Empagliflozin Reduced Risk of Renal Disease Progression, CV Death Across CKD Spectrum in EMPA-KIDNEY | Canada News Media
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Empagliflozin Reduced Risk of Renal Disease Progression, CV Death Across CKD Spectrum in EMPA-KIDNEY

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Among a wide range of persons with chronic kidney disease (CKD) at high risk, the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin reduced the risk for disease progression or cardiovascular (CV) death by 28% vs placebo, according to findings from the landmark phase 3 EMPA-KIDNEY trial announced November 4th by scientific collaborators Boehringer Ingelheim and Eli Lilly.

The results were presented during the American Society of Nephrology (ASN)’s Kidney Week 2022 and published simultaneously online in the New England Journal of Medicine.

EMPA-KIDNEY also is the first such trial in which an agent in the class significantly reduced all-cause hospitalization (14%), a positive indicator for the health care system, study authors say, given the association of CKD with a 2-fold greater risk for hospitalization.

The US Food and Drug Administration in March 2020 granted empagliflozin fast track designation toward an approval for the drug’s cardiorenal protective effects and EMPA-KIDNEY was stopped early in March 2022 by an independent monitoring board based on the significantly positive results-to-date.

EMPA-KIDNEY, according to a Lilly statement, is “the largest and broadest SGLT-2 inhibitor trial in CKD.” Participants in the study had a wide range of comorobidities spanning CV, renal, and other metabolic conditions and CKD severity.

“The design of the EMPA-KIDNEY trial included a wider range of patients than ever before,” said Professor Richard Haynes, co-principal investigator, in the statement. “Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine. Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.”

Haynes and colleagues from the EMPA-KIDNEY Collaborative Group designed the multinational, randomized, placebo-controlled trial to assess the effect of empagliflozin on the primary outcome they defined as time to a first event – either a composite of progression of kidney disease (end-stage kidney disease, sustained decrease in eGFR to <10 ml/min/1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from CV causes.

The final cohort numbered 6609 patients both with and without diabetes and with and without albuminuria who were randomized to empagliflozin 10 mg/day or matching placebo. Median follow up was 2 years, during which Haynes and team observed progression of kidney disease or death from CV causes in 13.1% (432 of 3304) of patients in the empagliflozin group and in 16.9% (558 of 3305) of patients receiving placebo (hazard ratio [HR], 0.72; 95% CI, 0.64 to 0.82; P<.01).

Importantly the authors report that these results were consistent whether patients had T2D or not. In analysis across subgroups defined according to eGFR ranges, they write, the results remained consistent as well.

The investigators also report that the rate of hospitalization for any cause was lower in the empagliflozin group than in the placebo group (HR, 0.86; 95% CI, 0.78 to 0.95; P=.003).

However, when they evaluated reductions in key secondary endpoints of hospitalization for heart failure (HF) or CV death (empagliflozin 4.0%, placebo 4.6%) or death from any cause (4.5% and 5.1%, respectively) researchers found no significant differences.

Hayes and colleagues suggest that the power to detect statistically significant differences in the key secondary outcome events was limited by the small number of events themselves but note that the risk reduction seen in this study is consistent with the totality of evidence from other trials.

The overall safety data were generally consistent with previous findings, confirming the well-established safety profile of empagliflozin, Lilly says.

“We know that there is an urgent need for new therapies proven to delay CKD progression which can lead to the need for dialysis or transplantation. Today’s results demonstrate that Jardiance may benefit adults at risk of progression, including those with or without diabetes, and across a wide range of kidney function,” said William Herrington, associate professor at the Medical Research Council Population Health Research Unit at the University of Oxford, honorary consultant nephrologist, and EMPA-KIDNEY co-principal investigator.

“By reducing the risk of kidney disease progression or cardiovascular death, Jardiance has the potential to positively impact healthcare systems worldwide.”

Empagliflozin has been approved to reduce the risk of CV death in adults with T2D and established CVD, and the risk of CV death in patients with HF.

In February 2022, the FDA approved empagliflozin for patients with HF, regardless of ejection fraction, to reduce the risk of CV death and hospitalization for HF.


