Treatment of H. pylori infection may reduce risk of colorectal cancer and associated mortality: Study

Although H. pylori infection does not itself cause illness but, chronic infection is associated with long-lasting inflammation in the stomach, which can cause complications like atrophic gastritis and stomach cancer.

According to a study published in the Journal of Clinical Oncology, H. pylori-positive individuals may exhibit a small yet statistically significant increase in the incidence and mortality rates of colorectal cancer (CRC). Untreated individuals, especially those with active infections, seem at the most significant risk.
Helicobacter pylori is the most common cause of infection-associated cancer worldwide. This study evaluated the impact of H. pylori infection and treatment on CRC incidence and mortality.
The study included patients in the US who completed H. pylori testing between 1999 and 2018. They conducted a retrospective cohort analysis among adults within the Veterans Health Administration who completed testing for H. pylori. The primary exposures were H. pylori test results (positive/negative) and treatment (untreated/treated) among H. pylori-positive individuals. The primary outcomes were CRC incidence and mortality. Follow-up started at the first H. pylori testing and continued until the earliest incident or fatal CRC, non-CRC death, or December 31, 2019.
Key findings of the study are:
  • 25.2 % of individuals among 812,736 tested positive for H. pylori.
  • Being H. pylori–positive versus H. pylori–negative was associated with higher CRC incidence and mortality.
  • H. pylori treatment versus no treatment was associated with lower CRC incidence and mortality through 15-year follow-up.
  • Being H. pylori–positive versus H. pylori–negative was associated with an 18 % and 12% higher incident and fatal CRC risk, respectively. The aHR was 1.18 and 1.12, respectively.
  • Individuals with untreated versus treated H. pylori infection had 23% and 40% higher incident and fatal CRC risk, respectively, with aHR of 1.23 and 1.40.
  • The results were more pronounced in the analysis restricted to individuals with nonserologic testing.
Concluding further, they said that H. pylori infection is linked to a higher incidence and mortality rate for colorectal cancer (CRC), particularly in those with active infections and who are untreated. The association is small but significant, they added.
Reference:
Shailja C. Shah et al. Impact of Helicobacter pylori Infection and Treatment on Colorectal Cancer in a Large, Nationwide Cohort. JCO 0, JCO.23.00703
DOI:10.1200/JCO.23.00703

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Single-use versus reusable ureteroscopes yield similar outcomes in intrarenal surgery for urinary stones: Study

Brazil: A systematic review and meta-analysis published in Urolithiasis compared the performance of single-use versus reusable flexible ureteroscopes in retrograde intrarenal surgery for urinary stones.

The researchers found that both scopes demonstrated similar outcomes in operative time, stone-free rates, incidence of post-operative fever, and UTIs. The results indicate that the choice between the two hinges on factors, such as cost, availability, and surgeon preference.

Flexible ureterolithotripsy is a frequent urological procedure, usually used for stone removal from the kidney and upper ureter. For that procedure, reusable uretero-scopes were the standard tool, but recent concerns regarding sterility and maintenance and repair costs created the opportunity to develop new technologies.

The first single-use digital flexible ureteroscope was introduced in 2016. Since then, other single-use ureteroscopes have been developed, and studies compared them with reusable ureteroscopes and yielded conflicting results. Therefore, Mikhael Belkovsky, Surgical Technique & Experimental Surgery Department, Universidade de São Paulo, São Paulo, Brazil, and colleagues aimed to describe the literature that compares the performance of single-use and reusable flexible ureteroscopes in retrograde intrarenal surgery for urinary stones.

For this purpose, the researchers performed a systematic review in October 2022 according to the PRISMA (Preferred Reporting Items for Systematic Reviews and MetaAnalyses) and Cochrane Handbook. A search in online databases retrieved 10,039 articles. After screening, twelve articles were selected for the Meta-Analysis.

Based on the review, the researchers reported the following findings:

  • No differences were found in stone-free rate (OR 1.31), operative time (MD 0.12), incidence of post-operative fever (OR 0.64), or incidence of post-operative urinary tract infection (OR 0.63 ).
  • No differences were observed in the studied variables.

