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Top 10 Things I Learned This Year

Top 10 Things I Learned This Year. Frank J. Domino, M.D. Professor Dept. Family Medicine & Community Health Un. Of Massachusetts Medical School Worcester, MA Frank.domino@umassmemorial.org. Disclosure. Editor in Chief 5 Minute Clinical Consult Author and Editor for Up To Date

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Top 10 Things I Learned This Year

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  1. Top 10 Things I Learned This Year Frank J. Domino, M.D. Professor Dept. Family Medicine & Community Health Un. Of Massachusetts Medical School Worcester, MA Frank.domino@umassmemorial.org

  2. Disclosure • Editor in Chief 5 Minute Clinical Consult • Author and Editor for Up To Date • Pri Med Curriculum Committee • Author/Editor: Rxpalm, Inc. • Author/Editor: www.Epocrates.com • Editor: www.Familydoctor.org

  3. By the end of this session, you will • Review new data that will change your practice about common medical problems • Reconsider what you might assume is the “standard of care” • Remain skeptical of how the medical literature influences the news, your patients, and someone’s income

  4. Which of the following is a result of Chronic PPI Use? • ↑ Hip Fracture • ↑ Community Acquired Pneumonia • ↑ Rates C. difficile • No Improvement in Asthma Control • ALL OF THE ABOVE

  5. Omeprazole (Prilosec) OTC March 2008

  6. PPIs & Hip Fracture • PPI -> Hypochlorhydria -> ↓ Calcium Absorption • Review of 1.8 Million Brits aged >/= 50 yrs • 13,556 Hip Fractures; After adjusting for cofounders • Relative Risk of Hip Fracture among PPIs (> 12 months) = 1.6 [CI: 1.41-1.89] • Risk Increased w/ duration of Tx & with ↑ doses • Use of H2 RAs were analyzed; NO ↑ Risk • JAMA 2006; 296: 2947-53, Yang, et al

  7. PPI & Pneumonia • Cohort Study Italy: Children on PPI for 4 months increased risk of: • Gastroenteritis OR=3.58 [1.87-6.86] & Comm. Ac. Pneumonia OR=6.39 [1.38-29] • Pediatrics 2006: 117: e817-20; Canani, R. • Case Control Netherlands: Adults using Acid Suppressing Rx • Pneumonia OR 1.89 [1.36-2.62] JAMA 2004; 292: 1955-60; Laheij, R.

  8. PPI & C. difficile • 1,100+ Hospitalized Pts on PPI • Adjusted for Antibiotic Exposure • C. diff OR 2.1 [1.2 – 3.5] (not for H2RA) AND, to decrease risk of confounding error, they performed: • Case Control of 94 Inpatients with C. diff • OR = 2.6 [1.3 – 5.0] • CMAJ 2004; 171: 33-8; Dial

  9. Asthma & GERD • 700 patients: inhaled corticosteroids treated with Nexium 40 mg bid or placebo • Divided into 3 Groups: • One group had nocturnal asthma and no GERD, • One had GERD and no nocturnal asthma, • and one had both GERD and nocturnal asthma. ***Nexium did NOT improve any clinically significant Sx: morning PEF, use of rescue inhalers, or quality-of-life scores in any subgroup Am J Respir Crit Care Med 2006 May 15; 173:1091-7 Cochrane 2003 – No Benefit in GERD Tx on Asthma

  10. PPI’s and Side Effects 4 Articles in May 10, 2010 Archives Int Med: PPI’s Woman’s Health Initiative 130,000 women on PPI x 7.8 years  ↑ Fx Risk of Spine, Forearm/wrist and total fractures 100,000 Hospital Discharges x 5 years for risk of developing nosocomial C. diff Infection H2RA (1.52) vs PPI/d (1.74) vs > 1 PPI/day (2.36) Arch Intern Med May 10, 2010

  11. 2. Sex and DrugsCDC: 2009 National Youth Risk Behavior Survey (YRBS) • 1 in 5 High School students say they have taken a prescription drug without a Rx • OxyContin, Percocet, Ritalin, Adderall, Xanax • White Students: 23% • Hispanic Students: 17% • African American: 12% • 26% of 12th graders, 20% Male & Female

  12. CDC: 2009 National Youth Risk Behavior Survey (YRBS) • Alcohol: 72% • Marijuana: 36% • Prescription 20% • Tobacco: 19% • Cocaine: 6.4% • Ecstasy: 6.7% • Methamphetamine: 4.1% • Passenger with Driver under Influence: 28% • Sexually Active: 46%; 2/3 not used condom last IC http://www.cdc.gov/healthyyouth/yrbs/index.htm

  13. 3. Drugs: Show of Hands • “How many times in the past year have you used an illegal drug or used a prescription drug for non-medical reasons?” • ~400 patients • Gold Standard: DAST-10 + Oral Fluid Testing • Sensitivity: ~100% • Specificity: ~75% Arch Intern Med 2010: 170(13): 1155-60

  14. Sources of Drugs: You & Me • Diversion: Unintended use of medication for unlawful purposes • Using Pseudophedrine for Crystal Meth • Using lawfully prescribed medications (narcotics, anxiolytics, amphetamines) for illegal purposes • Diversion Perspective • $8 Oxycontin sells for >$100.00 on street

  15. 30 Deaths/Day Drug Fact • Prescription Opioids cause more drug overdose deaths than cocaine and heroin combined. • 40% of teens and an almost equal number of their parents think abusing prescription painkillers is safer than abusing "street" drugs CDC/FDA 2008

  16. Prevalence of STI’s: 14-19 Females • 838 females who completed a National Health & Nutrition Examination Survey 2003-04 • Specimens (urine, self obtained vaginal swabs) • GC, Chlamyida, Trichomonas, HS II, ↑ Risk HPV • 24% were + for at least 1 HPV: 18.3% Chlamydia: 3.9% Trich: 2.5% HSV: 1.9% GC: 1.3% Pediat 2009; 124: 1505-12

  17. 4. DiabetesUpdate on the ACCORD Trial • Gluc: A1C-- lower is not better • BP: 120 not better than 140 to prevent Endpoints: Non-fatal MI, CVA or CHD Death • Lipids: adding fibrate to statindid not decrease end points and may, in women, increase adverse outcomes NEJM; 2010: 362(17): 1628

  18. Landing on the U-Shaped CurveWhere is the Ideal A1C ??? • 2 cohort studies, ~28,000 T2DM >/= 50 Yrs • Compared Mean A1C and All Cause Mortality A1CHazard Ratio for Death • 6.4% 1.52 • 10.4% 1.79 • Insulin based vs. oral agents 1.49 Conclusion: Ideal A1C Level was 7.5% NEJM 2010: 362(17): 1563

  19. Oral Agents Alone Insulin Based Tx

  20. Editorial: Glycemic Control in Type 2 Diabetes: “Time for an Evidence-Based About Face” “Tight glycemic control burdens patients with complex treatment programs, hypoglycemia, weight gain, and costs, and offers uncertain benefits in return. “Glycemic control efforts should individualize A1C targets so that those targets and the actions necessary to achieve them reflect patients’ personal and clinical context and their informed values and preferences” Montori; Ann of Intern Med 2009; 150: 803-808

  21. American Diabetes AssociationAmerican College of Cardiology FoundationAmerican Heart Association Joint Position Statement • “intensive vs. standard glycemic control have not shown a significant reduction of CVD outcomes” • Tx Goals: “Blood pressure control, Lipid Lowering w/Statin, ASA & Lifestyle modification” AND: • A1C < 7.0: “w/o Hx hypoglycemia, short duration of DM, long life expectancy, no CVD” • A1C > 7.0: “w/ Hx hypoglycemia, limited life expectancy, advanced micro or macrovascular complications, extensive co-morbidities, or long standing DM in whom the general goal is difficult to attain…” Diabetes Care 2009; 31(1): 187-192

  22. Aspirin Recommendation for DM? • AHA, ACC, ADA Position Statement on Primary Prevention in Diabetes • Meta Analysis of 9 RCTs of Aspirin • Low Dose ASA is “reasonable” for Pt with 10 Yr CVD risk > 10% & no risk for bleeding • ASA should NOT be recommended for men < 50 or women < 60 Yrs with no other CHD RF • ASA MIGHT be acceptable in the 5-10% riskDiabetes Care 2010; 33: 1395

  23. http://hp2010.nhlbihin.net/atpIII/calculator.asp?usertype=profhttp://hp2010.nhlbihin.net/atpIII/calculator.asp?usertype=prof

  24. 5. GoutLow Dose Colchicine • RCT of 1.8 mg in 1 hour (1.2 onset, 0.6 in 1 Hr) vs4.8 mg in 6 Hr (1.2 onset, then 0.6-1.2 per hour) • Outcome was >50% reduction pain @ 24 Hr and Adverse EventPainAE (D, SD, V)Low Dose 31% 23%, 0%, 0% High Dose 34% 77%, 19%, 17% Placebo 50% 20%, 0%, 0% Arthritis Rheum 2010; 62(4): 1060

  25. Low Dose High Dose Placebo Why did someone do a study of a Generic Medication?

  26. New Trends: Rx that Reinvent • Colchicine: Generic: 30 Pills $25 Colcrys 30 Pills $170 • Acetic Acid/Hydrocortisone Otic Generic 15 ml $8 Brand Name 15 ml $210.00 • Doxepin (Sinequan) Generic 10 mg $19/90 Brand 3, 6 mg $118/30 Pill Cutter $ 2.00

  27. 6. Low Back PainWhat Predicts Chronic Low Back Pain • SR of 20 studies (10,000+ Patients) to see what predicts Chronic LBP at 1 Year Median LR • Non-Organic Signs 3.0 • Mal-adapative Coping Behav. 2.5 • Functional Impairment 2.1 • Psychiatric Co-morbidities 2.2 • Low Health Status 1.8 JAMA 2010; 303(13): 1295

  28. Opioid Use & Acute LBP • Early opioid Rx & subsequent disability from back injuries • “Receipt of opioids for >6 days doubled odds of disability”Spine 2008:15;33(2):199-204. • Relationship between early opioid prescribing for acute occupational low back pain and disability duration • 8000+ Workers Comp Cohort • Pts who received Opioids disabled 69 days longer than not. • “CONCLUSION: Given the negative association between receipt of early opioids for acute LBP and outcomes, it is suggested that the use of opioids for the management of acute LBP may be counterproductive to recovery.” Spine 2007; 32(19):2127-32

  29. 7. Pain ReliefRunning Hot or Cold • RCT of 60 adults w/Acute Neck or Back pain • 400 mg Ibuprofen + Ice or Heat Pack x 30 Min • “no difference in pain severity in Cold or Heat groups before or after treatment” or in need for additional medication • 80% would use same approach for next injury Acad Emerg Med 2010; 17(5): 484

  30. Osteoarthritis and the Knee • RCT of ~225 patients with OA of Knee • Usual Care (home exercise, NSAIDs, PT) vs • Spa Therapy (18 days “hydrojet Tx, massage under mineral water, mineral mud & mineral pool exercises) + Usual Care • At 6 months: 50% of Spa vs 36% of Usual Care had “Minimal Clinically Important Improvement” Ann Rheum Dis 2010; 69: 660

  31. Migraine: Aspirin, really?? • SR of 13 studies; 4000+ • ASA (1000 mg + 10 metoclopramide) vs others agents (Sumatriptan 50 or 100 mg) • “Sumatriptan 50 mg did not differ from ASA alone at 2 Hr Pain Free & HA relief” • Sumatriptan 100 mg was better than ASA+Meto At 2 hour Pain Free, BUT NOT HEADACHE RELIEF & had > Side Effects Cochrane DSR 2010

  32. Acetaminophen & NSAIDs Together, again • SR 21 studies, 1900 patients for Pain Control • Paracetamol vs. NSAID vs Para+NSAID • “Combination of Para. And NSAID was more effective than Para. Or NSAID alone in 85% and 64% of relevant studies, respectively” • “Current evidence suggests that a combination of Para. And an NSAID may offer superior analgesia compared to either drug alone. • NO increase in adverse events from combination Anesth Analges 2010; 110: 1170

  33. Seabreeze 1 Part Vodka 3 Parts Cranberry Juice 3 Parts Grapefruit Juice

  34. 8. Food and DrugsGrapefruit Juice & Statins • Grapefruit Juice inhibits intestinal C P-450 3A4 • Can inhibit first pass metabolism and may result in ↑ serum concentrations of some drugs. • Can reduce P-450 by ~45% • Clinically: 1 case report of a 40 y/o woman on 80mg Simvastatin, daily exercise, skydiving, and eating 1 grapefruit/day x 2 weeks • Use Pravstatin or rosuvastatin Nutrit Journal 2007; 6:33 Am Fam Phys 2006; 74:605

  35. Why be on a Statin??? • Meta Analysis of 65,000 “intermediate to high risk individuals without history of CVD” and Statin use and All Cause Mortality • “Use of statins in this high risk population was NOT associated with a statistically significant reduction in All Cause Mortality” Arch Intern Med 2010: 170(12): 1024

  36. Warfarin and Food • High vitamin K intake can ↓effectiveness of warfarin • Large amounts: ~14 oz of high Vit. K vegetables • Typical servings (4 oz) have little impact on INR. • 2005 Dietary Guidelines for Americans recommends: • 3 cups/week of dark-green vegetables (contain ~100-570 microg/serving) of vitamin K1. Nutr Rev. 2005 Mar;63(3):91-7. • Cranberry Juice: Ancedotal reports of interaction • “Moderate consumption does not affect anticoagulation” Am J Med 2010 123(5): 384

  37. 9. AHRQ: Update on Prevention Grade A. Folic Acid for Pregnancy: 0.4-0.8 mg/day B. Mammography (50-74) Biennial B. Obesity: start Age 6 Years B. Screen Adolescents for Depression C. Mammography < 50 years I. Screening for Hyperbilirubinemia for infants www.ahrq.gov

  38. CA: 59 (4): 215 - 275 

  39. Summing the data • Man screened is 48 times more likely to be harmed than saved at 9 years after diagnosis; • Harms: Impotence, Incontinence, mental anguish, and “even death” • Screening doubles risk of Dx but does not significantly decrease risk of dying • 1985: 8.7% risk of Dx; 2.5% risk of death • 2005: 17% risk of Dx; 3% risk of death • Is it really worth it?

  40. Boyle & Brawley Conclusion • “Testing has been based on blind faith in early detection as opposed to being based on evidence of a decrease mortality” • “Prostate Cancer screening and treatment of early disease is also a profitable industry” • “If we are to stem the spiraling costs of health care, we must move toward the use of evidence based, rather than faith based or profit based practice of medicine.” • “The collective data clearly cannot justify mass screening and indeed appear to justify support for a recommendation against mass screening.” • “Shared decision making.. should include discussion of the quantified risks and benefits.” CA: 59 (4): 215 - 275

  41. Colonoscopy Safety Post Colonoscopy surveillance 21,000 adults -GI Bleeding 1.59/1000 exams (Risk ↑ w/Warfarin, but not ASA/NSAIDs-Perforations 0.19/1000 exams -Diverticulitis 0.23/1000 exams -Postpolypectomy Synd 0.09/1000 exams Overall Incidence of SE 2.01/1000 exams Clin Gastroent Hepat 2010; 8(2): 166

  42. 10. All the other stuffHow long is your average day? • 6000 British civil servants lifestyle; x=7.5 Hr/d • 60% male, 40% female; 39-61 Yrs x 11 years • Outcomes: Fatal MI, Non-Fatal MI, Angina • Adjusted for CHD Risk Factors • Conclusions: 3-4 hours of overtime (beyond 7.5 Hr)  60% ↑in risk of Outcomes European Heart Journal 2010

  43. Life Expectancy of Men in US WhiteBlack • Physician 73.0 68.7 • Lawyers 72.3 62.0 • All Professionals 70.9 65.3 • All Men 70.3 63.6 Am J Prev Med. 2000 Oct;19(3):155-9.

  44. Vitamin D • Vitamin D’s job is to regulate serum Ca • Annual High Dose Vitamin D & Fractures • RCT of 500,000 IU D3 x 3-5 Years • ↑ Risk of Falls (83/100 Person Yrs vs 72/100 PY) • ↑ Risk of Fractures (4.9/100 PY vs 3.9/100 PY)JAMA 2010; 303(18): 1815-22; Editorial 1861

  45. Calcium Supplementation • Meta Analysis of 15 Trials, ~12,000 • Evaluated trials of calcium Supp. And CHD • Calcium Supp of > 500 mg/day (Without Vitamin D Supplementation) • Hazard Ratio MI = 1.31 • Non-Signif. Increase in risk of CVA, Death, & composite Endpoint of MI, CVA or Death BMJ. 2010 Jul 29;341:

  46. First BB for CHF, now COPD??? • Retrospective analysis 2230 patients w/COPDBeta BlockNon BB • Death: 27.2% 32.3% • COPD Exacerb 42.7% 49.3% • Mortality benefit in seen in cardioselective BB (Atenolol, Metoprolol) Arch Intern Med 2010; 170(10): 880

  47. Summary • Use PPI’s for < 1 Yr, then Step Down • Screen for Rx drug use, limit their use • Screen teens for STI’s • Diabetes: A1C goal of 7.5 unless no comorbidities, ASA only for risk > 10% • Gout: Colchicine 1.2, then 0.6 @ 1 Hr

  48. Summary 6. Acute Low Back Pain: no Narcotics 7. Pain Relief: • NSAID + Hot or Cold, Spa Tx • Migraine: ASA 1000mg + 10 Metoclopramide • NSAID + Acetaminophen Safe & Effective 8. Statins, Warfarin and diet 9. Screening: ∆ Breast & Prostate Ca; Colon-safe 10. Keep the work to < 10 hours per day

  49. Frank .domino@umassmemorial.org

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