In the United States, 34.2 million people have diabetes,¹ the majority of them have type II diabetes. Type II diabetes is a chronic disease characterized by elevated blood glucose. Management of type II diabetes is multifactorial: diet, exercise, and pharmacotherapy are all part of the treatment. 

Recently, a new medication called tirzepatide has had promising results during clinical trials. This article will focus on the action mechanism  of tirzepatide and summarize the outcomes of the clinical trials. Tirzepatide is not yet approved for use by the Food and Drug Administration.

Tirzepatide is a glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) combination therapy.² GLP-1 therapies are well-established treatments to lower glucose by increasing glucose-dependent insulin secretion and slowing gastric emptying.³ In contrast, GIP was thought to have no use as a type II diabetes drug because it lacks insulinotropic effects.² However, new evidence suggests that it has synergistic effects when administered with a GLP-1 and can increase insulin secretion and glucagon secretion. These results led to developing a once-weekly subcutaneous injection therapy of GIP/GLP-1, also known as ‘twincretin’.

The phase I proof of concept trial was a randomized, placebo-controlled, double-blind study. It comprised three parts: single-ascending dose (SAD) and 4-week multiple-ascending dose (MAD) protocols in healthy subjects, followed by a 4-week multiple-dose Phase 1b proof-of-concept (POC) in patients with T2DM. There were 146 subjects randomly assigned either dulaglutide, LY3298176 (tirzepatide), or placebo. The results showed that the healthy subjects treated in the MAD study had significant reductions in fasting glucose with tirzepatide 4.5 mg compared to placebo on Day 29. 

Between tirzepatide and placebo, fasting insulin did not differ. In patients with T2DM treated with tirzepatide in the Phase 1 b POC study, HbA1c decreased in a dose-dependent manner from baseline compared to placebo. Significant differences were seen in the 5/5/10/10 mg and 5/5/10/15 mg titration groups on Day 29 (LSM differences [95% CI]: −0.84% [−1.17, −0.52] and −0.58% [−0.92, −0.24], respectively). Fasting glucose and fasting serum insulin were significantly decreased in subjects treated with the 5/5/10/10 mg and 5/5/10/15 mg titration doses compared to placebo on Day 23. 

As far as weight loss is concerned, all treatment groups had statistically significant weight loss compared to placebo except for the 0.5 mg group. From a  safety perspective, no deaths occurred. The most common adverse effects associated with the therapy were gastrointestinal adverse effects, such as decreased appetite, vomiting, diarrhea, and abdominal discomfort. There were no cases of severe hypoglycemia. 

The SURPASS trial was a randomized, parallel-assigned, interventional, double-masked, phase-III clinical trial.⁴ Participants were placed in SURPASS-1, SURPASS-2, SURPASS-3, SURPASS-4, and SURPASS-5. The start date was May 2017 and the completion date was March 31, 2019. 

The trial’s focus  was to establish the safety and efficacy of tirzepatide. The primary outcome of the trial was changed from baseline in hemoglobin A1c (HbA1c) at week 52. There were multiple secondary outcomes, including but not limited to: 

• percentage of participants with HbA1c of <7.0%, 
• change from baseline in Fasting Serum Glucose, 
• change from baseline in body weight, and  
• ate of total hypoglycemia. 

The once-weekly dosing tirzepatide scheme was for doses of 5 mg, 10 mg and 15 mg.² A dose-escalation algorithm, created from the results of the phase II trial, was used in SURPASS. The starting dose was at 2.5 mg weekly for the initial 4 weeks, then the dose increment of 2.5 mg every 4 weeks until the maintenance dose of 5 mg, 10 mg, or 15 mg is reached. 

Therefore, it takes:

•  4 weeks to reach the 5 mg dose, 
• 12 weeks for the 10 mg dose, and 
• 20 weeks for the 15 mg dose. 

The results of the SURPASS trials are briefly summarized below⁵:

Furthermore, there are many ongoing and upcoming associated trials, such as SURPASS-5, that include people who take metformin with/without a sulfonylurea and tirzepatide versus insulin glargine. The estimated study completion is March 2022. 

