An epidemic is sweeping the country, with no end in sight. Heart failure and other ketone side effects are on the rise, but there’s not much we can do to stop them.
The “kombiglyze manufacturer” is a drug that has been in the news lately. The drug has been linked to heart failure and other side effects. If you are looking for more information on this drug, then you can find it here.
Kombiglyze XR (saxagliptin and metformin), a type 2 diabetes medicine, may raise the risk of heart failure and other cardiovascular problems in certain people.
Patients with a history of cardiovascular difficulties are 27 percent more likely to be hospitalized for heart failure when using Kombiglyze XR or its sister medication Onglyza, according to studies (saxagliptin). The FDA now requires AstraZeneca, the drug’s producer, to insert a warning on the drug’s labeling that patients may have heart failure or other cardiovascular problems as a result of these results.
What Is Kombiglyze XR and How Does It Work?
Kombiglyze XR is used to treat type 2 diabetes by assisting the body in producing more insulin and responding to it more effectively, as well as lowering the quantity of glucose produced by the body.
Kombiglyze XR and Onglyza are incretin mimetics, a family of medicines that includes Byetta, Victoza, and Januvia. These medications work by simulating a hormone that causes the body to create more insulin.
Onglyza belongs to a subclass of dipeptidyl peptidase-4 (DPP-4) inhibitors within that class. These medications target DPP-4, an enzyme that degrades GLP-1, a hormone produced in the stomach. This is significant for type 2 diabetes patients because GLP-1 stimulates the pancreas to make insulin, which is necessary for blood glucose regulation. Drugs like Onglyza target DPP-4, allowing the body to retain GLP-1 for longer periods of time and, as a result, create larger amounts of insulin in the body.
Kombiglyze has a similar impact on patients, but it also combats high blood sugar in additional ways since it combines Onglyza (saxagliptin) with metformin.
Metformin, manufactured by Bristol-Myers Squibb, belongs to a class of medicines called as biguanides. These medications do not help the body create more insulin; instead, they help the body react to insulin more effectively. They also assist in lowering the quantity of blood sugar produced by the liver and absorbed by the intestines.
Kombiglyze is a DPP-4 inhibitor and metformin combination medicine that treats type 2 diabetes by assisting the body in producing more insulin and responding to it more effectively, as well as lowering the quantity of glucose produced by the body. Merck’s Janumet works in a similar way by mixing Januvia (sitagliptin) with metformin.
Is Kombiglyze XR Increasing the Risk of Heart Failure in Patients?
When compared to individuals who were given a placebo, those who were given Onglyza and Kombiglyze XR had a 27 percent higher likelihood of being hospitalized for heart failure.
According to the findings of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, or SAVOR study, financed by AstraZeneca and Bristol-Myers Squibb, patients using Kombiglyze XR and Onglyza may have a higher risk of being hospitalized for heart failure.
Almost the course of two years, the researchers monitored over 16,000 people with a history of cardiac issues. Half of the participants were given Onglyza or Kombiglyze XR while the other half were given a placebo.
When compared to individuals who were given a placebo, those who were given Onglyza and Kombiglyze had a 27 percent higher likelihood of being admitted to the hospital for heart failure. While using these medicines, participants faced a high risk of all-cause death.
Following a review of the SAVOR findings, 14 of the 15 FDA panelists decided to require Onglyza and Kombiglyze XR to contain a warning about the risk of cardiac harm. Kombiglyze was cautioned by the FDA in 2016 that it might induce heart failure in certain patients, especially those with a history of heart disease and renal illness.
But why do these medications have such an effect? Scientists are still undecided. One possibility is that they impact heart rate and that there may be GLP-1 receptors in the heart’s atrium that the medications are influencing.
“If you have a patient with heart failure and want to add this drug—and this drug does have a lot of important [beneficial] effects (e.g., doesn’t cause weight gain, doesn’t cause hypoglycemia, etc.)—you should closely monitor your patient,” Dr. Raz, one of the SAVOR trial’s leading researchers, advised.
What Does the SAVOR Trial Look Like in Comparison to Other Research?
