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Top 10 Things I Learned This Year
Frank J. Domino, M.D.Professor
Dept. Family Medicine & Community HealthUn. Of Massachusetts Medical School
Worcester, [email protected]
Disclosure
Editor in Chief
5 Minute Clinical ConsultAuthor and Editor for Up To DatePri Med Curriculum CommitteeAuthor/Editor: Rxpalm, Inc. Author/Editor: www.Epocrates.comEditor: www.Familydoctor.org
By the end of this session, you will
Review new data that will change your practice about common medical
problemsReconsider 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
Which of the following is a result of Chronic PPI Use?
1. ↑ Hip Fracture2. ↑ Community Acquired Pneumonia3. ↑ Rates C. difficile4. No Improvement in Asthma Control
5. ALL OF THE ABOVE
Omeprazole (Prilosec) OTC March 2008
PPIs & Hip FracturePPI -> Hypochlorhydria -> ↓ Calcium Absorption Review of 1.8 Million Brits aged >/= 50 yrs13,556 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 ↑ dosesUse of H2 RAs were analyzed; NO ↑ Risk
JAMA 2006; 296: 2947-53, Yang, et al
PPI & PneumoniaCohort 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 RxPneumonia OR 1.89 [1.36-2.62]
JAMA 2004; 292: 1955-60; Laheij, R.
PPI & C. difficile
1,100+ Hospitalized Pts on PPIAdjusted for Antibiotic ExposureC. 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. diffOR = 2.6 [1.3 – 5.0] CMAJ 2004; 171: 33-8; Dial
Asthma & GERD 700 patients: inhaled corticosteroids treated with
Nexium 40 mg bid or placebo Divided into 3 Groups:1. One group had nocturnal asthma and no GERD, 2. One had GERD and no nocturnal asthma, 3. 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
PPI’s and Side Effects4 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 InfectionH2RA (1.52) vs PPI/d (1.74) vs > 1 PPI/day (2.36)
Arch Intern Med May 10, 2010
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 RxOxyContin, Percocet, Ritalin, Adderall,
Xanax
White Students: 23%Hispanic Students: 17%
African American: 12%26% of 12th graders, 20% Male &
Female
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
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 patientsGold Standard: DAST-10 + Oral Fluid
Testing
Sensitivity: ~100%Specificity: ~75%
Arch Intern Med 2010: 170(13): 1155-60
Sources of Drugs: You & Me
Diversion: Unintended use of medication for unlawful
purposesUsing Pseudophedrine for Crystal MethUsing lawfully prescribed medications
(narcotics, anxiolytics, amphetamines) for illegal purposes
Diversion Perspective$8 Oxycontin sells for >$100.00 on street
Drug FactPrescription 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
30 Deaths/Day
Prevalence of STI’s: 14-19 Females838 females who completed a National Health
& Nutrition Examination Survey 2003-04Specimens (urine, self obtained vaginal
swabs) GC, Chlamyida, Trichomonas, HS II, ↑ Risk
HPV24% 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
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 statin did not decrease end points and may, in women,
increase adverse outcomes
NEJM; 2010: 362(17): 1628
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
A1C Hazard Ratio for Death
6.4% 1.5210.4% 1.79Insulin based vs. oral agents 1.49
Conclusion: Ideal A1C Level was 7.5%
NEJM 2010: 362(17): 1563
Oral Agents Alone Insulin Based Tx
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
American Diabetes AssociationAmerican College of Cardiology Foundation
American Heart AssociationJoint 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
Aspirin Recommendation for DM?
