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Is Ozempic hard on kidneys?

The analysis found that significant beneficial effects on kidney function and renal outcomes were seen with Ozempic and Victoza, with fewer people showing a persistent eGFR reduction and people with pre-existing kidney disease achieving significantly slower annual loss of kidney function versus placebo.

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The analysis found that significant beneficial effects on kidney function and renal outcomes were seen with Ozempic and Victoza, with fewer people showing a persistent eGFR reduction and people with pre-existing kidney disease achieving significantly slower annual loss of kidney function versus placebo. The GLP-1 agonist was found to be non-inferior to placebo in the PIONEER 6 trial, with 3.8% of patients taking it experiencing cardiovascular complications compared to 4.8% of the control group, with an added 50% reduction in death. Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk told PharmaTimes exclusively that “All these investments; the SOUL trial, the FLOW trial, the STEP trial and FOCUS trial - in a matter of a few weeks we have started three major outcome studies which is a really unique situation for one single medicinal product. It’s because we aim to invest heavily in semaglutide, to show that it has all of these possible indications. So, that’s the dream come true for us and for the patients too I believe.” He went on to explain why the drugs are important for this area of significant unmet need, saying: “SGLT-2 inhibitors are doing great things for the kidneys. However, that’s for one class of patients only, and they don’t have any anti-diabetic action because they are dependent on the kidneys filtering, and when they kidneys stop filtering, they stop working. “Even though they can protect the kidneys, they can’t do anything for the diabetic condition when patients have severely impaired renal function. But, Ozempic and Victoza work independently from the kidneys. They are not eliminated by the kidneys and they can even be given to a patient via haemodialysis. “They can be given to patients with any degree of kidney dysfunction or impairment. So, it is a relatively unique situation. Victoza saw a 22% kidney improvement and Ozempic saw 36%, in the LEADER and SUSTAIN 6 trials respectively.” Despite reno protective standard of care recommendations, up to 40% of people with type II diabetes develop chronic kidney disease, but Novo Nordisk are aiming for “semaglutide to be the director of the metabolic orchestra”, and for it to be see as “more of a cardio metabolic renal agent, tackling the whole complex.” Ozempic was approved by the European Commission on 8 February 2018, based on the SUSTAIN programme, a global clinical development programme that comprised eight phase 3a trials, encompassing more than 8,000 adults with type II diabetes. In Europe, approved in 2009, Victoza is indicated for the treatment of adults with insufficiently controlled type II diabetes together with diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes.

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Does Ozempic come in a pill form?

For people with type 2 diabetes, new study results show that a once-daily pill (oral) version of Ozempic (semaglutide) is safe for the heart. The study, called PIONEER 6, is the first-ever trial examining heart outcomes for a GLP-1 agonist delivered as a pill (they are normally injected).

By Emma Ryan and Ann Carracher

New study results from the PIONEER 6 trial show that once-daily pill semaglutide does not increase the risk of heart-related death, heart attack, and stroke For people with type 2 diabetes, new study results show that a once-daily pill (oral) version of Ozempic (semaglutide) is safe for the heart. The study, called PIONEER 6, is the first-ever trial examining heart outcomes for a GLP-1 agonist delivered as a pill (they are normally injected). Compared to placebo (a “nothing” pill), oral semaglutide reduced the risk of a combination of heart-related death, non-fatal heart attack, and non-fatal stroke by 21%, but this difference was not statistically significant. This general benefit was mainly driven by a 51% risk reduction for heart-related death. Novo Nordisk plans to seek US and European approval for oral semaglutide in the first half of 2019. Full results from PIONEER 6, including changes in weight and A1C, will likely be released sometime in 2019.

Why do these results matter?

People with type 2 diabetes are at a higher risk of heart disease. Having the option to take one medication that has glucose-lowering, weight loss, and heart protection effects would be welcome to many. There are already diabetes medications with heart benefits, including Jardiance, Invokana, and Victoza. On the other hand, there are diabetes medications like Onglyza that may be less suitable for people with existing heart failure. If you are looking to discuss heart health with your healthcare provider, check out this discussion guide created by the American Diabetes Association and the American Heart Association.

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