In conclusion, both scopes demonstrated comparable outcomes in operative time, stone-free rates, the incidence of postoperative fever, and UTIs.

“Hence, the device choice should rely on the cost analysis, availability, and surgeons’ preference,” the researchers wrote.

Reference:

Belkovsky M, Passerotti CC, Maia RS, de Almeida Artifon EL, Otoch JP, Da Cruz JAS. Comparing outcomes of single-use vs reusable ureteroscopes: a systematic review and meta-analysis. Urolithiasis. 2024 Feb 28;52(1):37. doi: 10.1007/s00240-024-01537-8. PMID: 38413490.

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Impacted lower third molar extraction: Lingual position of IAN near LTM ups risk of neurosensory deficits, study finds

Austria: A recent study published in the Journal of Clinical Medicine, for the first time, has distinguished between short-term (7 days postoperatively) and enduring (at least 12 months) sensory deficits after the extraction of lower third molars (LTMs).

The researchers reveal an increased risk of neurosensory deficits when the inferior alveolar nerve (IAN) is directly positioned lingually to the tooth roots, and the use of cone-beam CT improves the risk assessment and comprehensive presurgical anatomic information.

“The overall incidence rate of acute neurosensory deficits of the mandibular nerve within the first seven days after the extraction of an LTM was 5.9%, with IAN impairment constituting 48.5% of cases and lingual nerve deficits constituting 36.4%,” the researchers reported.

The incidence rate of persisting deficits of the mandibular nerve was 1.3% of the removed teeth, impacting the IAN and lingual nerve in 0.8% and 0.5% of cases, respectively.

Neurosensory deficits are one of the leading complications that occur after impacted lower third molar extraction resulting in an impaired patient’s quality of life. Marcus Rieder, Medical University of Graz, Graz, Austria, and colleagues aimed to evaluate the incidence of neurosensory deficits after lower third molar extraction and compare it radiologically to the corresponding position of the inferior alveolar nerve.

For this purpose, the researchers compiled all patients who underwent impacted lower third molar extraction between January and December 2019 in a retrospective study. Therefore, they assessed clinical data as well as preoperative radiological imaging.

The study led to the following findings:

  • The study included 418 patients who underwent lower third molar extractions (n = 555). Of these, 5.9% had short-term (i.e., within the initial seven postoperative days) and 1.3% long-term (i.e., persisting after 12 months) neurosensory deficits documented.
  • The inferior alveolar nerve position concerning the tooth roots showed apical position in 27%, buccal position in 30.8%, lingual position in 35.4%, and inter radicular position in 6.9%

The occurrence of neurosensory deficits at the mandibular nerve after lower third molar surgery is relatively rare.

According to the authors, their results are consistent with the majority of published studies found. “A lingual position of the IAN close to the LTM significantly increases the risk of nerve deficits. In this context, cone beam computed tomography scan use appears promising as it can improve risk assessment and provide comprehensive preoperative patient information,” the researchers wrote.

“It is noteworthy that in our study, no decreased quality of life was observed in patients with persistent nerve deficits,” they concluded.

Reference:

Rieder, M., Remschmidt, B., Schrempf, V., Schwaiger, M., Jakse, N., & Kirnbauer, B. (2022). Neurosensory Deficits of the Mandibular Nerve Following Extraction of Impacted Lower Third Molars—A Retrospective Study. Journal of Clinical Medicine, 12(24), 7661. https://doi.org/10.3390/jcm12247661

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Dexmedetomidine reduces cardiac surgery-associated AKI by reducing oxidative stress: Study

China: Dexmedetomidine (Dex) reduces cardiac surgery-associated (CSA) acute kidney injury (AKI) by regulating metabolic disorders and reducing oxidative stress, findings from a prospective clinical trial have shown. The findings were published online in Revista Española de Cardiología, the official publication of the Spanish Society of Cardiology.

Cardiac surgery-associated acute kidney injury is a well-recognized complication resulting in higher mortality-morbidity after cardiac surgery. In its most severe form, it increases the odds ratio of operative mortality 3–8-fold, length of stay in the Intensive Care Unit (ICU) and hospital, and care costs. Early diagnosis is important for the optimal treatment of this complication.

