US FDA issued a warning: two diabetes drugs may be associated with an increased risk of heart failure April 11, 2016 Source: Bio Valley US health officials warned on Tuesday that diabetes drugs containing saxagliptin and alogliptin may increase the risk of heart failure, especially in patients with heart disease or kidney disease. According to the US FDA, the drugs containing these components are saxagliptin tablets (Onglyza) and saxagliptin hydrochloride (KombiglyzeXR, prolonged saxagliptin and metformin release), alogliptin tablets (Nesina), Kazano (A Gliptin and metformin) and Oseni (alogliptin and pioglitazone). The US FDA said that patients with type 2 diabetes who take these drugs should not stop taking them without consulting with a doctor. However, the US FDA also added that patients taking these drugs should consult their doctor if they show signs and symptoms of heart failure. These signs and symptoms include: (1) In the daily activities, abnormal shortness of breath occurs; (2) difficulty breathing when lying down; (3) fatigue, weakness or fatigue; (4) Weight gain accompanied by swelling of the ankles, feet, legs or stomach. The US FDA said that for these security risks, it requires writing new warning messages on the labels of these drugs. Saxagliptin and alogliptin belong to the class of dipeptidylpeptidase-4 (DPP-4) inhibitors and are used in combination with proper diet and appropriate exercise to reduce blood glucose levels in adult patients with type 2 diabetes. The US FDA said its warning was based on the results of two large clinical trials involving heart patients. These two clinical trials have found that patients taking saxagliptin or alogliptin are more likely to be hospitalized for heart failure than patients receiving placebo. In the saxagliptin clinical trial, 3.5% of patients receiving this drug were hospitalized for heart failure, compared with 2.8% of patients receiving placebo. This means that of every 1,000 patients taking this drug, 35 were hospitalized for heart failure, and 28 out of every 1,000 patients who did not take the drug were hospitalized for heart failure. The US FDA added that risk factors also include a history of heart failure or kidney damage. The US FDA said that in the alogliptin clinical trial, 3.9% of patients receiving this drug were hospitalized for heart failure, compared with 3.3% of patients receiving placebo. This means that of every 1,000 patients taking this drug, 39 were hospitalized for heart failure, and 33 out of every 1,000 patients who did not take the drug were hospitalized for heart failure. The US FDA said it is asking doctors to consider suspending saxagliptin or alogliptin in patients with heart failure. It also said that if the current treatment drug does not control blood sugar levels well, then other diabetes drugs may be needed. Dr. MinishaSood, director of the Inpatients Diabetes Division at Lenox Hill Hospital, New York, USA, “It is still unclear whether this is the 'class effect' for all drugs in the DPP-4 inhibitor type. It is only unique to saxagliptin and aglitin. It is still unclear whether this recommendation is applicable to patients with a relatively low risk of heart disease." Sood said that some studies have shown that DPP-4 inhibitors do reduce cardiovascular problems in some patients. “Therefore, the final impact of these drugs on cardiac events remains to be seen and further research is needed,†she said. Sood said that these drugs "are still a good treatment option for many people with diabetes because they are oral medications that effectively lower blood sugar levels and the resulting side effects are generally tolerable." She added that patients should discuss any symptoms or side effects with their health care providers before changing medications. For the Sports Nutrition and food supplement market, we have created a range of unique high-quality ingredients. All of Our protein is certified to applicable organic standards: National Organic Program (NOP) and European Union (EU), in order to ensure that your product benefits from optimal positioning, whether you operate on a global or local scale, we`ll work to keep you ahead of trends and improve your profitability. Plant Protein,Organic Rice,Brown Rice Protein,Pumpkin Seed Protein Organicway (xi'an) Food Ingredients Inc. , https://www.organicwayinc.com
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