Faculty/Presenter Disclosures

Transcription

1 What s New, What s True, and What s Poo FMF November 2018 Tina Korownyk, Adrienne Lindblad, Mike Allan, Mike Kolber PEER Team, U of A & CFPC Faculty/Presenter Disclosures Faculty: Michael Kolber, Tina Korowynk, Adrienne Lindblad, Mike Allan Relationships with financial sponsors: Grants/Research Support: Alberta College of Family Physicians; Toward Optimized Practice Speakers Bureau/Honoraria: ACFP; Alberta Health Consulting Fees: N/A Patents: N/A Other: Employee University of Alberta or Alberta College of Family Physicians; EMPRSS (Kolber), Canadian College of Family Physicians (Allan) 1

2 An Aspirin a Day RCTs: ASA 100 mg vs placebo Moderate Risk: pts (64 yo), 6 year FU Sponsor Bayer, Intellectual COI MACE: ~4% each arm, Any GI bleed: 1% vs 0.5% (NNH=200) Diabetics: 2 ~16000 UK pts (63 yo), 7 year FU CVD: 8.5% v 9.6%, NNT~100, Major Bleeds: 4.1% v 3.2%, NNH ~100 No difference mortality, cancers Older: 3 ~19000 pts (74yo), 5 year FU - terminated for futility Death, disability, dementia: no diff. CVD: 3.5% vs 3.9%, NSS, Major Bleed: 3.8 vs 2.8%: NNH=100 Death: 5.9 vs 5.2%: NNH=143 (Cancer Death: 3.1 vs 2.3%, NNH=125) Bottom-Line: For primary CV prevention (moderate risk, diabetics and elderly) potential harms of ASA exceed benefits. 1 Lancet 2018; 2 NEJM 2018; DOI ASPREE, NEJM 2018 DOI: Anti-Depressants Meta-Analysis (Network): 522 RCTs ( pts) Mean duration 8 weeks. Two Outcomes: Versus Placebo Efficacy ( 50% depression scale improvement): Odds Ratio was for 19 of 21 anti-ds. Elavil= 2.13, Reboxetine =1.37. Tolerability (not dropping out): All same as placebo except aglomelatine (OR=0.84), Fluoxetine (OR=0.88), clomipramine (OR=1.30) Newer drugs seemed better (?) Bottom-Line: Nothing new. Anti-depressants work marginally well. They are very similar. Cipriani A, et al. Lancet 2018 e pub 2

3 AL Management of Acute Pain RCT (411 adults), 52% male, acute extremity pain 62% sprain, 22% fracture, rest contusion, muscle pain, etc Outcome: Baseline Pain 8.7 (scale 0-10) 400mg Ibuprofen 1000mg Aceta 5mg oxycodone 325mg Aceta 5mg hydrocodone 300mg aceta 30mg codeine 300mg Aceta Morphine Eq Pain 2 hr Rescue 18% 14% 18% 22% No diff in any outcome. None 1.3 (MCID) better than the other; AE not reported Bottom-Line: For acute pain, NSAIDs + Acetaminophen is good place to start. JAMA 2017;318(17):1661 Chronic Back or OA Pain: Opioid vs Other RCT: 240 pts (mean 58 yrs; 87% male), 1 yr, unblinded. Opioids vs non (Aceta, NSAID, TCA, topical lidocaine/capsaicin, pregabalin/ duloxetine, +/- tramadol. 65% back & 35% OA Primary Outcome: Function (scale or 30%) No diff Pain: start 5.4 down to 4 vs 3.5 (ss). 30%= 41% vs 54% (NNT=8) QoL, visits, ED use, most measures = no difference. Opioid: 15% pts on 50mg ME. Tramadol in 11% non-opioid. AE: 2 vs 1 out of 19 score (ss). Discontinue med 19% vs 8% Bottom-Line: Vs opioids, other meds are same or more effective, with less adverse events and easier to tolerate. JAMA. 2018;319(9):