Xiaohong Li, Department of Anesthesiology, First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China, and colleagues aimed to evaluate the impact of dexmedetomidine on cardiac surgery-associated acute renal failure, kidney function, and oxidative and metabolic stress in patients undergoing coronary artery bypass grafting (CABG) with heart-lung machine support.

For this purpose, they conducted a randomized double-masked trial with 238 participants (50-75 years) undergoing CABG from January 2021 to December 2022. The participants were categorized into Dex (n = 119) and normal saline (NS) groups (n = 119). Dex was administered at 0.5 mcg/kg over 10 minutes, then 0.4 mcg/kg/h until the surgery’s end; the NS group received equivalent saline.

Urine and blood sampling were done at several time points pre-and post-surgery. The study’s primary outcome measure was the incidence of CSA-AKI, defined as the AKI occurrence within 96 hours after surgery.

The researchers reported the following findings:

  • The incidence of CSA-AKI was significantly lower in the Dex group than in the NS group (18.26% vs 32.46%).
  • There were substantial increases in the estimated glomerular filtration rate value at T4–T6 and urine volume 24 hours after surgery.
  • There were marked decreases in serum creatinine level, blood glucose level at T1–T2, blood urea nitrogen level at T3–T6, free fatty acid level at T2–T3, and lactate level at T3–T4.

In conclusion, dexmedetomidine mitigates acute kidney injury after coronary artery bypass grafting.

“Dexmedetomidine reduces cardiac surgery-associated-acute kidney injury, potentially by reducing oxidative stress and regulating metabolic disorders,” the researchers wrote.

Reference:

Zhang, C., Zhang, Y., Liu, D., Mei, M., Song, N., Zhuang, Q., Jiang, Y., Guo, Y., Liu, G., Li, X., & Ren, L. (2024). Dexmedetomidine mitigates acute kidney injury after coronary artery bypass grafting: A prospective clinical trial. Revista Española de Cardiología (English Edition). https://doi.org/10.1016/j.rec.2024.02.005

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Gout patients with negative dual-energy CTs generally have milder illness and lower comorbidities: Study

Dual-energy computed tomography (DECT) is used in the imaging of gouty arthritis. It has become increasingly widely used in recent years. DECT is a non-invasive method for visualizing, characterizing, and quantifying monosodium urate crystal deposits, aiding clinicians in early diagnosis, treatment, and follow-up of the condition.

Victor Laurent and colleagues, in their recent study, concluded that the correlation between the 0.1 cm3 threshold and clinical presentation and evolution was stronger than that of the 0.01 cm3 threshold. Gout patients with negative DECTs generally have milder symptoms and a lower burden of comorbidity. While they may not have particularly easy-to-treat hyperuricaemia, they may have a lower risk of flares.

This study is published in Rheumatology.
The study investigated the relationship between dual-energy CT (DECT) thresholds and MSU crystal deposition in gout patients starting urate-lowering therapy (ULT) and to determine which threshold is more clinically significant.
Researchers selected CRYSTALILLE cohort patients diagnosed with gout naïve to ULT with baseline DECT scans of the knees and feet. The study examined two thresholds for detecting MSU crystal deposition via DECT: <0.01 cm3 and <0.1 cm3. Baseline characteristics and the likelihood of achieving SU levels <6.0 and 5.0 mg/dl and experiencing flares at 6, 12, and 24 months were compared between patients with negative and positive DECT scans.
Key findings from the study are:
• 211 patients with a median age of 66.2 years with three years of median symptom duration were included in the study.
• 18 % and 43 % had negative DECT scans for the 0.01 and 0.1 cm3 thresholds, respectively.
• Younger age, shorter symptom duration and an absence of heart disease for both volume thresholds were factors associated with negative DECT scans.
• 23.1%, 11.5% and 5.6% of patients with <0.1 cm3 MSU crystals had flares at 6, 12 and 24 months, respectively, when compared with 40%, 25 % and 11.1% of patients with ≥0.1 cm3.
• 68.3% reached SU levels <6.0 mg/dl, and 48.9% reached levels <5.0 mg/dl, without any difference between positive and negative DECTs, with ULT dosages that tended to be lower in patients with negative DECTs.
In conclusion, the study results suggest that the 0.1 cm3 threshold correlates better with clinical presentation and evolution than the 0.01 cm3 threshold. Gout patients with negative DECTs generally have milder illness and lower comorbidities. They do not have particularly easy-to-treat hyperuricaemia but may have a lower risk of flare-ups.
Reference:
Victor Laurent et al. Are gout patients with negative dual-energy computed tomography for monosodium urate crystal deposition easy to treat? Rheumatology, 2024;, keae061, https://doi.org/10.1093/rheumatology/keae061

