Tag Archives: Functional Medicine

Newer Injectable Medications for Chronic Weight Management

      Newer Injectable Medications for Type II Diabetes or Chronic Weight Management

By Cathy Rosenbaum, PharmD MBA RPh CHC CDP CFNC

The American Medical Association (AMA) officially recognizes type II diabetes mellitus and obesity as complex chronic diseases that require a multifactorial range of treatment and prevention options.

Obesity can be caused by a combination of changes in the environment (family eating habits, lifestyle choices, behaviors), genes/metabolism, and stress and is oftentimes associated with depression in women (Pratt and Brody 2014).

As a certified health coach and certified fitness nutrition coach, I have been helping clients with their chronic weight management journey for many years.  Regarding treatment interventions, use of the prescription phentermine is decreasing due to its side effect profile of increased heart rate, blood pressure, and nervousness. Dietary supplement and OTC medication usage has also decreased due to lack of efficacy.  By comparison, newer injectable prescription medications have dramatically increased in popularity and I’m monitoring their place in weight management therapy.

The two types of injectable medications for weight management are called glucagon-like peptide-1 (GLP-1) receptor agonists or glucose-dependent insulinotropic polypeptide (GIP) receptor agonists.  Consumer demand is causing intermittent supply disruptions and drug shortages for patients needing the FDA-approved indication of type II diabetic management.

Injectable GLP-1 and GIP Receptor Agonists

For perspective, GLP-1 is a hormone produced in the intestine that interacts with our hunger hormones. GLP-1 receptor agonists decrease appetite by slowing gastric emptying and increasing satiety after eating. They increase the pancreas’s production of insulin when glucose levels are high.

GIP is another hormone released from the small intestine. GIP receptor agonists reduce secretion of stomach acid and increase insulin sensitivity to control blood sugar after meal ingestion.

GLP-1 and GIP receptor agonists are combined in the injectable prescription medication, Mounjaro (tirzepatide) that is FDA approved for type II diabetes mellitus but not FDA approved for chronic weight management (e.g., off-label use).

Victoza (liraglutide) is FDA approved to treat type II diabetes mellitus, Saxenda (liraglutide) is FDA approved for chronic weight management in a different dosage regimen.

Ozempic (semaglutide) is FDA-approved for type II diabetes mellitus, and Wegovy (semaglutide) is approved for chronic weight management in a different dosage regimen.

Injectables are covered by insurance for type II diabetics but may not be covered for the weight management indication (cost ~$1000-$1200/month).

 

Generic Drug Name FDA Approved Type II Anti-Diabetic Drug/Brand Name Chronic Weight Management in Adults with or without Type II Diabetes Drug/Brand Name Comments
Semaglutide Ozempic (SQ)

 

Rybelsus (Oral)

Wegovy* – inject SQ once weekly GLP-1 receptor agonist

 

Is now FDA approved for chronic weight management in children > 12 years old who meet criteria.

Liraglutide Victoza Saxenda* – inject SQ once daily GLP-1 receptor agonist
Tirzepatide Mounjaro No different brand name yet, since it’s not yet FDA approved for this indication- inject SQ once weekly. Combination GLP-1 receptor agonist and GIP receptor agonist

GLP-1 receptor agonist side effects:

  • Nausea & vomiting
  • Diarrhea
  • Constipation & abdominal pain
  • “Ozempic face”

GIP receptor agonist side effect: Anti-emetic (good in combination with GLP-1 receptor agonists that can cause nausea)

Contraindications: Injectable GLP-1 receptor agonists and GIP receptor agonists are contraindicated in pregnancy and with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

GLP-1 receptor agonists carry a boxed warning about a risk of thyroid C-cell tumors (based on animal data, no corresponding human data).

Length of Therapy for Weight Management

Chronic diseases like obesity may require long-term treatment. The FDA has approved subcutaneous Saxenda and subcutaneous Wegovy for long-term weight management.

Please remember to only use chronic weight management medications after all other options have been exhausted and then only as an adjunct to healthy diet and regular exercise routine. It has been reported that once these medications are discontinued, weight comes back even more than before medication use.

Your health care provider will create a plan tailored to your weight-management goals. You’ll need to visit your health care provider 4 months after you begin taking Saxenda or Wegovy to review your progress and renew your prescription if appropriate.

Dietary Supplements Touted for Chronic Weight Management

In 2015 the NIH Health Office of Dietary Supplements reviewed 19 ingredients in dietary supplements touted for chronic weight management.  None demonstrated significant beneficial effects on weight management or change in body composition.

Product Alleged Pharmacology (Animal/Lab Studies) Side Effects Comments
GTF Chromium May promote glucose utilization and increased sensitivity of insulin receptors Vertigo, N&V Essential trace mineral.

