Early coronary disease, impaired heart function found in asymptomatic people with HIV: Study

A new study found increased coronary vessel wall thickness that was significantly associated with impaired diastolic function in asymptomatic, middle-aged individuals living with HIV. The study was published  in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA).

According to the World Health Organization, approximately 39 million people were living with HIV at the end of 2022. Since 2010, HIV-related deaths have been reduced by 51%, but HIV continues to be a major global public health issue, claiming 40.4 million lives so far.

As effective therapy drugs increase the life expectancy for people living with HIV, non-AIDS-related health concerns are increasingly common. Recent research has shown that cardiovascular disease is higher in persons living with HIV compared with individuals without HIV, with an estimated 4-fold higher rate of sudden cardiac death compared with the general population.

Researchers at the National Institutes of Health (NIH) set out to assess early coronary atherosclerosis burden, and its relation to how the heart is functioning, in people living with HIV who were asymptomatic and had low cardiovascular disease risk. For the study, the researchers recruited 74 adults (mean age of 49 years) living with HIV without known cardiovascular disease and 25 matched healthy controls (mean age of 46 years). Controls were negative for HIV and were required to be healthy with no known significant medical conditions, including coronary disease. All underwent MRI to measure coronary vessel wall thickness and an echocardiogram to assess left ventricular function.

“Prior studies have shown cardiovascular disease in persons living with HIV, however not at such an early stage,” said senior author Ahmed M. Gharib, M.D., senior clinical investigator, and director of the Biomedical and Metabolic Imaging Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in Bethesda, Maryland.

The HIV and control groups were matched by corresponding age, sex and race. A detailed medical history, physical examination and laboratory tests were obtained from participants, including detailed review of any exposure to antiretroviral therapy-the combination of several antiretroviral medicines used to slow the rate at which HIV makes copies of itself (multiplies) in the body-and traditional cardiovascular disease risk factors. Each participant had lab tests that included the following: fasting lipid panel, T-cell counts and HIV viral load.

The results showed increased coronary vessel wall thickness in the HIV group, compared to controls. The increased coronary artery vessel wall thickness was independently associated with elevated left ventricular mass index and impaired diastolic function.

Coronary artery vessel wall thickness was also associated with the duration of exposure to didanosine, one of the medications used in combination with other drugs for the treatment of HIV.

“The ability to detect early coronary artery disease in persons living with HIV and potentially prevent detrimental effects on the heart muscle is important,” said lead author Khaled Z. Abd-Elmoniem, Ph.D., M.H.S., staff scientist in NIDDK’s Biomedical and Metabolic Imaging Branch. “This research shows the impact of HIV on developing subtle subclinical coronary artery disease and its effects on heart function.”

The researchers emphasized that early identification of subclinical cardiovascular disease in young HIV patients is an urgent necessity, potentially opening avenues for more effective intervention and disease management.

Reference:

Khaled Z. Abd-Elmoniem, Hadjira Ishaq, Julia Purdy, Jatin Matta, Ahmed Hamimi, Hwaida Hannoush, Colleen Hadigan , Ahmed M. Gharib, Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease–Risk Persons Living with HIV, Radiology Cardiothoracic Imaging, https://doi.org/10.1148/ryct.230102.

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Preemptive use of corticosteroids enhances success of local anesthesia among patients undergoing endodontic therapy: Study

Preemptive use of corticosteroids enhances the success of local anaesthesia among patients undergoing endodontic therapy suggests a study published in the Journal of Endodontics.

Chronic inflammation in irreversible pulpitis leads to heightened sensitivity of nociceptive receptors, resulting in persistent hyperalgesia. This poses significant challenges in achieving effective anesthesia for patients with irreversible pulpitis. Various anesthetic techniques and pharmacological approaches have been employed to enhance the success of local anesthesia. Recently, the preemptive use of anti-inflammatory agents, specifically corticosteroids, has gained attention and shown promising results in randomized controlled trials. This systemic review and meta-analysis aimed to evaluate the impact of systemically administered corticosteroids on enhancing anesthetic success in patients undergoing endodontic treatment. A comprehensive search was conducted across multiple databases including PubMed, Cochrane Library, Embase, Scopus, Dentistry & Oral Science, and ProQuest. Additionally, the references of primary studies and related systematic reviews were manually searched for additional relevant publications.