SURPASS-CVOT includes people with type II diabetes, confirmed atherosclerotic cardiovascular disease, overweight, and tirzepatide versus dulaglutide. The estimated completion date for SURPASS-CVOT is October 2024. In addition, SURMOUNT-1 includes people with type II diabetes plus obesity or BMI 27 kg/m2 and related comorbidities and tirzepatide versus placebo. It has an estimated completion date of May 2024. 

To summarize, tirzepatide is a GLP-1/GIP therapy for type II diabetes. The trials have observed that tirzepatide significantly reduces A1c and weight versus other diabetes pharmacotherapy choices. Although the results observed that patients taking tirzepatide have similar cardiovascular outcomes as those taking insulin alone, more studies need to be conducted to demonstrate the cardiovascular implications of the drug. Furthermore, patients frequently had GI adverse effects but were less likely to have hypoglycemic events. Tirzepatide is not yet approved for use, however, the results from the trials are very promising and tirzepatide could be a very effective therapy for those diagnosed with type II diabetes. 

If you have Medicare patients with diabetes and other chronic conditions, PharmD Live® can develop a customized program to coordinate care and capture data to improve patient quality outcomes. Remote Patient Monitoring, Medication Therapy Management, and Chronic Care Management can work seamlessly for you through our proprietary AI platform. Our clinical pharmacists, as partners in your quality improvement program, are available to patients 24/7. They answer questions, monitor drug interactions, flag gaps in treatment, and watch for potential adverse drug events.

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About the author:

Hannah Grice, PharmD, graduated from Texas Tech University Health Sciences Center School of Pharmacy in 2021 and has been with PharmD Live® since May of 2020. Dr. Grice’s interests include geriatrics, specialty pharmacy, and collaborative disease state management. She lives in Fort Worth, TX, with her husband and basset hound. In her free time, she enjoys playing tennis and hosting game nights with friends and family.

References:

1. Diabetes basics. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/index.html. Published June 15, 2021. Accessed October 30, 2021. 
2. Min T, Bain SC. The Role of Tirzepatide, Dual GIP and GLP-1 Receptor Agonist, in the Management of Type 2 Diabetes: The SURPASS Clinical Trials. Diabetes Ther. 2021;12(1):143-157. doi:10.1007/s13300-020-00981-0
3. Dulaglutide. In: Lexi-Drugs [database online]. Hudson, Ohio: Wolters Kluwer Health. Updated periodically. Accessed October 30, 2021.
4. A study of Tirzepatide (LY3298176) compared to Dulaglutide in participants with type 2 diabetes – full text view. A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes – Full Text View – ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03861052. Accessed October 30, 2021. 
5. https://diabetes.medicinematters.com/tirzepatide/type-2-diabetes/a-quick-guide-to-the-surpass-and-surmount-trials/18478154

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What is Medication Risk Management?

All medications have risks and benefits. The FDA, physicians, providers, and pharmacists all work to ensure that the balance of risks and benefits is favorable to each patient when they take their medication. The practice of assessing risks versus benefits and developing tools to minimize risk while preserving benefits is known as Medication Risk Management (MRM).¹ 

In diabetes, patients often take multiple medications. MRM is especially important in diabetes care to reduce the risk of potential complications while optimizing outcomes for patients. Monitoring patients properly for high and low blood sugar can avoid two of the most common risks while using medications to treat diabetes. Below are ways to identify when these adverse events occur. Remote patient monitoring is a valuable tool to keep your patients within prescribed guidelines.

Managing Low Blood Sugar

Identification and initial management

The most serious medication-related adverse event in diabetes management is low blood sugar, otherwise known as hypoglycemia. Low blood sugar may present as shaking, sweating, nervousness or anxiety, irritability or confusion, dizziness, or hunger.²  A blood sugar level below 70 mg/dL is considered low, while blood sugar less than 55 mg/dL is considered severely low. 

Always check your patient’s blood sugar if you think it is low, or treat it if you cannot check. To treat a blood sugar between 55-69, use the “15-15” rule. Consume 15 grams of carbohydrates and check your blood sugar after 15 minutes. Repeat the procedure until the blood sugar exceeds 70 mg/dL, and advise a good meal or snack to maintain appropriate blood sugar. If blood sugar is below 55, injectable glucagon is the best option. Have your patient seek medical attention after receiving a glucagon injection. Consider whether your patient should carry a glucagon kit if you have not already prescribed one.