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Add on batoclimab tied to sustained improvement in activities of Daily Living score in Myasthenia Gravis : JAMA

MG is caused by autoantibodies disrupting the neuromuscular junction. The neonatal fragment crystallizable receptor (FcRn) antagonists, efgartigimod and rozanolixizumab, reduce circulating immunoglobulin G (IgG) levels and alleviate symptoms in generalized MG cases.

A recent study found that batoclimab led to a sustained improvement in the Myasthenia Gravis Activities of Daily Living score compared to the placebo group. No severe side effects were reported. This suggests that batoclimab, an FcRn inhibitor, could be an important addition to the limited treatments available for Myasthenia gravis (MG).
This original investigation was published in JAMA Neurology.
The clinical trial was conducted at 27 centres in China from September 15, 2021, to June 29, 2022. It enrolled adult patients who tested positive for antibodies. These patients received either batoclimab or a placebo in addition to standard treatment. Each cycle consisted of six weekly subcutaneous injections of batoclimab or placebo, followed by four weeks of observation. A second cycle was given to those who required ongoing treatment. The primary outcome was a 3-point or greater improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score for at least four consecutive weeks in individuals with antibodies to acetylcholine receptors or muscle-specific kinase.
Key findings from the study are:
• The study population included 43 men and 88 women, the mean age being 43, with a history of generalized myasthenia gravis.
• The study was carried out in 27 hospitals in China.
• The rate of sustained MG-ADL improvement in the first cycle in antibody-positive patients in the placebo and batoclimab groups was 31.3% (20/ 64) and 58.2% (39/ 67), respectively, with an odds ratio of 3.45.
• The MG-ADL score diverged between the two groups as early as week 2.
• The rates of treatment-related and severe treatment-emergent adverse events in patients were 36.9% and 7.7% in the placebo group vs 70.1% and 3.0% in the batoclimab group, respectively.
Study strengths include a more significant number of participating centres and a broad representation of the overall generalized MG patient population.
Study limitations include limited treatment cycles, lack of data on long-term safety, and enrolment of only one patient with negative AChR/MuSK antibodies.
Concluding further, batoclimab resulted in a higher rate of sustained MG-ADL improvement in adult patients with generalized MG than placebo.
Reference:
Yan C, Yue Y, Guan Y, et al. Batoclimab vs Placebo for Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. Published online March 04, 2024. doi:10.1001/jamaneurol.2024.0044

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Rare but Manageable: Pediatric Patients with Leukemia Navigate COVID-19 Challenges

In a groundbreaking retrospective case series, researchers from St Jude Children’s Research Hospital and its affiliate sites shed light on the impact of COVID-19 on pediatric patients undergoing treatment for acute lymphoblastic leukemia or lymphoma (ALL/LLy). These findings contribute to our understanding of the interplay between COVID-19 and cancer treatment in pediatric patients, highlighting the challenges in maintaining chemotherapy schedules and the importance of considering individual patient characteristics in managing COVID-19 in this population.

The study results were published in the journal JAMA Network Open.

A detailed description of COVID-19 in pediatric patients with acute lymphoblastic leukemia or lymphoma (ALL/LLy) has not been provided, and its potential impact on both chemotherapy administration and long-term outcomes remains unclear. Hence, researchers conducted a study to describe the clinical presentation of COVID-19 and chemotherapy modifications in pediatric patients with ALL/LLy.

