Dalbavancin & Oritavancin – PART 2

November 17th, 2014 by Warren S. Joseph DPM FIDSA
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In my post last week I mentioned I would write a follow up to discuss my opinions on the use of these drugs for lower extremity infections.  I have not yet had the opportunity to try either so these are really “top line” thoughts taken what I know, have read or heard from others, into consideration.

– These drugs are expensive and I wonder who will cover the cost. The two doses of dalbavancin reportedly cost somewhere in the neighborhood of $4500 while the single dose of oritavancin is considerable less at around $2600 for the required single dose. Given hospital pharmacies are always worried about their budgets (they complained about the cost of linezolid when it was originally only about $1500!) can they be convinced to stock these drugs? What about insurance companies when they can demand patients receive generic vancomycin for next to no cost at all?

– The argument is made by the companies that these drugs will keep patients out of the hospital thus saving costs. That does make a lot of sense…on the surface. If you don’t admit the patient you don’t run up costs for the actual stay and only the outpatient treatment. The problem with this line of thinking is that many, especially for profit, hospitals make money by having “heads in beds”. The last thing they would want to do is decrease the number of admissions from the E.D. I make this statement with the disclosure that I am far from expert in hospital reimbursement economics, it’s just what I have been told by some hospital administrators.

– Who will make the decision to administer these drugs? The Emergency Physician? I doubt most would feel comfortable with these antibiotics. Furthermore, would they just stock it in the E.D? Who’s budget does it go under? The Pharmacy or the E.D.? What about the out-patient infusion center. This is probably the most likely scenario, especially if run/owned by an ID specialist, depending or reimbursement considerations.

– If the patient did receive a dose in the E.D. and the decision was made to admit the patient, the patient no longer needs IV antibiotics. Would the admission be denied as not meeting hospital level care?

– What if the patient developed an adverse event (“AE”). Neither of these drugs is dialyzed out of the blood. Will the AE be present for the entire length of the half life? That being said the clinical trials showed that AEs were rare and those that did occur were self limiting. Of course, with widespread use of any new drug previously untoward reactions can be discovered.

I guess my bottom line is that I am totally fascinated by these drugs and their unique pharmacokinetics.  I can see weekly doses to treat osteomyelitis (although neither are FDA approved for this nor even tested).  I can see taking a patient with an infection who is not doing well on an oral MRSA drugs, such as doxycycline or TMP/SMX, and just treating them with an IV dose or two.  Perhaps, treating a patient who, for whatever reason, can’t take oral linezolid or tedizolid but does not require hospitalization for their infection is another potential use. I will continue to watch and learn about these two new drugs whenever I can and pass along any information I can.

Posted in Antibiotics, Infections, MRSA, Osteomyelitis | No Comments »

New Antibiotics – Dalbavancin & Oritavancin PART 1

November 10th, 2014 by Warren S. Joseph DPM FIDSA
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In this entry I will continue to explore some of the new antibiotics that have been recently approved for use in acute bacterial skin and skin structure infections (ABSSSI). I will discuss these two together since they are quite similar in a number of important ways and share many of the same properties.

Both dalbavancin (Dalvance™ – Actavis) and oritavancin (Orbactive™ – The Medicines Company) are classified as “semisynthetic lipoglycopeptide” antibiotics. Both are effective against resistant gram positive organisms including MRSA.  They have both been around for quite awhile having been studied and then turned down for approval by the FDA back around 2007-8 citing lack of sufficient data.  Both were then dropped by their original companies and eventually picked up by others who finished the study process to get them FDA approved.  They also both share similar pharmacokinetics with very long half lives allowing weekly dosing.  Dalbavancin is dosed 1 gram IV on day 1 followed by 500mg on day 8, while Oritavancin is given in a single 1200mg IV dose.

