Self-Monitoring of BP in Pregnancy Care may empower expectant mothers to advocate for their care, finds study

The rapid spread of COVID-19 prompted a quicker adoption of telemedicine, particularly in maternity care, with a focus on self-monitoring blood pressure during pregnancy as a potential vital aspect of healthcare post-pandemic. The BUMP trials investigated the effectiveness of adding self-monitoring blood pressure to routine care to see if it enhanced identifying or managing hypertension in expectant individuals at risk of or experiencing hypertension during pregnancy. Recent study evaluated the experiences of using self-monitoring of blood pressure (BP) during pregnancy as part of the BUMP trials. The trials aimed to determine if self-monitoring of BP improved detection or control of hypertension in pregnant individuals at risk or with hypertension.

Qualitative Process Evaluation

The qualitative process evaluation involved 39 in-depth interviews with participants in the intervention arm of the trials, 8 who declined participation, and 11 from the usual care arm. The findings show that self-monitoring of BP was generally acceptable, convenient, and reassuring for most participants. It allowed them to develop a better understanding of their BP patterns and factors that influenced it, empowering them to advocate for their care. Some declined participation due to concerns about becoming preoccupied or anxious.

Impact of Intervention

The intervention did not lead to earlier clinic-based detection of hypertension or improved BP control. This may have been impacted by participants selectively or delaying reporting of raised readings, and repeatedly testing to obtain normal readings. Interestingly, many in the usual care arm also self-monitored independently.

Healthcare Professionals’ Engagement

Healthcare professionals’ engagement with participants’ self-monitored readings varied. While some incorporated the data into collaborative decision-making, others dismissed or did not trust the readings, particularly when clinic and home readings differed. This highlighted the need for clearer guidance on interpreting variation in readings and managing discrepancies between self-monitored and clinic readings.

Findings and Considerations

The findings emphasize the potential value of self-monitoring in maternity care, but also the challenges around responsibility, ambiguity, and integration with clinical practice. As maternity services consider the role of remote monitoring post-pandemic, attention is needed to ensure self-monitoring is implemented equitably and with appropriate support, rather than inadvertently increasing burden on pregnant individuals.

Key Points

1. The study evaluated the experiences of using self-monitoring of blood pressure (BP) during pregnancy as part of the BUMP trials, which aimed to determine if self-monitoring of BP improved detection or control of hypertension in pregnant individuals at risk or with hypertension.

2. The qualitative process evaluation found that self-monitoring of BP was generally acceptable, convenient, and reassuring for most participants, allowing them to better understand their BP patterns and factors that influenced it, and empower them to advocate for their care. However, some declined participation due to concerns about becoming preoccupied or anxious.

3. The intervention did not lead to earlier clinic-based detection of hypertension or improved BP control, potentially due to participants selectively or delaying reporting of raised readings, and repeatedly testing to obtain normal readings. Interestingly, many in the usual care arm also self-monitored independently.

4. Healthcare professionals’ engagement with participants’ self-monitored readings varied, with some incorporating the data into collaborative decision-making, while others dismissed or did not trust the readings, particularly when clinic and home readings differed, highlighting the need for clearer guidance on interpreting variation in readings and managing discrepancies.

5. The findings emphasize the potential value of self-monitoring in maternity care, but also the challenges around responsibility, ambiguity, and integration with clinical practice.

6. As maternity services consider the role of remote monitoring post-pandemic, attention is needed to ensure self-monitoring is implemented equitably and with appropriate support, rather than inadvertently increasing burden on pregnant individuals.

Reference –

Chisholm A, Tucker KL, Crawford C, Green M, Greenfield S, Hodgkinson J, Lavallee L, Leeson P, Mackillop L, McCourt C, Sandall J, Wilson H, Chappell LC, McManus RJ, Hinton L. Self-monitoring blood pressure in pregnancy: evaluation of women’s experiences of the BUMP trials. BMC Pregnancy Childbirth. 2024 Nov 28;24(1):800. doi: 10.1186/s12884-024-06972-4. PMID: 39604875; PMCID: PMC11603728.

Powered by WPeMatico

Newer epilepsy medications used during pregnancy do not affect neurological development in children

Children of mothers who took certain antiseizure medications while pregnant do not have worse neurodevelopmental outcomes at age 6, according to a long-running study funded by the National Institutes of Health (NIH). The study was published in JAMA Neurology.

“Controlling seizures during pregnancy is an important part of prenatal care for women with epilepsy, but for years, the effects of newer antiseizure medications on their children was unknown,” said Adam Hartman, M.D., program director at NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “One major component of this study was correlating the cognitive abilities of children with maternal blood levels of the drugs. This opens the door to future work and might inform better dosing strategies.”

Treating epilepsy during pregnancy is challenging, as some antiseizure medications, primarily older drugs such as valproate, are known to cause serious birth defects and cognitive problems in children, including lower IQ and autism spectrum disorders. Newer antiseizure drugs that are widely used today are generally considered safe, but little is known about whether they affect cognition in children after fetal exposure.

In the study, researchers assessed language abilities in 387 children at age 6 (298 were born to women with epilepsy who took antiseizure medications). Children were tested on a variety of verbal abilities, including vocabulary and matching spoken words to pictures. There were no differences in language scores between children of women who took the medications and those who didn’t. Most women were taking lamotrigine, levetiracetam, or a combination of both drugs during and after pregnancy.

“What makes this study meaningful is that when you assess a child at 6, the tests are a lot more sensitive than at earlier ages, especially 2-year-olds. There’s measurable impact on school performance and results are more predictive of adult cognitive ability,” said Kimford Meador, M.D., co-lead investigator of the study and professor of neurology at Stanford University.

Finding the most effective and safest doses during pregnancy is also a challenge, and risks tend to vary between antiseizure drugs. Prior studies from the same research team have shown that high doses of levetiracetam could lead to poorer cognitive outcomes at age 2 and 3, and worse adaptive functioning at age 4 and a half, but the overall outcomes for all ages were positive.

“We need to balance making sure there is enough medicine on board to protect the mother and her developing fetus from seizures, but not too much where we’re creating risk for the child,” said Dr. Meador.

The study also found that folate use during the first 12 weeks of pregnancy was associated with better cognitive and behavioral outcomes, even at higher doses. Folate is an essential nutrient that can help prevent birth defects in the brain and spine of a developing fetus. This held true for children of women with and without epilepsy. High doses at or above 4 mg per day did not have adverse effects, which contrasts with prior studies that found long-term risks associated with high doses of folic acid.

This report is part of the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, a prospective, long-term study that looked at how antiseizure medications affect pregnant women with epilepsy and their children from birth up to 6 years of age. Led by Dr. Meador and Page Pennell, M.D., chair of neurology at the University of Pittsburgh, the study took place at 20 medical centers across the United States.

Additional analyses revealed no adverse effects of antiseizure medications on breastfeeding. Researchers point out that more studies need to be done to understand the risks of high doses of folate and less common antiseizure medications, including newer drugs on the market.

Reference:

Meador KJ, Cohen MJ, Loring DW, et al. Neuropsychological Outcomes in 6-Year-Old Children of Women With Epilepsy: A Prospective Nonrandomized Clinical Trial. JAMA Neurol. Published online November 25, 2024. doi:10.1001/jamaneurol.2024.3982

Powered by WPeMatico

Undiagnosed Mullerian anomalies may impact standard intra and postoperative management of ectopic pregnancies: Study

To describe the intraoperative and postoperative
implications arising from the unexpected diagnosis of a Mullerian anomaly
during the surgical management of an ectopic pregnancy, authors Shelun Tsai et
al carried out complete resolution of a left rudimentary uterine horn ectopic
pregnancy through surgical excision of the pregnancy sac without
hemihysterectomy in an academic centre.

A 39-year-old nulligravid woman with anovulation and
irregular menstrual cycles presented to the office. Her urine pregnancy test
result was incidentally positive; the serum b-human chorionic gonadotropin
level was 5,644 mIU/mL. Outpatient transvaginal ultrasonography demonstrated a
2.1 x 1.7 x 2.2–cm thick-walled structure in the left adnexa without an
intrauterine pregnancy. These findings were highly suspicious for a left tubal
ectopic pregnancy. The patient was consented for laparoscopy with planned left
salpingectomy. The patient included in this video gave consent for publication
of the video and posting of the video online including social media, the
journal website, scientific literature websites (e.g., PubMed, ScienceDirect,
and Scopus), and other applicable sites.

Diagnostic laparoscopy did not show an obvious left tubal
ectopic pregnancy. Instead, a right unicornuate uterus with a dilated
rudimentary left uterine horn was seen. Both fallopian tubes and ovaries
appeared normal. These laparoscopic findings were consistent with an ectopic
pregnancy in the rudimentary horn. However, in the absence of informed consent
for a hemihysterectomy and no evidence of ectopic rupture or bleeding within
the pelvis, we decided to proceed with excision of the ectopic pregnancy from
the uterine horn. An incision was made over the anterior surface of the uterine
horn, and the pregnancy sac was dissected from the underlying myometrium and
excised in its entirety. Left salpingectomy was also performed. The patient was
discharged home the same day, and her b-human chorionic gonadotropin levels
decreased to <5 mIU/mL within 28 days of surgery.

Postoperative hysterosalpingography demonstrated a right
unicornuate uterus with normal fill and spill of the right fallopian tube.
Magnetic resonance imaging of the pelvis confirmed the findings of a right
unicornuate uterus with a noncommunicating left rudimentary uterine horn that
did not contain any endometrial tissue. Thus, the patient did not require an
interval hemihysterectomy. She underwent letrozole and intrauterine
insemination treatment 5 months after the initial surgery, which resulted in a
clinical intrauterine pregnancy. However, this pregnancy was terminated in the
early second trimester because of findings of trisomy 18. She conceived
naturally 1 year later, and this pregnancy resulted in a full-term vaginal
birth at 39 weeks of gestation.

It can be concluded that undiagnosed or unexpected Mullerian
anomalies can impact the standard intraoperative and postoperative management
of ectopic pregnancies.

Source: Shelun Tsai, M.D.,a Aleksandra Uzelac, B.Sc., M.Sc.,
M.D.,b Steven R. Lindheim; Fertil Steril® Vol. 122, No. 5, November 2024

https://doi.org/10.1016/j.fertnstert.2024.07.036

Powered by WPeMatico

Low-dose ketamine shows promise for pain relief in emergency department patients, finds study

 A new study that investigates low-dose ketamine (LDK) as an adjunct to morphine for treating acute pain has been published in the October issue of Academic Emergency Medicine (AEM), the peer-reviewed journal of the Society for Academic Emergency Medicine (SAEM).

The study, titled Low-dose ketamine as an adjunct to morphine: A randomized controlled trial among patients with and without current opioid use highlights the potential of low-dose ketamine as a valuable tool in pain management, providing a safe and effective option for emergency medicine physicians managing acute pain.

Pain remains one of the most common and challenging complaints among patients presenting to the emergency department (ED). For individuals with opioid tolerance, achieving effective pain relief can be particularly difficult, as they often require higher doses of opioids, which increases risks of hyperalgesia and withdrawal symptoms. In their randomized, placebo-controlled trial, lead author Stine Fjendbo Galili, MD, and colleagues explored the effectiveness of LDK as an adjunct to morphine in a diverse ED population with varying levels of opioid use. The study demonstrated that a single dose of 0.1 mg/kg of ketamine provided significant reductions in pain scores for 30 minutes compared to a placebo.

The study concluded that LDK may be an effective short-term adjunct analgesic to morphine for managing acute pain, offering relief to both opioid-tolerant and opioid-naïve patients. Importantly, the findings open the door for future research to refine low-dose ketamine administration methods, such as bolus or continuous infusions, to achieve longer-lasting pain relief. 

Reference:

Stine Fjendbo Galili, Bodil Hammer Bech, Hans Kirkegaard, Low-dose ketamine as an adjunct to morphine: A randomized controlled trial among patients with and without current opioid use, Academic Emergency Medicine, https://doi.org/10.1111/acem.14983

Powered by WPeMatico

Intravenous Lidocaine Ineffective for Gut Function Recovery After Colon Surgery, finds research

UK: A recent clinical trial published in the Journal of the American Medical Association (JAMA) has shed light on the potential benefits of intravenous (IV) lidocaine in promoting gut function recovery following colonic surgery. The researchers found that among patients undergoing elective minimally invasive colon resection, perioperative administration of 2% intravenous lidocaine did not improve the return of gut function at 72 hours.

While this study reported no adverse events linked to the lidocaine administration schedule used, concerns remain about the potential risks of systemic toxicity and fatal outcomes associated with its use.

Despite the recovery benefits associated with minimally invasive surgical techniques, delayed return of gut function following colectomy remains a frequent obstacle to timely hospital discharge. Considering this challenge, Hugh Paterson, University of Edinburgh, Edinburgh, United Kingdom, and colleagues set out to assess the impact of a 2% perioperative intravenous lidocaine infusion on gut function recovery after elective minimally invasive colon resection.

For this purpose, the researchers conducted the ALLEGRO trial, a randomized, placebo-controlled, double-blind study in 27 UK hospitals. Between August 2018 and April 2023, 590 adults undergoing elective minimally invasive colon resection for benign or malignant conditions were randomized to receive 2% intravenous lidocaine or saline placebo. Lidocaine was administered as a 1.5-mg/kg bolus followed by a 1.5 mg/kg/h infusion for 6 or 12 hours, while the placebo group received saline.

The primary outcome was gut function recovery at 72 hours post-surgery, with 11 secondary outcomes, including postoperative ileus, recovery timelines, opioid use, and quality of life measures.

The following were the key findings of the study:

  • A total of 590 patients were enrolled, 295 were randomized to the intervention group and 295 to the control group.
  • After 33 postrandomization exclusions, 557 patients were included in the analysis (279 intervention, 278 control).
  • The study population included 249 female patients (44.7%), with a mean age of 66.
  • Of the participants, 96% received the randomized treatment.
  • Return of gut function at 72 hours, defined by the GI-3 composite outcome, was achieved by 57.3% of patients in the lidocaine group and 59.0% in the placebo group.
  • The adjusted absolute difference in gut function recovery between groups was −1.9%.
  • No significant differences were observed between the intervention and control groups for the 11 secondary endpoints.

This study had limitations, including no data on race, ethnicity, or socioeconomic status, exclusion of complex colorectal surgeries, and lack of strict protocols for anesthetic or surgical techniques. Additionally, subgroup analysis showed no difference between 6-hour and 12-hour lidocaine infusions, making longer durations unlikely to improve outcomes and riskier.

“The findings showed that in adults undergoing elective minimally invasive colon resection, perioperative infusion of 2% IV lidocaine showed no improvement in gut function recovery at 72 hours,” the researchers concluded.

Reference:

Paterson H, Vadiveloo T, Innes K, et al. Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial. JAMA. Published online November 27, 2024. doi:10.1001/jama.2024.23898

Powered by WPeMatico

ZENITH Trial Breakthrough: Winrevair Shows Significant Impact on Outcomes of Pulmonary Arterial Hypertension

USA: In patients with advanced pulmonary arterial hypertension (PAH), adding the biologic sotatercept-csrk (Winrevair; Merck) to the maximum tolerated background therapy significantly lowers the risk of death compared to background therapy alone, as shown by the top-line results of the ZENITH trial.

Merck announced yesterday that an interim analysis of the ZENITH trial confirmed it had achieved its primary endpoint, which measured the time to the first morbidity or mortality event. Following this finding, the trial’s independent data monitoring committee recommended ending the phase III trial early to enable all participants to transition into an open-label extension study and access the drug.

The ZENITH trial enrolled 172 patients with PAH classified as WHO Functional Class III or IV. Participants were randomized to receive either WINREVAIR or a placebo alongside their maximum tolerated PAH therapy. The study’s primary endpoint was the time to the first morbidity or mortality event, defined as all-cause death, lung transplantation, or PAH-related hospitalization lasting 24 hours or more. Secondary measures included overall survival and transplant-free survival.

An interim analysis revealed statistically significant and clinically meaningful results. Compared to placebo, sotatercept reduced the risk of morbidity and mortality events, prompting an independent data monitoring committee to recommend early trial termination. This decision allows all participants to transition to an open-label extension study, SOTERIA, ensuring continued access to the drug.

WINREVAIR’s mechanism of action as an activin signaling inhibitor is groundbreaking. Modulating vascular proliferation restores the balance between pro- and antiproliferative signals, addressing a key aspect of PAH pathophysiology. Based on data from the STELLAR trial, this innovative approach has already led to regulatory approval in the U.S. and 36 other countries.

The STELLAR study had previously demonstrated sotatercept’s effectiveness in improving exercise capacity, as measured by a 6-minute walk test while reducing mortality and clinical worsening rates. Building on this foundation, the ZENITH trial has provided robust evidence of the drug’s impact on survival outcomes.

Adverse events in ZENITH were balanced between the treatment and placebo groups, reinforcing the safety profile of sotatercept. According to Merck, the results set a new standard for PAH treatment, offering hope to patients who face limited therapeutic options.

Dr. Vallerie McLaughlin, an investigator in the ZENITH trial, noted that the findings represent a significant milestone. “This is the first study in PAH where overwhelming efficacy led to early trial termination, bringing optimism to the field,” she remarked.

Full results from ZENITH will be presented at an upcoming medical conference and are expected to inform further regulatory submissions. With its potential to transform PAH management, WINREVAIR continues to garner attention as a pivotal development in cardiopulmonary medicine.

Powered by WPeMatico

Early-Onset Atopic Dermatitis Linked to Increased Risk of Atopic March: Study Identifies Key Risk Factors

USA: A recent study has found that early-onset atopic dermatitis (AD), diagnosed before the age of one, is linked to a heightened risk of asthma (19.21%), allergic rhinitis (28.27%), and food allergies (16%). Additionally, the study revealed that 10.69% of patients with AD went on to develop the full atopic triad, comprising asthma, rhinitis, and food allergy.

Key risk factors contributing to the progression of AD to the atopic march included male gender, severe AD, and a family history of atopy. The findings published in the Journal of the American Academy of Dermatology emphasize the importance of early identification and management of AD to mitigate its broader health impacts.

The relationship between atopic dermatitis (AD), the progression to the atopic march, and the associated risk factors remains insufficiently explored. For this purpose, Shawn G. Kwatra, Department of Dermatology, University of Maryland School of Medicine, Baltimore, MD, and colleagues aimed to identify the risk factors for the atopic march in patients with early-onset AD and examine the temporal association between AD and the development of the atopic march.

For this purpose, the researchers utilized the MarketScan Research Database to conduct a retrospective cohort analysis spanning 2010 to 2018. They compared infants diagnosed with atopic dermatitis (AD) before the age of one to a control group without early-onset AD.

The primary outcomes of interest were hazard ratios (HR) for developing asthma, allergic rhinitis, and food allergy.

The study led to the following findings:

  • Among 27,228 AD patients compared to 55,174 controls, higher proportions developed asthma (19.21% versus 8.65%), allergic rhinitis (28.27% versus 12.62%), food allergy (16.00% versus 2.27%), and all atopic triad conditions (10.69% versus 0.71%).
  • Male AD patients were more likely to develop the atopic triad (HR 1.66).
  • Severe AD significantly increased the likelihood of the atopic triad (HR 3.16).
  • A family history of atopy was associated with a greater than threefold risk of the atopic triad (HR >3.40).
  • Among AD patients, 20.1% developed allergic rhinitis.

The study, based on healthcare claims data, highlights that early-onset atopic dermatitis (AD) is associated with significantly higher rates of developing conditions within the atopic march compared to controls.

“These findings emphasize the importance of focusing on risk factors and implementing proactive screening strategies for the atopic march in patients with early-onset AD,” the researchers concluded.

Reference:

Choi, U. E., Deng, J., Parthasarathy, V., Liao, V., D’Amiano, A., Taylor, M., Bordeaux, Z. A., Kambala, A., Cornman, H. L., Canner, J. K., Drucker, A. M., & Kwatra, S. G. (2024). Risk factors and temporal associations of progression of the atopic march in children with early-onset dermatitis. Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2024.10.107

Powered by WPeMatico

PRX-115 promising treatment option for patients with gout, finds study

A recent study presented by Orit Cohen Barak in the ACR Convergence 2024 showed that with the extra advantage of a potentially broad dose interval, PRX-115 (Protalix BioTherapeutics) may provide an efficient urate-lowering medication that might improve patient compliance and treatment flexibility of gout cases.

PEGylated uricases have previously shown promise as a therapeutic approach for treating individuals with refractory gout. Utilizing a novel plant cell-based expression technique, the recombinant homotetrameric uricase enzyme PRX-115 is generated from Candida utilis. After purification, the enzyme undergoes a unique modification using unique polyethylene glycol (PEG) molecules. High specific activity, enhanced stability, and decreased immunogenic potential are all features of PRX-115’s design.

A single intravenous (IV) infusion of PRX-115 was used to evaluate its safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in a first-in-human single ascending dosage, double-blinded research (FIH-SAD, NCT05745727). A total of 64 participants, the majority of whom had high urate levels (>6.0 mg/dL), were recruited for the trial and randomly assigned to either PRX-115 or a placebo in a 3:1 ratio (8 cohorts; 6 participants on active and 2 on placebo each cohort). The participants were monitored for 12 weeks, or 85 days. 

The findings suggest that PRX-115 single ascending dosages were usually well tolerated, according to key findings from the first 7 cohorts. A total of 18 associated Treatment Emergent Adverse Events (TEAEs) were reported by 11 (26%) subjects who received PRX-115; most of them were mild to moderate and temporary in character. At a modest dosage, one significant adverse event (SAE, anaphylactic response) happened right after the infusion started. The person persisted in the trial when the SAE had completely resolved.

Exposure to PRX-115 grew in a dose-dependent manner, with detectable amounts up to 85 days (12 weeks) after treatment at the high dosages and peak concentrations being recorded right after infusion. A single dosage of PRX-115 quickly lowered plasma urate below 6.0 mg/dL in all tested doses. With urate levels below 6.0 mg/dL that persisted for 12 weeks, the urate-lowering efficacy and response duration were dose-dependent.

Overall, the findings of this FIH-SAD study’s first seven cohorts show that PRX-115 may be able to provide a broad dose interval and is a potentially effective therapy choice for gout patients. To validate these results and determine PRX-115’s long-term safety and effectiveness in gout patients, more research is necessary.

Source:

Prolonged plasma urate-lowering after a single intravenous administration of PRX-115, a novel PEGylated uricase, in participants with elevated urate levels. (2024, October 15). ACR Meeting Abstracts. https://acrabstracts.org/abstract/prolonged-plasma-urate-lowering-after-a-single-intravenous-administration-of-prx-115-a-novel-pegylated-uricase-in-participants-with-elevated-urate-levels/

Powered by WPeMatico

PET CT outperforms Computed Tomography Scan in determining suspected Bone metastasis: Study

A recent study found that fluorodeoxyglucose
positron emission tomography/computed tomography ([18F] FDG
PET/CT) was better for determining bone biopsy sites and identifying bone
metastasis. It was also more cost-effective than computed tomography, as per the
trial results published in the Cancer Imaging journal

More than half of all cancers
develop metastasis, and bone is the most common site of metastasis after the
lungs and liver. This metastasis often leads to the development of complicated
skeletal-related events like fractures, spinal cord compression, etc, affecting
the quality of life and survival rates. Hence, early diagnosis is essential in
cancers. Bone biopsy of the suspected tissue is the gold standard test. Imaging
techniques like scintigraphy, computed tomography scans, and [18F] FDG
PET/CT are essential for guiding bone biopsies. Even though [18F] FDG
PET/CT offers high accuracy, its accessibility is limited in certain areas. Hence,
researchers conducted a study to determine whether [18F] FDG PET/CT
could more accurately determine a puncture site than CT to improve the
diagnostic accuracy of biopsy. They also determined the best cutoff value of
clinical indicators for differentiating malignant bone metastases using a
noninvasive examination and [18F] FDG PET/CT.

Also Read: Bone Mineral Density Declines More Rapidly in Adults With Cystic Fibrosis, finds study

A prospective, single-center,
comparative imaging study compared the performance of [18F] FDG
PET/CT with CT in detecting bone metastases. Between 2020 and 2021, about 273
patients with bone lesions were enrolled and treated. Patients were randomly
assigned to undergo the scans before biopsy to determine the puncture site. The
two imaging tests’ accuracy, sensitivity, specificity, second biopsy rate,
diagnostic time, and cost-effectiveness were compared.

Findings:

  • The [18F] FDG PET/CT group showed a
    significantly higher accuracy and sensitivity in detecting bone metastases than
    the CT group.
  • The need for a second biopsy was also significantly
    lower in the [18F] FDG PET/CT group.
  • The [18F] FDG PET/CT group showed a
    lesser diagnostic time of 18.33 ± 2.08 days than 21.28 ± 1.25 days in the CT
    group ( P < 0.05).
  • The cost of [18F] FDG PETCT is
    11428.35 yuan, and the cost of CT is 13287.52 yuan; the incremental cost is
    1859.17 yuan.
  • SUVmax > 6.3 combined with ALP > 103 U/L demonstrated
    a strong association for tumor metastases with an AUC of 0.901.
Also Read: False-Positive Mammograms May Deter Women from Future Screenings: Research Finds

Thus, the researchers concluded
that [18F] FDG PET/CT is better suited and cost-effective than CT for
localizing the bone biopsy site for suspect bone metastases. The authors also
recommended [18F] FDG PET/CT as an imaging test for localizing the site of bone
biopsy.

Further reading: Chang, Y., Gu,
Y., Ruan, S. et al. [18F]FDG PET/CT performs better
than CT in determining the bone biopsy site : randomized controlled clinical
trial. Cancer Imaging 24, 160 (2024). https://doi.org/10.1186/s40644-024-00804-6.

Powered by WPeMatico

AstraZeneca Estimates Rs 35 Crore Tax Benefit After ITAT Remands Transfer Pricing Issues

New Delhi: AstraZeneca Pharma India Limited has estimated a potential tax benefit of approximately Rs 35 crore following a favorable ruling from the Income Tax Appellate Tribunal (ITAT) on its tax disputes for the assessment years 2017-18 and 2018-19. The ITAT granted full relief on corporate tax matters, while remitting the transfer pricing issues back to the Assessing Officer (AO) for further review, in line with its directions.

The company disclosed the development to the stock exchanges, indicating that the final tax impact will be determined once the AO completes the review process.

The ITAT’s decision granted complete relief to the company on corporate tax matters. However, the tribunal remitted the transfer pricing issue back to the Assessing Officer for further review, directing that the matter be resolved in line with the ITAT’s guidance.

In a ruling on November 26, 2024, the ITAT, Bangalore delivered its judgment concerning the appeals filed by AstraZeneca Pharma India Limited against the assessment orders for the assessment years 2017-18 and 2018-19.

The company had contested various adjustments made by the Assistant Commissioner of Income Tax (ACIT), Bengaluru, related to transfer pricing and other corporate tax matters.

Key Issues and Rulings

  1. Transfer Pricing Adjustments: One of the primary issues in the appeals related to adjustments made in transfer pricing, specifically concerning the Unilateral Advance Pricing Agreement (APA) entered between the company and the Central Board of Direct Taxes (CBDT) in June 2023. This agreement covered assessments for the years 2016-17 to 2020-21. AstraZeneca’s arguments were accepted, as the adjustments were found to be resolved through the APA, rendering the adjustments for these years unnecessary. As a result, these grounds were dismissed by the Tribunal.
  2. Selling, Marketing, and Distribution Expenses: A major point of contention was the disallowance of Rs. 30,47,64,640 for selling, marketing, and distribution expenses. The Tribunal noted that this issue had been previously raised in the assessment year 2016-17, and the matter had been remitted to the Assessing Officer (AO) for fresh adjudication. The Tribunal decided that this issue should also be sent back to the AO/TPO for proper review, aligning with the directions from the earlier ruling.
  3. Club and Entrance Fees: Another significant matter concerned the addition of Rs. 1,78,659 for club and entrance fees, which the Assessing Officer (AO) had disallowed as personal expenditure. The Tribunal observed that the Dispute Resolution Panel (DRP) had already ruled in favor of AstraZeneca, directing the AO to delete this addition. However, the AO had failed to comply, and the Tribunal ordered that the addition be deleted in accordance with the DRP’s direction.
  4. Adjustment of Book Profits under Section 115JB: A contentious issue revolved around the adjustment of book profits under Section 115JB of the Income Tax Act, particularly regarding transfer pricing adjustments. The AO had added adjustments related to transfer pricing and other corporate disallowances to the book profits. However, the Tribunal ruled that such adjustments were not permissible under Section 115JB, referencing previous rulings that disallowed such adjustments. The Tribunal thus directed the AO to exclude these adjustments in the final computation of book profits.
  5. Penalty Proceedings: The Tribunal also addressed the initiation of penalty proceedings under Section 270A, but determined that it was premature to make any decision at this stage, dismissing the issue as infructuous.

The Tribunal’s final decision was favorable to the appellant, AstraZeneca Pharma, in several areas, especially regarding the corporate tax issues and the treatment of certain expenses.

The case will now be returned to the Assessing Officer for further proceedings, particularly on the transfer pricing adjustments and other disallowed expenses. The final ruling also confirmed the company’s favorable tax impact of approximately Rs 35.01 crores, though this remains an estimate pending the completion of the AO’s review.

The Tribunal’s order on the two appeals, IT(TP)A Nos. 419 & 876/Bang/2022, covering both the assessment years 2017-18 and 2018-19, is partially allowed, mainly for statistical purposes, as the matters are to be further adjudicated by the AO in line with the Tribunal’s directions.

Meanwhile, in its recent communication to the stock exchanges, AstraZeneca disclosed about the ITAT order, adding that the company will now work with the AO to ensure that the final order aligns with the ITAT’s directions.

Further, expressing on the financial implications, the drug maker said, “The expected overall financial implication cannot be determined at this stage. However, the estimated favorable tax impact on account of the captioned ITAT order could be Rs. 35.01 crores (approx.).”

To view the original order, click on the link below:

https://indiankanoon.org/doc/85401656/

Powered by WPeMatico