Insulin

Too much insulin can cause low blood sugar. Insulin is very potent, and receiving a few extra units may cause blood sugar to fall to dangerously low levels. Have patients double-check syringes and pen needles to ensure the number of units administered is correct.

Other medications

Medications not intended for use in diabetes treatment can, in rare cases, cause low blood sugar. These include: 

• beta-blockers (like atenolol or propranolol), quinidine, indomethacin, and 
• antibiotics (fluoroquinolones and trimethoprim-sulfamethoxazole).³ 

Make sure that your patient understands that this is why you ask about all medications the patient is taking.

Managing High Blood Sugar

Identification and initial management

High blood sugar or hyperglycemia can be a severe side effect in diabetes management. Explain to patients that high blood sugar can cause them to feel tired and thirsty, have blurry vision, and can make them feel like they need to urinate more often.⁴ If the blood sugar is above 240mg/dL, use a urine ketone test. The presence of ketones can be a sign of diabetic ketoacidosis, which is a medical emergency. 

Use the teach-back method to be sure patients understand the best way to treat hyperglycemia is prevention. Have them develop and share a meal plan that helps them identify the number of carbohydrates they consume. Encourage them to work with you and the pharmacist to ensure they appropriately use the prescribed insulin and medication regimen.

Insulin

Hyperglycemia may occur if the patient receives less insulin than needed. If your patient has an insulin pen, remind them to prime it before each use.⁵ To properly prime, attach the needle to the pen, then turn the dial to two units. Point the needle up and push the knob to see at least a drop of insulin emerge from the needle. Without priming the pen, the patient may receive less insulin than expected if there is an issue with the pen or the needle.

Other medications

Medications not used to treat diabetes may cause hyperglycemia. These include:

• antibiotics (dapsone, rifampin), 
• antipsychotics (olanzapine, risperidone, clozapine, quetiapine, aripiprazole, ziprasidone, lithium), 
• phenytoin, 
• corticosteroids (prednisone, methylprednisone), 
• estrogens, 
• oral contraceptives, 
• thyroid hormones (Synthroid, levothyroxine), and 
• ritonavir.⁶ 

Again, make sure that your patient understands why you ask about all medications the patient is taking. It doesn’t always make sense that they are putting themselves at risk.

Conclusion

Managing diabetes is a complex balance of lifestyle, diet, and medications. Proper use of medications can help avoid the risks that accompany their use. Always ask if your patients have questions about medications, especially new ones that may affect blood sugar. In addition, you might recommend they wear a medical ID to help emergency personnel identify the patient has diabetes if they have an adverse drug event and can’t speak for themselves.

PharmD Live® partners with medical practices, healthcare systems, hospitals, and ACOs to deliver CCM and RPM telehealth programs for Medicare patients with chronic conditions. Our care coordinator/clinical pharmacists use our proprietary AI platform to benefit your patient’s health outcomes, as well as your bottom line.

Remote therapy management and our diabetes prevention program reinforce physician recommendations. When patients increase their participation in setting and achieving goals, they more often succeed in preventing diabetes II.

Our pharmacists can produce complete and auditable reports for their partners to see patient engagement and claim total reimbursements from CMS. We provide seamless reporting to help physicians with their quality improvement plan and CMS submission. For more information, call +1 (202) 765-1429 or visit pharmdlive.com.

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About the author:

Matthew Gehrlein is a PharmD/MBA candidate at Texas Tech University Health Science Center School of Pharmacy. He has experience working in retail and hospital pharmacy, and clinical research. Matthew’s interests include infectious diseases, critical care, and cardiology. After graduation, he plans to apply to residency and pursue a clinical specialty. In his free time, he enjoys spending time with his wife and daughter, cooking, and playing ultimate frisbee. 

Sources

1. Center for Drug Evaluation and Research. Managing medication risks. U.S. Food and Drug Administration. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/fdas-role-managing-medication-risks 
2. How to treat low blood sugar (hypoglycemia). Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/low-blood-sugar-treatment.html. Published March 25, 2021.
3. Drug-induced low blood sugar: Medlineplus Medical Encyclopedia. MedlinePlus. https://medlineplus.gov/ency/article/000310.htm.
4. Manage blood sugar. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/managing/manage-blood-sugar.html. Published April 28, 2021.
5. Insulin Pen Injections. Cleveland Clinic. https://my.clevelandclinic.org/health/treatments/17923-insulin-pen-injections.
6. Medications that affect blood sugar. TriHealth. https://www.trihealth.com/institutes-and-services/diabetes/living-w-diabetes/medications/medications-that-affect-blood-sugar.