The primary outcome assessed was the success of anesthesia, and the effect measure was Risk Ratio (RR) using the random-effects inverse variance method. Statistical significance was set at p < .05. The certainty of the evidence was evaluated using the GRADE approach. Results: Twelve studies involving 917 participants were analyzed to determine the frequency of successful anesthesia. The corticosteroid group demonstrated a significantly higher number of patients achieving successful anesthesia (RR = 1.66; 95% CI, 1.34 to 2.06;p< .00001). However, heterogeneity within the pooled data analysis was observed (I2= 57%,p=0.007). Moderate certainty evidence indicates that preemptive use of systemic corticosteroids enhances the success of local anesthesia, specifically inferior alveolar nerve block (IANB), in cases of irreversible pulpitis.

Reference:

Alajlan N, Carrasco-Labra A, Karabucak B, Lee SM. Systemic Corticosteroid Uses in Endodontics- Part 2: Enhancing the Success of Local Anesthesia. J Endod. 2024 Mar 13:S0099-2399(24)00161-4. doi: 10.1016/j.joen.2024.03.002. Epub ahead of print. PMID: 38490300.

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Radiation before mastectomy cuts time delays for reconstructive surgery in breast cancer patients: JAMA

Researchers at The University of Texas MD Anderson Cancer Center showed that altering the sequence of breast cancer treatment to administer radiation before mastectomy allowed for concurrent breast reconstruction surgery, which reduced the number of operations required, minimized treatment delays and improved patient satisfaction.

The Phase II trial results, published in JAMA Network Open, evaluated 49 patients who received radiation therapy followed by mastectomy with immediate breast reconstruction. There were no complete flap losses or disease recurrences at a median of 29.7 months of follow-up.

“Our trial represents a pioneering achievement in the U.S., demonstrating the safety and effectiveness of this paradigm-shifting treatment sequence for patients with breast cancer,” said lead author Mark Schaverien, M.D., associate professor of Plastic Surgery. “This sequence not only enhances surgical outcomes but also eliminates the need for patients to defer breast reconstruction surgery, significantly enhancing their quality of life.”

Currently, when planning breast reconstruction for patients needing radiation therapy after mastectomy, the main goal is to prevent radiation from reaching the final reconstruction. This is done to reduce long-term side effects and to ensure patients are happy with the results.

Typically, women have a tissue expander placed during their mastectomy procedure, which is expanded with saline. This is followed by approximately six weeks of daily radiation therapy to the remaining chest wall and lymph node tissues. Final reconstruction is typically deferred until 6-12 months after radiation.

During the time between radiation and final reconstruction, there are negative quality-of-life effects from not having a reconstructed breast and potential negative medical effects from the tissue expander, with one in five women experiencing complications resulting in removal of the expander.

Schaverien explains that changing the order of treatment, to begin with radiation followed by mastectomy with breast reconstruction in one operation, provides immediate benefits to the patient.

The study enrolled women from participants in the SAPHIRE trial. The median age was 48 years, and 94% of patients had received neoadjuvant systemic therapy. Twenty-four patients were randomized to receive short course (40.05 Gy/15 fractions) and 25 to receive standard course (50 Gy/25 fractions) radiation therapy to the chest wall and regional lymph nodes. Patients underwent mastectomy with immediate breast reconstruction surgery, at a median of 23 days after completing radiotherapy.

The rate of surgical complications after the operation was similar to the complication rate from standard-of-care reconstructive surgery, showing a favorable comparison. Patients who underwent hypofractionated (short course) radiation therapy exhibited similar complication rates to those receiving conventional (standard course) radiation therapy. All the patients who underwent tissue-based reconstruction had successful reconstructive surgeries and none of these patients had any serious complications in follow-up.

“For many patients, this approach represents a significant breakthrough,” said co-author Benjamin Smith, M.D., professor of Radiation Oncology and Health Services Research. “It allows women to swiftly resume their lives following breast cancer treatment, feeling and looking confident, without the need for prolonged delays before undergoing reconstructive surgery.”

These findings led to the initiation of the Phase III TOPAz trial, which is currently enrolling patients. The study aims to compare the standard amount and timing of radiation treatment with a reduced radiation dose given before breast cancer removal and reconstruction surgery.

Reference:

Schaverien MV, Singh P, Smith BD, et al. Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(4):e245217. doi:10.1001/jamanetworkopen.2024.5217.

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Mechanical and oral antibiotic bowel preparation may reduce morbidity in patients undergoing elective rectal resection: JAMA

Mechanical and oral antibiotic bowel preparation may reduce morbidity in patients undergoing elective rectal resection suggests a new study published in the JAMA.

