Thoracentesis via wall suction as good as gravity drainage for procedural discomfort and dyspnea improvement, suggests study

Researchers have found that both wall suction and gravity drainage led to equivalent amounts of procedural chest pain and improvement in dyspnea among patients undergoing large-volume thoracentesis. A recent study was conducted by Samira S. and colleagues published in the journal Chest. Thoracentesis is a procedure to remove excess fluid from the pleural space and is frequently performed to help relieve symptoms such as breathlessness in patients suffering from pleural effusions.

Although previous studies showed no difference in procedural discomfort between manual aspiration and gravity drainage, the effect of wall suction drainage on chest discomfort has not been adequately addressed. This study aimed to bridge this gap by comparing wall suction with gravity drainage regarding procedural discomfort and related outcomes in patients with large free-flowing effusions.

This was a multicenter, single-blinded, randomized controlled trial that involved 228 patients, of whom 221 completed the study. Patients had large free-flowing pleural effusions of ≥ 500 mL and were randomly assigned at a 1:1 ratio to wall suction or gravity drainage.

  • Wall suction drainage: The technique involved a suction system with vacuum pressure set at full vacuum.

  • Gravity drainage: Carried out with a drainage bag located 100 cm caudal to the site of catheter insertion, connected via straight tubing.

Pain assessment was performed using a 100-mm VAS at preprocedure, during the procedure, and postprocedure. The main outcome measured was postprocedural chest pain at 5 minutes; other outcomes included pain, relief from dyspnea, procedure time, volume aspirated, and complications including pneumothorax and reexpansion pulmonary edema.

Key Findings

Chest Pain:

  • Procedural chest discomfort at 5 minutes was not significantly different between the wall suction and gravity drainage groups (p=0.08).

Dyspnea Relief:

  • No significant differences in dyspnea improvement were noted between the groups.

Procedure Time:

  • Gravity drainage took approximately 3 minutes longer than wall suction.

Fluid Volume:

  • Similar volumes of fluid were drained in both groups.

Safety:

  • The rates of pneumothorax and reexpansion pulmonary edema were matched between the groups, giving no evidence that either poses additional risk.

Thoracentesis performed using wall suction or gravity drainage resulted in similar levels of procedural chest discomfort, dyspnea improvement, and complication rates. The findings highlight the equivalence of these methods, allowing clinicians to tailor procedural techniques to individual patient needs and clinical settings.

Reference:

Shojaee, S., Pannu, J., Yarmus, L., Fantin, A., MacRosty, C., Bassett, R., Jr, Debiane, L., DePew, Z. S., Faiz, S. A., Jimenez, C. A., Avasarala, S. K., Vakil, E., DeMaio, A., Bashoura, L., Keshava, K., Ferguson, T., Adachi, R., Eapen, G. A., Ost, D. E., … Grosu, H. B. (2024). Gravity- vs wall suction-driven large-volume thoracentesis. Chest, 166(6), 1573–1582. https://doi.org/10.1016/j.chest.2024.05.046

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FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Diabetes patients

The U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.

The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).

Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.

“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”

Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults, but has been increasingly diagnosed in children, teens and young adults.

Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1 in the pancreas, which is often found in insufficient levels in type 2 diabetes patients. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes.

The prescribing information for the generic liraglutide injection approved today includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma should not use liraglutide, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2. In addition, people who have a prior serious hypersensitivity reaction to liraglutide or any of the product components should not use liraglutide. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to medicines.

The development of complex drug products such as liraglutide can be more difficult due to their complex active ingredient, formulation or mode of delivery. As a result, many complex drugs lack generic competition. To address this issue and facilitate timely development and approval of needed medications, particularly complex products, the FDA works to clarify regulatory expectations for applicants early in the development process, including through guidance for industry and the pre-ANDA program. These efforts make it more feasible for manufacturers to develop generic drugs and can enhance patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need.