 

Found in broccoli, whole wheat and rye breads, grape juice, potatoes, turkey breast, apples with peels, green beans, bananas, romaine lettuce)

Green Tea Extract –

 

Camellia sinensis

 

Caffeine may stimulate body’s metabolism Anxiety, irritability, insomnia Caffeine, active

 

Catechins (flavonoids) are antioxidants (general health)

 

Vanadium (vanadyl sulfate – oxidative form) May improve insulin sensitivity and glucose uptake Abdominal discomfort, diarrhea, gas, loss of energy Trace mineral.

 

Found in pepper, dill, radishes

Raspberry Ketones May stimulate the hormone adiponectin, an enhancer of fatty acid oxidation, glucose regulation Jitteriness, increased heart rate, increased blood pressure Found in red raspberries, kiwifruit, peaches, and apples
Green Coffee Bean Extract Possible inhibition of the enzyme glucose-6-phosphatase

 

In vitro, glucose-6-phosphatase induces glucose production in the liver

Increased heart rate, increased blood pressure Chlorogenic acid (antioxidant)

 

Caffeine, active

Garcinia Cambogia May reduce synthesis of fatty acids and glycogen storage via inhibition of ATP citrate lyase Liver toxicity, long term in higher dose (case studies) Hydrocitric acid, active

Holistic Weight Loss Strategy

Any successful chronic weight management program is first and foremost dedicated comprehensive, healthy lifestyle choices (e.g., walking, exercise, stress management, socialization, sleep hygiene, spiritual health, other healthy food choices and portions).

The initial recommendation for safe weight loss is 5%-10% of body weight over six months to reduce risk of developing type II diabetes mellitus, high cholesterol, and high blood pressure.  This translates into a decrease in daily calorie intake by ~500 below daily energy needs (e.g., 1-2 pounds/week). A greater rate of weight loss does not yield better long-term results.

Evidence-based dietary guidelines (U.S. Department of Agriculture 2015-2020) have given us www.choosemyplate.gov for proper portion control and recommend dividing one’s plate into 4 quarters (1/2 for fruits and veggies, ¼ for lean protein, and ¼ with whole grains, plus milk or calcium-rich foods for bone health).  The Mediterranean Diet is the world’s gold standard for plant-based nutrition.

How to Eat Mindfully (National Society of Health Coaches)

  • Set a mealtime S.M.A.R.T. satisfaction goal with a health coach
  • Create your personal ‘I’m done eating’ signal
  • Sit down to eat and minimize outside distractions with a focus on the present
  • Be mindful of your hunger and fullness level before, during, and after eating
  • Create several mindful pauses before, during and after eating
  • Express mindful attitudes of self-compassion, non-judgment, kindness, patience, joy, and thanksgiving regarding food intake

Take Home Message

  • Physicians and CNP’s with prescribing privileges should be aware of national injectable chronic weight management/type II diabetes mellitus treatment medication supply shortages
  • All medications and dietary supplements can have side effects, and some interact so they are ideally be managed by talking with a pharmacist
  • Work with a health coach to assess your readiness to change and your commitment to change and personal values about taking medications before embarking on a weight loss program
  • Purchase and use a fitness wearable to track steps, calories burned, heart rate, REM sleep
  • Weight yourself once a week; regularly exercise with a routine approved by your physician and guided by a trainer
  • Measure your waistline at least once a month (high risk of developing chronic condition if > 35 inches for women and >40 inches for men)

References

  1.   Reducing risk of obesity: defining the role of weight loss drugs.  Pharmacotherapy 2013:
  2. The safety and effectiveness of natural supplements for weight loss in populations with obesity: a critical review of the literature from 2006 to 2016.  Crit Rev Food Sci Nutri 2019:
  3. Obesity therapy: How and why? Curr Med Chem 2019:26:1-12.
  4. The Medical Letter on Drugs and Therapeutics Volume 64, Issue 1651, May 30, 2022.
  5. The Medical Letter on Drugs and Therapeutics Volume 65, Issue 1670, February 20, 2023.

Functional Medicine Pharmacists Alliance Membership

I am pleased to announce that I am a new member in the Functional Medicine Pharmacists Alliance (FMPHA).  Membership allows me to incorporate key FM principles and comprehensive FM tools into my client ‘root cause’ health & wellness evaluations as well as subsequent health recommendations for more sustainable, positive patient outcomes.

As a Certified Fitness Nutrition Coach, Certified Health Coach, and FM Pharmacist, I emphasize the importance of incorporating ‘food as medicine’ nutrition along with lifestyle modifications into any health change regimen.

As a Holistic Clinical Pharmacist, I may refer clients to other healthcare providers for optimal whole-person healing (e.g., acupuncture, guided imagery, aromatherapy, music therapy, and FM or Traditional, Integrative & Complementary Medicine physicians).

For information, to refer a client, or to schedule an in-person/Zoom virtual health & wellness evaluation, please visit www.rxintegrativesolutions.com or contact me at [email protected]

 

Dr. Cathy’s Speaker’s Bureau

This is a short list of topics that Dr. Cathy, a Holistic Clinical Pharmacist, from Rx Integrative Solutions, offers to communities, corporations, support groups, and workshops upon request.  Please email her at [email protected] for more information, course descriptions, or to schedule an event.

  • The A to Zzz’s of Sleep Health
  • Memory Health: Even Elephants Forget Sometimes
  • Bottled Water: What You Don’t Know May Harm You
  • FDA and PhRMA: dance Partners or Double-Edged Swords?
  • Caregiving: From Compassion Fatigue to Compassion Satisfaction
  • Homegrown Medicinal Herbal Teas
  • Debunking Myths About Dietary Supplements
  • Hemp Cannabinoids: The Healthcare Professional’s Perspective
  • Antioxidants, Multivitamins, and Health: Insurnace Policies to Healing?
  • Managing Polypharmacy in Seniors
  • The Eight-Balance Point Model for Integrative Health and Healing
  • Integrative Health & Wellness Trends 2023-2028
  • Managing Stress: Holistic Interventions, Health Coaching
  • Functional Medicine
  • Primer of Integrative Health & Wellness Systems (TCM, Ayurveda, Naturopathy)
  • Let’s Have Some Applause for Menopause

 

Is Functional Medicine Another Holistic Practice?

The short answer is, ‘Absolutely. Yes!’  In the 1970’s Jeff Bland PhD FACN FACB CNS, former Professor of Chemistry at the University of Puget Sound in Washington state, started his work in Functional Medicine (FM).  Ten years later Dr. Bland began teaching practitioners how to implement preventive nutritional medicine in their professional practices.  FM, like many health practices, spotlights whole-food nutrition as a cornerstone of healing.

The Institute for Functional Medicine was launched in 1991, with Dr. Bland as the Co-Founder.  The organization offers a FM Certification Program for physicians and health care professionals holding at least a Masters’ degree and licensure in their fields.

In 2014, the Cleveland Clinic established The Center for Functional Medicine with the Functioning for Life™ 10-Week Program where patients can select from a disease-specific series of options to meet their individual functional health needs.  Please visit https://my.clevelandclinic.org/departments/functional-medicine for more information.

FM is a proactive, personalized care approach that incorporates three distinct paths into a patient’s health assessment/history, namely natural medicine, molecular medicine, and systems biology.  FM health practitioners are MDs, DOs, DCs, CNPs, and PharmDs, among others.  The University of Western States offers a degree in Human Nutrition and Functional Medicine (see https://www.uws.edu/human-nutrition-functional-medicine/ ).

FM practice attempts to address the underlying root cause of disease rather than just symptoms and symptom management.  FM is based on the principle that a diagnosis can be the result of more than one cause, or one cause (e.g., inflammation) may lead to multiple diagnoses over time.  The primary FM outcome goal is for a patient to modify as many lifestyle choices as necessary to address the root cause of their issues and to prevent illness as much as possible.

Typical laboratory blood tests ordered by FM practitioners to help assess patterns of imbalance may include, but are not limited to, the following biomarkers:

  • Nutrient deficiencies (e.g., blood or genetic test)
  • Immune and inflammation
  • Digestive
  • Oxidation
  • Neurotransmitters
  • Hormones
  • Toxicity (e.g., heavy metals)

 

The FM physician will assess your medical and surgical history, home/life environment, lifestyle choices, possibly your genetics, and how any/each may be influencing your symptoms.  An individual FM intervention/treatment plan will be built around your whole-person health needs.

By comparison to Integrative Health and Medicine (IHM), FM embraces much of the philosophy of IHM, while adding a biologic systems-oriented approach to proactive patient care.  Comprehensive IHM involves traditional medicine health care plus complementary, holistic, mind body spirit interventions that may include other IHM practitioners on the health team.

Your physician’s IHM care recommendations may include meditation/stress management, acupuncture, Yoga, massage, dietary supplements, nutrition education, exercise, and lifestyle changes to improve your health.  For more information about IHM, visit the American Board of Integrative Medicine @ https://www.abpsus.org/aboim/ or the Andrew Weil Center for Integrative Medicine in Tucson AZ @ https://integrativemedicine.arizona.edu/ .

For perspective, the American Academy of Family Physicians does not embrace FM principles in their entirety.  Regardless of your preference for FM or IHM, it is important to enlist a trained licensed physician as your gatekeeper to coordinate your health team.

Check with your insurance carrier to see if FM office visits and laboratory tests are covered by your insurance carrier.  Several FM practitioners are located within the Greater Cincinnati Northern Kentucky area from which to choose.  Holistic pharmacists are becoming more involved in FM practices in the areas of nutrition coaching and pharmacogenomics/nutrigenomic testing throughout the country.  For more information visit https://wwwifm.org/find-a-practitioner .  For more information on FM research, visit www.clinicaltrials.gov.