Benign Conditions

Benign Prostatic Hyperplasia

Bladder Cancer

Female Urology

Genitourinary Cancers

Genomic Testing

Hormone Therapy

Kidney Cancer

Challenging Anatomy

Innovative Techniques

Laser Lithotripsy

PCNL Tech & Devices

Ureteroscopy Tech & Devices

Kidney Stones

Men's Health

Next-Generation Imaging

Voiding Dysfunction

OAB and Incontinence

Pediatrics

Controveries in Urologic Cancer

Drug Therapy

Prostate Cancer

Sexual Dysfunction

UTUC

Cosmetic Surgery

Urologic Surgery

Business

Practice Management

Malpractice Consult

Health Law & Policy

Media

Case-Based Peer Perspectives

Investigator Perspectives 

Medical World News

Podcasts

Urology Medical Perspectives

UTv Videos

Peer Exchange

Special Report

Virtual Tumor Board

Insights

Medcast

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

Clinical Forums Recaps

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Treatment Landscape Evolutions

Subscribe

Articles

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

The findings highlight a lack of awareness on the signs and symptoms of prostate cancer, as well as common misconceptions about testicular cancer. 

Survey data shows lack of awareness on prostate, testicular cancer

The FDA has declined to approve 89Zr-DFO-girentuximab for PET imaging of ccRCC. 

FDA issues complete response letter for 89Zr-DFO-girentuximab in ccRCC

The findings were derived from the multicenter, prospective, phase 3 STAMPEDE trial.

Decipher test is predictive of chemotherapy benefit in metastatic prostate cancer

Weight is the vice chair over research and the center director for urologic oncology at the Cleveland Clinic in Ohio.

Christopher Weight, MD, MS, discusses the current state and directions of AI and prostate cancer. 

AI and prostate cancer: Balancing hope and caution

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times – News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Authors

Winoker is the director of endourology and director of the Center for Kidney Stone Disease at Lenox Hill and an assistant professor of urology at The Zucker School of Medicine at Hofstra/Northwell in New York, New York.

"We...observed an exceedingly high degree of safety across the board, with very few complications,” says Jared S. Winoker, MD.

Jared S. Winoker, MD, discusses real-world study of CVAC 2.0 for kidney stones

Jared S. Winoker, MD, addresses the wide range of stone burdens treated by the CVAC system for the study.

Study results show CVAC 2.0 is safe, efficacious for wide range of kidney stones

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric patients 12 years and older with uncomplicated gonorrhea, Innoviva Specialty Therapeutics announced in a news release.

The Prescription Drug User Fee Act (PDUFA) target action date for the application is December 15, 2025.

Zoliflodacin is an oral antibiotic that inhibits type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. According to the company, “If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.”

The FDA has also granted a Qualified Infectious Disease Product designation to zoliflodacin, which enables the agent to benefit from priority review and market exclusivity.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, in the news release.

 “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

The NDA for zoliflodacin is supported by data from several clinical trials conducted through a collaboration with the Global Antibiotic Research & Development Partnership (GARDP). This portfolio of studies includes a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm, representing a difference of 5.3% (95% CI, 1.4% to 8.7%) across patients in the micro-intent-to-treat (ITT) population.

The 2 cohorts also demonstrated comparable results on the trial’s secondary end point of microbiological response at extragenital (rectal or pharyngeal) sites. Specifically, at pharyngeal sites, the cure rate was 79.2% in the zoliflodacin arm vs 78.6% in the ceftriaxone/azithromycin arm (difference, -0.67%; 95% CI, -20.8 to 16.3). At rectal sites, the cure rate was 87.3% and 88.6%, respectively (difference, 1.23%; 95% CI, -14.4 to 12.6).

Zoliflodacin was generally well-tolerated in the trial. Treatment-emergent adverse events (TEAEs) occurred in 46.2% of patients in the zoliflodacin arm vs 46.4% of patients in the ceftriaxone/azithromycin arm. The most common TEAEs in the zoliflodacin arm included headache (9.9%), neutropenia (6.8%), and leukopenia (3.9%).

There were no deaths or serious adverse events reported in either arm.

In total, the phase 3 trial included 930 patients with uncomplicated gonorrhea, including patients living with HIV. The study enrolled participants across 16 clinical trial sites in the US, Belgium, the Netherlands, South Africa, and Thailand.

According to Innoviva, the phase 3 study was “the largest clinical trial ever conducted for a new treatment against gonorrhea infection.”

Those enrolled in the study were randomly assigned 2:1 to receive 3 g single-dose, oral zoliflodacin (n = 621) or to 500 mg ceftriaxone intramuscular plus 1g oral azithromycin (n = 309). The primary end point was microbiological cure by culture at urogenital sites in the micro-ITT populations, with a non-inferiority margin of 12%. The trial’s secondary end point was microbiological cure at extragenital sites.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Manica Balasegaram, Executive Director of GARDP, in the news release.

 “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

1. Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. News release. Innoviva Specialty Therapeutics. Published online and accessed June 10, 2025. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/

2. FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. Published online and accessed June 12, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025 

3. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf

The FDA has accepted the NDA for zoliflodacin, a novel oral antibiotic for treating uncomplicated gonorrhea in patients aged 12 and older. Zoliflodacin, which inhibits type II topoisomerase, has been granted a Qualified Infectious Disease Product designation, allowing for priority review. Clinical trials, including a pivotal phase 3 study, demonstrated that zoliflodacin is non-inferior to the standard regimen of ceftriaxone and azithromycin. The trials showed comparable microbiological cure rates at urogenital and extragenital sites, with zoliflodacin being generally well-tolerated and no serious adverse events reported.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea. 

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Health Canada has approved darolutamide (Nubeqa) for use in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), Bayer announced in a news release.

With this decision, darolutamide becomes the only androgen receptor inhibitor approved in Canada for mCSPC either with or without docetaxel. The combination of darolutamide plus ADT was also approved in the US in June 2025 as well as in the European Union in July 2025.

"This latest authorization reaffirms Nubeqa's role as a therapy for men with prostate cancer," said Shurjeel Choudhri, senior vice president and head of medical and scientific affairs for Bayer Canada, in the news release.

 "We extend our thanks to the scientists, doctors, patients, and their families for their contributions that allowed us to offer this new treatment option for metastatic castration-sensitive prostate cancer."

The approval is supported by data from the phase 3 ARANOTE trial (NCT04736199), which showed that darolutamide plus ADT significantly extended radiographic progression-free survival (rPFS) compared with placebo plus ADT in patients with mCSPC.

At 24 months, the rate of rPFS was 70.3% in the darolutamide arm vs 52.1% in the placebo arm, translating to a 46% reduction in the risk of radiographic progression or death (HR, 0.54; 95% CI, 0.41 to 0.71; 

 < .0001). The median rPFS was not reached (NR) in the darolutamide arm, compared with 25.0 months (95% CI, 19 to NR) in the placebo arm.

According to the authors, all subgroups derived benefit from treatment with darolutamide plus ADT. The HR for high-volume disease was 0.60 (95% CI, 0.44 to 0.80), and the HR for low-volume disease was 0.30 (0.15 to 0.60).

In a final analysis of the data, there was no statistically significant improvement in overall survival (OS) with the addition of darolutamide (HR, 0.78; 95% CI, 0.58 to 1.05). At 24 months, the OS rate was 79.8% in the darolutamide arm and 75.5% in the placebo arm.

In total, the double-blind, global ARANOTE trial included 669 patients who were randomly assigned 2:1 to receive 600 mg darolutamide twice daily plus ADT (n = 446) or to matching placebo plus ADT (n = 223). The median age of participants was 70 years (range, 43 to 93). Among all participants, 31.2% were Asian and 9.7% were Black.

The primary end point for the trial was rPFS. Secondary end points included OS, time to castration-resistant prostate cancer (CRPC), time to prostate-specific antigen (PSA) progression, time to pain progression, time to subsequent systemic anticancer therapy, and safety.

The results from the trial, which were published in the 

 also showed improvements in the trial's key secondary end points with the addition of darolutamide.

Specifically, darolutamide was associated with a trend toward clinical benefit in the secondary end points of time to metastatic CRPC (HR, 0.40; 95% CI, 0.32 to 0.51) and time to PSA progression (HR, 0.31; 95% CI, 0.23 to 0.41). Additionally, 62.6% of patients in the darolutamide arm achieved a PSA less than 0.2 ng/mL at any point during the treatment period, compared with 18.5% of patients in the placebo arm.

Time to pain progression (HR, 0.72; 95% CI, 0.54 to 0.96), and time to subsequent systemic anticancer therapy (HR, 0.40; 95% CI, 0.29 to 0.56) were also delayed in the darolutamide arm.

Regarding safety, the combination was well tolerated across both study arms. The incidence of treatment-emergent adverse events (TEAEs) was similar between the 2 groups, with TEAEs leading to permanent discontinuation of the study drug in 6.1% of patients in the darolutamide arm and 9.0% of patients in the placebo/ADT arm. No new safety signals were reported.

"Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with androgen-deprivation therapy," said principal investigator Fred Saad, MD, FRCS, professor, chairman of surgery, and director of genitourinary oncology at the University of Montreal Hospital Center, in the news release from Bayer.

 "Today's approval further expands options for how physicians can use Nubeqa in the treatment of mCSPC, giving them greater flexibility in choosing treatment plans for their patients."

1. Health Canada grants marketing authorization for an additional indication of Bayer’s NUBEQA (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). News release. Bayer Inc. August 21, 2025. Accessed August 25, 2025. https://www.biospace.com/press-releases/health-canada-grants-marketing-authorization-for-an-additional-indication-of-bayers-nubeqa-darolutamide-for-the-treatment-of-metastatic-castration-sensitive-prostate-cancer-mcspc

. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. 

. 2024;42(36):4271-4281. doi:10.1200/JCO-24-01798

Health Canada has approved darolutamide in combination with androgen deprivation therapy (ADT) for treating metastatic castration-sensitive prostate cancer (mCSPC). This makes darolutamide the only androgen receptor inhibitor approved in Canada for mCSPC, with or without docetaxel. The approval is based on the phase 3 ARANOTE trial, which demonstrated significant improvements in radiographic progression-free survival (rPFS) and other secondary endpoints. The combination was well tolerated, with similar adverse event rates between treatment and placebo groups, and no new safety concerns were identified.

Darolutamide plus ADT has also been approved in the US as well as in the European Union.

Health Canada approves darolutamide for metastatic castration-sensitive prostate cancer

Clinical data from Jyong Biotech’s investigational candidates in benign prostatic hyperplasia (BPH) and prostate cancer were recently shared at the 22nd Urological Association of Asia (UAA) Congress, the company announced in a news release.

The presentations featured results from several phase 3 studies of the oral botanical drug BOTRESO (MCS-2) for BPH and lower urinary tract symptoms (LUTS), as well as on the prostate cancer prevention drug MCS-8 (PCP).

Topline data on the drug candidate BOTRESO (MCS-2) included results from 2 pivotal trials (NCT01002417 and NCT01002664) and 2 open-label extension studies (NCT01002222 and NCT01002274). The pivotal trials, conducted in the US and in a pooled Tawain-US population, randomly assigned patients to receive BOTRESO or placebo for 12 weeks. In the open-label extension studies, all patients were treated with BOTRESO for 1 year in order to assess the drug’s long-term safety.

In the US-based pivotal trial, data showed comparable efficacy between the BOTRESO and placebo groups in the intent-to-treat populations (those who received at least 1 dose of treatment). However, in the Asian (Taiwan) subgroup and in the pooled Taiwan-US population, patients in the BOTRESO arm experienced a statistically significant improvement in LUTS compared with patients in the placebo arm.

In the extension studies, BOTRESO “consistently showed long-term improvement from baseline,” according to Jyong Biotech. Patients in the BOTRESO arm did not experience an increased risk of adverse events (AEs) compared with patients in the placebo arm. Further, no serious drug-related AEs were reported.

Overall, the company noted that BOTRESO was well-tolerated across all 4 phase 3 trials.

According to Jyong Biotech, “This is the first case that a Taiwanese-developed oral botanical drug has been approved IND (Investigational New Drug) number from the U.S. FDA to proceed to Phase III clinical trials.” The company plans to submit a new drug application (NDA) for BOTRESO to the FDA, with integration of clinical trial data from Taiwan and the US.

Data on Jyong Biotech’s investigational agent in prostate cancer, MCS-8 (PCP), was also presented at the 22

 UAA Congress. MCS-8 is being evaluated for the potential prevention of prostate cancer.

Overall, the phase 2 trial of the agent met its primary end point by demonstrating that receipt of MCS-8 was associated with lower rates of positive prostate biopsies and high-grade prostate cancer compared with placebo. The agent was also well-tolerated, with no serious AEs reported.

Pending regulatory guidance, the company plans to initiate a large-scale phase 3 trial of the agent to further assess its preventive potential.

1. Jyong Biotech Ltd. participated in the 22nd Urological Association of Asia Congress to display the clinical data for its phase III studies of BOTRESO and phase II study of MCS-8 (PCP). News release. Jyong Biotech Ltd. August 22, 2025. Accessed August 22, 2025. https://www.globenewswire.com/news-release/2025/08/22/3137831/0/en/Jyong-Biotech-Ltd-Participated-in-the-22nd-Urological-Association-of-Asia-Congress-to-Display-the-Clinical-Data-for-its-Phase-III-Studies-of-BOTRESO-and-Phase-II-Study-of-MCS-8-PCP.html

Jyong Biotech presented clinical data on BOTRESO (MCS-2) for benign prostatic hyperplasia (BPH) and MCS-8 for prostate cancer prevention at the Urological Association of Asia Congress. BOTRESO showed significant improvement in lower urinary tract symptoms (LUTS) in Asian populations and was well-tolerated in phase 3 trials. MCS-8 met its primary endpoint in a phase 2 trial, demonstrating reduced rates of positive prostate biopsies and high-grade cancer. Both drugs were well-tolerated, with no serious adverse events reported, and further trials are planned.

The presentations featured data on the drug candidate BOTRESO for BPH and LUTS, as well as on the prostate cancer prevention drug MCS-8.

Positive data on BOTRESO and MCS-8 highlight dual advances in prostate health 

 show that use of vaginal estradiol tablets was not associated with an increased risk of recurrent ischemic stroke in post-menopausal women with a prior history of ischemic stroke.

“We were cautiously hopeful about the findings, and it was reassuring to discover that the use of vaginal estrogen did not raise the risk of recurrent stroke in this high-risk population,” said lead author Kimia Ghias Haddadan, MD, of the department of cardiology at Copenhagen University Hospital – Herlev and Gentofte in Copenhagen, Denmark, in a news release on the findings.

 “US-based studies, such as the Women’s Health Initiative and the Nurses’ Health Study, have shown no increased stroke risk with vaginal estrogen in healthy women. Our study extends this reassurance to women with a history of stroke.”

In total, the nested case-control study included data from 34,274 postmenopausal women using a national registry in Denmark. All patients were aged 45 or older, had a prior history of a stroke from 2008 to 2017, and had no history of vaginal estrogen use prior to their stroke diagnosis. The median age of participants was 75 years (SD, 12).

Using incidence density sampling, the investigators matched 3353 cases of women who developed recurrent ischemic stroke during the follow-up period with 3353 controls (women who did not experience a second stroke) based on birth year. Use of vaginal estrogen tablets was characterized as current (within 3 months), recent (3 to 24 months), or past (more than 24 months prior to the study).

Overall, the study found no association between current use of vaginal estradiol tablets and recurrent ischemic stroke compared with no use (aHR, 0.79; 95% CI, 0.52 to 1.20; 

 = .27). Patients with recent use (aHR, 1.09; 95% CI, 0.73 to 1.63; 

 = .67) or past use (aHR, 1.48; 95% CI, 0.95 to 2.30; 

= .08) of vaginal estradiol tablets also showed no increased risk of recurrent ischemic stroke compared with patients who had no use.

Additionally, the study found no association between high-dose current use (aHR, 0.70; 95% CI, 0.41 to 1.21; 

 = .20) or low-dose current use (aHR, 1.14; 95% CI, 0.68 to 1.91; 

The authors also added, “There was no significant association between quintiles of total cumulative dose and recurrent ischemic stroke compared with no use.”

Based on these findings, the authors suggest that vaginal estradiol tablets are unlikely to increase the risk of recurrent ischemic stroke in women with a prior history of stroke.

However, they note several limitations of the current analysis. Data for the study were collected from prescription records, which prohibited confirmation of actual use or adherence. Additionally, the study only assessed vaginal estradiol tablets, since they are the most common mode of administration in Denmark. The findings, therefore, cannot necessarily be generalized to all forms of vaginal estradiol therapy.

Despite these limitations, the authors suggest that these findings are valuable for clinicians prescribing vaginal estrogen tablets.

“We hope our findings reassure health professionals caring for postmenopausal women with a history of stroke,” Haddadan concluded in the news release.

A study involving 34,274 postmenopausal women in Denmark found no increased risk of recurrent ischemic stroke associated with the use of vaginal estradiol tablets. The research, which matched 3,353 cases of recurrent stroke with controls, showed no significant risk increase for current, recent, or past users of vaginal estradiol. The study also found no association between high or low-dose use and stroke recurrence. Despite limitations, such as reliance on prescription records, the findings suggest vaginal estradiol tablets may be a safe option for women with a history of stroke.

“We hope our findings reassure health professionals caring for postmenopausal women with a history of stroke,” says Kimia Ghias Haddadan, MD. 

Jared S. Winoker, MD

Articles

Latest Updated Articles