Blood test finds knee osteoarthritis up to eight years before it appears on X-rays: Study

A blood test successfully predicted knee osteoarthritis at least eight years before tell-tale signs of the disease appeared on x-rays, Duke Health researchers report.

In a study appearing in the journal Science Advances, the researchers validated the accuracy of the blood test that identifies key biomarkers of osteoarthritis. They showed that it predicted development of the disease, as well as its progression, which was demonstrated in their earlier work.

The research advances the utility of a blood test that would be superior to current diagnostic tools that often don’t identify the disease until it has caused structural damage to the joint.

“Currently, you’ve got to have an abnormal x-ray to show clear evidence of knee osteoarthritis, and by the time it shows up on x-ray, your disease has been progressing for some time,” said senior author Virginia Byers Kraus, M.D., Ph.D., a professor in the departments of Medicine, Pathology, and Orthopedic Surgery at Duke University School of Medicine. “What our blood test demonstrates is that it’s possible to detect this disease much earlier than our current diagnostics permit.”

Osteoarthritis (OA) is the most common form of arthritis, afflicting an estimated 35 million adults in the U.S. and causing significant economic and societal impacts. While there are currently no cures, the success of potential new therapies could hinge on identifying the disease early and slowing its progression before it becomes debilitating.

Kraus and colleagues have focused on developing molecular biomarkers that can be used for both clinical diagnostic purposes and as a research tool to aid in the development of effective drugs. In previous studies, the blood biomarker test demonstrated 74% accuracy in predicting knee OA progression and 85% accuracy in diagnosing knee OA.

The current study further honed the test’s predictive capabilities. Using a large United Kingdom database, the researchers analyzed serum of 200 white women, half diagnosed with OA and the other half without the disease, matched by body mass index and age.

They found that a small number of biomarkers in the blood test successfully distinguished the women with knee OA from those without it, catching molecular signals of OA eight years before many of the women were diagnosed with the disease by x-ray.

“This is important because it provides more evidence that there are abnormalities in the joint that can be detected by blood biomarkers well before x-rays can detect OA,” Kraus said. “Early-stage osteoarthritis could provide a ‘window of opportunity’ in which to arrest the disease process and restore joint health.”

Reference:

Virginia Kraus, An Osteoarthritis Pathophysiological Continuum Revealed by Molecular Biomarkers, Science Advances (2024). DOI: 10.1126/sciadv.adj6814.

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Nalbuphine bests fentanyl as intrathecal additives for postoperative analgesia in infraumbilical surgeries: Study

Recently published study compared the efficacy of nalbuphine and fentanyl as intrathecal additives alongside local anesthetic for postoperative analgesia in infraumbilical surgeries. A total of 166 patients were included in the double-blind randomized controlled trial, with Group N receiving 2.5 mL of 0.5% bupivacaine + 1 mg of nalbuphine and Group F receiving 2.5 mL of 0.5% bupivacaine + 25 mcg fentanyl. The study compared parameters such as onset and duration of sensory and motor blockade, intraoperative hemodynamics, and side effects. Results showed that nalbuphine provided a longer duration of analgesia (267.27 ± 172.099 minutes in Group N vs. 161.35 ± 14.957 minutes in Group F) with better hemodynamic stability.

Importance of Spinal Anesthesia and Adjuvants

The study highlighted the importance of spinal anesthesia for infraumbilical surgeries and emphasized the need for adjuvants to prolong postoperative analgesia. It discussed the use of conventional and newer local anesthetic agents and the challenge of maximizing the duration of analgesia in the postoperative period. The study focused on the use of nalbuphine and fentanyl as intrathecal adjuvants and their effects on postoperative analgesia, sensory and motor blockade, and hemodynamic parameters.

The findings revealed that nalbuphine as an intrathecal additive along with local anesthetic provided a more prolonged duration of postoperative analgesia compared to fentanyl, and it offered better hemodynamic stability. The study discussed the dosage, administration, and safety profile of nalbuphine, and highlighted that the findings were in line with previous studies. It also acknowledged limitations such as the lack of intragroup analyses on the type of surgery’s effects on hemodynamic parameters and the optimal dose of nalbuphine. Finally, the study concluded that intrathecal nalbuphine was found to be more safe and effective than intrathecal fentanyl for postoperative analgesia in infraumbilical surgeries.

Key Points

– The study compared the efficacy of nalbuphine and fentanyl as intrathecal additives alongside local anesthetic for postoperative analgesia in infraumbilical surgeries. It involved a double-blind randomized controlled trial with 166 patients, where Group N received nalbuphine and Group F received fentanyl, and compared parameters such as onset and duration of sensory and motor blockade, intraoperative hemodynamics, and side effects.

– Nalbuphine provided a longer duration of analgesia with better hemodynamic stability compared to fentanyl. The duration of postoperative analgesia was 267.27 ± 172.099 minutes in Group N vs. 161.35 ± 14.957 minutes in Group F.

– The study highlighted the importance of spinal anesthesia for infraumbilical surgeries and the need for adjuvants to prolong postoperative analgesia. It also concluded that intrathecal nalbuphine was found to be more safe and effective than intrathecal fentanyl for postoperative analgesia in infraumbilical surgeries.

References –

Jananimadi S, Arish B, Hariharasudhan B, et al. (April 17, 2024) Comparison of Postoperative Analgesia Between Intrathecal Nalbuphine and Intrathecal Fentanyl in Infraumbilical Surgeries: A Double-Blind Randomized Controlled Trial. Cureus 16(4): e58503. DOI 10.7759/cureus.58503

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Preterm Preeclampsia independent Risk Factor for Thromboembolism, reveals study

USA: Preeclampsia, a potentially life-threatening condition characterized by high blood pressure during pregnancy, has long been recognized as a significant risk factor for adverse maternal and fetal outcomes. In a groundbreaking development, a large national cohort study has uncovered preterm preeclampsia as an independent risk factor for thromboembolism, adding a new dimension to the understanding of this complex condition.

Preterm preeclampsia is independently associated with an increased risk of thromboembolic events, the study stated. The study was published online in the American Journal of Obstetrics and Gynecology on May 04, 2024.

Preterm preeclampsia is a product of vascular dysfunction and is associated with prolonged hospital admission and proteinuria, which are significant risk factors for thromboembolism in pregnancy. Thromboembolism risk in preterm preeclampsia warrants further investigation. Therefore, Lara Slesnick, University of Illinois-Chicago, Department of Obstetrics and Gynecology, Chicago, IL, and colleagues aimed to determine the relationship between preterm preeclampsia and thromboembolic risk. They hypothesized that preterm preeclampsia is an independent risk factor for thromboembolism in pregnancy.

For this purpose, the research team conducted a retrospective cohort study using the National Inpatient Sample database via HCUP-AHRQ from 2017-2019. It included all subjects with an ICD-10 code for pregnancy or peripartum encounters. Subjects were excluded if the gestational age at delivery was less than 20 weeks or if they had a history of thromboembolism, antiphospholipid syndrome, or inherited thrombophilia.

Patients with preterm (delivered less than 37 weeks) preeclampsia and term (delivered 37 weeks or greater) preeclampsia were compared to those without preeclampsia. The primary outcome was a composite of any thromboembolic event, including deep vein thrombosis, pulmonary embolism, transient ischemic attack (TIA)/cerebral thrombosis, or other thromboses. The secondary outcomes were rates of each type of thromboembolic event.

The study led to the following findings:

· Of individuals in the database, more than 2.2 million met the inclusion criteria. 2.7% had preterm preeclampsia, and 6.7% had term preeclampsia.

· Those with preterm preeclampsia were more likely to be older, identify as non-Hispanic black, be obese, have chronic hypertension among other chronic diseases, and be in the lowest quartile of income.

· Among patients with preterm preeclampsia, 0.32% experienced thromboembolism, while those with term preeclampsia and without preeclampsia experienced thromboembolism 0.10% and 0.09%, respectively.

· After controlling for confounders that differed between groups, preterm preeclampsia remained independently associated with any thromboembolic event (aOR 2.21) and each type of thromboembolism.

· Term preeclampsia was not associated with an increased risk of thromboembolism (aOR 1.18).

In conclusion, the study’s findings underscore the importance of recognizing preterm preeclampsia as an independent risk factor for thromboembolism in pregnant individuals. By integrating these findings into clinical practice and prioritizing research efforts aimed at elucidating the underlying mechanisms, strides can be made toward improving maternal outcomes and enhancing the quality of care for individuals affected by this complex condition.

Reference:

DOI:https://doi.org/10.1016/j.ajog.2024.04.049

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Efficacy of Erector Spinae Plane Block for Thoracic and Abdominal Surgeries- Retrospective Case study

In a recently published study “Efficacy of Erector Spinae Plane (ESP) Block for Non-cardiac Thoracic and Upper Abdominal Surgery,” the authors aimed to evaluate the efficacy of the ESP block in treating acute postoperative pain in patients undergoing thoracic and abdominal surgeries. The retrospective study included 50 patients in each of the non-cardiac thoracic surgery group (undergoing bilateral breast mastectomy with reconstruction) and the abdominal surgery group (undergoing robotic or laparoscopic sleeve gastrectomy). All patients received bilateral ESP blocks under ultrasound guidance. The study evaluated parameters such as oral morphine equivalents (OMEs) and visual analog scale (VAS) scores during different time points postoperatively, as well as the use of antiemetic medications.

The results showed that compared to the thoracic surgery group, the abdominal surgery group had statistically higher VAS scores and OME consumption in the post-anesthesia care unit (PACU), as well as a greater need for antiemetic medications. However, despite higher OME utilization in the PACU for the abdominal group, there was no difference in cumulative OME use in the first 24 hours. The study demonstrated that ESP blocks are an effective regional anesthesia technique to reduce postoperative pain and opioid consumption for thoracic and upper abdominal surgeries.

The study highlighted the versatility, simplicity, and safety of the ESP block, which is a paraspinal fascial plane block that can be easily adapted to various clinical situations. The ESP block was found to provide opioid-sparing analgesia and better pain scores when compared to no block care. However, the study also identified limitations such as variability in the study population and surgery type, as well as the need for future studies to examine the effect of additives or liposomal bupivacaine on prolonging single ESP blocks. Overall, the study provides valuable insights into the efficacy of the ESP block for perioperative pain management in thoracic and upper abdominal surgeries.

The authors acknowledged the limitations of the study, including the retrospective nature, demographic variability, and the lack of a control group for comparison. They also highlighted the need for future research to address these limitations and further explore the potential of the ESP block as a regional anesthesia technique for enhanced recovery pathways in perioperative care.

Key Points

– The study aimed to assess the effectiveness of the Erector Spinae Plane (ESP) block in managing acute postoperative pain in patients undergoing non-cardiac thoracic and upper abdominal surgeries. It included 50 patients in each group and evaluated parameters such as oral morphine equivalents (OMEs) and visual analog scale (VAS) scores at different time points postoperatively, as well as the use of antiemetic medications.

– The results indicated that the abdominal surgery group had statistically higher VAS scores and OME consumption in the post-anesthesia care unit (PACU) compared to the thoracic surgery group. Despite higher OME utilization in the PACU for the abdominal group, there was no difference in cumulative OME use in the first 24 hours. The study demonstrated that ESP blocks are effective in reducing postoperative pain and opioid consumption for thoracic and upper abdominal surgeries.

Reference –

Hymes-Green Z, LaGrone E L, Peabody Lever J E, et al. (April 24, 2024) Efficacy of Erector Spinae Plane (ESP) Block for Non-cardiac Thoracic and Upper Abdominal Surgery: A Single Institute Comparative Retrospective Case Series. Cureus 16(4): e58926. DOI 10.7759/cureus.58926

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CDSCO Panel grants Zydus Lifscience Proposal For Additional Indication of Trivalent Influenza vaccine in 6 months to 17 years age

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Zydus Lifscience’s proposal for additional indication for an already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

However, this approval is subject to the condition that Zydus Lifesciences conduct a Phase IV Clinical trial and submit the clinical trial protocol within 3 months.

This came after Zydus Lifesciences presented the proposal for approval of additional indication for an already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

Trivalent flu vaccines protect against three strains of the virus: influenza A (H1N1), influenza A (H3N2), and one influenza B/Victoria lineage virus. Influenza B viruses are classified into two lineages: B/Yamagata and B/Victoria. However, as per USFDA, the evidence indicates that the B/Yamagata lineage virus no longer poses a public health threat.

In the interest of public health, the FDA strongly recommended to influenza vaccine manufacturers the removal of the B/Yamagata lineage virus from seasonal influenza vaccines in the U.S. for the 2024-2025 influenza season.

At the recent SEC meeting for Vaccine held on 30th April 2024, the expert panel reviewed the proposal for approval of additional indication for the already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

The committee noted that the firm already has manufacturing permission for the Inactivated Quadrivalent Influenza vaccine for the same age group. The applied Inactivated Trivalent Influenza vaccine has the same composition as the approved Quadrivalent Influenza vaccine except that it does not contain the B/Yamagata strain.

Further, the committee also noted WHO recommendations for the use of the Trivalent Influenza vaccine instead of the Quadrivalent Influenza vaccine from 2024 onwards.

After detailed deliberation and based on the above, the committee recommended the approval of the additional indication in the age group of 6 months to 17 years with clinical trial waiver with the condition to conduct Phase IV Clinical trial and the clinical trial protocol should be submitted within 3 Months.

Also Read: Diabetes drug: Sanofi unveils Soliqua in India

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Dr Reddy’s Labs expects strong product pipeline in North America for FY25

Bengaluru: Dr. Reddy’s Laboratories, based in India, forecasts a strong product lineup for its key market in North America in the fiscal year 2024-25, the generic pharmaceutical firm has declared. This announcement came after it reported fourth-quarter profits that surpassed expectations.

Lenalidomide, the company’s generic version of Bristol-Myers Squibb’s blockbuster cancer drug Revlimid, will continue to be a meaningful contributor for the next three quarters, the drugmaker said in a post earnings media call.

The drug has been persistently boosting Dr Reddy’s U.S. sales since its launch in 2022.
Other generic drugmakers such as Cipla, Sun Pharma and Zydus Lifesciences have also benefitted from rising sales of their own copycat versions of Revlimid in the U.S.
According to Reuters report, Bristol Myers is facing pressure from generic competition for Revlimid, once its top-selling drug.
Meanwhile, generic drugmakers are grappling with pricing pressures amid intensifying competition.
“Price erosion trends are stable,” Dr Reddy’s CFO Parag Agarwal said, adding he does not see any structural impact or change in the market.
Dr Reddy’s consolidated net profit for three months ended March 31 rose 36.5% from a year earlier to 13.10 billion rupees (about $157 million), beating analysts’ average estimates of 12.42 billion rupees, per LSEG data.
The drugmaker’s total revenue climbed 13% to 71.14 billion, in line with analysts’ expectations, led by a 29% climb in the North American generics business, its biggest segment. Sales in Europe rose 5%.
The company said M V Narasimham, who is currently deputy CFO, will take over as the finance chief from Parag Agarwal, who will retire on July 31.
Rival Cipla will report its fourth-quarter results on Friday.
Read also: Dr Reddy’s Labs unveils Doxycycline Capsules, 40 mg in US to treat inflammatory lesions of rosacea

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Nearly 12 percent of India’s eligible children received no dose of measles vaccine: Study

New Delhi: Nearly 12 percent of children in India who are eligible for measles vaccination have received none of the recommended double-dose, signalling a “concerning gap” in immunisation coverage, a new study has found. The findings showed that zero-dose cases were high in the northeastern states, with Nagaland reporting the greatest share at 26 per cent. Tamil Nadu was found to report the lowest at 4.6 per cent.

Researchers from the Ministry of Health and Family Welfare and Banaras Hindu University in Varanasi investigated previously overlooked critical aspects of measles vaccination, focusing on zero-doses, partially vaccinated, and those fully immunised. They analysed data of over 43,000 children aged 2-3 years, collected through the National Family Health Survey 2019-21 (NFHS-5).

The team found that close to 30 per cent of the eligible children have received only one measles-containing vaccine (MCV1), while about 60 per cent have been fully immunised (MCV2). The findings are published in the journal Vaccine.

In 2017, India adopted the National Strategic Plan for Achieving and Sustaining Measles and Rubella Elimination. The researchers acknowledged that disruptions due to the COVID-19 pandemic heightened the risk of measles in vulnerable populations.

While immunisation programmes were eventually resumed in a phased manner, measles zero-dose children pose a significant obstacle to achieving goals of eliminating the acute and highly contagious viral disease, the researchers said. Occurring primarily in children, symptoms can include high fever, cough, runny nose and a rash all over the body.

Being vaccinated is the best way to avoid getting sick and spreading the disease, according to the World Health Organization.

The analysis also revealed huge inter-district variations, according to the researchers. They found that in Uttar Pradesh, while Prayagraj and Banda districts were found to have about 34 per cent and 32 per cent of these cases, respectively, Hapur and Etawah have 2.6 per cent and 2.1 per cent of zero-dose cases.

The researchers said Arunachal Pradesh was another such example, where the West Siang district had the greatest share with almost 50 per cent of eligible children receiving no dose of the vaccination, while the Lower Dibang Valley district had only 2.8 per cent of such cases.

Socio-demographic factors were analysed to influence the measles vaccination status of children, with those born later in the family being less likely to have received no dose.

Low levels of wealth and mother’s education too were found to increase the odds of children not receiving any dose of the vaccination.

Vaccine hesitancy, possibly influenced by culture and misinformation, can also lead to lower inoculation rates, the researchers said.

“Socioeconomic factors play a significant role in measles transmission, with individuals from lower socioeconomic classes experiencing higher attack rates resulting in outbreaks,” the authors wrote.

The findings underscored the need for tailored strategies, especially within districts displaying close to 10 per cent variability in zero-dose cases, the researchers said.

“The identification of a notable percentage (11.5 per cent) of children receiving zero-doses signals a concerning gap in immunisation coverage,” the authors wrote.

“This highlights the importance of last mile effort and application of big push theory in terms of more frequent rounds of campaigns mode vaccine delivery for the target of 95 per cent vaccine coverage for population-level immunity,” they wrote.

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Removing gut bacteria’s potential ‘safe house’ may lower risk of colorectal cancer subtype

The appendix, once dismissed as an unnecessary human organ, has more recently been shown to play a role in the immune system. However, we lack a clear understanding of how its removal to treat appendicitis affects long-term human health.

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Radiotherapy with hormone therapy can help some advanced prostate cancer patients avoid chemotherapy

Radiotherapy can be used alongside hormone treatment, delaying the need for chemotherapy and therefore significantly protecting their quality of life for some patients with advanced prostate cancer, according to researchers from The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London.

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Endoscopic procedure burns stomach lining to reduce ‘hunger hormone’ and lead to weight loss

A new weight-loss treatment could be on the horizon with an innovative endoscopic procedure that ablates (burns) the stomach lining to reduce production of ghrelin, a hormone that triggers hunger, resulting in decreased appetite and significant weight loss, according to a first-in-human trial to be presented at Digestive Disease Week (DDW) 2024.

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