Archive for month: May, 2024

A study by Rutgers Health experts of more than 31 million hospital records shows that infertility treatment patients were twice as likely as those who conceived naturally to be hospitalized with heart disease in the year after delivery.

Patients who underwent infertility were particularly likely-2.16 times as likely as those who conceived naturally-to undergo hospitalization for dangerously high blood pressure or hypertension.

“Postpartum checkups are necessary for all patients, but this study indicates they are particularly important for patients who undergo infertility treatment to achieve a conception,” said Rei Yamada, an obstetrics and gynecology resident at Rutgers Robert Wood Johnson Medical School and lead author of the study.

The study authors say their results support standards of care that now call for an initial postpartum checkup three weeks after delivery, standards that some health systems have yet to adopt. Much of the elevated risk came in the first month after delivery, particularly for patients who developed dangerously high blood pressure.

“And these results aren’t the only ones to indicate that follow-up should occur early,” said Cande Ananth, chief of the Division of Epidemiology and Biostatistics in the Department of Obstetrics, Gynecology, and Reproductive Sciences at Rutgers Robert Wood Johnson Medical School and senior author of the study. “We have been involved in a series of studies over the past few years that have found serious risks of heart disease and stroke to various high-risk patient populations within those initial 30 days after delivery-risks that could be mitigated with earlier follow-up care.”

The study analyzed the Nationwide Readmissions Database, which contains nationally representative data on about 31 million hospital discharges and readmissions per year. The database contains diagnosis codes, which let researchers find specific populations and identify reasons for readmission.

The researchers used data from more than 31 million patients who were discharged following delivery from 2010 to 2018, including 287,813 patients who had undergone any infertility treatment.

Although infertility treatment predicted a sharply elevated risk of heart disease, the study authors said the relative youth of infertility treatment patients kept their overall risk fairly low. Just 550 of every 100,000 women who received infertility treatment and 355 of every 100,000 who conceived naturally were hospitalized with cardiovascular disease in the year after delivery.

The cause of the elevated risk of heart disease associated with infertility treatment remains unclear. The increase in heart disease could stem from the infertility treatments themselves, the underlying medical issues that made patients infertile or some other cause.

“Looking forward, I’d like to see if different types of infertility treatment and, importantly, medications are associated with different risk levels,” said Yamada. “Our data gave no information about which patients had undergone which treatment. More detailed information might also provide insight into how infertility treatment impacts cardiovascular outcomes.”

Reference:

Rei Yamada, Devika Sachdev, Rachel Lee, Mark V. Sauer, Cande V. Ananth, Infertility treatment is associated with increased risk of postpartum hospitalization due to heart disease, Journal of Internal Medicine, https://doi.org/10.1111/joim.13779.

The SELECT Trial has revealed the potential of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in combating kidney function decline among individuals with overweight or obesity and established cardiovascular disease but without diabetes.

Unveiling the results today at the 61st ERA Congress, researchers presented the impressive secondary analysis from the SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) trial, a randomised trial comprising a participant pool of 17,604 individuals.

Experts believe the study’s results offer hope for those affected by obesity, a condition known to exacerbate the risk of kidney function decline and macroalbuminuria (abnormal amounts of the albumin protein in urine).

With an average follow-up of approximately 3.5 years, among patients who were administered a once-weekly subcutaneous injection of semaglutide 2.4 mg (n=8,803) adverse kidney-related events were experienced by 22% fewer persons (1.8%) compared to those receiving placebo (n=8,801) (2.2%) (p<0.05). These events included death from kidney causes, initiation of chronic kidney replacement therapy, significant (≥ 50%) decline in kidney function, or onset of persistent macroalbuminuria. Semaglutide’s ability to prevent the onset of macroalbuminuria was highlighted as a pivotal factor in reducing the likelihood of kidney-related complications.

The study also assessed the impact of semaglutide on estimated glomerular filtration rate (eGFR), a measure of kidney function in removing waste and excess water from the blood through urine. The findings indicated a significantly lesser decline in eGFR among semaglutide recipients compared to the placebo group, with the effect being more pronounced in participants with baseline eGFR below 60 mL/min/1.73 m² (p<0.001). These results indicate the potential for semaglutide to particularly protect kidney function in individuals with a pre-existing kidney impairment.

The reduction in urinary albumin-to-creatinine ratio (UACR) further substantiated semaglutide’s beneficial effect on kidney health, with a significant decrease observed in semaglutide-treated individuals compared to placebo (p<0.001). UACR analysis measures the ratio of albumin (a protein) to creatinine (a waste product) in urine, aiding the detection of albuminuria, which can signal kidney damage or dysfunction. With semaglutide, there was a net 8.1% decrease in UACR in those with normal albumin levels at baseline, a 27.2% decrease in those with microalbuminuria (slightly raised albumin) at baseline, and a 31.4% decrease in those with macroalbuminuria at baseline relative to placebo.