The post Medication Risk Management in Diabetes appeared first on Pharmdlive.

By: Cynthia Nwaubani, PharmD and Tessa Culhane

Type 2 diabetes is the most common type of diabetes in the world. As many as 34 million Americans have diabetes, and 90-95% have type 2 diabetes.¹ With the growing number of people being diagnosed with type 2 diabetes, everyday health care professionals devote more time to managing the disease in their patients. 

When cells are not responding to insulin the pancreas makes, the pancreas tries to produce more insulin to trigger a response, but eventually, the pancreas can not keep up with production. The result is hyperglycemia, leading to microvascular effects, such as retinopathy, nephropathy, and neuropathy. It can also lead to macrovascular complications, such as heart failure, stroke, and peripheral vascular disease.² This can make diabetes management an enormous challenge as it is a chronic condition that will require lifelong treatment. 

Glycemic control is crucial in every patient that is diagnosed with type 2 diabetes. Treatment usually focuses on an oral antidiabetic to help control the patient’s glucose levels. Patients that have type 2 diabetes are usually on multiple medications due to coexisting conditions. These patients are at a higher risk of developing drug therapy problems (DTP) because of their numerous drug regimens. A DTP is defined as an event that interferes with the patient receiving optimal care. Some common DTPs seen in diabetic patients include their dosage being too low, drug therapy ineffective, or the need for additional drug therapy.³ One study conducted in Jordan found that 81.2% of patients recruited with type 2 diabetes had at least one drug therapy problem.⁴ Another study in Ethiopia found that 58.2% of their study participants diagnosed with type 2 diabetes had at least one DTP.⁵ These include drug therapy problems, such as drug interactions, polypharmacy, and incorrect drug choice. These problems can cause increased mortality, prolonged hospitalization, and serious adverse events among diabetic patients. 

Another common problem seen among patients with type 2 diabetes is nonadherence to their therapies. Medication adherence in type 2 diabetic patients is essential for maintaining good therapeutic outcomes. Patients require education on the importance of their diabetic medications for their disease. Some common barriers to adherence with diabetic medications are the cost of the medicine and the adverse effects associated with these treatments. Health care professionals should help address any concerns the patient has to help them achieve optimal glycemic control. 

Polypharmacy can also contribute to DTPs in patients that are diagnosed with type 2 diabetes. For example, type 2 diabetes patients have a significantly higher risk of developing cardiovascular (CV) diseases, such as heart failure or stroke, in their lifetime. Many studies have linked poor control of glucose levels to the increase in CV disease.⁶ Proper control and treatment of type 2 diabetes shows patients can control the progression of many CV diseases. However, multiple medical conditions will result in more medications. Numerous therapies can pose risks for patients, such as falling, decreased quality of life, and adverse drug events/interactions. 

Drug therapy problems can pose significant challenges to healthcare professionals. However, in most cases, these DTPs are preventable. Many studies suggest using a medication review team consisting of pharmacists and physicians reviewing patients’ charts for medication errors. One study found that in reviewing 31 patient charts and dispensing events, they discovered 2,194 medication errors.⁷ Early identification of DTPs in patients can help prevent any severe adverse events. Pharmacists can help play an essential role on the review team by ensuring that diabetes patients have safe, appropriate, and effective medications. 

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About the authors:

Dr. Nwaubani is a board-certified geriatric pharmacist. She is the CEO and founder of PharmD Live®. Dr. Nwaubani has a working history delivering high-quality and cost-effective medication management and chronic care services to patients in various healthcare settings.

