New Year, New You!

newyearsresolutions

So, I have conversations about diet, exercise and weight loss every day in my practice. But it seems that sometime around Jan 1, those conversations are more often started by my patients.  We are moving from the indulgent end of the year holiday season, to the fresh start of a new year.  So it seems natural to try to start fresh- live healthier, better, richer…

Well, maybe not richer. But there are a lot of people getting richer of our desires to look and feel healthier. So there are a lot of theories about how we got her, and promises to do this one thing, cut out this, take this pill, and turn your life around. Face it, a quick fix seems pretty damn appealing to all of us.  And I am in the pill pushing business. A big part of my job is to prescribe medicines.  So with all of these conversations about losing weight, medicine is a frequent question.

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So today, I’m going to build on a recent morning report lecture on obesity to focus on medical treatments for obesity.  We’ll talk about old, new, tried and true and up and coming.  I’ll try to highlight the evidence base for these so that you can discuss in an informed way with your patients.

I also want to start with a disclosure.. I almost never prescribe medicine for weight loss. My bias (and I’ll argue, the evidence) is that these are generally not that helpful, and almost always patients gain back weight, plus more, once they stop taking them.  The studies that got these medicines approved were always coupled with a solid diet and exercise plan, and I think that most of the weight loss comes from that activity, NOT from the medicine.

peptobismol3Orlistat

Orlistat inhibits pancreatic lipases, so less fat is absorbed in digestion. In studies, patients on orlistat lost 5-10kg (compared to 3-6kg with diet/exercise alone). It also has been shown to lower blood pressure, and LDL levels more than would be expected by the weight loss alone.  It is safe, as most of it remains un-absorbed. However, the main side effects are GI related: bloating, nausea, and diarrhea. These are generally pretty limiting, and I haven’t found many patients willing to even try orlistat after hearing these effects. However, if patients can stick to a low-fat diet, the effects can be minimized.

 

Phentermine

Phentermine is a stimulant that suppresses appetite. It is the oldest of the approved medicines for weight loss, and also one of the cheapest. It is approved for 12 weeks of therapy, so most studies are of short duration only.  Studies show around 7kg of weight loss. Side effects include hypertension, tachycardia, anxiety, insomnia- in my experience these are pretty limiting.

There is a new medicine that combines phentermine with topiramate, Qsymia. The phentermine dose is lower than if prescribed separately, and it is approved for longer term use.  The initial trial for this Rx showed patients lost 8-10 kg in the first year, and could maintain weight loss if they continued for another year. Only about 60% of patients took the Rx for the whole first year.

Topiramate

So what about just Topiramate itself? Currently topiramate is approved for treatment of epilepsy and migraine. Using it for weight loss is off label- so beware. However, it has been studied, and patients lost about 4kg over 6 months in the various trials.

Lorcaserin

Lorcaserin (Belviq) is a serotonin receptor agonist, and thus serves as an appetite suppressant. A few other serotonin agonists have been tried over the years- fenfluramine- and lead to cardiac valve disease. Lorcaserin is more specific to the 2C receptor, which should minimize cardiovascular effect. In trials, more patients on lorcaserin lost at least 5% of their body weight (mean 5kg). There were also decreases in BP, HR, LDL, CRP, and glucose. All of the trials had dropout rates close to 50%.  Side effects include headache, nausea, URI sx, and back pain.

 

Diabetes Drugs: 

Liraglutide (Victoza, Saxenda- same Rx, two brand names) is the one drug in this group with an indication for weight loss. In patients without diabetes, trials showed around 7kg of weight loss, and in one trial, patients who lost weight pre medicine were more likely to maintain the weight loss if on liraglutide. Side effects include diabetesnausea/vomiting/diarrhea and rarely, pancreatitis.

Metformin Old drug, lots of data on weight loss, but still no indication for obesity treatment. Why? Patients don’t tend to lose a lot of weight with metformin- about 2kg.  But what different with metformin, is that there is long-term data that showed that patients could maintain that weight loss as long as they stayed on the Rx.  And it decreases incidence of diabetes in these people as well. Certainly something to consider in obese patients with pre-diabetes or otherwise at high risk.