Importantly, the study found no increased risk of acute kidney injury associated with semaglutide treatment, irrespective of baseline kidney function.

Over one billion people worldwide are affected by obesity.3 Rates of obesity are rising significantly, having doubled among adult women (8.8% to 18.5%) and nearly tripled in adult men (4.8% to 14.0%) between 1990 and 2022. The total number of children affected by obesity in 2022 was nearly 160 million, compared to 31 million in 1990.

Professor Helen M. Colhoun, lead study author, commented, “By addressing key markers of kidney health, semaglutide 2.4 mg weekly may contribute to a significant reduction in the risk of kidney-related complications, including chronic kidney disease and end-stage renal disease. This could lead to improved management of comorbidities and, ultimately, enhance the quality of life for individuals with obesity.”

“The observed benefits in eGFR and UACR are particularly encouraging, suggesting potential for the enhanced management of kidney complications in the patient population with overweight and obesity without diabetes. The findings also underscore the importance of continued research into the possible renal benefits of semaglutide and highlight its role as a promising therapeutic option in the multifaceted management of cardiovascular and renal health in this high-risk population.”

Reference:

Semaglutide may protect kidney function in individuals with overweight or obesity and cardiovascular disease, BEYOND, Meeting:61st ERA Congress.

An international study has found no evidence to support use of an arthritis medication sometimes prescribed ‘off-label’ to patients living with the long-term disabling effects of stroke.

Etanercept, an anti-inflammatory drug targeting tumor necrosis factor, received attention from the stroke survivor community after previous studies pointed towards drastic decreases in post-stroke disability.

However, in presenting its findings today at the European Stroke Organisation Conference (ESOC) 2024, the Perispinal Etanercept to improve Stroke Outcomes (PESTO) study found no evidence of any benefit.

PESTO was a phase 2b, international, randomised, placebo-controlled trial, patients with a stroke 1 to 15 years prior to enrollment and a current functional outcome score of at least 2 on the modified Rankin scale, were randomised to a perispinal injection of etanercept or placebo. The researchers primarily focused on the quality of life (QoL) as measured using the Short Form 36 Health Inventory (SF36-HI) at 28 days after injection, but also assessed safety outcomes, functional outcome, fatigue, anxiety and depression, and the effects of an additional dose of etanercept.

In total, 63 patients were randomized to perispinal etanercept and 63 patients to placebo. By 28 days, 53% of the patients in the etanercept group experienced an improvement with 5 points on the SF36-HI versus 58% in the placebo group. (Adjusted Odds Ratio: 0.82; 95% Confidence Interval 0.40-1.67). The rates of serious adverse outcomes were low with 1 reported in each group by day 28. No signals of benefit or harm were seen in the secondary outcome measures, including the second dose analysis.

Professor Thijs, one of the lead investigators, from The Florey and the University of Melbourne, Australia, said PESTO provided important evidence for clinicians. “We can give the stroke survivor community a scientific answer to the question they raised themselves. The trial was very clear in showing no signal at all. That is also an important take-to-the- clinic message.”

Improving life after stroke is a key priority according to the Stroke Action Plan for Europe 2018-2030, but very few medical post-stroke treatment options are available. Etanercept targets tumor necrosis factor, a pro-inflammatory factor which may remain elevated in the central nervous system following stroke due to activated microglia.

Unfortunately, as etanercept has a high molecular weight, it does not cross the blood brain barrier when given systemically. A proposed solution for this problem is to inject it perispinally, followed by a supine, head down position. Although this strategy remains controversial, perispinal etanercept has received a lot of attention from the stroke survivor community because of previous studies pointing towards drastic increases in post-stroke disability.

Professor Thijs said the trial had a unique design. “First of all, this trial was patient-driven, as many stakeholders believe in the potential of etanercept. Second, as the drug is already being applied for a diverse group of stroke survivors, we aimed to mimic this real-world experience by including patients up to 15 years after their stroke and applying the exact same method of perispinal injection as is done in private clinics.”

Ms Brooke Parsons, the consumer member of the PESTO Steering Committee adds: “The trial’s consumer-driven approach highlights the demand for innovative healthcare solutions. However, the neutral findings offer clarity, addressing the anticipation for answers and emphasising the significance of scientific rigor in assessing potential treatments amidst previous uncertainty.”

Reference:

THIJS V, CLOUD G, GILCHRIST N, ET AL. A MULTICENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL, TO DETERMINE SAFETY AND EFFICACY OF PERISPINAL ETANERCEPT ON QUALITY OF LIFE. Presented at the European Stroke Organisation Conference; 15 May 2024; Basel, Switzerland.

High BMI associated with increased major complications after surgery suggests a new study published in Urogynecology.