Category: medications

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Review of Insulin Fiasp

Fiasp® (insulin aspart; Novo Nordisk)

Is the first of the next generation of faster-acting mealtime insulin analogues.

How does Fiasp differ from other fast-acting mealtime insulins?

Fast-acting analogues include:

  1. Humalog® (insulin lispro; Lilly)
  2. NovoLog® (insulin aspart; Novo Nordisk)
  3. Apidra® (insulin glulisin; Admelog® (insulin lispro, Lilly)

This next generation insulin, resulted in a more rapid appearance of insulin in the blood after injection and a better coverage of the mealtime excursion in glucose that is associated with Type 1 Diabetes, resulting in fewer peaks and troughs in insulin levels 3–4 hours from injection of the insulin at mealtime.

After the development of continuous glucose monitoring (CGM) systems, we discovered that these fast-acting mealtime insulins were still too slow and that peaks and troughs in glucose levels still occur after meals. We discovered that these insulins should ideally be injected not immediately before meals but 10–20 minutes before the meal.

However, this is not convenient for patients before breakfast when trying to get ready and even before some of the other meals. Many patients inject during their meal or even after the meal if there is uncertainty about what patients will eat (for example children and elderly patients). Hence Industry has been working on extra-fast insulins.

These have altered the excipients in which the insulin aspart is solubilized. They have added L-arginine and vitamin B, two natural agents that are approved by the European Medicines Agency and the US Food and Drug Administration. These facilitate the rapid movement of insulin through the capillaries into the blood. The pharmacokinetic profiles show 5-minute shift to the left.  Fiasp is also 2.5-minute absorption into the blood stream. This will have a great impact on the quality of life of our patients as it will allow them to inject insulin at a time closer to the meal and will better cover glucose excursions.

Insurance coverage

For information go to: https://www.fiasppro.com/getting-patients-started/savings-and-coverage.html#

Are there any limitations of Fiasp?

Studies have compared injections of Fiasp immediately before a meal with insulin aspart and found that Fiasp gives smaller glucose excursions as well as a small but statistically significant difference (around 0.1%) in glycated hemoglobin (HbA1c) after 6 months and 1 year. We have also demonstrated that injection of Fiasp within 20 minutes after starting a meal gives the same effect as if it was injected before the meal. This is useful if people forget their injections or if it is not possible to predict what a patient will eat.

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Deprescribing

As part of the medication review, pharmacist should also be assessing patients for polypharmacy. While polypharmacy is often associated with the elderly, it can also be found in younger patients with multiple comorbidities, sick children, low literacy patients and patients with diminished capacity. Address polypharmacy by deprescribing.
Deprescribing is the process of identifying and stopping medications that are unnecessary, ineffective, and/or inappropriate. Reducing polypharmacy improves health outcomes. Deprescribing is a process that weighs the benefits vs. harms of medications. This process considers patient’s care goals, current level of functioning, life expectancy, values, and preferences.

Polypharmacy is associated with multiple medications, four or more. Negative consequences include:

• an increased risk for adverse drug events (ADEs)
• drug-drug and drug-disease interactions
• reduced functional capacity
• multiple geriatric syndromes
• medication non-adherence
• increased mortality
• Polypharmacy also contributes to increased health care costs for both the patient and the health care system
Polypharmacy often results from prescribing cascades, which occur when an adverse drug effect is misinterpreted as a new medical problem, leading to the prescribing of more medication to treat the initial drug induced symptom.

Safe and Effective deprescribing strategies

Deprescribing process constitutes:

Starting the deprescribing process:

1. Review all current medications: include prescription, over the-counter (OTC), and complementary/alternative medicine (CAM) agents.
a. Consider the potential benefits and harms of each medication.
b. Assess whether the patient is taking all medications prescribed
c. identify any reasons for missed pills (e.g. adverse effects, dosing regimens, understanding, cognitive issues).

2. Talk about stopping some medications with the patient:
a. risks and benefits of deprescribing
b. prioritize which medications to address in the process. Prioritize the medications by balancing patient preferences known benefit.
c. Stop medications lacking evidence supporting the benefits
d. consider known or suspected adverse effects
e. consider decreasing pill burden
f. consider the patient’s preferences and goals of care
g. remaining life expectancy
h. time until drug benefit is obtained
i. length of drug benefit after discontinuation.