The FDA granted the approval of generic liraglutide injection to Hikma Pharmaceuticals USA Inc.

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Prenatal substance use may increase sudden unexpected infant death risks through unsafe sleep practices: Study

A recent study used data from the Sudden Death in the Young Registry and highlighted the startling link between maternal substance use during pregnancy and increased risks of sudden unexpected infant death (SUID), particularly through unsafe sleep environments and social vulnerabilities. After analyzing cases from 2015 to 2020, the study published in the Pediatrics journal identified critical differences in sleep-related SUID among infants who were prenatally exposed to substances when compared to the ones not exposed.

Of the 2,010 infant sleep-related deaths studied, 283 (14%) involved infants exposed to substances prenatally. The data revealed that more than half of all deaths occurred in hazardous sleep environments, such as adult beds (52%) or when surface sharing with adults (53%). These risks were disproportionately higher among infants with prenatal substance exposure by suggesting the need for targeted prevention measures.

One of the most concerning findings was the impairment of supervisors at the time of infant death. Among prenatally exposed cases, 34% of supervisors were impaired (e.g., under the influence of drugs or alcohol) when compared to 16% of non-exposed cases. This points to the necessity of support systems to ensure safe infant care during periods when parents or caregivers might be unable to provide attentive supervision.

Beyond the immediate sleep environment, the study also identified stark social vulnerabilities contributing to these outcomes. Families impacted by prenatal substance use were significantly more likely to undergo barriers such as limited access to health care, involvement with child welfare systems, intimate partner violence, and inadequate insurance coverage. These factors collectively exacerbate the risks of unsafe sleep practices and SUID. 

The study emphasize that addressing these disparities requires a two-pronged approach, one being the targeted safe sleep education and the other by tackling the underlying social determinants of health. Safe sleep messaging should focus on discouraging adult bed-sharing and surface sharing, along with promoting the use of cribs or bassinets for infants. Support systems must be engaged to assist families during periods of impairment.

Also, the structural support is crucial where the families must have improved access to health care, safe sleep materials (like cribs), and interventions to reduce social vulnerabilities like addressing intimate partner violence and ensuring stable insurance coverage. Overall, this study brings out the importance of tailoring prevention efforts to meet the unique needs of substance-affected families.

Reference:

Deutsch, S. A., Loiselle, C. E., Hossain, J., & De Jong, A. (2024). Sleep-Related Sudden Unexpected Infant Death Among Infants Prenatally Substance Exposed. In Pediatrics. American Academy of Pediatrics (AAP). https://doi.org/10.1542/peds.2024-067372

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12 questions to ask for better brain health in 2024

Improving your brain health in the new year can start with a simple step, talking with your neurologist or primary care physician about 12 factors to protect your brain. The factors are outlined in an Emerging Issues in Neurology article developed by the American Academy of Neurology and published in the online issue of Neurology.

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More blood transfusions linked to lower 6-month mortality in heart-attack patients with anemia

Giving more blood to anemic patients after a heart attack may save lives, according to a Rutgers Health–led study. The study, published in NEJM Evidence, affirms research conducted in 2023 that suggested mortality rate or recurrent heart attacks were more frequent in anemic patients who received less blood.

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TNF inhibitors prevent complications in kids with Crohn’s disease: Study recommends them as first-line therapies

Early treatment of pediatric Crohn’s disease with anti-tumor necrosis factor medications can substantially reduce the risk of perianal fistulas, a particularly debilitating complication of Crohn’s disease.

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Public acceptance of RSV vaccine grows as hesitancy plateaus

A year after becoming available, vaccines to protect against RSV in newborns and older adults are being more widely accepted by the American public, according to a new Annenberg Public Policy Center (APPC) health survey conducted in November 2024.

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Physician union petitions filed from 2023–2024 increase significantly over those filed during previous two decades

The number of union petitions including physicians in the bargaining units filed and certified increased from 2023 to May 2024, according to a research letter published online Dec. 18 in the Journal of the American Medical Association.