In the Phase III clinical trials for dalbavancin, entitled the “Discover 1 & Discover 2 “ trials (http://www.nejm.org/doi/full/10.1056/NEJMoa1310480 ), dalbavancin given in the 2 dose regimen was found to be noninferior to IV vancomycin followed by po linezolid  (clinical success 90.6% for Dalbavancin vs. 93.8% for the comparator) with adverse events being less frequent in the dalbavancin group.

Similarly, in the two Phase III trials of oritavancin (http://www.nejm.org/doi/full/10.1056/NEJMoa1310422) the single dose regimen was compared to twice daily IV vancomycin for 7 to 10 days.  The primary end point (reduction in lesion size by 20% at 48-72 hours – the current FDA standard and probable topic for a future post) was met in 82.3% for oritavancin vs. 78.9% of the time.  Although adverse event rates were similar, nausea was found more commonly in the oritavancin group.

So, where do these drugs fit in terms of our clinical usage in the management of lower extremity infections? As you can imagine, I have my opinions…but you will have to wait for my next post!

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ONYCHOMYCOSIS – What Are We Teaching?

November 3rd, 2014 by Warren S. Joseph DPM FIDSA
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I have been doing LOTS of talks on onychomycosis over the past few months. The vast majority of these have been CME lectures where I spend significantly more time reviewing the background information of onycho than talking about new drug therapies.  What has amazed me since I first started speaking on this topic over 25 years ago is the lack of understanding of the science behind this INFECTION.  Yes, you read that correctly…onychomycosis is an INFECTION and should be treated with anti-INFECTIVES.  We don’t think twice about treating a bacterial infection with an antibiotic, why don’t we feel as strongly about treating a fungal infection with an antifungal?  This has been my introductory statement in every lecture I give about this disease since I first became interested in this topic and my feeling has not waivered about it.

Perhaps I will expand upon that concept in a future post but for this entry, I want to talk about the total lack of understanding/interest in learning about onycho exhibited by our next generation of this profession; our students and residents. Many students and residents have been attending some of these CME lectures. I don’t know that they are necessarily there to hear my talk or rather it is just a diversion between the “more interesting” surgical topics that are being presented at the same meetings.  Their lack of knowledge about onychomycosis, however, was driven home to me recently while I was speaking at the PRESENT Residency Summit in Teaneck, NJ.

At this well attended seminar I was in front of close to 200 podiatric residents. I started my talk by polling the audience asking how many of them could recite for me the Lauge Hansen Classification of ankle fractures.  As you could imagine, every single resident raised their hand.  I then asked how many could recite the Zaias Classification of onychomycosis**…NOT A SINGLE HAND was raised!  My comment to them was: “Let me get this straight.  Everyone one of you can recite a classification system for a condition that 1/3 of  you may see twice a year but NONE of you can recite the classification system used in every scientific paper written about a condition you will see 20-30 times a day!”

I believe that this is an indictment of our educational system. This lack of knowledge is not necessarily the fault of the residents/students.  They are just learning what has been preached to them as being “important” by their school faculty residency directors and attendings.  Onychomycosis is something to be palliated (debrided, trimmed, ground, etc) and then discharged and reappointed for 60+ days, not treated as the potentially important infection that it is.  I am afraid that more is being taught about how to properly code onychomycosis than any science behind it. (There are, of course, notable faculty members who really believe in teaching this information as something critically important)  We need to start concentrating on the cognitive, medical aspects of podiatric medicine as well as, if not even more than surgical technique.  Being as common a condition as it is, I see no better place to start that new paradigm of podiatric education than in teaching about onychomycosis.

**In 1972, Nardo Zaias, MD, one of the “Godfathers” of onychomycosis in the dermatology world, developed the classification system that is still used today (with some minor modifications) identifying 4 types: Distal Subungual (DSO), White Superficial (WSO), Proximal Subungual (PSO) and Candidal onychomycosis

Posted in Infections, Onychomycosis | No Comments »

New Antibiotics – Tedizolid

October 23rd, 2014 by Warren S. Joseph DPM FIDSA
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As I mentioned in my previous post, this has been a pretty exciting time in the area of lower extremity infectious diseases. Not only do we have 2 new drugs for onychomycosis (to be covered in future posts) but we also have 3 new FDA approved antibiotics for the treatment of, in FDA Speak; “acute bacterial skin and skin structure infections” (aBSSSI).  These drugs are tedizolid, dalbavancin and oritavancin.  Of these, the one that I am most interested in, at least at this moment, is tedizolid.

