Post-AKD kidney function may independently predict long-term prognosis of patients with AKI on dialysis: JAMA

Taiwan: A recent cohort study of 6703 participants has revealed the cruciality of evaluating baseline and post-acute kidney disease (AKD) kidney function for understanding the risk of adverse outcomes in patients with acute kidney injury requiring dialysis (AKI-D).

The researchers, in their study published in JAMA Network Open, revealed that baseline kidney function and post-AKD kidney function were significant independent factors linked with major adverse cardiac events (MACEs), all-cause mortality, readmission, and end-stage kidney disease (ESKD) in patients with AKI-D.

“Worse post-AKD kidney function was linked with a progressive rise in the risk of adverse outcomes; however, AKD severity was not associated with adverse outcomes,” the researchers wrote.

The researchers mentioned significant associations of interplay among baseline kidney function, severity of acute kidney disease, and post-AKD kidney function with patient outcomes. However, a comprehensive understanding of how these factors are collectively associated with mortality, MACEs, and ESKD in patients with AKI-D is yet to be explored fully. Considering this, Heng-Chih Pan, Chang Gung University College of Medicine, Taoyuan, Taiwan, and colleagues aimed to examine the associations of baseline kidney function, AKD severity, and post-AKD kidney function with MACEs, mortality, and ESKD in patients with AKI-D.

For this purpose, the researchers conducted a nationwide, population-based cohort study of patients with AKI-D between 2015 and 2018, using data from several healthcare settings included in the Taiwan nationwide population-based cohort database.

Exposure to severe AKI and baseline and post-AKD kidney function were determined.

The study’s primary outcomes included all-cause mortality and incident MACEs and secondary outcomes were risks of permanent dialysis and readmission.

The study led to the following findings:

  • A study enrolled 6703 of 22 232 patients (mean age, 68.0 years; 57.4% male) with AKI-D, with post-AKD kidney function follow-up and AKD stage data.
  • During a mean 1.2 years of follow-up, the all-cause mortality rate was 28.3%, while the incidence rates of MACEs and ESKD were 11.1% and 16.7%, respectively.
  • After adjusting for known covariates, both post-AKD kidney function and baseline kidney function, but not AKD severity, were independently associated with all-cause mortality, MACEs, ESKD, and readmission.
  • Worse post-AKD kidney function correlated with progressive and significant increases in the risk of adverse outcomes.

In conclusion, in the cohort study of patients with acute kidney injury requiring dialysis, more than one-quarter of patients died following 1.2 years of follow-up. Baseline and post-AKD kidney functions are important factors linked with the long-term prognosis in AKI-D patients.

“Therefore, concerted efforts to understand the transition from post-AKD to chronic kidney disease are crucial,” the researchers wrote.

Reference:

Pan H, Chen H, Teng N, et al. Recovery Dynamics and Prognosis After Dialysis for Acute Kidney Injury. JAMA Netw Open. 2024;7(3):e240351. doi:10.1001/jamanetworkopen.2024.0351

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Innovative Triple-Combination Gel tied to Swift and Lasting Acne Relief, Study Finds

In
a significant advancement in acne treatment, a novel once-daily
triple-combination gel has demonstrated remarkable efficacy, outshining
conventional monotherapies and dual-combination products. This new approach,
combining an antibiotic, antibacterial agent, and retinoid, is designed to
deliver expedited and sustained improvement in acne lesions. the first FDA-approved
triple-combination topical acne product, clindamycin phosphate 1.2%/adapalene
0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated significantly greater
lesion count reductions compared to its dyads and vehicle as early as week 4,
with sustained efficacy after 12 weeks of treatment.


The trial results were published in the Journal
of Drugs in Dermatology. 

Also Read: Ultraviolet-induced fluorescence dermoscopy improves precision in non-neoplastic dermatoses

Implementing
a daily regimen that combines an antibiotic, antibacterial agent, and retinoid
may yield accelerated improvements in acne compared to single or dual-component
products. Hence, researchers conducted a post-hoc analysis to compare the
reductions in acne lesions between clindamycin phosphate 1.2%/adapalene
0.15%/benzoyl peroxide 3.1% (CAB) gel and its paired formulations and a control
vehicle.