Tessa Culhane

Tessa Culhane is a PharmD candidate at Lake Erie College of Osteopathic Medicine. Tessa’s main areas of interest include psychiatric medicine and infectious disea

References: 

1. Type 2 diabetes. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/type2.html. Published August 10, 2021. Accessed November 4, 2021. 
2. Long AN, Dagogo-Jack S. Comorbidities of diabetes and hypertension: mechanisms and approach to target organ protection. J Clin Hypertens (Greenwich). 2011;13(4):244-251. doi:10.1111/j.1751-7176.2011.00434.x
3. Demoz GT, Berha AB, Alebachew Woldu M, Yifter H, Shibeshi W, Engidawork E. Drug therapy problems, medication adherence and treatment satisfaction among diabetic patients on follow-up care at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. PLoS One. 2019;14(10):e0222985. Published 2019 Oct 1. doi:10.1371/journal.pone.0222985
4. Al-Taani GM, Al-Azzam SI, Alzoubi KH, et al. Prediction of drug-related problems in diabetic outpatients in a number of hospitals, using a modeling approach. Drug Healthc Patient Saf. 2017;9:65-70. Published 2017 Jul 28. doi:10.2147/DHPS.S125114
5. Mechessa DF, Kebede B. Drug-Related Problems and Their Predictors Among Patients with Diabetes Attending the Ambulatory Clinic of Gebre Tsadik Shawo General Hospital, Southwest Ethiopia. Diabetes Metab Syndr Obes. 2020;13:3349-3357 https://doi.org/10.2147/DMSO.S267790
6. Leon BM, Maddox TM. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World J Diabetes. 2015;6(13):1246-1258. doi:10.4239/wjd.v6.i13.1246
7. Grasso BC, Genest R, Jordan CW, Bates DW. Use of chart and record reviews to detect medication errors in a state psychiatric hospital. Psychiatr Serv. 2003;54(5):677-681. doi:10.1176/appi.ps.54.5.677

The post Risk Management in Type 2 Diabetes Population appeared first on Pharmdlive.

Currently, an estimated 15.5 million Americans have tried weight loss drugs and experts predict nine percent of Americans will be taking them by 2035, a five-fold increase from mid-2024. Prescription drugs approved by the FDA for chronic weight management can support individuals who have tried lifestyle modifications like diet and exercise but have not experienced significant weight loss. However, the drugs have significant considerations such as side effects, cost and accessibility issues. 

PharmD Live® is well equipped to support clinics in discussing weight loss drug usage with patients and offering their expertise in real-time 24/7 for questions that arise from patients intending to use or currently taking the drugs. PharmD Live®’s virtual clinical pharmacists empower healthcare providers and patients with their expertise and leverage AI-driven technology and telehealth solutions to support patients wherever and whenever they have questions about their prescriptions.

The Growing Role of Virtual Pharmacist Care Managers 

Virtual PCMs at PharmD Live® address critical healthcare challenges, such as adverse drug events (ADEs), chronic disease management and medication adherence. 

The expertise and around-the-clock accessibility of PCMs goes beyond the role of traditional pharmacists. For weight loss drugs, patients may have questions about at-home injections, side-effects or other prescriptions interfering with weight loss drugs. PCMs can help people at any time and from anywhere they reside. 

This immediate intervention allows patients to take control of their health, gives providers actionable clinical intelligence and serves as a lifeline between patients and their care teams. This valuable distinction increases patient safety – a key component of PharmD Live®’s mission to improve care, as research shows that nearly 50% of medications are not taken as prescribed and ADEs contribute to over 770,000 injuries and deaths annually. 

PCMs can reduce these issues by conducting regular medication reviews, educating patients on the importance of adherence and adjusting treatment plans as necessary to optimize care.

PharmD Live® partners with provider practices and clinics, as well as employers, Accountable Care Organizations and Integrated Delivery Networks, offering solutions that support personalized care for high-risk and high-cost patients and ensuring that medication regimens are safe, effective and aligned with their unique health needs.

Through collaborative relationships with payers and payviders, PharmD Live® boosts CMS quality metrics and generates revenues with no upfront costs. Its services reduce clinical workload, improve care coordination, and generate additional revenue through enhanced care management and optimization of quality measures. 

Pharmacist Care Managers Improve Patient Outcomes

PharmD Live®’s services revolutionize chronic care and medication management. Its  pharmacist-led, AI-powered solutions deliver proactive, patient-centered care that supports both healthcare providers and patients. Contact us to learn more.

The post Beyond the Prescription: Virtual Pharmacists Analyze Weight Loss Drugs appeared first on Pharmdlive.