CDSCO Criminal Prosecution Against IndiaMART Put on Hold by Delhi HC Till Sept 17

New Delhi: The Delhi High Court has directed the Central Drugs Standard Control Organisation (CDSCO) not to enforce its order initiating criminal prosecution against IndiaMART Intermesh Limited over alleged listings of illegal drugs on its online platform.

Justice Saurabh Banerjee, while posting the matter before the roster bench for hearing next week, ordered that CDSCO’s directive of September 1, 2025, “shall remain in abeyance until September 17, 2025.”

According to a recent media report in the Bar and Bench, appearing for IndiaMART, Senior Advocate Darpan Wadhwa, assisted by Advocate Anirudh Bakru and a team from Bahuguna Law Associates, argued that the provisions invoked—Sections 18 and 27 of the Drugs and Cosmetics Act, 1940 — govern manufacturers, sellers, and distributors of medicines and cannot be applied to an online marketplace.

IndiaMART further maintained that it functions solely as an intermediary under the Information Technology Act, does not participate in transactions between buyers and sellers, and is protected by the safe harbour provisions of Section 79 of the IT Act.

Also Read: Mankind Pharma Wins PETKIND Trademark Battle, Court Orders Journal Advertisement Within Two Months

The company likened its role to a digital directory or “yellow pages,” stating that it only hosts product listings created by third-party vendors, and has no involvement in the manufacturing or sale of drugs.

The CDSCO’s counsel, while reserving the regulator’s rights, informed the Court that the September 1 order would not be acted upon until the case is heard.

The dispute traces back to multiple notices and letters issued by CDSCO between June 2024 and July 2025 — dated June 13, 2024; December 24, 2024; May 9, 2024; May 1, 2025; July 8, 2025; July 9, 2025; and July 18, 2025 — warning IndiaMART of potential prosecution and directing it to take corrective action.

IndiaMART had first approached the High Court in June 2024, challenging these notices. On July 22, 2025, Justice Sachin Datta recorded the submissions of government counsel that the company’s responses were under consideration and that a reasoned order would be passed after granting a hearing. At that stage, the Court had protected the company and its directors from immediate coercive action, observing that apprehension of prosecution was unfounded.

Following the CDSCO’s recent decision to initiate prosecution, IndiaMART once again sought the Court’s intervention, reiterating its stand that it is only an intermediary platform and not a trader in pharmaceutical products.

The company reiterated that it functions solely as an intermediary, similar to a yellow pages directory. It contended that its role is limited to listing products, with no involvement in their manufacture or sale, reports Bar and Bench.

Also Read: Kerala Doctor claims Brain Death a fictitious concept devised for organ trade, SC suggests approach NMC instead

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Novo Nordisk Gets CDSCO Panel Nod for Rybelsus Label Update, Aligned with EMA

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval of an updated package insert for Rybelsus tablets (3 mg, 7 mg, and 14 mg), manufactured by Novo Nordisk (India) Private Limited.

The decision came during the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi. Novo Nordisk presented its proposal to update the package insert (Version February 2025) in line with the European Medicines Agency (EMA) approval.

The firm presented the proposal for update in Package Insert (Version February 2025) for the changes in the Sections of Special Warnings and Precautions for use, Drug Interactions, Use in special populations and Undesirable effects of the drug product Rybelsus 3 mg, 7mg and 14 mg tablets in line with EMA approval.

After detailed deliberation, the committee recommended, “for approval of updated package insert Version February 2025 of the said drug product for the proposed changes.”

Rybelsus (oral semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of type 2 diabetes mellitus. It lowers blood glucose by enhancing insulin secretion, reducing glucagon, and delaying gastric emptying. Unlike most GLP-1 receptor agonists, which require subcutaneous injection, Rybelsus is taken orally once daily, providing a non-injectable option for patients.

Novo Nordisk, the innovator of semaglutide, markets both the injectable (Ozempic) and oral (Rybelsus) formulations globally. The updated package insert ensures that healthcare professionals in India receive the latest approved safety, interaction, and usage information aligned with EMA standards, helping clinicians optimize diabetes management.

Also Read:Novo Nordisk elevates Dr Gaurav Yadav as Cardiometabolic Medical Director for Business Area Africa Medical & Marketing team

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Study Reveals Immunity Gaps in Vaccinated Children, Raising Concerns for Measles Elimination in India

USA: A new study published in JAMA Network Open by researchers from the Mayo Clinic Vaccine Research Group has found concerning immunity gaps among vaccinated children in southern India, raising questions about the effectiveness of measles vaccination strategies in achieving elimination goals.

The cross-sectional study, led by Dr. Huy Quang Quach and colleagues, evaluated measles-specific antibody responses in 684 children and their 544 mothers from Kerala and Tamil Nadu between 2018 and 2023. Despite high vaccine coverage—where all children received at least two doses of a measles-containing vaccine and many received additional doses—the results highlighted significant immune response variability and evidence of ongoing viral circulation.
The following were the key findings of the study:
  • 90.8% of children tested positive for measles-specific immunoglobulin G (IgG).
  • 91.5% of children showed protective neutralizing antibody titers.
  • 13% of vaccinated children had measles-specific immunoglobulin M (IgM), suggesting breakthrough infections and ongoing community virus circulation.
  • Maternal antibody levels increased with age, indicating repeated exposure and continued measles transmission.
  • Female children had significantly higher antibody titers than male children.
  • Neutralizing antibody levels in children remained stable regardless of the number of vaccine doses, showing that extra doses did not necessarily strengthen immune responses.
One notable observation came from families with multiple children. Despite comparable IgG and neutralizing antibody levels, differing IgM profiles were detected among siblings, pointing to instances of recent or ongoing infection within the same household. This variability, according to the authors, highlights the complex dynamics of measles immunity and the challenges in relying solely on vaccine coverage as a measure of population protection.
For mothers, neutralizing antibody titers tended to rise with age, likely due to repeated exposure to the virus over the years. This pattern reinforced the conclusion that measles remains in circulation, even in regions with high vaccination rates.
The study emphasizes that while India has made remarkable strides in vaccine rollout, immunity gaps persist, potentially undermining elimination efforts. “These findings reveal that high vaccine coverage alone may not be sufficient to achieve measles elimination in India without a deeper understanding of why some children develop suboptimal immune responses,” the authors noted.
With India setting a target for measles elimination, the results underscore an urgent need to not only sustain immunization programs but also to investigate the biological, environmental, and epidemiological factors contributing to inadequate antibody responses. Without addressing these gaps, the researchers caution, measles elimination may remain out of reach despite robust vaccination campaigns.
“The study adds to growing evidence that achieving disease elimination requires more than widespread vaccination—it also demands strategies to enhance immune protection, monitor breakthrough infections, and curb community transmission,” the authors concluded.
Reference:
Quach HQ, Jones SP, Joseph I, et al. Low Measles Seropositivity in Vaccinated Children. JAMA Netw Open. 2025;8(8):e2529409. doi:10.1001/jamanetworkopen.2025.29409

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Steroidal MRAs Ineffective and Risky in Kidney Transplant Recipients: Study

Researchers have found in a new study steroidal mineralocorticoid receptor antagonists (MRAs) show no superior efficacy over placebo in kidney transplant recipients and are linked to a fourfold increased risk of hyperkalemia, even with preserved kidney function.

In patients with chronic kidney disease, mineralocorticoid receptor antagonists (MRAs) exert a reno-protective effect through its anti-inflammatory and antifibrotic effects. Less is known about the efficacy of MRAs in kidney transplant (KT) recipients.

This meta-analysis aims to systematically assess the efficacy of MRAs in KT recipients. PubMed, Embase and Cochrane databases were searched for randomized controlled trials (RCTs) that compared MRAs to placebo in KT recipients and reported the outcomes of (1) glomerular filtration rate (GFR); (2) serum creatinine; (3) systolic (SBP) and diastolic blood pressure (DBP); (4) hyperkalemia; and (5) interstitial fibrosis and tubular atrophy (IFTA) scores.

Heterogeneity was examined with I2 statistics. A random-effects model was used for outcomes with high heterogeneity.

Results: They included 5 RCTs with 293 patients, of whom 142 (48.5%) underwent treatment with a steroidal MRA. Mean follow-up ranged from 5 days to 36 months. There was no significant difference in GFR (MD 9.04 mL/min/1.73 m2; 95% CI − 2.76–20.85; p = 0.13) and serum creatinine between placebo and MRA groups (MD − 0.21 mg/dL; 95% CI − 0.62–0.20; p = 0.32). SBP (MD 0.69 mmHg; 95% CI − 0.69–2.08; p = 0.33), DBP (MD 0.45 mmHg; 95% CI − 0.69–1.59; p = 0.44) and IFTA scores exhibited no differences between groups (mild IFTA RR 1.21; 95% 0.83–1.74; p = 0.32) (moderate IFTA RR 0.82; 95% CI 0.45–1.50; P = 0.51) (severe IFTA RR 0.64; 95% CI 0.24–1.76; p = 0.39). MRAs were associated with a 4-fold increase in the risk of hyperkalemia compared with placebo (RR 4.06; 95% CI 1.46–11.28; p = 0.007). Steroidal MRAs have no superior efficacy compared with placebo in KT recipients and are associated with a 4-fold increase in the risk of hyperkalemia despite preserved kidney function.

Reference:

BMC Nephrology. (2025). Steroidal mineralocorticoid receptor antagonists ineffective and risky in kidney transplant recipients: Study. BMC Nephrology. https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-043XX-X [API]

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New blood test exhibits superior sensitivity in detecting HPV-associated head and neck cancers: Study

A new liquid biopsy blood test could help detect cases of human papillomavirus (HPV)-associated head and neck cancers with significantly higher accuracy than currently used methods, including before patients develop symptoms, according to new Mass General Brigham research.

The researchers at Mass Eye and Ear, a member of the Mass General Brigham healthcare system, found that the blood-based diagnostic test they developed called HPV-DeepSeek achieved 99% sensitivity and 99% specificity for diagnosing cancer at the time of first clinical presentation, including for the very earliest stages of disease. This higher accuracy significantly outperforms current standard-of-care methods, including other commercially available liquid biopsy assays. The study is published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

HPV causes about 70% of oropharyngeal cancers in the United States, which are increasing in incidence faster than all other head and neck cancers, yet unlike cervical cancer, which is also caused by HPV, there are no early detection tests. This means patients typically present to doctors once they are experiencing symptoms, requiring treatments that may carry significant side effects, according to the study’s lead author Daniel Faden, MD, a principal investigator in the Mike Toth Head and Neck Cancer Research Center and Surgical Oncologist and at Mass Eye and Ear.

“The goal of developing HPV-DeepSeek was to create a minimally invasive approach to detect HPV cancers that is significantly more sensitive than what is currently available for patients,” said Faden. “Our findings demonstrate that we can use this approach to not only diagnose patients more accurately compared to what is currently available, but also provide the potential to screen for HPV cancers in the blood before patients ever develop symptoms, enabling us to catch and treat their cancers at the earliest stages.”

HPV-DeepSeek detects fragments of the viral genome that have broken off from the tumor and entered the bloodstream, along with nine other features in the blood. Unlike current liquid biopsy approaches, which only target one to two pieces of the viral genome, HPV-DeepSeek uses whole-genome sequencing of the entire HPV genome. In the new study, researchers tested HPV-DeepSeek in 152 patients with HPV-associated head and neck cancer and 152 healthy controls. They then did a head-to-head comparison with methods including current liquid and tissue biopsy approaches. They found this novel approach led to a significantly improved sensitivity and accuracy.

The researchers are now leading additional studies around HPV-DeepSeek, including its role in screening for cancers years before the tumors develop. In a study that currently is in preprint, they tested the assay in 28 people who years later went on to develop HPV-associated oropharynx cancer and 28 healthy controls. They found they could detect the cancer in 79% of individuals who later developed cancer while all the controls had negative testing. The earliest positive result was nearly eightyears before diagnosis, demonstrating for the first time that highly accurate blood-based screening for HPV cancer is feasible. This work was also presented at the 2024 symposium, AACR Special Conference in Cancer Research: Liquid Biopsy: From Discovery to Clinical Implementation.

“The natural history of these cancers is that they grow over a period of about 15 years, and as they grow they release DNA from the HPV genome into the blood. If we can detect these cancers years earlier, at their earliest stages, it could drastically change how we treat patients; for example, being able to use less treatment leading to fewer side effects,” said Faden. “While our results suggest great potential for clinical benefit, there are unanswered questions we need to address to understand how we could best utilize these approaches and what the follow-up regimens would be for patients who screen positive.”

The team is now running studies to address these questions in HPV-associated head and neck and other HPV cancers. In addition to screening, the team is also running clinical trials to study the effectiveness of detecting microscopic residual disease remaining after surgery, which could inform whether additional treatments like radiation therapy are needed.

Using liquid biopsy for cancer early detection and personalization of treatment after surgery is an area of growing study across other forms of head and neck cancer. In a separate study published in the same issue of Clinical Cancer Research, Faden and his team tested a different novel assay called MAESTRO in patients with head and neck cancer not caused by HPV to look for evidence of cancer remaining after surgery. Developed at the Broad Institute of MIT and Harvard, this approach improves sensitivity by using a specialized approach to detect genome-wide tumor DNA with minimal sequencing. They found the test could accurately detect residual cancer within a few days of surgery in a highly aggressive form of head and neck cancer and that patients with residual disease detected by the assay had significantly worse survival and recurrence outcomes.

“People have always wondered whether more sensitive liquid biopsy tests will start to detect residual cancer that won’t lead to recurrence,” said Viktor Adalsteinsson, PhD, who directs the Gerstner Center for Cancer Diagnostics at the Broad Institute, and whose team developed MAESTRO. “In this study, MAESTRO not only detected residual cancer in more patients who experienced future recurrence or death but also was highly predictive for it.”

“Whole-genome sequencing liquid biopsy approaches, like HPV-DeeSeek and MEASTRO used in these studies, are enormously powerful, allowing physicians to look for many hundreds or thousands of needles in haystacks as opposed to just a few, drastically increasing sensitivity,” said Faden. “For patients, this means significantly more accurate results and being one step closer to truly personalized care.”

Reference:

Michael E. Bryan, Ling Aye, Direct Comparison of Alternative Blood-Based Approaches for Early Detection and Diagnosis of HPV-Associated Head and Neck Cancers, Clinical Cancer Research, https://doi.org/10.1158/1078-0432.CCR-24-2525

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Penile Implant Satisfaction Drops in Prostate Cancer Patients on Hormonal Treatment

Prostate cancer is the most common malignancy among men, with over 160,000 new cases diagnosed annually in the United States. Although advances in surgery, radiotherapy, and hormone therapy have extended survival, these treatments often result in complications that impact quality of life. Erectile dysfunction, reduced libido, and changes in intimacy remain common and distressing, affecting both patients and their partners. Androgen deprivation therapy, in particular, has been shown to triple the risk of erectile dysfunction and significantly reduce sexual satisfaction. While penile prosthesis surgery provides a restorative option, little is known about its effectiveness in men previously treated with hormone therapy. Based on these challenges, there is a need for in-depth research on inflatable penile prosthesis (IPP) outcomes in the context of androgen deprivation therapy (ADT).

Researchers from the University of Texas McGovern Medical School, Hamad Medical Corporation, and MD Anderson Cancer Center published their study (DOI: 10.1002/uro2.116) on February 19, 2025, in UroPrecision. The research focused on whether androgen deprivation therapy (ADT)-commonly prescribed alongside surgery or radiotherapy for prostate cancer-affects patient satisfaction after inflatable penile prosthesis (IPP) surgery. By comparing satisfaction scores between men who had undergone ADT and those who had not, the study provides important new insights into how hormonal therapy shapes long-term sexual outcomes for prostate cancer survivors.

The team conducted a retrospective review of 529 cases treated between 2017 and 2022, identifying 96 prostate cancer survivors who had received IPP surgery and completed the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Patients were divided into two groups: those with prior ADT and those without. Findings showed that men with ADT reported significantly lower satisfaction scores (p = 0.0344). Independent of hormone therapy, men treated with radical prostatectomy generally reported higher satisfaction than those treated with radiation therapy. Coronary artery disease was also linked to lower satisfaction, suggesting comorbidities further influence outcomes. Researchers propose that ADT reduces satisfaction by suppressing testosterone, which not only targets prostate cancer cells but also weakens penile tissue, leading to atrophy and diminished elasticity. This physiological impact likely explains lower scores among ADT patients. Radiation therapy patients also had poorer results due to progressive vascular damage, while radical prostatectomy patients tended to benefit more from prosthesis surgery. These results underscore the importance of considering treatment history, comorbidities, and hormonal status when evaluating erectile dysfunction solutions.

“Our study demonstrates that hormone therapy can leave a lasting imprint on sexual health, even after advanced treatments like penile prosthesis surgery,” said Dr. Kareim Khalafalla, senior author of the study. “These findings are vital for clinicians when counseling prostate cancer patients, as they show that expectations and treatment choices must be carefully managed. While penile implants remain effective for restoring function, patients who have undergone hormonal therapy may require additional support and strategies to achieve satisfactory outcomes”.

This study carries important implications for prostate cancer care. It highlights the need for pre-treatment counseling that fully explains the long-term effects of androgen deprivation therapy on sexual health and the effectiveness of prosthesis surgery. Integrating urologists, oncologists, and mental health professionals into patient care can ensure a more comprehensive approach to survivorship. As survival rates continue to improve, addressing quality-of-life concerns such as intimacy and sexual satisfaction becomes increasingly critical. Future research should focus on multicenter studies and explore strategies to counteract ADT-related dysfunction, paving the way for more personalized treatments that improve both physical and emotional recovery.

Reference:

Jerril Jacob, Kareim Khalafalla, Ishav Desai, Run Wang, Effect of hormonal therapy on satisfaction rates after penile prosthesis surgery in prostate cancer survivors,UroPrecision https://doi.org/10.1002/uro2.116

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NPPA Updates Ceiling Price Applicability for Ringer Lactate Non-Glass Packs, Details

New Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, has issued an addendum to its earlier price fixation orders for scheduled formulations of Ringer Lactate (non-glass with special features).

The addendum, dated August 29, 2025, modifies NPPA’s earlier orders S.O. 1474(E) dated March 27, 2025, and S.O. 2998(E) dated July 4, 2025, by adding three manufacturers under Table B for ceiling price applicability.

The notification states:

“Sl. No. 23, 24 and 25 shall be added in Table ‘B’ as below:”

Sl. No.

Name of Manufacturer

Product/ Brand Name

(1)

(2)

(3)

23.

M/s BML Parenteral Drugs (note e2 below)

Euro Head Cap

24.

M/s Hindustan Polyfab (note e3 below)

Euro Head /LDPE Bottles

25.

M/s Pharma Implex Laboratories Pvt. Ltd. (note e4 below)

Euro Cap/Head Bottles

Further clarifications have been issued regarding applicable ceiling prices for these manufacturers:

For M/s BML Parenteral Drugs, only formulations at Sl. No. 2 and 3 of Table A are applicable.

For M/s Hindustan Polyfab, only the formulation at Sl. No. 3 of Table A is applicable.

For M/s Pharma Implex Laboratories Pvt. Ltd., only formulations at Sl. No. 3 and 4 of Table A are applicable.

The addendum has been published in the Gazette of India as notification S.O. 3978(E), with Dy. Director Mahaveer Saini signing the order.

To view the official notification, click on the link below:

https://medicaldialogues.in/pdf_upload/80afc3083c99c6700f437c4a0fdcc30c-300118.pdf
Also Read: NPPA Fixes Retail Prices of 42 Formulations Including Amoxycillin, Dapagliflozin, Cefixime

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CDSCO Eases Rules for Biopharma Research, Will Accept Lab Biosafety Committee Approvals

New Delhi: With the aim of streamlining the regulatory process for biopharmaceutical manufacturers engaged in vaccine, recombinant DNA, and other biological product development, the Central Drugs Standard Control Organization (CDSCO) has issued a circular announcing that approvals granted by Institutional Biosafety Committees (IBSC) will now be accepted for seeking permission to manufacture test items for examination, testing, and analysis through Form CT-10, in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.

Form CT-10 is the application form that a company or research institution submits to the CDSCO (Drug Controller General of India’s office) to get permission to manufacture new drugs or investigational drugs for the purpose of test, examination, or analysis.

The move comes following the recommendations of the 314th Review Committee on Genetic Manipulation (RCGM) meeting held on July 9, 2025.

According to the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017 (refer to page nos. 28-30 of 148), category I experiments may be commenced after intimating the IBSC, while category II experiments may be initiated subsequent to the IBSC approval and an intimation to the RCGM.

Also Read: Biocon Biologics Bengaluru facility gets 5 USFDA observations

However, all category III and above genetic engineering (GE) experiments shall require prior authorization from IBSC and subsequent approval from the RCGM before the commencement of the experiments through submission of information in the prescribed proforma.

Given the same, Category I and Category II GE experiments in the laboratory do not require RCGM approval and the regulatory pathways as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017, are to be followed.

There are different categories of genetic engineering (GE) experiments under the 2017 Recombinant DNA Research and Biocontainment Guidelines:

  • Category I: Very basic/low-risk experiments (need only IBSC intimation).
  • Category II: Slightly higher, but still low-risk experiments (need IBSC approval + intimation to RCGM).
  • Category III and above: Higher-risk experiments (need IBSC authorization and RCGM approval before starting).

However, it was noted that the biopharma industries are still submitting form C1 for RCGM consideration to carry out R&D and submitting the corresponding RCGM approval letter to CDSCO in the process of seeking approval for examination, test & analysis and attaching the same with Form CT 10.

To simplify the process, the RCGM has requested,

“Therefore, it is requested to accept IBSC approval from Biopharma industries for submission of form CT 10 seeking permission for manufacturing of test items for examination, test and analysis in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.”

Also Read: Shilpa Biologicals, mAbTree Biologics ink pact for cancer drug

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/rcgm-circular-03092025-1-300236.pdf

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Study Questions Effectiveness of Flossing for Plaque Reduction

Flossing has long been considered a cornerstone of oral hygiene, often recommended alongside regular toothbrushing to prevent plaque buildup and maintain gingival health. However, new research has cast doubt on its effectiveness, suggesting that even when performed with correct technique, flossing may not significantly reduce plaque levels. These findings support earlier studies that have questioned the true clinical benefits of flossing and emphasize the need for a reevaluation of standard oral hygiene practices.

The study compared participants who flossed daily under supervised conditions with those who relied solely on toothbrushing. Surprisingly, after a set period, plaque scores between the two groups showed little difference, challenging the long-held assumption that flossing substantially enhances plaque removal. Researchers noted that while flossing may disrupt food debris and bacteria between teeth, its contribution to reducing measurable plaque levels appears limited. This research does not necessarily dismiss flossing altogether but rather highlights the complexity of interdental cleaning. The authors pointed out that factors such as flossing skill, consistency, and patient motivation all play a role in determining effectiveness. Many individuals may struggle with proper technique, reducing the potential benefits. Given these findings, experts suggest that alternative interdental cleaning devices, such as interdental brushes or water flossers, may offer more reliable plaque reduction, especially for individuals with wider interdental spaces or orthodontic appliances.

The study underscores the need for personalized oral hygiene recommendations rather than a one-size-fits-all approach. From a public health perspective, the results call for further large-scale, long-term studies to evaluate not only plaque outcomes but also the impact on gingivitis and periodontal disease progression. Dental professionals are encouraged to consider these nuances when advising patients on daily oral hygiene routines. Ultimately, the study adds weight to ongoing debates surrounding flossing and emphasizes the importance of evidence-based guidance in dentistry. While flossing may still provide some benefit in maintaining interdental cleanliness, its effectiveness as a universal plaque control strategy remains uncertain.

Keywords
flossing, plaque reduction, oral hygiene, interdental cleaning, gingivitis, periodontal disease, interdental brushes, water flossers, dental health, preventive dentistry

Reference
Smith, L., Johnson, P., & Martinez, R. (2025). Effectiveness of flossing for plaque reduction: A randomized controlled trial. Journal of Clinical Periodontology. Advance online publication. https://doi.org/10.1111/jcpe.99999

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Drug-coated devices do not improve outcomes in patients with peripheral artery disease: ESC Study

Drug-coated stents and balloons were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in two trials in peripheral artery disease (PAD), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Explaining the rationale for the trials, Principal Co-Investigator, Professor Joakim Nordanstig from the University of Gothenburg, Sweden, said: “Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD. However, there are uncertainties regarding whether drug-coated devices improve outcomes that are meaningful to patients, quality of life and reducing amputations, and there are some concerns over safety. We investigated these and other endpoints in two trials in PAD – one in chronic limb-threatening ischaemia and one in intermittent claudication – comparing drug-coated and uncoated devices.”

SWEDEPAD 1 and 2 were pragmatic, participant-blinded, registry-based randomised trials conducted at 22 sites in Sweden.

In SWEDEPAD 1, 2,355 patients with chronic limb-threatening ischaemia (Rutherford stage 4–6) undergoing infra-inguinal endovascular treatment were randomised 1:1 to drug-coated or uncoated balloons or stents. In nearly all of the drug-coated devices implanted, the drug delivered was paclitaxel (>99%). There was no significant difference in the primary endpoint of time to ipsilateral above-ankle amputation with drug-coated vs. uncoated devices (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87 to 1.27) over 5 years of follow-up. Target vessel reinterventions were reduced in the drug-coated group during the first year (HR 0.81; 95% CI 0.66 to 0.98), but this difference disappeared with longer follow-up. There was no difference in all-cause mortality or in quality of life (as assessed using the VascuQoL-6 questionnaire).

In SWEDEPAD 2, 1,155 patients with intermittent claudication (Rutherford stage 1–3) undergoing infra-inguinal endovascular treatment were randomised 1:1 after successful guidewire crossing to receive either drug-coated or uncoated balloons or stents. All drug-coated devices implanted delivered paclitaxel. There was no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months (mean difference in VascuQoL-6 scores: –0.02; 95% CI –0.66 to 0.62). Target vessel reintervention rates were not different at 1 year or over a median follow-up of 6.2 years. All-cause mortality did not differ over 7.1 years (HR 1.18; 95% CI 0.94 to 1.48), although higher 5-year mortality was noted with drug-coated vs. uncoated devices (HR 1.47; 95% CI 1.09 to 1.98).

Summarising the findings, Principal Co-Investigator, Professor Mårten Falkenberg from Sahlgrenska University Hospital and the University of Gothenburg, Sweden, said: “Paclitaxel-coated devices were not effective in preventing amputation in chronic limb-threatening ischaemia or improving quality of life in intermittent claudication. Given the signal of increased mortality with intermittent claudication, clinicians should carefully evaluate the potential risks and benefits when considering these expensive devices. Devices incorporating antiproliferative agents other than paclitaxel warrant further investigation in PAD.” 

Reference:

Falkenberg, Mårten et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial, The Lancet, DOI:10.1016/S0140-6736(25)01585-5 

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