The
subject of this post hoc analysis is the clindamycin phosphate 1.2%/adapalene
0.15%/benzoyl peroxide 3.1% (CAB) gel, the first FDA-approved
triple-combination topical acne product. The study aimed to assess its impact
on acne lesion reduction compared to its dyads and a control vehicle.


Conducted
in two phases, encompassing 741 participants in phase 2 and 363 participants in
phase 3, these double-blind, 12-week studies targeted individuals aged ≥9 years
with moderate-to-severe acne. Participants were randomly assigned to use
once-daily CAB gel or a control vehicle. The phase 2 study included three
additional dyad gel arms for comparison. The
analysis centered on the percentage of participants achieving varying degrees
of reduction in both inflammatory and noninflammatory acne lesions. The results
underscored the superiority of CAB gel over its dyads and vehicles.


Findings:


  • In
    the phase 2 study, as early as week 4, CAB gel exhibited an impressive 82.7%
    reduction in inflammatory lesions, surpassing the three dyads and vehicles
    (61.1-69.8%).

  • These
    early reductions persisted throughout the study, with CAB-treated participants
    consistently outperforming in achieving ≥50% reduction in inflammatory lesions
    from weeks 4-12.


  • By
    the end of the 12-week study, CAB gel showcased substantial reductions of ≥75%
    in participants, significantly outpacing the dyads and vehicles (65.8% vs
    49.9-51.2% and 21.6%).

  • Similar
    trends were observed for noninflammatory lesions in the phase 2 study and both
    inflammatory and noninflammatory lesions in the phase 3 studies.

Also Read: Bimekizumab effectively clears skin lesions in severe palmoplantar pustular psoriasis: JAMA


The
accelerated and sustained efficacy of CAB gel, coupled with its optimized
formulation, once-daily dosing, and favorable tolerability profile, may
revolutionize acne treatment. This innovative triple-combination approach not
only demonstrates its superiority over traditional therapies but also holds the
potential to positively impact patient adherence due to its faster-acting and
lasting benefits.

As
the field of dermatology continues to evolve, the emergence of this
triple-combination gel marks a significant leap forward in acne management,
providing a promising solution for those seeking more effective and efficient
alternatives for this common skin condition.

Further
reading: Early and Sustained Acne Lesion Reductions With Fixed-Dose Clindamycin
Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel. Doi: 10.36849/jdd.7907

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Calcium hydroxyapatite injection may correct orbital volume deficit with post enucleation socket syndrome: Study

Injectable calcium hydroxyapatite (CAHY) has emerged as a promising option for correcting orbital volume deficit in post enucleation socket syndrome. However, data on its long-term efficacy and safety are limited. A recent observational study aimed to evaluate the 10-year outcomes of injectable CAHY for orbital volume augmentation.

Postenucleation socket syndrome often leads to enophthalmos, causing functional and cosmetic concerns for patients. Injectable CAHY offers a minimally invasive approach to address this issue, but its durability and persistence over time have not been extensively studied. This study was published in the journal Ophthalmic Plastic and Reconstructive Surgery by Di Maria and colleagues.

The study conducted a clinical review of 31 patients with post enucleation socket syndrome who underwent injectable CAHY placement for orbital volume augmentation. Patients were followed up for 10 years, and the amount of CAHY injected was tailored to the degree of orbital volume deficit. Patients with previous radiotherapy or inadequate conjunctival fornix were excluded.

The key findings of the study were:

  • Patients demonstrated a mean increase in orbital volume of 3.35 ± 0.91 at 6 months and 2.97 ± 1.35 at 10 years post-injection.

  • The mean follow-up duration was 219 ± 18 months, with clinical and cosmetic improvement observed to persist for 10 years.

  • Complications were minimal, including peribulbar ecchymosis, two cases of extrusions of the internal prosthesis, and two cases of ptosis.

  • The study highlights the long-term efficacy and safety of injectable CAHY for correcting orbital volume deficit in post enucleation socket syndrome.

  • The sustained improvement observed over 10 years, along with minimal complications, underscores the reliability of this technique.

Injectable CAHY emerges as a safe, simple, and cost-effective option for treating orbital volume deficiency in post enucleation socket syndrome. Its semi permanent nature and negligible volume loss over 10 years make it a promising solution for patients seeking lasting cosmetic improvement. Further research and larger studies are warranted to validate these findings and optimise treatment protocols.

Reference:

Di Maria, A., Ferraro, V., Trenti, N., Morenghi, E., Gaeta, A., Vinciguerra, P., & Confalonieri, F. Ten-year follow-up of orbital volume augmentation with calcium hydroxyapatite filler in postenucleation socket syndrome. Ophthalmic Plastic and Reconstructive Surgery,2024;40(1):49–54. https://doi.org/10.1097/iop.0000000000002500

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Severe hypocalcemia linked to transient ischemic attack, suggests study

Indonesia: Evidence from available literature has suggested a possible link between severe hypocalcemia and transient ischemic attack (TIA) that occurred in a patient.

The aim of the study, published in Narra J, was to present an individual experiencing a transient ischemic attack that possibly occurred due to severe hypocalcemia associated with hypoparathyroidism after total thyroidectomy. The researchers also explored the available evidence of its cause-effect relationship through available literature.
Transient ischemic attack, also known as a mini-stroke, is a transient episode of neurological dysfunction that often lasts for less than 24 hours, caused by a temporary blood flow blockage to a certain part of the spinal cord, brain, or retinal ischemia without tissue injury or acute infarction.
Hypocalcemia and TIA are different medical disorders; however, limited evidence indicates a possible link between the two. The underlying pathomechanisms by which hypocalcemia may lead to cerebrovascular damage are difficult to comprehend.
Hendra Zufry, Universitas Syiah Kuala, Banda Aceh, Indonesia, and colleagues presented the case of a 68-year-old man presented to Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia, with complaints of weakness, particularly in the right limb that worsened in the last week.
The patient experienced unconsciousness for an hour before admission; anterograde amnesia, and disorientation over the time of recovering of consciousness. Other complaints were numbness in both arms and legs, frequent muscle cramps, swallowing difficulty, dizziness, vomiting, and nausea.
The patient had a history of total thyroidectomy for a large struma diffuse 18 years ago and was prescribed several medications. However, the patient was overwhelmed by forgetfulness, which increased in frequency in recent months resulting in medication nonadherence.
The vital signs were stable, and Chovsteck’s sign was positive. The Montreal Cognitive Assessment (MoCA) showed impairment in the executive/visuospatial component and delayed memory.
Laboratory tests revealed altered thyroid function, severe hypocalcemia, elevated D-dimer and fibrinogen, hypomagnesemia, and vitamin D deficiency. Severe hypocalcemia and TIA were proposed as the diagnosis. Prompt initiation of appropriate treatment, including anticoagulation, calcium supplementation, and neuroprotective agents, led to significant clinical improvement.
In conclusion, the authors stated that permanent hypoparathyroidism is prone to chronic hypocalcemia, which necessitates lifetime treatment. Evidence suggests the possibility of the relationship between hypocalcemia and TIA, although the exact pathophysiological mechanism of how severe hypocalcemia could cause TIA is not well understood.
“Therefore, it is critical to regularly monitor the calcium levels in patients with a thyroid or parathyroid surgery to avoid transient ischemic attack and other hypocalcemia-associated complications. Calcium supplementation is the most effective strategy to date,” the researchers wrote.
Reference:
Zufry H, Debbyousha M, Firdausa S, et al. Severe hypocalcemia as a cause of transient ischemic attack? A debatable case and evidence from literature. Narra J 2023; 3 (2): e228 – http://doi.org/10.52225/narra.v3i2.228.

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Radiation therapy in breast cancer linked to increased risk of melanoma and hemangiosarcoma: JAMA

Previous studies have suggested a potential link between radiation therapy for breast cancer and an increased risk of subsequent nonkeratinocyte skin cancers. However, the evidence supporting this association has been limited. A recent population-based cohort study aimed to investigate whether radiation therapy for breast cancer is associated with an elevated risk of developing nonkeratinocyte skin cancers, particularly localized to the skin of the breast or trunk.

This study was published in the journal JAMA Network Open by Shawheen J. and colleagues. Radiation therapy is a common treatment modality for breast cancer, but its potential long-term effects on skin health have been a subject of concern.