4 Remeasuring BP better than Treating? 38,620 pts with 80,864 visits: age 61yo, 41% Initial BP >140/90 on visits (39% of visits) Remeasured 26,089 of those (83% of the time) BP 8mmHg systolic on average (range 2-17) 36% had normal (<140/90) on repeat. Just repeating BP, increased overall BP control from 61% to 73% In patients with initial BP : ~43% <140/90 when remeasured. Bottom-Line: Remeasure BP. It will result in less meds and better BP control for your practice JAMA Internal Medicine. 2018; 178: Recurrent UTIs and Drinking Water RCT of 140 Bulgarian w recurrent UTIs (3.3/ year) + self report drinking < 1.5 litre water / day. Randomized to 3 x 500cc bottled water or control. FU 1 year. Mean # UTIs: 1.7 (water) vs 3.2 controls Bottom Line: for w recurrent UTIs, consider encouraging drinking 1.5 additional litres of water JAMA Intern Med. doi: /online October 1,

5 AL Low Fat vs Low Carb: It s in your Jeans RCT 609 (mean age 40, BMI 33, 57% female) 22 dietitian interventions (groups of 17) ++ on genetic predisposition/insulin sensitivity At 1 year (q3 months): range -30 to +10kg Low at -5.3kg vs Low Carb -6kg. No stat diff. No real difference in any outcomes. Bottom-Line: Little difference between diets; & 23andme won t help. JAMA. 2018;319(7): AL N-3 Fatty Acids: Dry Eyes and CVD 535 patients mod-severe dry eyes oral 3000 mg of fish-derived N-3 fatty acids vs olive oil capsule x 1 yr. 14 better vs 13 better (from 44/100). P=0.40 Other eye outcomes not statistically different. ASCEND: diabetics, 1000mg n-3 Fatty Acids v plac x7.4 yrs. CVD: 11.4% v 11.5% Rate Ratio 1.00 ( ) No effects on any outcome. VITAL: 25k pts, marine omega 3. At 5 years: no diff in CVD, cancer Bottom-Line: Do not use n-3 fatty acids for dry eyes. Still no benefit in CVD. DREAM Group NEJM (epub) ASCEND NEJM (epub), VITAL NEJM 5

6 N-3 Fatty Acids: With a Twist! REDUCE IT: 8179 pts, with trigs ( ) despite statins. Mean age 64 yo. 70% 2 CV prevention, 60% DMs Randomized to icosapent ethyl (4gr per day) or placebo x 4.9 years CVD: 17.2 vs 22.0% (NNT = 21) LDL 3.1% on treatment (10% on placebo), trigs 18% Aes: AF (NNH 72) Bottom-Line: Traditional n-3 fatty acids (10 RCTs of ~80,000 pts) still does not decrease CVD events. Newer agent, Isopropyl ether (not yet available in Canada) shows benefit. ASCEND Study NEJM (epub), VITAL, REDUCE-IT, JELIS Pediatric Asthma Action Plan: 5x Inhaled Steroid is the new 2x RCT (254 kids): age 5-11 (mean 8), 64% male, Required daily low-dose steroid + one exacerbation last year. Fluticasone 44µg BID then yellow 220µg BID (or stay 44µg) Outcomes: Exacerbation=oral steroids Exacerbation: No effect, 0.48/yr vs 0.33/yr, RR=1.3 ( ) No difference in time to first exacerbation, ER or urgent care visits, rescue inhaler use, symptom burden, etc. Growth: 5.43 cm vs 5.65 (diff=0.23 cm, p=0.06) Bottom-Line: When asthma symptoms worsen in children, giving 5Xs the dose of inhaled steroids does not help and may have small growth reduction. N Engl J Med 2018;378:

7 Smoking Cessation, Weight Gain and Mortality Three ~20 year US cohorts, q 2 year surveys. Smoking (current, recent, never), weight gain (0, < 5kg, 5-10 kg, > 10 kg), mortality N Engl J Med 2018;379:623 Smoking Cessation, Weight Gain and Mortality Three ~20 year US cohorts, q 2 year surveys. Smoking (current, recent, never), weight gain (0, < 5kg, 5-10 kg, > 10 kg), mortality You are healthier if you quit smoking. At any weight! And those gained 5-10kg did best! N Engl J Med 2018;379:623 7