Bupropion

Another off label use here, but post marking data did show a tendency toward weight loss in patients on bupropion. Remember, this drug increases norepinephrine effect, so likely has some sympathomimetic benefits. In one short (6 month) trial, patients on bupropion lost 7-10% of their body weight (compared to 5% lost on placebo).

There is a brand new combo drug that uses Naltrexone and Bupropion (Contrave). Patients got about 5% weight loss over a longer study (56 weeks), but only about half of the patients were able to complete the study. Nausea, headache, and constipation were common side effects. There is also a cardiovascular concern that is being actively monitored in the post-marketing period.

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Big Picture

Diet and exercise are the key- slow and steady wins the race. There may be some small incremental gains with the medicines above, but I think that the evidence is thin, there are clear side effects, and the risks are not always understood. Given the millions of Americans that could end up on these medicines, I’d prefer to hang back and wait for the fallout before becoming an early prescriber of any of these.

Managing Sexual Assualt in Primary Care

Thanks to those who participated in a great discussion in AMR last week. I wanted to share some of what we talked about here…

Sexual assault is an unusal complaint inside of a primary care clinic.  Many victims head straight for the ER or a Rape Crisis Center, others never report their attack. But for many, their primary care doctor may seem like a trusted source for health care in a very scary and chaotic situation. Since it is also a scary and chaotic situation for the provider, I thought that an organized process may help you know what to do in such a scenario.


Legal Issues

The patient may need or want an exam in order to collect evidence for future charges against an attacker. There is a very specialized process that is used to collect evidence, and maintain the chain of custody.  I would recommend that you contact your Emergency Dept or Rape Crisis Center for help.  In Birmingham, the Crisis Center offers Sexual Assault Nurse Examiner (SANE) Exams in a safe and secure facility, and may be a more comfortable alternative to an ED.  They have a SANE nurse on call 24/7. Many times, this exam must be done within 72 hours of the attack.

Pregnancy Prevention

Most women should be offered post-coital contraception after a sexual assault.  The most effective oral option is Le
vonorgestrel, (Plan B is one brand name).  Ulipristal (Ella) is a newer form of emergency contraception that is effective up to 120 hours after unprotected sex.

 

STI Prevention

The CDC recommends antibiotic prophylaxis for GC, Chlamydia, and Trichomonas.  If your patient declines, you should see her back in a week for testing.  You need to give (all single dose therapies):

  • Ceftriaxone 250mg IM for Gonorrhea
  • Azithromycin 1g PO for Chlamydia
  • Metronidazole 2g PO for Trichomonas

Hepatitis B Prevention

If the Hepatitis B status of the attacker is not known, and the victim is not already immune, the victim should receive the Hepatitis B vaccine on first visit, and then at 1 and 6 months.  If the attacker has Hepatitis B, then you should offer HBIG.

HIV Prevention

There is some data that post-exposure prophylaxis with antiretroviral drugs prevents HIV transmission. Most of this data is in the healthcare setting, when folks like us are exposed with needles. The studies done in sexual exposure and IV drug users are all small and observational. Side effects with these medicines are fairly common, and usually of the GI variety.

Given limited data, and relatively low risk of transmission for a single sexual exposure (0.1% for consensual vaginal intercourse and 2% for consensual anal intercourse- transmission rates with nonconsensual sex are likely to be higher), the CDC only recommends post exposure prophylaxis (PEP) if:

  • The assailant is known to be HIV positive
  • The victim presents within 72 hours
  • There was exposure OF: eye, mouth, vaginal, rectum, other mucus membrane or nonintact skin
  • WITH: semen, vaginal fluid, blood, rectal secretions, milk, or other bodily fluids that are known to transmit HIV.

However, they do give you an option to treat other patients on a case-by-case basis. Many experts recommend that PEP is offered to all victims of sexual assault that present in the first 72 hours and have a chance at HIV exposure.  If you were going to prescribe, it should start within 72 hours (the earlier the better), and continue for 4 weeks. Three drug combinations are usually used, the same as in occupational HIV PEP.

  • Tenofovir/emtricitabine 300/200 plus Dolutegravir 50mg once daily
  • Tenofovir/emtricitabine 300/200 plus Raltegravir 400mg twice daily

Psychologic Support

Probably the most important thing that you can do. Your patient came to use because you were trusted, available, and supportive. You need to continue to be those things. After an assault, many victims will struggle with nightmares, anorexia, guilt, anxiety, and PTSD.  As a primary care doctor, you can gently ask about these issues, and guide your patients to helpful therapies and supportive environments. Again, rely on your local resources for crisis counseling and psychiatry, in addition to using all of your own talents.

Here is a NEJM article (subscription needed) if you are interested in reading more: NEngl J Med 2011; 365:834-841.

Pneumonia Shots- Part 2: Immunocompromised Adults

Welcome back to Part 2 of the great Prevnar vs Pneumovax Update here at I Hate Rashes.

Last time, I talked about the differences between the two vaccines and the current recommendations for adults >65.  To recap, Pneumovax is a polysaccharide vaccine that covers 23 serotypes of S. Pneumoniae (PPSV23).  This is great because it is so broad.  Prevnar is a Conjugate polysaccharide vaccine that covers 13 serotypes (PCV13).  This is great because conjugating the pneumococcal polysaccharide to a diphtheria toxin boosts immunity and helps lead to herd immunity.  ACIP currently recommends that we give both PCV13 and PPSV 23 to our patients over 65. It is probably best to give PCV 13 first if the patient hasn’t had any pneumococcal vaccines. 
But what about all of those adults who get the pneumococcal vaccine BEFORE age 65? What should we do with them?  It is probably helpful to divide our recommendations between the immunocompetent vs immunocompromised conditions.

Those who are immunocompromised actually have long been recommended to get both PCV13 and PPSV23. This includes patients with asplenia, CSF leaks,  cochlear implants, HIV and other immunodeficiencies, nephrotic syndrome, leukemia/lymphoma, myeloma, transplants, and iatrogenic immunosuppression.  Iatrogenic immunosuppression includes chronic steroids, radiation therapy, and probably immunomodulators used in rheumatologic diseases. Most of these will need revaccination with PPSV23 5 years after their first vaccine: there is no need to revaccinate with the PCV13.

The immunocompetent patients continue to get just the PPSV23 prior to age 65.  This is for our patients with diabetes, COPD/Asthma/smoking, chronic heart disease, and chronic liver disease/alcoholism.  Once they turn 65, give them PCV13 and then repeat the PPSV23 about a year later.

Here’s a handy chart if you are more of a visual learner.

Risk group

Underlying medical condition

PCV13

PPSV23

Recommended

Recommended

Revaccination 5 yrs after first dose

Immunocompetent persons

Chronic heart disease

Chronic lung disease§

Diabetes mellitus

Cerebrospinal fluid leak

Cochlear implant

Alcoholism

Chronic liver disease, cirrhosis

Cigarette smoking

Persons with functional or anatomic asplenia

Sickle cell disease/other hemoglobinopathy

Congenital or acquired asplenia

Immunocompromised persons

Congenital or acquired immunodeficiency

Human immunodeficiency virus infection

Chronic renal failure

Nephrotic syndrome

Leukemia

Lymphoma

Hodgkin disease

Generalized malignancy

Iatrogenic immunosuppression**

Solid organ transplant

Multiple myeloma

Let’s practice some more:  For each patient, do you give PCV13 vs PPSV2, or both

  1. 55 newly diagnosed diabetic
  2. 60 year old with COPD, never had pneumococcal vaccine before
  3. 62 year old with COPD, had PPSV23 3 years ago, takes prednisone 5mg daily.
  4. 25 year old with coclear implants, never had pneumococcal vaccine before
  5. 35 year old with well controlled HIV, never had PCV13, had PPSV23 10 years ago, at diagnosis.

Let me know your answers or questions in the comments!

Here’s a link to the CDCs Adult Vaccine Schedule- note the new guideline for adults age 65 and over is not included here, yet.  There’s also an app for that.