Tedizolid phosphate (Sivextro™, Cubist) is an oxazolidinone antibiotic. This is only the second drug in this class to be approved, the first being linezolid back in 2000.  As with linezolid, its spectrum of activity is essentially gram positive organisms including MRSA and VRE.  The difference between the two drugs is what makes it interesting. Linezolid is dosed 600mg (IV or PO) q12h for 10 days.  Tedizolid is dosed 200mg (IV or PO) once daily for only 6 days. By giving the significantly lower dose for a shorter period of time leading to a much lower total drug exposure, some of the more commonly feared adverse events found with linezolid, in particular myelosuppression and possible serotonin syndrome in patients taking SSRIs, look to be significantly lessened, if not totally eliminated. Furthermore, the cost, always an issue when trying to prescribe linezolid, should also be lower.

The two pivotal clinical trials, titled ESTABLISH -1 (oral only) and ESTABLISH-2 (IV with possible switch to oral;

http://www.ncbi.nlm.nih.gov/pubmed/23403680 http://www.ncbi.nlm.nih.gov/pubmed/24909499

Compared tedizolid 200mg daily for 6 days to linezolid 600mg q12h for 10 days. Both studies found tedizolid to be non-inferior (also FDA speak) to linezolid.

So where does this new drug fit in the treatment of lower extremity infections? Because it was approved under the more recent FDA aBSSSI Guidance as opposed to the previous “complicated skin and skin structure infection” guidance, diabetic foot infections is specifically excluded.  This is a flaw in the current aBSSSI guidance document that some of us have been debating with FDA. That does not mean it won’t work in DFI, just that it was not included in the trials.  Furthermore, just because there were no DFIs does NOT mean that there weren’t any lower extremity infections.  In fact, about 40% of the patients in the trials did, in fact, have infections of the lower extremity including infected ulcers, surgical wounds, abscesses, etc.

Given its narrow spectrum of activity against pathogens we find, shorter duration of therapy and possibly enhanced safety profile, tedizolid seems to fit nicely with current concepts of antimicrobial stewardship. This is one new antibiotic that I feel may have an excellent niche in the treatment of LEIs.

Posted in Antibiotics, Diabetic Foot, Infections, MRSA, Wounds | No Comments »

I’M BAAAACCK

October 20th, 2014 by Warren S. Joseph DPM FIDSA
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Dear Readers,

It’s been awhile. Time really does fly. I realize it has been over a year and a half since my last post. I really don’t have any excuses. Life just seems to happen that way. One day I am posting all sorts of updates on what’s happening in the world of lower extremity infections and then I just stopped. Over these past months, I have had a number of people ask me what ever happened to the blog as they really enjoyed reading it and felt it was valuable. I’ve heard from students, residents, colleagues, my publisher and a surprising number of people I would have never expected to be interested. It made me realize how large my readership and reach really was.

I’ve heard you. I believe that the time is finally right to start things up again. You may have seen the recent ad that DataTrace placed on PM News about the resurrection of the blog. www.podiatrym.com/pmnews.cfm.  There has been quite a bit happening in the world of antibiotics and antifungals for onychomycosis. After having only one FDA approved antibiotic in 5 years, now we have had 3 new drugs released in just a few months. The antifungal situation is even more exciting. It has been 15 years since any new drug has been approved for the treatment of onychomycosis. In just over a month this summer, two new topical agents were approved and are now being marketed. And, that is just the beginning. The literature continues to contain studies on diabetic foot infections, onychomycosis and osteomyelitis at a seemingly increasing rate. I have become a big fan of My NCBI (www.ncbi.nlm.nih.gov/) a free service that allows you to sign up for alerts to newly published literature using any search terms you wish. For example, every Monday morning I receive weekly emails alerting me to papers on the topics of “foot osteomyelitis”, “diabetic foot infections”, and “onychomycosis”.