8 Recombinant Zoster Vaccine (Shingrix TM ) Two industry placebo-controlled RCTs of Recombinant (RZV) in patients without shingles or previous vaccine. Outcomes converted to 3 years. Shingles (Adults >50 yo): RZV: 0.08 vs 2.7% placebo, NNT~40, Comparable live vax: NNT~70. 3,4 Shingles (Adults > 70 yo): 2 Recombinant: 2 0.4% vs 3.5% placebo, NNT ~40 Comparable live vax (pts 60 years): NNT~60. 5 Post Herpetic Neuralgia: All ages: Recombinant: NNT= 422, Live ~360 RZV: 2 doses, costs ~50% more: 320$ vs 200$ Bottom Line: RZV prevents 1 additional case of shingles for ~40 patients treated compared to 1 for ~60-70 with live vaccine. Both vaccines risk of post-herpetic neuralgia. RVZ is more expensive and requires 2 injections. TFP 2018 In Press, NEJM 2015; 372:2087, NEJM 2016; 375:1019, NEJM 2005; 352:2271. TFP# 77, 2016 AL Vulvovaginal menopause symptoms: Vaginal Estradiol vs Moisturizer vs Placebo RCT: 302 women (mean 64 yrs) 12 wks. 3 arms: Vagifem, Replens, or placebos. Primary Outcome: Most Bothersome Symptom (0-3) MBS= vaginal penetration pain (63%) dryness (21%), itching, irritation and pain dryness. MBS = ~2.5 baseline, all improved ~1.1 Vaginal Symptom Index, Female Sexual Function Index, etc. All no difference (at 4 or 12 weeks, cut-offs or mean change). No difference in adverse events either Bottom-Line: Nothing worked better than placebo (gel) Mitchell CM. JAMA Intern Med. doi: /jamainternmed

9 Bath Additives for Eczema RCT (482 kids), age 1-11 (mean 5), 49% male Mean POEM 10 (0-28, 8-16 is moderate). Emollient Bath Additive of choice vs no additive 45% Oilatum, 26% Aveeno oil, 4.5% Balneum oil, & 30% other Outcomes: over 16 weeks and at 1 yr. 50% adherence to bath additive: 93% bath additive vs 8% Bath Additive improved 0.41 (-0.27 to 1.1) more. MCID=3 Subgroup: if bath 5x/wk: POEM 2.3 ( ) better No difference in exacerbations, quality of life, steroid use, etc Bottom-Line: Bath additives don t add to eczema treatment (except maybe if there are lots of baths). BMJ 2018;361:k1332 RESEARCH 9

10 Self-Colonoscopy 2018 Nobel Ig Prize Could be a valuable research tool repetitively study the effects of therapies Small-caliber c-scope Results: cecum in 4 minutes. So easy à 3 more Xs in 8 weeks mild discomfort, each one different Bottom Line: In our personal experience, self colonoscopy proved not only possible but simple and efficient. may need a special chair GASTROINTESTINAL ENDOSCOPY 2006; 63 (1): 119 Renal Stone: Off to Disney World A pyelocalyceal renal model (could not use animal models) 3 different stones (4.5 mm, 13.5mm, and 65mm) 20 rides on Big Thunder Mountain Railroad roller coaster at Walt Disney World in Orlando, Florida. Seating varied. Passage to ureter was 64% when in roller-coaster rear vs 17% in front. Upper (69%) better than lower (29%), due to gravity, but size no difference! Bottom-Line: Patients should consider riding moderate-intensity roller coasters to promote passage of small stones/fragments. J Am Osteopath Assoc. 2016;116(10):647 10

11 AL Mom Spit: Is it a good cleaner. Used Saliva to clean a variety of surfaces oil paintings, gold-leaf Two actions: 1) Aqueous action (it s wet); 2) Enzymatic Activity (catalyzing dirt degradation) - particularly -amylase Results: Good cleaning but may be too powerful for vermilion and azurite No mention of children's faces before pictures Bottom-Line: Confirmed saliva as the 'best' cleaner for the surfaces tested, especially for the gilded ones Studies in Conservation 1990; 35: 153 High Socio-Economic Status = Unethical Behavior Study 1: Not waiting at 4-way stop: Highest quintile 30%, others ~12% Study 2: Not stopping for pedestrian: Highest 2 quintiles ~45%, 3 Lowest 0-30% Study 3 & 4: Higher SES generally reported more likely to do unethical things Study 4: Higher SES individuals took more candy designated for children Study 5: Higher SES more likely to lie to new staff when negotiating salary Study 6: Positive attitude to greed more likely dishonest (to increase winning) Study 7: If encouraged to think why greed s good, lower SES also unethical. Bottom-Line: Greed and SES linked, leading to unethical thoughts/behavior. Unless primed, then everyone s bad! Proc Natl Acad Sci USA 109: