Questioning Medicine
Questioning Medicine
Questioning Medicine
130. Antibiotics, BIOTOK and Knee Osteoarthritis, and Bempedoic Acid
24 minutes Posted May 19, 2020 at 1:58 am.
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Fox MT et al. Comparative effectiveness of antibiotic treatment duration in children with pyelonephritis. JAMA Netw
vOpen 2020 May 1; 3:e203951. (https://doi.org/10.1001/jamanetworkopen.2020.3951)
Rates of treatment failure did not differ significantly between the short and prolonged courses (11.2% and 9.4%).
https://jamanetwork.com/journals/jama/fullarticle/2765729?guestAccessKey=2169ba8b-43fc-4360-bed7-acf7a31b1c9d&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jama&utm_content=etoc&utm_term=051220
Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial
In jama may 12 – look to see if special biomechanical footwear could help osteoarthirits knee pain-
At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, −1.3 [95% CI, −1.8 to −0.9]; P 
Hum SW, Shaikh KJ, Musa SS, Shaikh N. Adverse events of antibiotics used to treat acute otitis media in children: a systematic meta-analysis. J Pediatr 2019;
How often do children experience adverse effects from the antibiotics used to treat otitis media?
diarrhea was the most common adverse event, but it ranged from 2.2% (azithromycin) to 18.9% (amoxicillin/clavulanate). The placebo caused diarrhea in approximately 7% of children, perhaps a reflection of underlying viral infections. BUT WE KNOW BOTH STUDIES AND FAMILIES WILL UNDERREPORT-- In the 3 studies that used diaries, the rate of diarrhea was higher (range = 14.6% - 21.1%). Diaper rash occurred in 4.6% of children and varied up to 14.8% in children treated with amoxicillin/clavulanate.
The FDA has approved bempedoic acid (marketed as Nexletol) --- which cost around 333$ a month per good RX-- to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease for whom statins are deemed insufficient.
But to be fair they weren’t really looking for a change because the follow up was 12 months. And there were low event rates aka the patients were healthy at baseline.
IN FACT!!!
Evidence suggests a possibility of harm with bempedoic acid, with a non-significant trend toward higher CV (0.4% versus 0.1%) and all-cause mortality (0.9% versus 0.3%) in the treatment group compared to the placebo group. – yes I know evidence doesn’t work that way but when you have such small events it would be nice to not see a 3 and 4 fold difference in the events that do occur.
For me – when you cant prove real benefit and in the phase three study the best you can show is a 18% change in an outcome I don’t care about with an although not statistically significant but 3-4 fold increase in CV and all-cause mortality compared to placebo--- I would say no thanks!