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Doctor Rape-Murder Case: Calcutta HC allows Doctors to continue protest at Esplanade

Kolkata: The Calcutta High Court on Monday upheld a December 20 order order allowing a demonstration during the Christmas season to demand speedy justice for the RG Kar hospital trainee doctor who was allegedly raped and murdered in August.

According to the PTI report, during the course of the hearing, the bench observed that the R G Kar incident was “unprecedented, unimaginable and horrible”.

The state had moved the division bench, challenging the order of the single bench of Justice Tirthankar Ghosh, which had permitted the Joint Forum of Doctors to hold the sit-in 50 feet away from Dorina Crossing at Esplanade in central Kolkata from December 20-26.

Such demonstrations on Christmas days would cause traffic snarls in the busy area and inconvenience revellers in the festive season, the state’s counsel argued.

The division bench of Justice Harish Tandon and Justice Hiranmay Bhattacharya allowed the forum to continue its agitation at the same spot after the defence counsel assured that the number of protesters would be within the specified limit of 100.

Also Read:Kolkata Rape-Murder Case: Doctors’ body plan 10-day demonstration

The forum’s counsel also submitted that the demonstrators wouldn’t spill over the barricaded area earmarked for holding the sit-in as discussed with the state police and administration.

The court also asked the agitating doctors to respond to the state’s proposal of suspending the sit-in for a day on December 25 and instead defer it to December 27.

Justice Ghosh, in his December 20 order, had said that since the organisers were doctors, they were expected to take into account the possible hardships to commuters in the area during the demonstration.

The court had directed that the stage for holding the demonstration should not exceed 40 feet in length and 23 feet in width and the number of participants in the sit-in should not exceed 250 at a time, news agency PTI reported.

In his submission before the division bench on Monday, state’s counsel Kalyan Banerjee found little merit in holding the sit-in at Dorina Crossing against the alleged delay in the CBI probe during Christmas.

Doctors’ counsel Bikash Bhattacharya countered his assertion, stating that the protests at Dorina Crossing for the past three days did not cause any traffic bottleneck or inconvenience the public.

He also submitted a video clip of the ongoing demonstration to buttress his claims and contended that people go to Park Street to celebrate Christmas, not Esplanade.

The on-duty postgraduate trainee doctor’s dead body was found in the seminar room of R G Kar Medical College and Hospital on August 9.

The Central Bureau of Investigation (CBI) has filed a charge sheet against the prime accused, Sanjay Roy, in the rape and murder case of the on-duty doctor.

In its charge sheet filed before a special CBI court here, the central agency said Roy, who was working as a civic volunteer with the local police, allegedly committed the crime on August 9 when the victim had gone to sleep in the hospital’s seminar room during a break.

Doctors’ bodies in the state have been holding demonstrations and protests, demanding speedy justice for the deceased medic.

Also Read:Kolkata Rape-Murder Case: Calcutta HC Grants Conditional Approval for Doctors’ Protest

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Biocon, Zentiva gets Decentralized Procedure approval for generic diabetes, weight management drug in EU

Bangalore: Biocon and its European partner, Zentiva, have received a Decentralized Procedure (DCP) approval for its complex formulation, Liraglutide, in the European Union (EU).

The approval is for the generic versions of Victoza to treat Type-2 Diabetes and Saxenda used in the treatment of weight management.

According to WHO, diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. In the past 3 decades the prevalence of type 2 diabetes has risen dramatically in countries of all income levels.

Medical Dialogues team had earlier reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of YESINTEK, an Ustekinumab biosimilar intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease – based on the application filed by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Read also: Approval of Biocon Biologics Yesintek recommended by EMA Committee

Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

Read also: Biocon Chief Kiran Mazumdar-Shaw conferred Jamsetji Tata Award by Indian Society for Quality

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