Surgical site infections (SSIs)—especially anastomotic dehiscence—are major contributors to morbidity and mortality after rectal resection. The role of mechanical and oral antibiotics bowel preparation (MOABP) in preventing complications of rectal resection is currently disputed. A study was done to assess whether MOABP reduces overall complications and SSIs after elective rectal resection compared with mechanical bowel preparation (MBP) plus placebo. This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 3 university hospitals in Finland between March 18, 2020, and October 10, 2022. Patients aged 18 years and older undergoing elective resection with primary anastomosis of a rectal tumour 15 cm or less from the anal verge on magnetic resonance imaging were eligible for inclusion. Outcomes were analyzed using a modified intention-to-treat principle, including all patients randomly allocated to and underwent elective rectal resection with an anastomosis. Patients were stratified according to tumour distance from the anal verge and neoadjuvant treatment given and randomised in a 1:1 ratio to receive MOABP with an oral regimen of neomycin and metronidazole (n = 277) or MBP plus matching placebo tablets (n = 288). All study medications were taken the day before surgery, and all patients received intravenous antibiotics approximately 30 minutes before surgery. The primary outcome was overall cumulative postoperative complications measured using the Comprehensive Complication Index. Key secondary outcomes were SSI and anastomotic dehiscence within 30 days after surgery. Results In all, 565 patients were included in the analysis, with 288 in the MBP plus placebo group and 277 in the MOABP group. Patients in the MOABP group experienced fewer overall postoperative complications; Wilcoxon effect size, 0.146; P < .001), fewer SSIs, and fewer anastomotic dehiscences compared with patients in the MBP plus placebo group. Findings of this randomized clinical trial indicate that MOABP reduced overall postoperative complications and rates of SSIs and anastomotic dehiscences in patients undergoing elective rectal resection compared with MBP plus placebo. Based on these findings, MOABP should be considered as standard treatment in patients undergoing elective rectal resection.

Reference:

Koskenvuo L, Lunkka P, Varpe P, et al. Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial. JAMA Surg. Published online March 20, 2024. doi:10.1001/jamasurg.2024.0184

Keywords:

Mechanical, oral antibiotic, bowel preparation, reduce, morbidity, patients, undergoing, elective rectal resection, JAMA, Koskenvuo L, Lunkka P, Varpe P

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Neurological Manifestations in COVID-19 patients Linked to Poor Long-Term Outcomes, claims study

Neurological complications have emerged as a significant concern in patients with Coronavirus Disease 2019 (COVID-19). A recent retrospective cohort study investigated the long-term outcomes of patients with and without neurological manifestations during their initial COVID-19 hospitalization. This study was published in PLoS Medicine journal. The study was conducted by Anna E. and colleagues.

The study aimed to shed light on the association between neurological involvement and post-discharge morbidity and mortality. Acute neurological manifestations are increasingly recognized as complications of COVID-19, affecting a considerable proportion of patients. However, the long-term implications of these neurological symptoms remain unclear.

Researchers analyzed data from patients admitted for COVID-19 at the Montefiore Health System in the Bronx, New York, during the early stages of the pandemic. A total of 414 patients with significant neurological manifestations were compared with 1,199 propensity-matched patients without such manifestations. Follow-up data were collected over a 3-year period to assess outcomes.

The key findings of the study were as follows:

  • Demographic characteristics were similar between the two cohorts, with no significant differences in sex distribution and ICU status. However, the neurological cohort had a higher proportion of black non-Hispanic patients.

  • Patients with neurological manifestations experienced higher rates of adverse outcomes post-discharge. This included increased mortality, stroke, major adverse cardiovascular events (MACE), and hospital readmission.

  • Mortality was significantly elevated in the neurological cohort compared to controls (hazard ratio: 2.346, p < 0.001).

  • Neurological cohort patients were more frequently discharged to acute rehabilitation or skilled nursing facilities and less often discharged home.

  • They exhibited higher incidences of stroke, MACE, and readmission post-discharge.

  • Several factors were associated with increased mortality post-discharge, including neurological manifestations, discharge disposition, congestive heart failure, higher COVID-19 severity score, and older age.

  • While both cohorts showed similar rates of radiological abnormalities, the neurological cohort exhibited significantly more age-adjusted brain volume loss.

The study’s findings highlight the profound impact of neurological involvement on the trajectory of COVID-19 illness. Patients with significant neurological manifestations faced a multitude of challenges, including higher rates of readmission, cardiovascular events, and mortality even after discharge from the hospital. These results underscore the importance of considering neurological symptoms as crucial markers of disease severity and prognosis in COVID-19 patients.

This study provides compelling evidence of the detrimental impact of neurological manifestations on the long-term outcomes of COVID-19 patients. By recognizing the significance of neurological involvement in COVID-19, healthcare providers can better anticipate and address the complex needs of affected individuals, ultimately improving patient care and clinical outcomes.

Reference:

Eligulashvili, A., Gordon, M., Lee, J. S., Lee, J., Mehrotra-Varma, S., Mehrotra-Varma, J., Hsu, K., Hilliard, I., Lee, K., Li, A., Essibayi, M. A., Yee, J., Altschul, D. J., Eskandar, E., Mehler, M. F., & Duong, T. Q. (2024). Long-term outcomes of hospitalized patients with SARS-CoV-2/COVID-19 with and without neurological involvement: 3-year follow-up assessment. PLoS Medicine, 21(4), e1004263. https://doi.org/10.1371/journal.pmed.1004263

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Inhaled treprostinil cuts mortality among patients of pulmonary hypertension associated with ILD: Study

Inhaled treprostinil cuts mortality among patients of pulmonary hypertension associated with interstitial lung disease suggests a study published in the BMJ thorax.

A post-hoc analysis of the INCREASE trial and its open-label extension (OLE) was performed to evaluate whether inhaled treprostinil has a long-term survival benefit in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Two different models of survival were employed; the inverse probability of censoring weighting (IPCW) and the rank-preserving structural failure time (RPSFT) models both allow construction of a pseudo-placebo group, thereby allowing for long-term survival evaluation of patients with PH-ILD receiving inhaled treprostinil. Time-varying stabilised weights were calculated by fitting Cox proportional hazards models based on the baseline and time-varying prognostic factors to generate weighted Cox regression models with associated adjusted HRs. Results In the INCREASE trial, there were 10 and 12 deaths in the inhaled treprostinil and placebo arms, respectively, during the 16-week randomised trial. During the OLE, all patients received inhaled treprostinil and there were 29 and 33 deaths in the prior inhaled treprostinil arm and prior placebo arm, respectively. With a conventional analysis, the HR for death was 0.71 (95% CI 0.46 to 1.10; p=0.1227). Both models demonstrated significant reductions in death associated with inhaled treprostinil treatment with HRs of 0.62 (95% CI 0.39 to 0.99; p=0.0483) and 0.26 (95% CI 0.07 to 0.98; p=0.0473) for the IPCW and RPSFT methods, respectively. Two independent modelling techniques that have been employed in the oncology literature both suggest a long-term survival benefit associated with inhaled treprostinil treatment in patients with PH-ILD.

Reference:

Nathan SD, Johri S, Joly JM, et alSurvival analysis from the INCREASE study in PH-ILD: evaluating the impact of treatment crossover on overall mortalityThorax 2024;79:301-306.

Keywords:

Inhaled, treprostinil cuts, mortality, patients, pulmonary, hypertension, interstitial lung disease, Study , BMJ thorax, Nathan SD, Johri S, Joly JM

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Peritoneal dialysis patients with longer serum phosphorus time in range tied to lower mortality risk: Study

China: A multicenter retrospective cohort study has revealed an association between longer serum phosphorus time in range and a lower mortality risk among peritoneal dialysis patients.

The findings, published in BMC Nephrology, highlight the importance of maintaining serum phosphorus levels within 1.13–1.78 mmol/L for peritoneal dialysis patients.

Mineral bone disease (MBD) is a common complication of end-stage kidney disease. Serum phosphorus is an essential element of the human body that is proven to be a central indicator in MBD and is critical for the initiation and progression of cardiovascular calcification (CVC), which is strongly related to cardiovascular (CV) events, CV mortality, and all-cause mortality. For every rise in 0.323 mmol/L (1 mg/dL) in phosphorus level, the risk of all-cause mortality and CV mortality increased by 18% and 13%, respectively.

Major studies about the phosphorus-mortality relationship have focused on the hemodialysis (HD) population, and the relationship between serum phosphorus time in range and mortality risk in peritoneal dialysis patients remains uncertain. Therefore, Guobao Wang, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou, China, and colleagues aimed to evaluate the association between serum phosphorus time in range and all-cause mortality in the Chinese PD population.

For this purpose, the researchers conducted a multicenter, retrospective, cohort study of 1,915 patients collected from 2008 to 2020 in four Chinese centers. Serum phosphorus time in range was estimated as the months during the first year a patient’s serum phosphorus level was within the target range (defined as 1.13–1.78 mmol/L).

The study’s primary outcome was all-cause mortality. The secondary outcomes included CV mortality and PD withdrawal. The association was assessed using the Cox proportional hazards regression model with comprehensive adjustments.

The study revealed the following findings:

· The primary outcome occurred in 13.0% of PD patients over a median follow-up of 28 months.

· The serum phosphorus time in range was negatively associated with all-cause mortality (per 3-month increments, adjusted HR [aHR], 0.83), PD withdrawal (per 3-month increments, aHR, 0.89), and CV mortality (per 3-month increments, aHR, 0.87).

· Competing-risk model showed that the relationship of serum phosphorus time in range with all-cause mortality remained stable.

· None of the variables including demographics, history of diabetes and CV disease, and several PD-related and clinical indicators modified this association.

In conclusion, the researchers observed that longer serum phosphorus time in range in the first year was significantly associated with lower all-cause mortality and CV mortality risk in PD patients. The findings stress the importance of maintaining serum phosphorus concentration within 1.13–1.78 mmol/L for PD patients.

“If confirmed, these findings suggest a potential avenue to improve clinical outcomes in this population,” the researchers wrote.

Reference:

Huo, Z., Liu, D., Ye, P. et al. Longer serum phosphorus time in range associated with lower mortality risk among peritoneal dialysis patients: a multicenter retrospective cohort study. BMC Nephrol 25, 117 (2024). https://doi.org/10.1186/s12882-023-03395-9

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Persistent postoperative hyperglycemia tied to increased risk of mortality in patients undergoing elective craniotomy: Study

China: A recent study published in the Journal of Neurosurgery has shown an association of moderate and severe persistent postoperative hyperglycemia with an increased mortality risk compared with normoglycemia in patients undergoing an elective craniotomy. The association was observed regardless of whether patients had preoperative hyperglycemia.

The impact of persistent postoperative hyperglycemia after craniotomy has not been explored yet. Considering this, Jialing He, Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, and colleagues aimed to investigate the hypothesis that persistent postoperative hyperglycemia is associated with mortality in patients undergoing an elective craniotomy.

Adult patients (age ≥ 18 years) undergoing an elective craniotomy between 2011 and 2021 at the West China Hospital, Sichuan University, were included in the study. Peak daily blood glucose values measured within the first seven days following craniotomy were collected.

Persistent hyperglycemia was defined by two or more consecutive serum glucose levels of mild, moderate, or severe hyperglycemia. Severe hyperglycemia, moderate hyperglycemia, mild hyperglycemia, and normoglycemia were defined as glucose values of > 10.0 mmol/L, > 7.8 and ≤ 10.0 mmol/L, 6.1 and ≤ 7.8 mmol/L, and ≤ 6.1 mmol/L, respectively.

A total of 14,907 patients undergoing an elective craniotomy were included. The study led to the following findings:

  • In the multivariable analysis, moderate (adjusted OR 3.76) and severe (adjusted OR 3.82) persistent hyperglycemia in patients were associated with higher 30-day mortality compared with normoglycemia. However, this association was not observed in patients with mild hyperglycemia (adjusted OR 1.32).
  • The association was observed regardless of whether patients had preoperative hyperglycemia.
  • There was no interaction between moderate or severe hyperglycemia and preexisting diabetes.
  • When postoperative peak blood glucose values within the first 7 days after craniotomy were evaluated as a continuous variable, for each 1-mmol/L increase in blood glucose, the adjusted OR of 30-day mortality was 1.17.
  • Postoperative blood glucose (area under the curve [AUC] = 0.78) was superior to preoperative blood glucose (AUC = 0.65) for predicting mortality.
  • Moderate and severe persistent hyperglycemia in patients was associated with an increased risk of deep venous thrombosis (adjusted OR 3.20), myocardial infarction (adjusted OR 4.38), pneumonia (adjusted OR 2.77), and prolonged hospital stays (adjusted OR 1.43).

In conclusion, the study assessed the association of persistent postoperative hyperglycemia with mortality after elective craniotomy. The results showed that in this population, moderate and severe persistent postoperative hyperglycemia were associated with an increased risk of mortality compared with normoglycemia, irrespective of preoperative hyperglycemia.

Reference:

He, Jialing, et al. “Association of Persistent Postoperative Hyperglycemia With Mortality After Elective Craniotomy.” Journal of Neurosurgery, vol. 140, no. 4, 2024, pp. 1080-1090.

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Aceclidine-based Eye Drops Effective in Treating Presbyopia, reveals phase 3 trial

The recent press release from a prominent biopharmaceutical company, LENZ Therapeutics, Inc. unveiled promising findings from its Phase 3 CLARITY study making a significant stride forward in the treatment of presbyopia. The study evaluated two formulations of aceclidine, LNZ100 and LNZ101 by demonstrating their potential to enhance the near vision in individuals with presbyopia.

Presbyopia is characterized by the gradual loss of near vision typically experienced by the individuals over 45 years and affects millions throughout the globe. This impacts the daily activities like reading and close-up work. The breakthrough of LENZ involves the development of aceclidine-based eye drops to reduce the effects of this condition to alternate the traditional corrective aids like reading glasses.

The Phase 3 trials comprised CLARITY 1 and 2 that showed compelling efficacy and safety profiles for LNZ100 with statistically significant improvements in Best Corrected Distance Visual Acuity (BCDVA) at near observed in the participants. Also, LNZ100 expressed rapid onset, sustained efficacy and reproducible near vision improvement across the diverse age groups and refractive ranges. Both LNZ100 and LNZ101 met primary and secondary endpoints, with LNZ100 emerging as the lead candidate due to its superior performance. Also, LNZ100 demonstrated a elevated responder rate and prolonged efficacy which garnered positive feedback from participants and investigators alike.

The President and CEO of LENZ Therapeutics expressed satisfaction with the study outcomes that emphasized the potential of LNZ100 as a promising therapy for presbyopia. With plans to submit a New Drug Application (NDA) in mid-2024, LENZ advances toward the commercialization to address the needs of the vast presbyopic population in the United States. The Chief Medical Officer of LENZ Therapeutics elucidated the transformative impact of LNZ100 by highlighting its ability to reduce the burdens associated with presbyopia and provide a convenient treatment option for affected individuals.

The successful completion of the CLARITY trials underlines the commitment of LENZ Therapeutics to the pioneering advancements in ophthalmic care. With further data presentations anticipated, the company remains poised to move the landscape of presbyopia management. LENZ Therapeutics is set to host a conference call and webcast to discuss the major results by providing stakeholders with insights into the potential of aceclidine-based eye drops in reshaping the treatment paradigm for presbyopia. This prevalent age-related vision disorder stands to witness a trend shift with the innovative approach of LENZ Therapeutics by offering hope to millions with presbyopia.

Reference:

LENZ Therapeutics announces positive topline data from phase 3 CLARITY presbyopia trials. News release. LENZ Therapeutics. April 6, 2024. https://www.businesswire.com/news/home/20240403843686/en/LENZ-Therapeutics-Announces-Positive-Topline-Data-from-Phase-3-CLARITY-Presbyopia-Trials.

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Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

New Delhi: Pharmaceutical major Eli Lilly has got marketing authorization from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in Prefilled Syringe (PFS) indicated for the treatment of moderate to severe active ulcerative colitis in adult.

This came after the drug maker Eli Lilly presented the proposal to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.

The committee noted that the drug is approved in USA, Europe, Canada, Japan, Australia and other countries.

Mirikizumab is a monoclonal antibody directed against the p19 subunit of human interleukin-23 (IL-23). The binding of mirikizumab to its target inhibits the interaction between IL-23 and the IL-23 receptor, thereby normalizing the overproduction of effector cytokines driving the pathogenesis of inflammatory diseases, including ulcerative colitis.

Mirikizumab is an anti-IL-23 monoclonal antibody used as a second-line therapy for moderate-to-severe active ulcerative colitis.

Mirikizumab-mrkz injection is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults.

At the recent SEC meeting for Gastroenterology and Hepatology held on 13th March 2024, the expert panel reviewed the proposal presented by Eli Lilly to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.

After detailed deliberation, the committee recommended a grant of marketing authorization to the firm for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS subject to the condition that the firm should conduct Phase IV clinical trial in the country.

Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol to CDSCO within 3 months of marketing approval.

Also Read: CDSCO Panel grants Novo Nordisk’s Protocol Amendment Proposal For Antidiabetic Drug Semaglutide study

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