Reference: Herrington WG, Staplin N, Wanner C, et al for the EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. New Engl J Med. Published online November 4, 2022. doi:10.1056/NEJMoa2204233


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Canada to donate up to 200,000 vaccine doses to combat mpox outbreaks in Africa

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The Canadian government says it will donate up to 200,000 vaccine doses to fight the mpox outbreak in Congo and other African countries.

It says the donated doses of Imvamune will come from Canada’s existing supply and will not affect the country’s preparedness for mpox cases in this country.

Minister of Health Mark Holland says the donation “will help to protect those in the most affected regions of Africa and will help prevent further spread of the virus.”

Dr. Madhukar Pai, Canada research chair in epidemiology and global health, says although the donation is welcome, it is a very small portion of the estimated 10 million vaccine doses needed to control the outbreak.

Vaccine donations from wealthier countries have only recently started arriving in Africa, almost a month after the World Health Organization declared the mpox outbreak a public health emergency of international concern.

A few days after the declaration in August, Global Affairs Canada announced a contribution of $1 million for mpox surveillance, diagnostic tools, research and community awareness in Africa.

On Thursday, the Africa Centres for Disease Control and Prevention said mpox is still on the rise and that testing rates are “insufficient” across the continent.

Jason Kindrachuk, Canada research chair in emerging viruses at the University of Manitoba, said donating vaccines, in addition to supporting surveillance and diagnostic tests, is “massively important.”

But Kindrachuk, who has worked on the ground in Congo during the epidemic, also said that the international response to the mpox outbreak is “better late than never (but) better never late.”

“It would have been fantastic for us globally to not be in this position by having provided doses a much, much longer time prior than when we are,” he said, noting that the outbreak of clade I mpox in Congo started in early 2023.

Clade II mpox, endemic in regions of West Africa, came to the world’s attention even earlier — in 2022 — as that strain of virus spread to other countries, including Canada.

Two doses are recommended for mpox vaccination, so the donation may only benefit 100,000 people, Pai said.

Pai questioned whether Canada is contributing enough, as the federal government hasn’t said what percentage of its mpox vaccine stockpile it is donating.

“Small donations are simply not going to help end this crisis. We need to show greater solidarity and support,” he said in an email.

“That is the biggest lesson from the COVID-19 pandemic — our collective safety is tied with that of other nations.”

This report by The Canadian Press was first published Sept. 13, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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How many Nova Scotians are on the doctor wait-list? Number hit 160,000 in June

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HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.

The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.

Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.

“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”

The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.

A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.

Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.

“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.

Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.

The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.

“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.

This report by The Canadian Press was first published Sept. 11, 2024.

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Newfoundland and Labrador monitoring rise in whooping cough cases: medical officer

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ST. JOHN’S, N.L. – Newfoundland and Labrador‘s chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.

Dr. Janice Fitzgerald says that so far this year, the province has recorded 230 confirmed cases of the vaccine-preventable respiratory tract infection, also known as pertussis.

Late last month, Quebec reported more than 11,000 cases during the same time period, while Ontario counted 470 cases, well above the five-year average of 98. In Quebec, the majority of patients are between the ages of 10 and 14.

Meanwhile, New Brunswick has declared a whooping cough outbreak across the province. A total of 141 cases were reported by last month, exceeding the five-year average of 34.

The disease can lead to severe complications among vulnerable populations including infants, who are at the highest risk of suffering from complications like pneumonia and seizures. Symptoms may start with a runny nose, mild fever and cough, then progress to severe coughing accompanied by a distinctive “whooping” sound during inhalation.

“The public, especially pregnant people and those in close contact with infants, are encouraged to be aware of symptoms related to pertussis and to ensure vaccinations are up to date,” Newfoundland and Labrador’s Health Department said in a statement.

Whooping cough can be treated with antibiotics, but vaccination is the most effective way to control the spread of the disease. As a result, the province has expanded immunization efforts this school year. While booster doses are already offered in Grade 9, the vaccine is now being offered to Grade 8 students as well.

Public health officials say whooping cough is a cyclical disease that increases every two to five or six years.

Meanwhile, New Brunswick’s acting chief medical officer of health expects the current case count to get worse before tapering off.

A rise in whooping cough cases has also been reported in the United States and elsewhere. The Pan American Health Organization issued an alert in July encouraging countries to ramp up their surveillance and vaccination coverage.

This report by The Canadian Press was first published Sept. 10, 2024.

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