AHA, ACC, ADA Position Statement on Primary Prevention in Diabetes
Meta Analysis of 9 RCTs of Aspirin1. Low Dose ASA is “reasonable” for Pt with 10
Yr CVD risk > 10% & no risk for bleeding2. ASA should NOT be recommended for men <
50 or women < 60 Yrs with no other CHD RF3. ASA MIGHT be acceptable in the 5-10% risk
Diabetes Care 2010; 33: 1395
http://hp2010.nhlbihin.net/atpIII/calculator.asp?usertype=prof
5. GoutLow Dose Colchicine
RCT of 1.8 mg in 1 hour (1.2 onset, 0.6 in 1 Hr) vs
4.8 mg in 6 Hr (1.2 onset, then 0.6-1.2 per hour)
Outcome was >50% reduction pain @ 24 Hr and Adverse Event
Pain AE (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
Low DoseHigh DosePlacebo
Why did someone do a study of a Generic Medication?
New Trends: Rx that Reinvent Colchicine:
Generic: 30 Pills $25Colcrys 30 Pills $170
Acetic Acid/Hydrocortisone OticGeneric 15 ml $8Brand Name 15 ml $210.00
Doxepin (Sinequan)Generic 10 mg $19/90Brand 3, 6 mg $118/30Pill Cutter $ 2.00
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 LRNon-Organic Signs 3.0Mal-adapative Coping Behav. 2.5Functional Impairment 2.1Psychiatric Co-morbidities 2.2Low Health Status 1.8
JAMA 2010; 303(13): 1295
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
7. Pain ReliefRunning Hot or Cold
RCT of 60 adults w/Acute Neck or Back pain400 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 medication80% would use same approach for next injury
Acad Emerg Med 2010; 17(5): 484
Osteoarthritis and the KneeRCT of ~225 patients with OA of Knee Usual Care (home exercise, NSAIDs, PT)
vsSpa 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
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
Acetaminophen & NSAIDs Together, again
SR 21 studies, 1900 patients for Pain ControlParacetamol 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
Seabreeze
1 Part Vodka
3 Parts Cranberry
Juice
3 Parts Grapefruit
Juice
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; 6:33Am Fam Phys 2006; 74:605
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
Warfarin and FoodHigh vitamin K intake can ↓effectiveness of
warfarinLarge amounts: ~14 oz of high Vit. K vegetablesTypical 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
9. AHRQ: Update on PreventionGradeA. Folic Acid for Pregnancy: 0.4-0.8 mg/day
B. Mammography (50-74) BiennialB. Obesity: start Age 6 YearsB. Screen Adolescents for Depression
C. Mammography < 50 yearsI. Screening for Hyperbilirubinemia for
infants
www.ahrq.gov
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 death2005: 17% risk of Dx; 3% risk of deathIs it really worth it?
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
Colonoscopy SafetyPost 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
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 yearsOutcomes: Fatal MI, Non-Fatal MI, AnginaAdjusted for CHD Risk FactorsConclusions:
3-4 hours of overtime (beyond 7.5 Hr)
60% ↑in risk of Outcomes European Heart Journal 2010
Life Expectancy of Men in US
White Black
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.
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
Calcium Supplementation
Meta Analysis of 15 Trials, ~12,000Evaluated trials of calcium Supp.
And CHDCalcium Supp of > 500 mg/day
(Without Vitamin D Supplementation)
Hazard Ratio MI = 1.31Non-Signif. Increase in risk of CVA,
Death, & composite Endpoint of MI, CVA or Death
BMJ. 2010 Jul 29;341:
First BB for CHF, now COPD???
Retrospective analysis 2230 patients w/COPD
Beta Block Non 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
Summary
1. Use PPI’s for < 1 Yr, then Step Down
2. Screen for Rx drug use, limit their use
3. Screen teens for STI’s4. Diabetes: A1C goal of 7.5 unless
no comorbidities, ASA only for risk > 10%
5. Gout: Colchicine 1.2, then 0.6 @ 1 Hr
Summary
6. Acute Low Back Pain: no Narcotics7. Pain Relief:
1. NSAID + Hot or Cold, Spa Tx2. Migraine: ASA 1000mg + 10
Metoclopramide3. NSAID + Acetaminophen Safe &
Effective8. Statins, Warfarin and diet9. Screening: ∆ Breast & Prostate Ca;
Colon-safe10. Keep the work to < 10 hours per
day
Frank [email protected]