Over the next few weeks I hope to cover all of these topics and more. I may experiment a bit with format providing some really brief entries to compliment the longer more in-depth posts that really take some time and effort to sit down and write.

I want to thank all of you who have inquired about the blog and asked me to re-start it. Also, thank you to ALL of my readers. The site had quite a nice sized following in the past and I hope to build it back up and surpass that reach in the near future.

Posted in Antibiotics, Diabetic Foot, Osteomyelitis | No Comments »

News Story About Pharma Industry Payments – Response

March 13th, 2013 by Warren S. Joseph DPM FIDSA
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I am sorry that it has been so long since I put up a post.  Things have been slightly hectic. Unfortunately, instead of reporting on new infectious disease information, with this entry I find myself responding to a story about my receiving payments to lecture from the pharmaceutical industry.  The story ran today (3/13/13) in the Philadelphia Inquirer and online at www.philly.com/philly/health/
20130312_Philly_foot_doc_among_highest_paid_by_Big_Pharma.html

When the original print story was run I had not had a chance to respond to the author, reporter Sam Woods.  I give Mr. Woods credit for updating the online story in response to some of my comments, reproduced below, which I emailed to him this morning.

I feel that the Pharma Industry has done an excellent job in disseminating important information that may otherwise not be available to those of us interested in saving limbs of patients with diabetes.  This is done in an unbiased, government approved and monitored way, under strict federal guidance.  My lectures are randomly, and independently audited for compliance with these guidelines and I have never been found to be deficient.

Here is my response to Mr. Wood in its entirety:

Sam

I read your article from today in Philly.com.  Just to respond to a few items:

1.   I did not call you yesterday since my family was at my father’s deathbed.  We lost him last night at 7PM.  You will probably see the obit in the Inquirer in the next day or so.  I had every intention of contacting you this morning (as I am doing now)

2.  As to responding to ProPublica, they phoned me while I was out of the country lecturing at a continuing education (non Pharma sponsored) meeting.

3.  All of my lectures given for the Pharma industry follow strict FDA guidelines and are consistent with the corporate integrity agreements entered into between the companies and the government.  There is full disclosure of this fact at all lectures.

4.  I have not worked at the Coatesville VA in a number of years.  I strictly work out of Roxborough and am a private, self-employed citizen; not an employee of any company, government, hospital, or health care organization.

5.  Thank you for at least quoting the article from last year.  I stand by what I said there.  Some organizations have an agenda to make interactions between Pharma and doctors somehow seem nefarious.  Let me give you some statistics if you want the REAL story:  There are 28 million people in the US with diabetes.  About 350 million worldwide (and yes, I have lectured around the world on this topic).  It used to be said that someone in the world loses a limb to diabetes every 30 seconds.  That is now down to every 20 seconds.  Diabetes is the cause for about 70-80,000 amputations per year in the US alone.  The single greatest cause. The 5 year mortality of people who present to their doctors for the first time with a diabetic foot ulceration is HIGHER than the 5 year mortality for breast cancer, prostate cancer and Hodgkin’s lymphoma.  If you add peripheral arterial disease to that, the 5 year mortality is even higher than colorectal cancer.  Diabetic foot infection accounts for about 33% of the >$100 BILLION spent on patients with diabetes each year and accounts for the greatest number of hospital days YET the NIH only provides <0.2% of all of their diabetes funding to study foot complications (soon to be presented new data).  The vast majority of research in the treatment of diabetic foot infections has been done by the private sector including the Pharma industry.  Yes, I go out and spread this information to my colleagues and it is often paid for by industry. However, by doing so I know I have saved countless limbs and lives.  Frankly, I don’t see anything nefarious about that…only good.

Kind Regards,

Warren Joseph, DPM, FIDSA

Consultant, Lower Extremity Infectious Diseases

Posted in Diabetic Foot, Infections, Uncategorized | No Comments »

Off Label Drug Promotion…Coming Soon?

December 12th, 2012 by Warren S. Joseph DPM FIDSA
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(I want to thank my friend and colleague Jeff Karr, DPM (www.osteomyelitiscenter.com) for alerting me to this news story.)

Just this past week the U.S. Second Circuit Court of Appeals ruled to prohibit criminal prosecution for truthful off label promotion of drugs as a First Amendment right. An excellent analysis of the case can by the law firm of Morgan, Lewis and Bockius can be found at:  http://www.morganlewis.com/pubs/WhiteCollar_LF_CriminalProsecutionTruthfulOff-LabelPromotion_6dec12.pdf and I direct anyone interested to read this summary.  I will not go into details but, rather, discuss how this may affect antibiotics and lower extremity infections (LEIs). 

The case, United States v. Caronia, was against a drug rep who was taped on two occasions discussing off label use of a drug, Xyrem used for narcolepsy, which is a misdemeanor.  From my interpretation of the referenced information, it appears that the Court decided that since the Food, Drug and Cosmetic Act allows physicians to legally prescribe any licensed drug for any indication, promotion of such use, as long as it was not false or misleading, was a “lawful activity” protected by the First Amendment. 

I will start by saying that I don’t believe that this will open the floodgates for armies of drug reps knocking down doors to speak about unapproved uses.  This will probably have to go higher in the court system with the next step being the Supreme Court.  Furthermore, many of the Big Pharma players are running somewhat scared of the Feds right now having sustained multi- BILLION dollar fines and signing “Corporate Integrity Agreements” with the Government that puts very strict rules in place on what they can, and cannot, do in terms of promotion. 

How does this impact antibiotics and LEIs?  Currently we only have 3 antibiotics FDA approved for the treatment of Diabetic Foot Infection; ertapenem, linezolid and piperacillin/tazobactam.  This may not change in the near future.  Under the current “Acute Bacterial Skin and Skin Structure Infection” (aBSSSI) guidance being followed by the FDA for new antibiotic approval, diabetic foot infection has been SPECIFICALLY EXCLUDED.  Although I am hoping that will change in the near future, without a pathway for approval, I don’t see any antibiotics being tested for this until there is a change in policy at the Agency.  A similar situation exists with osteomyelitis.  Because the FDA does not currently have Guidance for Industry on performing a clinical trial for osteo, no antibiotic has been approved for the indication in close to 20 years.  In the meantime, there have been a number of excellent antibiotics with good clinical data for both DFI and osteo that have not been promoted for lack of indication.  If this current ruling stands I don’t see why a rep couldn’t speak to a doc in a truthful and scientific manner, using published literature, to discuss the possible off-label use of a given drug.  I really feel that all would benefit.  The physician would be getting sound information to which they may not have been aware and the patient would receive evidenced based therapies which may currently be withheld from them over fears of unlabeled use.  To me, this is a no-brainer.  Thoughts?  Comments?

Posted in Antibiotics, Diabetic Foot, Infections, Osteomyelitis | 2 Comments »

What’s New & Interesting in the Infectious Diseases Literature – Summer 2012

August 13th, 2012 by Warren S. Joseph DPM FIDSA
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I confess…I have been a bit lackadaisical in my scanning through the journals I receive each month.  This point was driven home to me yesterday when I went to find room on my desk to put some work and realized it was totally covered with stacks of journal back issues I had put aside with all good intentions to eventually read through!  It was time to start clearing my desk with the side benefit of realizing I could probably come up with some interesting articles to blog about.  Well, I did.  In fact, I think I have enough for a few upcoming posts.

Those of you who have heard me lecture on MRSA know that I am not a big fan of the use of trimethoprim/sulfamethoxazole for the treatment of even mild outpatient infections.  My main objection has been increased toxicity of this drug vs. other options including; Stevens-Johnson syndrome, renal toxicity, allergies, drug-drug interactions, etc.   However, I have also questioned the evidence supporting its use and have frequently stated that we don’t even know the proper dosing!  Most clinicians use this drug at the “standard” dose of 1 DS tablet bid (160mg/800mg).  However, some authorities have argued that that dose is too low for MRSA and an increased dose of 2 DS tabs bid should be used.  This has always concerned me because of the potential risk for increased adverse events with the higher dose.  A study published in the December 2011 (I told you I was behind on my reading!) Clinical Infectious Diseases by Cadena and colleagues compared the two dosing regimens and found no difference in outcomes with those treated with the higher dose vs. those treated with the lower “standard” dose (http://www.ncbi.nlm.nih.gov/pubmed?term=Cadena%20J%20AND%20trimethoprim). There was no difference in patient and infection characteristics or in clinical response; 73% (n=121) high dose vs. 75% (n=170) low dose P = 0.79.  Although they did not specifically look at the number of adverse events in each group they do comment that none were found with either group “…although one might anticipate a higher rate of adverse events in those who received the higher dose”.   None of this has changed my mind.  I still prefer doxycycline or minocycline to the use of TMP/SMX although I do see situations where this drug would be useful.

Another huge area of debate on which I have commented a number of time both here in the blog and when I speak on the topic, is this concept of increasing vancomycin dosing to keep trough levels between 15-20 mg/ml.  I fall strongly on the side that this is not only unnecessary for all skin and skin structure infections (it may be necessary for blood stream or pneumonia but that is outside my scope) but is also extremely dangerous.  I do not think that it improves outcomes and not only believe, but have seen, increased cases of nephrotoxicity (aka “Acute Kidney Injury or AKI” in current parlance).   For a more thorough discussion on my reasoning, just search this site for the term “vancomycin” and you can see my posts on the matter.  I always like seeing new papers that support my opinion on something!  In the December 2011 issue of Antimicrobial Agents and Chemotherapy (AAC), Bosso and colleagues prospectively assessed nephrotoxicity in relation to trough concentrations in patients with MRSA treated with vancomycin.  (http://www.ncbi.nlm.nih.gov/pubmed/21947388)    They found that “Nephrotoxicity was observed for 42 patients (29.6%) with trough concentrations >15 mg/ml and for 13 (8.9%) with trough concentrations ≤15 mg/ml.” They concluded that the increased trough concentrations were associated with 3-fold increased risk of nephrotoxicity.  I have to ask…when will this nonsense stop?!  The entire concept of increasing doses of vancomycin is based on a pharmacodynamic model known as the AUC/MIC ratio.  There is essentially no evidence to show that it increases efficacy of vancomycin for the infections we treat in the lower extremity but it IS more toxic.  Yet, I frequently hear of clinicians and clinical pharmacists pushing for this higher dosing even in skin and skin structure infections – a dosing, by the way, NOT supported by the IDSA MRSA Guidelines. If you feel you need to push vanco this high, then consider alternative agents such as linezolid, daptomycin or ceftaroline.

To change tone completely, I was recently giving some lectures in Florida. I spoke in Miami, Ft. Lauderdale, Hialeah and Lakeland.  Nothing like the heat and humidity of August in the Sunshine State to make me appreciate the heat and relative dryness (I can’t believe I am saying that) of August in Philadelphia! Little did I know that my visit may have put me at risk for exposure to extended spectrum beta-lactamase (ESBLs).  The May 2012 issue of AAC contains an article by Poirel and colleagues “Wild coastline birds as reservoirs of broad spectrum β lactamase producing Enterobacteriaceae in Miami Beach, Florida” (http://www.ncbi.nlm.nih.gov/pubmed/22314536). The investigators collected 53 fecal samples of wild seagulls and 10 specimens from pelicans.  A total of 10 Enterobacteriaceae isolates containing ESBLs were obtained from 8 (14%) specimens.  They go on to discuss the exact phenotypes and the cross-resistance between various antibiotics.   They conclude that “…beaches may play a significant role for dissemination of various resistance determinants and may be a source of (ESBL) community acquired infections.”  I could make some light of this and compare this report to what the movie Jaws did to destroy beach towns back in the 1970s, but I will show restraint.  This is actually a serious issue.  Multi-drug resistant gram negative rods are, in my opinion, the organisms of the future.   Unlike MRSA where we have a number of different viable antibiotic choices, we have precious few resources to use against these organisms.  To see that they can be found in bird droppings at one of the top beach destinations in the World only adds to the urgency that more be done to fight these bugs. 

That is all for now.  As promised, I still have plenty left

Posted in Antibiotics, Diabetic Foot, Infection control, Infections, MRSA, Wounds | No Comments »

Radio Interview About Diabetic Foot Infections and SALSAL

July 17th, 2012 by Warren S. Joseph DPM FIDSA
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This past Sunday, July 15, I had the pleasure of participating in a radio interview on WOKV, Jacksonville, FL, the largest, most listened to talk radio station in Northern Florida. Here is the link to the audiostream:

http://wokv.media.streamtheworld.com/audio/save_leg_save_101730761.mp3

The show was hosted by Desmond Bell, DPM.  Des, a former student “done good”, is the Executive Director of the Save a Leg, Save a Life Foundation  http://savealegsavealife.org/ or SALSAL. From its modest beginnings as a way for Des and his wife De Anna, a nurse practitioner and wound specialist, to get local providers in the Jacksonville area up to speed in the area of wound care, SALSAL has grown into a nationwide organization with at least 30 local chapters spread throughout the US.  As I mention in the interview, the scope of the organization did not really hit me until I was giving a dinner lecture to the local chapter in Seattle a few months back and over 70 health care providers of all specialties attended.  I have seen this organization grow from its first small meeting in Jacksonville, where I don’t think there even were 70 attendees, to a significant national “player” in the area of limb salvage.  Congrats to Des and De Anna.

In the interview, which was part of the weekly hour long show Des now hosts, we discussed; why diabetic feet become infected, what patients should look for when examining their feet, my thoughts on routinely soaking and the problems with MRSA and antibiotic resistance. Although my comments were directed to a “lay” audience, I felt that readers of this site might just be interested in the discussion we had. I really feel that this sort of outreach to the general public can only be helpful in promoting the message of proper foot care in patients with diabetes and driving patients to their health care provider before it becomes too late to save a leg, save a life.

Posted in Diabetic Foot, Infections, MRSA | No Comments »

New 2012 IDSA Diabetic Foot Infection Guidelines

May 22nd, 2012 by Warren S. Joseph DPM FIDSA
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As promised, I would post a link to the newly revised, updated IDSA DFI Guidelines as soon as they were available.  Well, I am honored, proud and excited to be able to let my readership know that after about 6 years in writing, multiple levels of peer review and well over 60 individual review comments, that the newly revised guidelines have been posted by IDSA on their website. Here is the link:    http://www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_Care/PDF_Library/2012%20Diabetic%20Foot%20Infections%20Guideline.pdf

Those of you familiar with the 2004 document will immediately notice the changes.  All IDSA Guidelines are now standardized to a “question, recommendation, evidence summary” format.  Each committee is assigned to determine which are the most critical questions that need to be answered.  In this case, we came up with 10 questions that cover everything from diagnosis to antibiotics, to osteomyelitis and wound care.  There are 44 evidenced based recommendations that  guide the clinician in the answers to those 10 questions.  The evidence is then summarized and graded by the British Medical Journal “GRADE” system.  This common sense approach matches the strength of the recommendation with the level of the evidence.  This is given in plain English.  For example “Strong, Low” means that there is a strong recommendation but a relatively low level of evidence on which the decision has been based.

I hope that you all find the new Guidelines helpful in your management of these patients.  I look forward to your comments

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