Following the SAVOR findings, a research published in the British Medical Journal (BMJ) looked into the link between DPP-4 inhibitors and heart failure further. They looked at findings from clinical studies published between June 25, 2015, and June 25, 2015, on Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov.
Because the only published data were based on trials with short follow-up periods, researchers determined that the risk of heart failure from these medicines was still unknown.
“Both randomized controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospitalization for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared to no use,” the researchers cautioned.
What Are the Other Side Effects of Kombiglyze XR?
Pancreatitis and Pancreatic Cancer are two diseases that affect the pancreas.
Patients using Kombiglyze XR may have a 50% enlargement of their pancreas in rare situations.
In addition to cardiovascular concerns, the FDA has issued a warning concerning Kombiglyze’s impact on the pancreas, stating that the medicine may induce pancreatic inflammation.
The FDA issued a pancreatitis warning in 2011. They warned in a 2013 safety notification that Kombiglyze’s impact on the pancreas might be more significant, citing pre-cancerous cellular alterations in the pancreas of some patients who took the medicine. They warned that these cellular alterations might lead to pancreatic cancer.
Although the exact etiology of pancreatitis caused by incretin mimetic medicines is unknown, doctors suspect it is linked to pancreatic enlargement in certain people. Patients on these medicines may develop a 50% enlargement of their pancreas in certain situations. Pancreatitis is caused by pancreatic enlargement, which produces compression and inflammation.
The desert-based Gila Monster provided the inspiration for the first incretin mimetic medication, exenatide. The lizard feeds infrequently, possibly for months at a time, but when it does, the polypeptides in its saliva aid in the quick growth of its pancreas to accept food.
It’s hardly unexpected that incretin mimetics like Onglyza and Kombiglyze XR cause the pancreas to grow in humans, according to BMJ experts, since it does so in the Gila Monster. The BMJ researchers questioned the pharmaceutical industry about why consumers and physicians weren’t informed about the health dangers of these medications sooner.
Lactic Acidosis is a condition in which the body produces too much lactate
Metformin has a boxed warning for Lactic Acidosis is a condition in which the body produces too much lactate—the highest warning the FDA bestows.
Lactic Acidosis is a condition in which the body produces too much lactate is another known side effect of Kombiglyze XR, which the FDA has officially issued a warning for. Lactic Acidosis is a condition in which the body produces too much lactate is when lactic acid builds up in the bloodstream, resulting in low pH which can be serious and even fatal.
Kombiglyze has a risk of causing Lactic Acidosis is a condition in which the body produces too much lactate because of the presence of metformin. Metformin has a boxed warning for the condition—the highest warning the FDA bestows. Patients with a history of kidney, liver, or heart problems are particularly at risk of suffering from Lactic Acidosis is a condition in which the body produces too much lactate.
Joint Pain that is Severe
The FDA issued a warning in 2015 after receiving many adverse event reports from patients who complained of joint discomfort. Some individuals had so severe joint pain that they needed to be admitted to the hospital.
Have there been any lawsuits filed against AstraZeneca?
Hundreds of cases allege that AstraZeneca and Bristol-Myers, who previously produced Onglyza and Kombiglyze XR before selling them to AstraZeneca, neglected to do proper safety assessments on the medications.
Individuals who have had heart failure or other cardiovascular ailments such as congestive heart failure or myocardial infarction may be able to file a case against AstraZeneca and Bristol-Myers. Contact us for a free, no-obligation legal consultation to learn more about lawsuit eligibility.
Frequently Asked Questions
What are the side effects of kombiglyze?
A: Kombiglyze is a drug that has been used for over 50 years and there are many side effects to this medication. Some of the most common side effects include shortness of breath, vomiting, dizziness, rapid heart rate, hives (skin rash), and muscle cramps.
What class of drugs has a boxed warning for congestive heart failure?
A: Boxed warnings can be found on the drugs package insert, which is a breakdown of information about an individual drug by its manufacturer.
Is kombiglyze safe?
A: Kombiglyze is a vegan protein that is 100% free of hormones, antibiotics, and pesticides. Furthermore, its made with organic brown rice syrup to provide healthy glucose and antioxidant benefits.