3. Deprescribe: when tapering a medication develop a schedule in partnership with the patient. Stop one medication at a time and monitor for withdrawal symptoms or for the return of a condition.

Potential Barriers to deprescribing

Patient barriers include: fear of a condition worsening, lack of support to manage condition, previous bad experience with stopping medication, and influence from other care providers (e.g., family, nurses, specialists). Using a team-based and stepwise patient approach to deprescribing aims to provide patients with appropriate education and support to begin to reduce unnecessary medicines.

Provider barriers include feeling uneasy about contradicting a specialist’s recommendations for initiation/continuation of specific medications, fear of causing withdrawal symptoms or disease relapse, lack of specific data to adequately understand and assess benefits and harms in the older adult population. Primary care physicians acknowledged worry about discussing life expectancy and that patients will feel their care is being reduced. Often there is limited time to discussed complex shared decision-making conversations. One way to overcome some of these concerns is to consider working with a clinical pharmacist. Pharmacist can help with Information regarding medication-specific factors, such as half-life and expected withdrawal patterns, can help the decision to deprescribe or not. Close communication with specialists, allows for discussions regarding medication concerns like adverse effects, limited benefits, or compliance. It will allow the development of a collaborative, cohesive, and patient-centered plan to deprescribe.

4. Follow up plan: develop a for monitoring and assessment. Patient should be told symptoms may occur in the event of drug withdrawal and which symptoms may suggest the return of a condition. Supports should be in place if needed (e.g., physical therapy, social support) to help ensure success.

The object is to improve outcomes, decrease risks for drug interactions and adverse effects. Keeping these goals in mind individualize each plan for each patient.

Reerences:

  1. American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers criteria for potentially inappropriate medication use in older adults.  J Am Geriatr Soc. 2015;63:2227-2246.
  2. O’Mahony D, O’Sullivan D, Byrne S, et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015;44:213-218. Orwig D, Brandt N, Gruber-Baldini AL. Medication management assessment for older adults in the community. Gerontologist. 2006;46:661-668.
  3. Anderson K, Jue SG, Madaras-Kelly KJ. Identifying patients at risk for medication mismanagement: using cognitive screens to predict a patient’s accuracy in filling a pillbox. Consult Pharm. 2008;23:459-472.
  4. Lenaerts E, De Knijf F, Schoenmakers B. Appropriate prescribing for older people: a new tool for the general practitioner. J Frailty & Aging. 2013;2:8-14.
  5. https://www.mdedge.com/sites/default/files/Document/June-2017/JFP06607436.PDF

 

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Groceries or Insulin

The high Cost of Insulin

Many patients are finding themselves unable to afford insulin, they must make a choice between buying groceries or insulin. As a follow up to my blog the High Cost of Insulin , the human cost of insulin. NBC News (8/15) reported on patients rationing insulin and leading to death. One of my favorite bogs also addressed this topic, E&M Blogosphere . In the article Hyma Gogineni, Pharm. D, MSc, BCACP, TTS, talks about why the high cost and list available programs that both insured, and uninsured can use to help afford insulin.

Recently USA today published an article calling for free medications for those who need it and can not afford it. This is a growing problem that is only getting worst. In January the New York Times wrote an article about drug makers accused of fixing insulin prices, that lead to a law suit. It seems like everyone from manufacturers, PBM and all middle players are getting rich while the neediest patients go without much needed insulin as reported by PBS news hour.

President Trump promised to lower prices of high cost medications as reported by AARP and Bloomberg.  We are still waiting for something to be done about high price medicines. Many practitioners have taken to petition state and federal law makers to curtail the cost of much needed medicines but not much has been accomplished. Meanwhile, many patients find themselves going without or rationing insulin to last them longer leading to many complications and in some cases as reported above to death.

Biosimilar

Two biosimilars recently approved with lower prices but still too high for patients to afford. Basaglar a biosimilar to Lantus and Admelog biosimilar to Humalog.  Whole sale prices of $348.78 for 15 milliliters (5 pens) of Basaglar and $251.83 for 10 milliliters of Humalog. Compared to Lantus price $430.14 and Humalog $294.85, the difference is not much. These biosimilars (almost an identical copy of an original product) are still too expensive for needy patients to afford.
Rightcare Alliance a petition directed to manufacturers to help patients afford insulin.

The Story behind  Rightcare Alliance was reported on WBUR, A Mother’s Day Message To Pharma: Lower Your Insulin Prices. Many more petitions can be found and many more tragic stories. Contact your senators and congress representatives and tell them make insulin affordable.

