance of continued treatment at follow-up </li></ul>
  24. 24. Cholesterol lowering effect not sufficient with simvastatin 40mg <ul><li>Compliance? </li></ul><ul><li>Increase simvastatin dose to 80mg </li></ul><ul><ul><li>Additional reduction of 6% </li></ul></ul><ul><li>Switch to atorvastatin 40mg daily and increasing to 80mg daily </li></ul><ul><ul><li>Additional reduction of 8-12% </li></ul></ul><ul><li>Ezetimibe 10mg daily may be considered in addition to simvastatin (NICE technology appraisal expected Nov 2007) </li></ul>
  25. 25. Good News! Statin Progress
  26. 26. % Low Cost Statin Prescribing for PCTs in the SE London Sector PCT Increase % Bexley 11.2 Bromley 5.9 Greenwich 16.8 Lambeth 11.4 Lewisham 9.1 Southwark 10.2
  27. 27. SEL Hospital Trust % Low Cost Statin Prescribing <ul><li>Hospital </li></ul><ul><li>Bromley </li></ul><ul><li>Queen Mary’s Sidcup </li></ul><ul><li>King’s College </li></ul><ul><li>Queen Elizabeth </li></ul><ul><li>GSTFT </li></ul><ul><li>Lewisham </li></ul><ul><li>% Aug-07 </li></ul><ul><li>94 </li></ul><ul><li>90 </li></ul><ul><li>87 </li></ul><ul><li>86 </li></ul><ul><li>79 </li></ul><ul><li>76 </li></ul>
  28. 28. Cost Saving Low Cost Statins <ul><li>PCT </li></ul><ul><li>Bexley </li></ul><ul><li>Bromley </li></ul><ul><li>Greenwich </li></ul><ul><li>Lambeth </li></ul><ul><li>Lewisham </li></ul><ul><li>Southwark </li></ul><ul><li>Apr-Aug 2007(£) </li></ul><ul><li>120,220 </li></ul><ul><li>65,531 </li></ul><ul><li>92,497 </li></ul><ul><li>75,524 </li></ul><ul><li>81,475 </li></ul><ul><li>99,187 </li></ul><ul><li>Total: 534,434 </li></ul>
  29. 29. What Next? <ul><li>New guidance awaited: </li></ul><ul><ul><li>NICE Ezetimibe TA – due Nov 28 th </li></ul></ul><ul><ul><li>NICE Hyperlipidaemia guideline – due Jan 08 (delayed) </li></ul></ul><ul><ul><li>NICE diabetes guideline – due Feb 08 </li></ul></ul><ul><li>Expect to see: </li></ul><ul><ul><li>New treatment targets for secondary prevention </li></ul></ul><ul><ul><li>Clarification of the role of ezetimibe </li></ul></ul>
  30. 30. Thank you and Questions?