Also Read: Breastfeeding may reduce risk of leukemia in children

The study, conducted between March 30, 2020, and June 20, 2022, on patients treated with the Total XVII protocol, offers valuable insights into the clinical presentation of COVID-19 and the subsequent modifications in chemotherapy administration. Of the 308 pediatric patients included in the study, 110 (36%) were diagnosed with COVID-19 at a median age of 8.2 years.

Findings:

  • The majority of cases occurred during the continuation/maintenance phase of chemotherapy, emphasizing the vulnerability of patients during this crucial period of their treatment journey.
  • Remarkably, severe cases of COVID-19 were rare, accounting for only 6% of the affected patients.
  • However, these severe instances were associated with specific factors, including older age, higher white blood cell counts at the time of ALL/LLy diagnosis, lower absolute lymphocyte counts at the onset of COVID-19, abnormal chest imaging findings, and instances of SARS-CoV-2 reinfection.
  • Unprecedented in its scope, the study also highlighted rare but serious thrombotic events, such as pulmonary embolism and cerebral venous sinus thrombosis, occurring in isolated cases.
  • Notably, no cases of multisystem inflammatory syndrome in children or deaths were reported among the pediatric patients.
  • One of the significant challenges revealed by the study was the impact on chemotherapy administration.
  • Chemotherapy interruptions affected a substantial 87% of the patients, leading to a careful examination of the duration of these interruptions.
Also Read: Obesity and high weight linked to adverse outcomes in leukemia treatment

Patients with severe disease, SARS-CoV-2 reinfection, and those diagnosed during the pre-Omicron variant period experienced longer interruptions compared to their counterparts diagnosed after December 27, 2021, when the Omicron variant emerged. SARS-CoV-2 reinfection emerged as a noteworthy aspect, occurring in 10% of patients and being more prevalent in older age groups and those receiving standard or high-risk ALL/LLy therapy. This finding underscores the need for tailored approaches to managing COVID-19 in pediatric patients, considering their specific treatment protocols. The study’s authors emphasized the necessity of conducting long-term studies to fully comprehend the outcomes of COVID-19 in this unique pediatric population. As the medical community continues to navigate the challenges posed by the pandemic, these findings contribute significantly to the evolving understanding of the intersection between COVID-19 and pediatric oncology, offering hope and insights for the future.

Further reading: Hashmi SK, Bodea J, Patni T, et al. COVID-19 in Pediatric Patients With Acute Lymphoblastic Leukemia or Lymphoma. JAMA Netw Open. 2024;7(2):e2355727. doi:10.1001/jamanetworkopen.2023.55727

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Faculty members of SSH Indore threaten mass resignation over delay in promotions

Indore: In a protest against the alleged delay in faculty promotion even after receiving a show cause notice by the Medical Education Commissioner, the faculty members of the Super Speciality Hospital (SSH), Indore have threatened to submit mass resignation from if their demands are not met.

The members have alleged that they decided to take a similar course of action as their counterparts in Rewa due to their frustration with the delay in promotions. Earlier, Assistant Professors in Rewa Medical College, working with SSH in Rewa, had also threatened the authorities, following which orders to promote the faculty members of Rewa were released. 

Also read- NMC Slaps Show-Cause To 100 Medical Colleges, Here Is The Reason

The faculty members of SSH Indore have claimed that the primary cause of the delay has been attributed to the lack of coordination between the Dean of MGM Medical College and the Divisional Commissioner. They also alleged that their promotions have been pending for several months but the MGM Medical College officials are not paying any notice to their demands.

“Promotion of many of the faculty members has been pending since August, last year but the officials are not taking appropriate steps for the same,’ said a faculty member in SSH, Indore.

In response to their concerns, the medical college administration asked the faculty members to delay their protest and gave them assurances to resolve their issues in a week. 

Speaking to Free Press Journal, Dr Sanjay Dixit, Dean, MGM Medical College, Indore said, “We have discussed the demands of faculty members and initiated steps for their due promotions. Their issues will be resolved in a week. We don’t have any information of mass resignation.’ 

Medical Dialogues team had earlier reported that deans of four government medical colleges of Indore, Gwalior, Jabalpur, and Rewa were served with a show-cause notice by the Medical Education Commissioner for the alleged delay in promoting the faculty members of the Super Speciality Hospitals.

Issuing show-cause, the Commissioner asked the officials to submit a reply within three days explaining why action must not be taken against them under the Sections of Madhya Pradesh Civil Sewa Acharan Niyam 1966.

Under the existing rules, the assistant professors in Super Speciality Hospitals get promoted to the post of Associate Professor within a period of two years. On the other hand, Associate Professors must get promoted to the post of Professor after three years.

Also read- Delay In Faculty Promotions: Deans Of 4 MP GMCs Issued Show-Cause Notice

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Apollo Hospital, surgeon, anaesthetist held liable for patient death post spinal surgery, slapped Rs 30 Lakh compensation

Chennai: The National Consumer Disputes Redressal Commission (NCDRC) has slapped a compensation of Rs 30 lakh on Apollo Speciality Hospital in Chennai and its two doctors, a consultant spine surgeon and anaesthetist, in a case of medical negligence wherein a patient did not regain consciousness after the surgery and was in a vegetative state.

The Commission was hearing a complaint regarding negligence on the part of the hospital and the two doctors in providing post-operative care to a patient after a spinal surgery in April 2015.

According to a recent PTI report, headed by its president Justice A P Sahi, the apex consumer body noted that the complaint was filed by the patient’s son and wife against Apollo Speciality Hospital, Chennai, Apollo Hospital Enterprise Ltd, consultant spine surgeon Dr Sajan K Hegde and anaesthetist Dr Vasantha Roopan.

Advocate Madhukar Pandey appeared for the complainants.

According to the complaint, the patient underwent spinal surgery on April 20, 2015, at Apollo Specialty Hospital in Chennai but never regained consciousness due to the negligence of the hospital and doctors.

The patient died during the pendency of the complaint in April 2017.

Noting the sequence of events, the commission said the patient failed to regain consciousness after the surgery after being extubated (removal of the tube which helps a patient breathe during surgery).

Also Read: Alleged Medical Negligence Leading To Death: 4 Apollo Doctors Arrested Under IPC 304A

BNN reports that the patient’s surgery led to unintended consequences when he failed to regain consciousness, attributed to a delay in medical response post-operation. The NCDRC pinpointed the failure to promptly reintubate the patient as a critical lapse in care. This inaction, over a span of five hours, was deemed “in all probability fatal” by the commission. The accountability was extended to both the anaesthetist, for not acting swiftly and the consulting spine surgeon for not ensuring his advice was followed, marking a clear instance of negligence.

The Commission said the advice for reintubating the patient, which was given at 4 pm on the same day, was not followed promptly.

“It is not understood as to why the anaesthetist did not attempt this and instead opted to wait for the CT scan,” the commission said, adding “There is no evidence of any active role being performed till 9 pm with no plausible explanation as to why the patient was left without intubation.”

In its order dated February 26, the NCDRC said the waiting period of around five hours, despite the advice of reintubation, was “in all probability fatal for the patient”.

The commission noted that there was “a clear negligent conduct” by the anaesthetist and other hospital staff who were attending to the patient.

It said the hospital staff responded only when the patient slipped into complete coma. The commission said;

“The surgeon has also not come forward to offer any plausible explanation as to why his own advice for reintubation was not followed or pursued by him when the patient was unresponsive and remained unconscious.”

The NCDRC held medical negligence and stated;

“The negligence is therefore proved and consequently, there is a failure on the part of the anaesthetist in not having attended to the patient promptly, diligently and skilfully and allowed him to embrace a permanent vegetative state due to such negligence.”

The surgeon was also “vicariously liable” and as the staff did not carry out his advice, the hospital was also liable for the negligence, the NCDRC said.

As quoted by PTI, the commission ordered;

“It would be appropriate to award Rs 10 lakh as damages for deficiency in services on anaesthetist Dr Vasantha Roopan, Rs 5 lakh on Dr K S Hegde for his vicarious role and Rs 15 lakh on the hospital for having allowed this situation to precipitate causing irreparable loss to the patient and consequential loss and suffering to the members of his family.”

It also awarded Rs 50,000 as litigation costs to the complainants.

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FDA approves new dermal filler for hollows in upper face

The US Food and Drug Administration (FDA) has approved hyaluronic acid dermal filler, Juvéderm Voluma XC for use in upper face for first time. The new dermal filler by Allergan Aesthetics’ shall help improve moderate to severe temple hollows in adult patients aged 21 years and older.

JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.

“The approval of JUVÉDERM® VOLUMA® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie. “This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients.”

JUVÉDERM® VOLUMA® XC temporarily adds volume to immediately lift and augment the shape, contour, and structure of the temple, creating a smooth transition from the cheekbone to the forehead, balancing a patient’s overall facial shape. In a clinical study, more than 80% of subjects had at least a one-point improvement in moderate to severe temple hollowing three months after treatment, and the improvement lasted for more than one year (73%). Additionally, more than 85% of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked three months after treatment.

In the clinical study, 68% of subjects reported satisfaction with how fresh their face looked, while 73% reported satisfaction with how rested their face appeared three months after treatment. Additionally, upwards of 80% of subjects were satisfied with how youthful their temples made them look and how well the shape of their temples complemented the shape of their face three months after treatment. With this addition, the Allergan Medical Institute (AMI) team can train aesthetic providers on safe and effective treatments using the Allergan Aesthetics portfolio to address 90% of the face.

“As an AMI trainer, I am excited to start training injectors on how to use JUVÉDERM® VOLUMA® XC to help address moderate to severe temple hollowing while reinforcing how treatment in this important area fits into a full-face approach that enhances facial balance (framing) and contour for my patients seeking subtle improvement,” said Dr. Deirdre Hooper, board-certified dermatologist at Audubon Dermatology, and clinical trial investigator. “In the clinical study, we found that patients said they looked an average of five years younger six months after JUVÉDERM® VOLUMA® XC treatment. Additionally, more than 85% of clinical study participants were satisfied with the treatment and would recommend it to a friend more than one year after treatment. Once training is completed, injectors like me will be able to offer patients true pan-facial assessments and treatments for safe, repeatable, and optimal results using the Allergan Aesthetics portfolio of products.”

Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for providers, which includes facial anatomy and considerations for patient selection, safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to the administration of JUVÉDERM® VOLUMA® XC, and as such, Allergan Aesthetics anticipates that treatment in the temples with JUVÉDERM® VOLUMA® XC will be available towards the end of this year.

In a randomized, controlled, multicenter clinical study to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® XC for correction of temple hollowing, 112 subjects were randomized to a treatment group and received injections in the temple area during the primary phase of the study; 58 subjects were randomized to a no-treatment control group.1 Touch-up treatments occurred approximately 30 days after initial injection, if needed.1 After the three-month blinded “no treatment” control period, control subjects were offered treatment; 53 control subjects elected to receive treatment.  A total of 40 treatment-group subjects opted for the optional maintenance treatment, which was offered to the treatment group 13 months after the last treatment.

Subjects used electronic diaries to record specific signs and symptoms of treatment site responses (TSR) experienced during the first 14 days after the initial touch-up and maintenance treatments. Subjects in the initial treatment group continued to use the electronic diary on even-numbered days from day 16 to day 30 to record specific signs and symptoms of TSRs. Subjects rated each TSR listed on the diary as “Mild (barely noticeable),” “Moderate (uncomfortable),” “Severe (severe discomfort),” or “None.”

After initial treatment with JUVÉDERM® VOLUMA® XC, 59% of the subjects with diary entries reported experiencing at least one TSR and 70.5% of subjects rated TSRs as mild or moderate (26.3%) in severity, with a majority (60%) of all reported TSRs resolving within three days. The incidence of TSRs for the touch-up and maintenance treatments was lower than that for initial treatment.

JUVÉDERM® VOLUMA® XC, one of six specifically designed products in the JUVÉDERM® Collection of Fillers, is currently also indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face, and for augmentation of the chin region to improve the chin profile.

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