Sign the ADA’s petition

The American Diabetes Association has set an online petition to make insulin affordable: Sign the petition now.

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Polypharmacy

Polypharmacy, or the use of multiple medications to treat a patient, has negative connotations. When it comes to medications more doesn’t mean better. What is polypharmacy? The definition of polypharmacy varies and as concluded by What is polypharmacy? A systematic review of definitions article, there is no consensus definition for polypharmacy.

Polypharmacy is more common in patients with multiple co-morbidities and is associated with the use of multiple medicines. Polypharmacy refers to the use of many medications, commonly considered the use of five or more medications. Since polypharmacy is a consequence of having several underlying medical conditions, it is much more common in elderly patients. An estimated 30 to 40 percent of elderly patients take five or more medications.

Taking multiple medications, whether prescription drugs, OTC treatments, herbal or dietary supplements; is a burden for patients and it can be dangerous. Dangers such as unwanted drug interactions and decrease drug adherence to essential medicines.

In the longitudinal study: Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the United States, 2005 vs 2011, found that 35.8% of adults in the United States were taking five or more medicines. Adverse drug events in ambulatory care, New England Journal of Medicine 2003; 348:1556–1564, a landmark study of adults receiving one or more prescriptions from their primary care physician.

The authors found that 25% of patients had an adverse drug reaction within three months of starting their prescriptions. While 39% of these were preventable errors, most were the result of inappropriate drugs or drug interactions. polypharmacy is the use of more medications than are clinically indicated, representing unnecessary drug use.

What are the reasons for polypharmacy?

• Many co-existing medical conditions. In the case of diseases such as heart failure and high blood pressure, combinations of two to three different medications are common and recommended.
• Medications added for symptomatic relief, medications prescribed to treat adverse effects of another drug.
• Seeing different physicians and being under the care of several specialists.
• Lack of documentation on the use of a medication is often missing in the medical record, making decisions to consider termination of treatment difficult to make later.

What are the consequences of polypharmacy?

The major consequence of polypharmacy to a patient is a much higher risk of adverse drug effects. Risk increases based on the number of medications prescribed and taken.

Adverse drug effects often require physician visits, emergency room visits or hospitalizations. It can be difficult figuring out which medication is causing the adverse effect, avoiding drug interactions and improving adherence.

Adverse drug events WHO: “Unintended and undesired effects of a medication at a normal dose”:
• Adverse Drug Reaction
• Medication Error
• Therapeutic Failure
• Adverse Drug Withdrawal Event
• Overdose

Polypharmacy makes it hard for the patients to remember when and how to take all prescribed medications. Multiple medications increase the risks of inappropriate medication use, non-adherence, adverse effects, and medical cost.

Physicians may hesitate to prescribe a new essential medication to a patient already on four or more medications. Polypharmacy can lead to under treatment.

Another consequence of overutilization is the soaring cost of health care in 2015, the U.S. spent $325 billion on retail prescription drugs (drugs purchased at pharmacies and through the mail), almost twice that of other developed countries. Higher expenditures can be justified if the health outcomes for U.S. patients measured as life expectancy, disease-specific mortality and other measures were more favorable but they are not.

Potentially inappropriate prescribing defined:

• Risk > Benefit
• Over‐prescribing
• Excessive doses/duration of medicines
• Polypharmacy
• Mis-prescribing Unfavorable choice of medicine, dose, or duration
• Under‐prescribing Not prescribing a clinically indicated medicine, despite the patient not having any contra‐indication to that medicine

Preventing and Reducing Polypharmacy

We strongly recommend medication review by a Pharmacist for patients prescribed a large number of medications. Other recommendations:

1) Primary care physician needs to coordinate the use of multiple medications.

2) Potentially Inappropriate Medications (PIMs):
Medications that pose more risks than benefits to older adults by themselves and considering the availability of alternative treatments.

3) Instead of adding a new medication to treat an unwanted side effect, stopping or changing the dose of the offending drug would solve the problem.

4) Medications lacking an indication, medications with limited value or are therapeutic duplication should be discontinued.

5) Always consider a new symptom as possible drug-induced (review chronology of medications)

6) Consider stopping/tapering medications

7) Consider reducing dose with age

8) Do a drug interaction check

9) Review the goals of care and treatment targets

10) Prescribe strategically (e.g. reduce pill burden, simplify regimen, use meds for more than one purpose)

Pearls for Decreasing Polypharmacy:

• Start low and go slow
• Don’t set it and forget it (PK)
• Ask about herbs, roots, nuts, berries
• Trust but verify
• Avoid narrow therapeutic index meds
• Review medication lists regularly
• Avoid too many changes at one time
• Begin with the end in mind
• Utilize Beers or START/STOP criteria for regular assessment

Decreasing medication use in the elderly can reduce adverse events (e.g. falls, hospitalizations), reduce pill burden and costs, increase adherence with remaining medications, Improve the quality of life. Patients, family members, and caretakers should be educated on the dangers of polypharmacy. for more information on patient education, see JAMA’s patient’s page on Polypharmacy.

Pharmacists, in general, are in the best position to help patients with polypharmacy. Ambulatory care pharmacists routinely see patients and should be conducted not only routine medication adherence but review for polypharmacy.

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Vitamin D and Diabetes

Vitamin D and Diabetes

There is evidence between the relationship between vitamin D and Diabetes. Patients who are vitamin D deficient are at higher risk of developing diabetes.  The question remains weather or not Vitamin D deficiency worsens the markers of diabetes.

Vitamin D

Vitamin D is a fat soluble vitamin that helps maintain enough calcium and Phosphate levels in the blood. Vitamin D is also needed in bone growth, remodeling and helps promotes calcium absorption from the gastrointestinal tract.

Chronic insufficient levels of vitamin D can cause osteoporosis and in severe cases rickets or osteomalacia. Other functions of vitamin D in the body include cell growth, neuromuscular, immune function and reduction of inflammation.

What is Vitamin D Deficiency?

Vitamin D is most accurately measured by 25(OH)D as it has a long half-life, reflects both vitamin D produced by the skin and obtained through diet.  It is hard to get enough vitamin D from food alone, most of the vitamin D is absorbed through the skin from sun light.

Vitamin D levels are categorized as follows:

  • < 10 ng/ml = severe deficiency
  • 10–24 ng/ml = mild-mod deficiency
  • 25–80 ng/ml = optimal
  • > 80 ng/ml = toxicity possible

Who is at risk of Vitamin D deficiency:

  • Have either liver or kidney dysfunction
  • GI disorders (ex. celiac disease, pancreatitis, low bile levels)
  • Aging skin
  • Darker skin color
  • Living at a higher latitude with less yearly sun exposure
  • Obesity (BMI >/=30)

Vitamin D deficiency can lead to consequences such as heart attack, poor immune function nd diabetes.  Vitamin D also has a protective role in breast cancer, prostate and colon cancer.  Your doctor can test you vitamin D level and tell you if you are vitamin D deficient.

Nutritional Vitamin D

Put this foods in your plate: wild cold-water salmon, mackerel, tuna, sardines, cod, and halibut. Also try milk, liver, egg yolks and fortified cereal.

Other ways to get Vitamin D

Sunshine: 15 to 30 minutes of sunlight without any sunscreen, can be done in small doses and not at high noon to avoid sun burn.

Vitamin D supplements for adults: try 4,000 to 5,000 IU daily of vitamin D3 (Cholecalciferol) which is the equivalent of fortified milk.  Excessive sun exposure does not cause vitamin D toxicity. Excessive intake in foods that contain large quantities of vitamin D are also very unlikely to cause toxicity. Toxicity is usually the result of high intake of vitamin D containing supplements.

How can Vitamin D deficiency lead to diabetes?

There are vitamin D receptors on different immune cells as well as the beta cells of the pancreas which are responsible for insulin secretion. There are a few different proposed mechanisms of how vitamin D is related to diabetes:

  • Active form of vitamin D, 1,25-dihydroxyvitamin D works by:
    (1) Improving insulin sensitivity of target cells in the liver, skeletal muscle, and adipose (fat) tissue.
    (2) Enhancing and improving B cell function in the pancreas.
    (3) Protecting B cells from immune cells by influences proliferation and differentiation of immune cells such as macrophages, dendritic cells, and T cells.
  • Vitamin D binding proteins, vitamin D receptors and 1alpha-hydroxylase (CYP1alpha) may affect insulin release and result in insulin resistant.
  • Affects glucose homeostasis through these mechanism:
    (1) Vitamin D helps to maintain adequate calcium levels. When calcium levels are low there is less glucose stimulated insulin secretion that occurs from the B cells.
    (2) Inadequate vitamin D can lead to increased PTH levels. This causes decreased glucose uptake by liver, muscle and adipose cells as well as suppression of insulin release.
  • Vitamin D may stimulate insulin secretion by the vitamin D receptors when there is enough calcium.

**Pancreatic Beta cell make insulin.

Studies finding a correlation between vitamin D Deficiency and type 2 Diabetes (T2DM).

(a) Randhawa F et al. Pak J Med Sci 2017;33:881-885: The purpose of this study was to access the effect of vitamin D supplementation on A1C for patients recently diagnosed with T2DM. Results: There was no significant difference between both groups’ A1C at 1, 3 and 6 months.
(b) Dalgard C et al. Diabetes Care 2011;34:1284-1288: This study looked at 668 participants who were all between the ages of 70-74. They lived in a North Atlantic fishing community where a large part of their diet consisted of fatty fish.
Of the 668 patients 24% had type 2 diabetes mellitus (T2DM) and >50% were considered vitamin D deficient (25(OH)D3 level <20 ng/ml).  There were not correlations found between vitamin D deficiency and plasma glucose levels (rs = -0.01; P = 0.78).  Vitamin D deficiency was associated with having an 80% increase in sex-adjusted odds of having diabetes compared with sufficient vitamin D levels (OR 1.8, 95% CI 1.23-2.64, P = 0.002). This was also adjusted to take BMI, serum triacylglycerides, serum HDL, PCB exposure, smoking & month of blood sampling into account (OR 1.67, 95% CI 1.11-2.50, P=0.013). Conclusion: Vitamin D deficiency (25(OH)D <20 ng/ml) doubles the risk of newly diagnosed diabetes. This data suggests that vitamin D may play a protective role preventing the development of T2DM.
(c) Pittas AG et al. Diabetes Care 2006;29:650–65: This study consisted of 83,779 women who were all greater than 20 years of age. They found that patients who had low vitamin  were at an increased risk of T2DM. When patients were treated with a combination of vitamin D 800 IU and calcium 1,000 mg they found their risk for T2DM was reduced by 33%.
(d) NHANES group (2003– 2006): This group evaluated 9,773 U.S. adults who were greater than 18 years old and had T2DM. They found that there was a correlation between serum vitamin D levels, glucose homeostasis, and the evolution of diabetes.  They concluded that patients with an elevated A1C should be evaluated for vitamin D insufficiency.
(e) Talaei A et al. Diabetol Metab Syndr 2013;5:8: This study looked at 100 patients with T2DM between 30 and 70 years old. Of all the patients, 24% had a vitamin D deficiency (25(OH)D ≤20 ng/m). All of these patients were given 50,000 unit of vitamin D3 orally per week for eight weeks. When comparing these patients baseline results to the results at the end of the study they found: Their conclusion was that vitamin D supplementation could reduce insulin resistance in patients with T2DM.
(f) Zhang J et al. Can J Opthalmol 2017;52:S39-44: This study looked at the correlation between diabetic retinopathy (both T1DM and T2DM) and vitamin D deficiency. This was a meta-analysis of 14 observational studies with a total patient population of 10,007. They found a statistically significant association between diabetic retinopathy and vitamin D deficiency. There were statistically significant lower serum vitamin D levels in patients with diabetic retinopathy than in the control group. The higher the degree of vitamin D deficiency, the higher the grade of diabetic retinopathy. Studies finding a correlation between vitamin D Deficiency and diabetes (T1DM)4.  Overall there is a lack of studies to support that vitamin D supplementation would improve treatment of T1DM after diagnosis.
(g) Hypponen E, et al. Lancet 2001;358:1500–1503. This study observed that children who took 2,000 IU of vitamin D daily were 80% less likely to develop T1DM.

Conclusion:

There is evidence to the relationship between vitamin D and diabetes.  Patients who are vitamin D deficient are at a higher risk of developing diabetes. There is also sufficient evidence showing a positive correlation between vitamin D deficiency and increased insulin resistance, decreased insulin production and higher A1Cs.

Patient with prediabetes and vitamin D deficiency can benefit from Vitamin D supplementation. Patients with diabetes who are obese, have a high A1C and have vitamin D deficiency, can also benefit from Vitamin D supplementation.

***A very special thanks to M. Langton PharmD candidate for her help in gathering information for this topic.

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Weight Loss in Diabetes

There is a known connection between obesity and Type 2 diabetes. It is known that the obesity epidemic is driving the Type 2 Diabetes epidemic world wide. There is strong evidence that modest weight loss can delay the progression from pre-diabetes to type 2 diabetes (1,2,3).  Weight loss in diabetes is beneficial in managing type 2 diabetes. Why lose weight question, for many type 2 diabetics is an important one to get their diabetes under control.
Studies have shown that reduction in calories lead to a reduction in A1C of 0.3% to 2.0% in adults with type 2 diabetes, leads to reduction in medication doses and improvement in quality of life (1). Maintaining weight loss is challenging (4) but offers long-term benefits. For example, maintaining weight loss for 5 years is associated with sustained improvements in A1C and cholesterol levels (5). Weight loss in diabetes can be attained with lifestyle programs that offer a 500–750 calorie energy deficit or offer 1,200–1,500 calorie for women and 1,500–1,800 calorie for men. For many obese individuals with type 2 diabetes, losing >5% can produce beneficial outcomes in sugar control, cholesterol, and blood pressure, and sustained weight loss of ≥7% is optimal (4).

Definition of Obesity

Body Mass Index, or BMI, is used as a screening tool for overweight or obesity.
• If your BMI is less than 18.5, it falls within the underweight range.
• If your BMI is 18.5 to <25, it falls within the normal.
• If your BMI is 25.0 to <30, it falls within the overweight range.
• If your BMI is 30.0 or higher, it falls within the obese range.
To calculate BMI, see the Adult BMI Calculator or determine BMI by finding your height and weight in this BMI Index Chart.

How does Obesity Lead to Type 2 Diabetes?

Increase weight leads to increase fat (adiposity), increase adiposity leads to insulin resistance which eventually will lead to diabetes.
To have weight loss in diabetes, there are three modalities: bariatric surgery, weight loss medications (pharmaceuticals) and energy deficit. A combination of any of the three modalities with behavior modification can help patients achieve weight loss.

Bariatric surgery

Bariatric surgery is indicated for patients with a BMI equal or greater than 40 or a BMI equal or greater than 35 with co-morbidities such as diabetes. The two most popular types of bariatric surgery are Roux-en-Y gastric bypass and Gastric sleeve surgery also known as vertical sleeve gastrectomy. Gastric sleeve is more popular because the number of side effects are less than with the Roux-en-Y bypass but is not as effective.

Weight loss Medications (Pharmaceuticals)

Prescription weight loss drugs: Belviq, Contrave, Saxenda, phentermine, and Qsymia. Over the counter you can find orlistat. Lifestyle intervention plus pharmacotherapy intervention lead to better response to calorie restriction. For patients on weight loss medications see an increase magnitude of response, average percentage of weight loss is greater. Overall pharmaceuticals can help extend weight loss sustained response. SEQUEL study data showed amount of weight loss group on pharmaceutical treatment lead to greater weight loss more than the placebo group.

Who can benefit from the use of Pharmaceuticals for weight loss?
Patients who report early hunger shortly after eating, patients who tend to have more than one plate of food to feel full, Patients with persistent food thoughts, strong emotional response to food or eating, and less than robust response to dietary plan. For some, pharmaceuticals can be use indefinitely or in maintenance can be use when needed.

Calorie Restriction

Type 2 diabetes is potentially reversible via an 8-week, very low-calorie diet followed by careful weight management for up to 6 months, new research shows. The findings were published online March 21, 2016 in Diabetes Care by Dr Sarah Steven of Newcastle University, United Kingdom, and colleagues.

The best weight loss response was seen in Younger age patients, in those with shorter duration of diabetes and not on insulin. STAMPEDE trial followed 150 patients with a BMI of 27-43 1 for five years 1 out of 3 patients were in remission after 5 years after bariatric surgery. Look AHEAD and DIRECT trial achieve 50% remission on an average weight loss of 10 kgs.
Calorie restriction paired with exercise provides patients with type 2 diabetes with a plan to lose weight and control blood sugars. Before starting any exercise, program consult your Primary care physician.
Lifestyle is always recommended to manage diabetes, for some patients with type 2 diabetes it may not be enough. Pharmaceuticals and bariatric surgery are other tools that can help. For patients who are morbidly obese bariatric surgery maybe the best alternative. Talk to your Primary Care Physician to find out what they recommend for you.
Weight loss in type 2 diabetes can lead to remission or well control diabetes at the levels of prediabetes leading to decrease complications from diabetes. Make weight loss part of your diabetes action plan.

References
  1. https://jandonline.org/article/S2212-2672(17)30333-7/abstract
  2. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002095
  3. http://annals.org/aim/fullarticle/2395729
  4. https://jandonline.org/article/S2212-2672(15)00259-2/fulltext
  5. http://drc.bmj.com/content/5/1/e000259
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Antibiotic Duration in Sinusitis

Current recommendations:

Current guidelines from the Infectious Diseases Society of America (IDSA) recommend only antibiotic treatment duration of 5 to 7 days in uncomplicated sinusitis. Recent findings from a research letter published in JAMA Internal Medicine, show that a significant number of antibiotic prescriptions for acute sinusitis are written for greater than10 days.

How the researches arrive at this conclusion:

Using the 2016 National Disease and Therapeutic Index (IQVIA), researchers identified an estimated 3,696,976 physician visits in which antibiotics were prescribed for a sinusitis. Patients were excluded if they had a concurrent antibiotic prescription for other conditions.

Results:

Results showed that the median duration of therapy for all antibiotics was 10.0 days with 69.6% of prescriptions given for ≥10 days (95% CI, 63.7%–75.4%). IDSA explicitly recommends against using azithromycin to treat sinusitis. After excluding azithromycin, the percentage of antibiotic courses that were given for over 10 days in duration jumped to 91.5%; 7.6% (95% CI, 4.1%-11.1%). Although the IDSA guidelines recommend against the use of azithromycin, 22.6% of prescriptions (95% CI, 17.2–28.0%) were for a 5-day course of azithromycin.
For patients at high risk or those who have failed initial treatment, 7 to 10 day courses of therapy may be appropriate, however it is unlikely those types of cases made up most patients in the study.
Based on their findings, the authors concluded that “the durations of most courses of antibiotic therapy for adult outpatients with sinusitis exceed guideline recommendations.

What is sinusitis?

Sinusitis an infection of your sinus that can cause by either a virus or a bacteria. For Viral sinusitis, antibiotics should not be use.

Why should we worry about duration of antibiotics in uncomplicated Sinusitis?

Because the number of antibiotic resistant infections is growing, and we do not have new antibiotics to treat those resistant infections. A recent article shows that inappropriate prescribing of antibiotics has remained the same.

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Metformin

Metformin is a medication for type 2 diabetes, decreases the liver’s glucose output and increases the muscles’ glucose uptake. Metformin remains not only first line therapy but one of the most used medications for Type 2 Diabetes.

Possible side effects: nausea, upset stomach, diarrhea (can sometimes be avoided by taking with food or by using the extended-release formulations).

Should not be taken by persons with decreased kidney function or certain other medical conditions.

Medications available: metformin (Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet).

Metformin is an inexpensive medication considered first-line therapy for treatment of glucose control in individuals with type 2 diabetes. It is also widely used to improve cardiovascular risk in adults with type 2 diabetes.

Reducing with Metformin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

This study examined if similar benefits could be expected for people with type 1 diabetes. Metformin may be prescribed for people with type 1 diabetes who are also overweight, to help control blood sugar and weight, allowing a lower daily insulin dose.

This multi-center, international clinical trial enrolled patients at 23 centers across the United Kingdom, Australia, Canada, Denmark and the Netherlands. Researchers investigated three years of treatment with metformin reduces heart disease in middle-aged adults with type 1 diabetes who are at increased risk for cardiovascular disease (CVD).

REMOVAL studied 428 middle-aged adults with longstanding type 1 diabetes–on average for 33 years. The patients had three or more risk factors for cardiovascular disease, including BMI over 27; A1C greater than 8.0; known CVD/peripheral vascular disease; current smoker; high blood pressure; high cholesterol or triglycerides; strong family history of CVD; or duration of diabetes more than 20 years.

Patients who received metformin lost weight, and their insulin doses were able to be reduced during the study.

However, A1C levels showed reduction only during the first three months of metformin treatment. Cholesterol was also reduced, even though more than 80 percent of trial participants were already taking statins. Weight reduction and lowering of cholesterol may therefore have played a role in reducing atherosclerosis.

The Diabetes Prevention Program Outcomes Study (DPPOS)

Was an extension of the Diabetes Prevention Program (DPP) to determine the longer-term effects of the two interventions, reduction in diabetes development and reduction of development of the diabetes complications. Complications like blindness, kidney failure, amputations and heart disease. Funded largely by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the new findings show that the lifestyle intervention and metformin treatment have beneficial effects, even years later, but did not reduce microvascular complications.

Metformin long term use:

Metformin treatment was associated with a modest degree of long-term weight loss. There is also a small increase in vitamin B-12 deficiency, overall metformin treatment has been extremely safe and well-tolerated.

Metformin Works Better in African Americans

In a study of electronic health records of 19,672 people with type 2 diabetes, starting on metformin led to a 0.90 percentage-point drop in A1C—a measure of blood glucose control for two to three months—in black participants versus just 0.42 in whites. The researchers took factors such as age, sex, body mass index, and starting A1C into account, so the difference more likely has to do with genetics.

Metformin may help fight off brain and nervous system diseases

Those taking metformin for two to four years had a 40 percent lower risk of developing Alzheimer’s disease, Parkinson’s disease, and other brain and nervous system problems, while those taking the medication for longer than four years had an 80 percent lower risk. The brain benefit remained even after the investigators accounted for factors such as age, gender, race, and obesity.

Polycystic ovary syndrome (PCOS)

The cause of PCOS is still unclear, but researchers know one thing for sure: There’s a link between PCOS and diabetes. Women with PCOS are often insulin resistant, a condition that’s an important trigger for type 2 diabetes. The insulin resistance of PCOS is often treated with metformin.

Metformin is a very safe medication, that doesn’t cause low blood sugars, can lead to a modest reduction in weight and the most important, a reduction in cardio vascular risks.

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COMMON MEDICATION ERRORS AT HOME

Health care providers assume that patients will take medications as directed at home. A recent study found that the rate of out-of-hospital serious medication errors reported to U.S. poison control centers doubled between 2000 and 2012. These at-home medication errors often lead to one-third of these error cases in being hospitalized, (Nichole Hodges, Ph.D., lead author of the study and research scientist at Nationwide Children’s Hospital in Columbus, Ohio (J Clin Toxicol.).

Cardiovascular medications errors are the highest with 21% of serious adverse events, these events were associated with more serious medical complications. Additionally, cardiovascular and analgesic medications combined to account for 66% of all the deaths that occurred during the study period. The most commonly occurring errors involved patients taking or giving the wrong medication or incorrect dosage, and inadvertently taking or giving a medication twice.

The pharmacist can help ensure that patients understand how prescribed medications should be taken at home, especially for individuals who cannot read or write. Can patients or caregivers repeat back the correct dose and do they know when it should be taken or administered? How do they organize and store medications at home? Do they have a system in place for ensuring they take the right medication at the right time?

Pharmacist are easily accessible and can help the patient ensure correct medication Use

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The High Cost of Insulin

For the past few years, it has become very apparent that the cost of insulin is skyrocketing. The cost of insulin rose nearly 200% between 2002 and 2013, according to a new study (Expenditures and Prices of antihyperglycemic Medications in the United States: 2002-2013).

Patients who have been diabetic for decades this is the first time that they can’t afford their insulin. For Medicare patients with type 2 diabetes who fall into the “doughnut hole,” can’t afford their insulin. The newly insured patients who didn’t understand what it means to have a high deductible are struggling because they’re paying the full price. For other patients have seen their insulin copays increase to a level where they can’t even afford the copays.

The Pharmacy Benefit Managers (PBMs) get rebates from the insulin companies, so they’re the ones who control which insulin goes to the patient. It’s all based on what they can profit from with those rebates.

The insulin companies have had no choice but to increase the price of insulin so that they can at least keep their profit margin. Insulin companies try to maintain a high-profit margin and the Pharmacy Benefit Managers (PBMs) try to leverage prices in their favor but the only ones losing are the patients.

The United States has the most expensive insulin in the world. Even human insulin is expensive. It costs $2 per vial for neutral protamine Hagedorn (NPH) insulin in India, but if you go to Walgreens and pay cash, it’s $140. Lantus in India is $12 per vial, but here in the United States, it’s between $250 and $300 for the same insulin.

The ADA has spoken to all of the insulin companies in detail and has come out with a statement on the accessibility and affordability of diabetes medications (http://www.diabetes.org/newsroom/press-releases/2016/statement-on-accessibility-and-affordability-of-diabetes-medications.html).

Here other blogs/news about the high prices of insulin: