- OZEMPIC for Weight Loss
- Semaglutide may help people with obesity lose weight
- Ozempic vs Victoza: Main Differences and Similarities
- Ozempic vs Victoza Side by Side Comparison
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- A1c Lowering and Weight Loss at Once-Weekly Convenience: Ozempic
- Questions About Possible Side Effects
- SIDE EFFECTS
- Clinical Trials Experience
- Pool Of Placebo-Controlled Trials
- Pool Of Placebo-And Active-Controlled Trials
- Common Adverse Reactions
- Other Adverse Reactions
- Injection Site Reactions
- Increases In Amylase And Lipase
- Increases In Heart
- Fatigue, Dysgeusia And Dizziness
- SIDE EFFECTS
- What is Ozempic?
- Who can take Ozempic?
- FDA-approved to treat obesity, even in those without diabetes
- Common Ozempic side effects
- Serious (less common) Ozempic side effects
OZEMPIC for Weight Loss
I am increasingly using a once a week simple injection to help patients lose weight. A pharmaceutical drug initially used to treat people with type 2 diabetes is helping obese people without diabetes lose weight. Novo Nordisk’s semaglutide compound, under the brand name Ozempic, is designed to act in the body similarly to the hormone glucagon-like peptide 1 (GLP-1). Traditionally taken once a week via injection, this GLP-1 hormone receptor agonist works in the body by regulating insulin secretion and suppressing appetite. The research was presented at the Endocrine Society’s 100th annual meeting. It has yet to be published in a peer-reviewed journal. “This randomized study of weight loss induced with semaglutide in people with obesity but without diabetes has shown the highest weight reductions yet seen for any pharmaceutical intervention,” explained Patrick M. O’Neil, PhD, director of the Weight Management Center and a professor of psychiatry and behavioral sciences at the Medical University of South Carolina. About 65 percent of participants taking semaglutide lost at least 10 percent of their body weight, compared to only 10 percent from the placebo group and 34 percent in the liraglutide group. Details about Ozempic: Like most medications, there are side effects with Ozempic. The most notable are nausea and mild digestion discomfort issues. It’s also crucial to start with a low dose and increase gradually as instructed by a healthcare professional. Some cautionary words: “The number one barrier to using weight loss meds is the cost,” Dr. Eric Sodicoff, author of the Phoenixville Nutrition Guide, told Healthline. “Most of these meds must be paid for out of pocket and Ozempic is an eye-popping $700 per pen.” In Sodicoff’s experience with treating people without diabetes struggling with weight loss, many patients stop taking the medication after a month or two. “They are not considered life-sustaining the way diabetes and blood pressure medications are,” explained Sodicoff. Before turning to prescribing medications, Sodicoff believes in teaching his obese patients without diabetes to focus on lifestyle changes first. “High-fat, moderate protein, low-carb diets can perform amazingly well in most patients,” said Sodicoff. “It’s always the first approach to which medications are then occasionally added.”
Semaglutide may help people with obesity lose weight
Posted: 20 March 2018 | Dr Zara Kassam (European Pharmaceutical Review) |
A compound that mimics a naturally occurring hormone that regulates appetite may help people who have obesity but not diabetes to lose weight…
A compound that mimics a naturally occurring hormone that regulates appetite may help people who have obesity but not diabetes to lose weight, a new study suggests.
The compound, semaglutide, has a chemical structure that is very similar to the hormone glucagon-like peptide 1 (GLP-1), which regulates both insulin secretion and appetite. In December, the US Food and Drug Administration approved the semaglutide injection Ozempic as a once-weekly adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
“This randomised study of weight loss induced with semaglutide in people with obesity but without diabetes has shown the highest weight reductions yet seen for any pharmaceutical intervention,” said lead author Dr Patrick M. O’Neil, Director of the Weight Management Center and Professor of Psychiatry and Behavioral Sciences at the Medical University of South Carolina in Charleston, S.C.
The new study included 957 participants, 35 percent of whom were male. All participants had a body mass index (BMI) of at least 30 but did not have diabetes. They were randomly assigned to seven different groups. Five groups received different doses of semaglutide (between 0.05 mg and 0.4 mg) via injection once daily; a sixth group received a placebo, and a seventh group received 3 mg of the diabetes drug Saxenda. All participants received monthly diet and exercise counselling.
After one year, all participants receiving semaglutide had lost significantly more weight than those receiving placebo. The higher the dose participants received, the greater their average weight loss. Participants who received 0.05 mg of semaglutide daily lost an average of 6.0 percent of their body weight; the 0.1 mg group lost an average of 8.6 percent; the 0.3 mg group lost an average of 11.2 percent; and those receiving a daily dose of 0.4 mg lost an average of 13.8 percent. Those receiving liraglutide lost an average of 7.8 percent of their body weight, while those in the placebo group lost only 2.3 percent on average.
Sixty-five percent of participants who received 0.4 mg of semaglutide per day lost at least 10 percent of their body weight, compared with 10 percent of those in the placebo group and 34 percent of the liraglutide group.
The most common adverse events in those taking semaglutide were mild/moderate nausea, as seen previously with GLP-1 receptor agonists.
Dr O’Neil noted that further studies of semaglutide for obesity are underway.
The research was presented at ENDO 2018, the Endocrine Society’s 100th annual meeting in Chicago, Ill.
Medical University of South Carolina
Dr Patrick M. O’Neil
Related diseases & conditions
Ozempic vs Victoza: Main Differences and Similarities
Ozempic and Victoza are injectable medications used for the management of blood sugar levels in diabetes. They are both classified in a group of medications known as GLP-1 agonists. Ozempic and Victoza essentially work by improving the effects of insulin in the body. They also increase feelings of fullness after eating which can help improve weight loss.
Ozempic is the brand name for semaglutide. It is a relatively new drug approved in 2017. Ozempic is used once weekly to improve high blood sugar levels for adults with type 2 diabetes mellitus. It is recommended to be used in combination with appropriate diet and exercise. It is not recommended as a first-line therapy.
Ozempic is available as a 2 mg/1.5 mL injection in prefilled single-use pens. There are two single-use pens available: a 0.25 mg or 0.5 mg per-injection pen and a 1 mg per-injection pen. Dosing is usually started at 0.25 mg once weekly and increased accordingly. Doses can be increased with a minimum time of two days between dose changes.
Victoza is the brand name for liraglutide. It is a GLP-1 agonist used once daily to treat type 2 diabetes mellitus. Recent updates in 2017 state that Victoza can also reduce the risk of major cardiovascular events such as stroke and heart attack. This may make it a preferred option for those with heart disease and diabetes.
Victoza is available as a 6 mg/mL solution in a multi-dose pen. Pens can administer doses of 0.6 mg, 1.2 mg, or 1.8 mg. It is usually started at 0.6 mg per day for one week. Doses can then be increased in weekly intervals.
Ozempic vs Victoza Side by Side Comparison
Ozempic and Victoza are similarly acting GLP-1 agonists. Their features can be further compared in the table below.
|Common Side Effects|
|Is there a generic?|
|Is it covered by insurance?|
|Average Cash Price|
|SingleCare Discount Price|
|Can I use while planning pregnancy, pregnant, or breastfeeding?|
Ozempic and Victoza are two GLP-1 agonists that can manage blood sugar levels in diabetes. They are also popular medications because of their weight loss benefits. While Victoza can improve diabetes and weight management, it can also reduce risks associated with heart disease. In this way, Victoza may be a preferred option for some people.
Ozempic and Victoza are administered by injection. Ozempic is injected once weekly while Victoza is injected once daily. Ozempic is only available in single-use pens while Victoza is available in multi-dose pens. However, this is reasonable considering their differences in frequency of dosing.
Both medications share similar side effects such as nausea, diarrhea, or constipation. However, these side effects usually resolve on their own. Both Ozempic and Victoza also have black box warnings for thyroid cancer. Therefore, they are not recommended in those with a personal or family history of thyroid cancer.
The information provided here should be discussed with your physician. Because of their possible risks and differences in dosing, both medications should only be used under the supervision of a healthcare provider. Ozempc or Victoza may be preferred depending on your condition and other medications you may be taking.
How does this medication work? What will it do for me?
Semaglutide belongs to a group of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It is used alone or with other medications to improve blood glucose (sugar) levels for people with type 2 diabetes.
Diabetes medications such as semaglutide are used when diet, exercise, weight reduction and medications such as metformin, glyburide, or insulin have not been found to lower blood sugar well enough on their own. It works by helping your body make more insulin and control blood glucose levels.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each 1 mL of clear, colourless solution contains 1.34 mg of semaglutide. Nonmedicianl ingredients: disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.
There are 2 forms of the pre-filled, multi-dose, disposable pen. One pen delivers doses of 0.25 mg and 0.5 mg semaglutide, while the other pen delivers 1 mg doses only.
Each pen contains 2 mg of semaglutide.
How should I use this medication?
The recommended adult starting dose of semaglutide is 0.25 mg once a week. Semaglutide is injected subcutaneously (under the skin) on your stomach area (abdomen), upper thigh, or upper arm, exactly as instructed by your doctor or diabetes educator. It can be injected at any time of the day, without regard to meals. After four weeks, your dose will increase to 0.5 mg once a week. If needed, your doctor may increase the dose again in four weeks to 1mg once a week. Do not change your dose unless your doctor has told you to do so.
If you are also using insulin, each medication should be injected separately.
Your doctor or diabetes instructor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor if you have any questions. If a caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 5 days since the missed dose, inject your dose as soon as possible. If it less than 48 hours until your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose or increase your dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Semaglutide should be clear and colourless. Do not use semaglutide if you notice particles or anything unusual in the appearance of the solution.
After the first use of the pen, this medication can be stored at room temperature or in the refrigerator for up to 56 days (8 weeks). Always store this medication without a needle attached to prevent contamination, infection, and leakage. To protect this medication from light, always keep the pen cap on when you are not using it.
Store this medication in the refrigerator, do not allow it to freeze, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to semaglutide or any ingredients of the medication
- are pregnant
- are breast-feeding
- have a personal or family history of thyroid cancer
- have multiple endocrine neoplasia syndrome type 2 (a disease where people have tumours in more than one gland in their body)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- change in the taste of food or drink
- decreased appetite
- gas or burping
- mild abdominal pain or bloating
- redness, itching, or swelling at the injection site
- weight loss
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of low blood glucose (e.g., anxiety, blurred vision, confusion, difficulty concentrating, difficulty speaking, dizziness, drowsiness, fast heartbeat, feeling jittery, headache, hunger, irritability, nausea, nervousness, numbness or tingling of the lips or tongue, sweating, tiredness, trembling, weakness)
- symptoms of gallstones (e.g., intermittent, severe, dull pain in the upper right part of the abdomen, nausea, vomiting, intolerance of fatty or greasy foods)
- symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
- vision changes caused by diabetic retinopathy (e.g., blurred or changing vision, floaters, changes in colour vision)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe hypoglycemia (e.g., disorientation, loss of consciousness, seizures)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- symptoms of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking medication to manage your blood glucose levels.
Heart problems: This medication may increase heart rate and may affect how electrical impulses travel through the heart muscle. If you have heart disease or an abnormal heart rhythm (e.g., heart block or fast heart rate), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: Semaglutide may cause decreased kidney function, kidney failure or worsening chronic kidney failure. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Low blood glucose (hypoglycemia): People who use semaglutide and are also taking a sulfonylurea (e.g., glyburide, gliclazide) or insulin to control high blood sugar are more at risk of experiencing hypoglycemia (low blood sugar). If you experience symptoms of hypoglycemia such as a cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue or lips, contact your doctor. Your doctor may need to adjust the dose of your medication(s).
Pancreatitis (inflammation of the pancreas): Semaglutide can cause pancreatitis. If you experience symptoms of pancreatitis such as severe and persistent abdominal pain that may move to the back with or without vomiting, contact your doctor immediately. If you have previously had pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Risk of thyroid cancer: In rare cases, people have developed thyroid cancer while using medications similar to semaglutide. People with a personal or family history of thyroid cancer or people who have multiple endocrine neoplasia syndrome type 2 (a disease where people have tumours in more than one gland in their body) should not use this medication. If you develop difficulty swallowing or breathing, hoarseness or notice a mass developing in your neck, contact your doctor as soon as possible.
Pregnancy: Semaglutide should not be used during pregnancy. If you become pregnant while using this medication, contact your doctor immediately.
Breast-feeding: It is not known if semaglutide passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between abacavir – lamivudine and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ozempic
A1c Lowering and Weight Loss at Once-Weekly Convenience: Ozempic
By Jeemin Kwon, Ann Carracher, and Payal Marathe
People with type 2 can now get the once-weekly injectable in the US. The latest GLP-1 to show strong A1c-lowering and weight loss, Ozempic will also reach Europe in the second half of 2018
Many in the diabetes world are buzzing about Novo Nordisk’s once-weekly GLP-1 injectable drug, Ozempic, which is now available in US pharmacies, following FDA approval two months ago for people with type 2 diabetes. Ozempic was also recently approved in Europe for people with type 2 diabetes, with a launch expected in the second half of 2018.
In clinical trials, Ozempic led to greater A1c reduction and weight loss than Bydureon and Trulicity. In the most recent direct comparison trial against Trulicity, Ozempic users had an average 1.8% drop in A1c compared to a 1.4% drop for Trulicity users (both started at an A1c of 8.2%), and lost 10-14 pounds with Ozempic (5-7% weight loss) compared to 5-7 pounds lost on Trulicity (2-3% weight loss).
Additionally, Ozempic has data from a two-year heart safety outcomes trial on its label. The heart safety trial, which compared Ozempic to placebo in patients with existing heart disease, found a 5-42% reduction in risk for non-fatal heart attacks, non-fatal strokes, or heart-related death. To strengthen the evidence of Ozempic’s heart benefit, Novo Nordisk is planning a major heart health study that will start later in 2018.
Ozempic comes in a FlexTouch pen, similar to the pens for Novo Nordisk’s once-daily injectable GLP-1, Victoza. In the US, Ozempic will be more expensive than Victoza, but priced similarly to Trulicity, another once-weekly GLP-1. While Novo Nordisk is still negotiating with insurance companies to determine reimbursement rates, people with private insurance could pay as little as $25 per month with the Ozempic savings card (maximum savings: $150 per prescription).
As a reminder, Ozempic is the latest in a class of type 2 diabetes drugs called GLP-1 agonists, which include once-weekly Bydureon and Trulicity, once-daily Victoza and Lyxumia, and twice-daily Byetta. So far, all of these drugs require injections. Novo Nordisk is working on a pill version of Ozempic, but it is still four or five years away from being available in pharmacies.
The GLP-1 class has become more popular with patients able to get it in the US, likely because of the weight loss associated with these drugs and the stability that it brings to diabetes management. diaTribe Advisory Board member Dr. Steve Edelman has previously said, “We have new approved fixed combinations, implantable micro pumps that deliver exenatide for a year, we have once-weekly agents, and all kinds of new options. If I had to pick one class with the biggest effect, I would have to pick GLP-1’s.”
Questions About Possible Side Effects
Ozempic may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
- Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Changes in vision. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. You should inform your health care provider if you have diabetic retinopathy or if you experience changes in vision during treatment with Ozempic®.
- Low blood sugar. Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low blood sugar may include:
- dizziness or light-headedness
- blurred vision
- anxiety, irritability, or mood changes
- slurred speech
- confusion or drowsiness
- fast heartbeat
- feeling jittery
- Kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
- Serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-cell Tumors
- Diabetic Retinopathy Complications
- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
- Acute Kidney Injury
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Pool Of Placebo-Controlled Trials
The data in Table 1 are derived from 2 placebo-controlled trials (1 monotherapy trial and 1 trial in combination with basal insulin) in patients with type 2 diabetes . These data reflect exposure of 521 patients to OZEMPIC and a mean duration of exposure to OZEMPIC of 32.9 weeks. Across the treatment arms, the mean age of patients was 56 years, 3.4% were 75 years or older and 55% were male. In these trials 71% were White, 7% were Black or African American, and 19% were Asian; 21% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.8 years and had a mean HbA1c of 8.2%. At baseline, 8.9% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m²) in 57.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m²) in 35.9% and moderately impaired (eGFR 30 to 60 mL/min/1.73m²) in 6.9% of patients.
Pool Of Placebo-And Active-Controlled Trials
The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 7 placebo-and active-controlled glycemic control trials including two trials in Japanese patients evaluating the use of OZEMPIC as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3150 patients with type 2 diabetes were treated with OZEMPIC for a mean duration of 44.9 weeks. Across the treatment arms, the mean age of patients was 57 years, 3.2% were 75 years or older and 57% were male. In these trials, 60% were White, 6% were Black or African American, and 31% were Asian; 16% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.2 years and had a mean HbA1c of 8.2%. At baseline, 7.8% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m²) in 63.1%, mildly impaired (eGFR 60 to 90 mL/min/1.73m²) in 34.3%, and moderately impaired (eGFR 30 to 60 mL/min/1.73m²) in 2.5% of the patients.
Common Adverse Reactions
Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo, and occurred in at least 5% of patients treated with OZEMPIC.
Table 1: Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus
In the pool of placebo-and active-controlled trials and in the 2-year cardiovascular outcomes trial, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC than placebo (placebo 15.3%, OZEMPIC 0.5 mg 32.7%, OZEMPIC 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation. More patients receiving OZEMPIC 0.5 mg (3.1%) and OZEMPIC 1 mg (3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).
Other Adverse Reactions
Table 2 summarizes the incidence of events related to hypoglycemia by various definitions in the placebo-controlled trials.
Table 2: Hypoglycemia Adverse Reactions in Placebo-Controlled Trials In Patients with Type 2 Diabetes Mellitus
Hypoglycemia was more frequent when OZEMPIC was used in combination with a sulfonylurea . Severe hypoglycemia occurred in 0.8% and 1.2% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 17.3% and 24.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea. Severe or blood glucose confirmed symptomatic hypoglycemia occurred in 6.5% and 10.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea.
Injection Site Reactions
Increases In Amylase And Lipase
In placebo-controlled trials, patients exposed to OZEMPIC had a mean increase from baseline in amylase of 13% and lipase of 22%. These changes were not observed in placebo-treated patients.
In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients.
Increases In Heart
Rate In placebo-controlled trials, OZEMPIC 0.5 mg and 1 mg resulted in a mean increase in heart rate of 2 to 3 beats per minute. There was a mean decrease in heart rate of 0.3 beats per minute in placebo-treated patients.
Fatigue, Dysgeusia And Dizziness
Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC include fatigue, dysgeusia and dizziness.
Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with OZEMPIC may develop anti-semaglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to semaglutide in the studies described below cannot be directly compared with the incidence of antibodies in other studies or to other products.
Across the placebo-and active-controlled glycemic control trials, 32 (1.0%) OZEMPIC-treated patients developed anti-drug antibodies (ADAs) to the active ingredient in OZEMPIC (i.e., semaglutide). Of the 32 semaglutide-treated patients that developed semaglutide ADAs, 19 patients (0.6% of the overall population) developed antibodies cross-reacting with native GLP-1. The in vitro neutralizing activity of the antibodies is uncertain at this time.
Read the entire FDA prescribing information for Ozempic (Semaglutide Injection)
Ozempic is one of the many injectable diabetes medications on the market today. While it’s similar to others on the market, it offers several unique details, too.
In this article, we’ll look at how Ozempic works, who can take it, and the most common side effects.
Table of Contents
What is Ozempic?
Semaglutide — known under the brand name Ozempic and manufactured by Novo Nordisk — is a glucagon-like peptide 1 (GLP-1) agonist. This drug category is also referred to as an incretin mimetic, which means it mimics the other hormones in the body that help regulate blood sugar levels.
Taken via injection once per week, Ozempic works to improve your blood sugar in several ways:
- Increases your body’s natural insulin production
- Reduces your appetite which can lead to weight-loss
- Reduces the amount of glucose produced by your liver
- Delays the emptying of food from your stomach into the small intestine
For many people with type 2 diabetes, your body may actually struggle to naturally produce enough of this hormone which leads to a cycle of overeating which further worsens insulin resistance, blood sugar levels, and weight-management struggles.
In a clinical study, Ozempic reduced the patient’s A1c by 1.4 to 1.6 percent after 30 weeks of treatment. It also reduced fasting blood sugar levels by 41 to 44 mg/dL over that time period.
Who can take Ozempic?
Ozempic is only recommended for people living with non-insulin-dependent diabetes (typically type 2 diabetes). Ozempic is not a substitute for insulin and is not approved for use in patients with type 1 diabetes.
Ozempic is not recommended as the first pharmaceutical treatment you try as a person with type 2 diabetes. Instead, medications like Metformin would be used first, and Ozempic could be an eventual choice if other options aren’t effective.
The dosage of Ozempic should start small and be increased gradually to the full dose over the course of 4 weeks. This should be managed closely by your healthcare team.
If you miss a dose, talk to your doctor as soon as you realize. Depending on how many days it’s been since your missed dose, you may be able to take it as soon as you remember. If it’s too close to your next Ozempic dose, you may be advised to wait until your next dose.
You should talk to your doctor before taking Ozempic if
- You have a history of problems with your pancreas or kidneys
- You have a history of diabetic retinopathy
- You are pregnant or plan to become pregnant soon
- You are breastfeeding
You shouldn’t take Ozempic if
- You have a history of pancreatitis
- You are under 18 years old
- You have a history of thyroid tumors or thyroid cancer
- You or a family member have ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
FDA-approved to treat obesity, even in those without diabetes
Initially intended for people with type 2 diabetes, Ozempic has gained a reputation in helping those struggling with obesity, too.
In a study with almost 1000 participants, all of whom had a body mass index of 30 or higher but did not have diabetes, Ozempic led to weight-loss in 65 percent of participants compared to only 34 percent of participants taken liraglutide (Victoza).
“This randomized study of weight loss induced with semaglutide in people with obesity but without diabetes has shown the highest weight reductions yet seen for any pharmaceutical intervention,” said study author Patrick M. O’Neil, Ph.D., director of the Weight Management Center in South Carolina.
While it’s similar to Trulicity (dulaglutide, manufactured by Lilly), Ozempic is the first GLP-1 drug approved for use in patients with obesity even if they do not have type 2 diabetes.
Always consult your healthcare provider before taking Ozempic. Ozempic should NOT be used as a weightloss drug without medical supervision.
Common Ozempic side effects
According to the manufacturer, the most common and most harmless side effects of Ozempic include:
- Abdominal pain
These side-effects are directly related to the drug’s impact on your stomach’s rate of digestion which benefits your blood sugars.
Serious (less common) Ozempic side effects
- Thyroid tumors — possibly cancerous
- Swelling in your neck
- Hoarseness in throat
- Difficulty swallowing
- Shortness of breath
- Pain in your abdomen or back
- Changes in your vision
- Tell your healthcare team immediately
- Low blood sugar
- Discuss this with your doctor to adjust the dosage or other meds
- Worsened kidney issues and kidney failure
- Serious allergic reaction
- Difficulty breathing
The concern regarding thyroid tumors is based on the results of Ozempic and similar medications in rats and mice. Some rats and mice developed thyroid tumors, some of which were cancerous. It’s not known if Ozempic has this effect in humans.
Interested in using Ozempic for your own diabetes management? Talk to your doctor to determine whether this might be an appropriate medication for you.
Suggested next posts:
- Victoza Side Effects: What You Need to Know
- Metformin Side Effects: What You Need to Know
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