This study utilized longitudinal data from the Surveillance, Epidemiology, and End Results (SEER) Program, covering the period from January 1, 2000, to December 31, 2019. Patients with newly diagnosed breast cancer were identified, and subsequent development of nonkeratinocyte skin cancers was evaluated. Standardized incidence ratios (SIRs) were calculated to assess the risk of nonkeratinocyte skin cancer development based on treatment type (radiation therapy, chemotherapy, or surgery), skin cancer site, and subtype.

Key Findings:

  • The study included 875,880 patients with newly diagnosed breast cancer, of whom 50.3% received radiation therapy.

  • From 2000 to 2019, 3,839 patients developed nonkeratinocyte skin cancers after breast cancer treatment, including melanoma (89.1%), Merkel cell carcinoma (3.2%), hemangiosarcoma (2.7%), and other subtypes.

  • The risk of nonkeratinocyte skin cancer diagnosis after breast cancer treatment with radiation was 57% higher (SIR, 1.57 [95% CI, 1.45-1.7]) compared to the general population, particularly on the skin of the breast or trunk.

  • Stratified by skin cancer subtype, the SIRs for melanoma and hemangiosarcoma were both statistically significant, indicating an elevated risk associated with radiation therapy.

  • Radiation therapy was associated with a greater risk of nonkeratinocyte skin cancer compared to chemotherapy and surgical interventions.

This study provides evidence of an increased risk of melanoma and hemangiosarcoma following breast cancer treatment with radiation therapy. Although occurrences of nonkeratinocyte skin cancers are rare, physicians should be aware of this elevated risk to facilitate appropriate follow-up care and surveillance strategies for patients who have undergone radiation therapy for breast cancer.

Reference:

Rezaei, S. J., Eid, E., Tang, J. Y., Kurian, A. W., Kwong, B. Y., & Linos, E. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Network Open,2024;7(3):e241632. https://doi.org/10.1001/jamanetworkopen.2024.1632

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Study identifies metabolites as risk factors for diabetic retinopathy

Finland: A recent study published in the Journal of Clinical Endocrinology & Metabolism has identified multiple metabolites associated with an increased and decreased risk for diabetic retinopathy (DR) from several different metabolic pathways.

“Our study is the first large population-based longitudinal study to identify metabolites for diabetic retinopathy,” the researchers wrote.

In patients with diabetes, DR is a specific microvascular complication and is the leading cause of blindness. Recent advances in omics, particularly metabolomics, offer the possibility of identifying novel potential biomarkers for DR. Lilian Fernandes Silva, University of Eastern Finland, Kuopio, Finland, and colleagues aimed to identify metabolites associated with DR.

For this purpose, they performed a 12-year follow-up study comprising 1349 participants with type 2 diabetes (1021 without diabetic retinopathy, 328 with DR) selected from the METSIM cohort. Subjects who had retinopathy before the baseline were excluded (n = 63). Retinopathy diagnosis was based on fundus photography examination. Non-targeted metabolomics profiling was performed to identify metabolites.

The study led to the following findings:

  • 17 metabolites were found to be significantly associated with incident diabetic retinopathy after adjustment for confounding factors.
  • Among amino acids, N-lactoyl isoleucine, N-lactoyl valine, N-lactoyl tyrosine, N-lactoyl phenylalanine, N-(2-furoyl) glycine, and 5-hydroxylysine were associated with an increased risk of DR, and citrulline with a reduced risk of DR.
  • Among the fatty acids N,N,N-trimethyl-5-aminovalerate was associated with an increased risk of DR, and myristoleate (14:1n5), palmitoleate (16:1n7), and 5-dodecenoate (12:1n7) with a decreased risk of DR.
  • Sphingomyelin (d18:2/24:2), a sphingolipid, was significantly associated with a decreased risk of DR.
  • Carboxylic acid maleate and organic compounds 3-hydroxypyridine sulfate, 4-vinylphenol sulfate, 4-ethylcatechol sulfate, and dimethyl sulfone were significantly associated with an increased risk of DR.

“Our longitudinal study shows that the development of diabetic retinopathy involves multiple changes in metabolism that ultimately diminishes retina function,” the researchers wrote.

These changes in the retina, reflected by concentration changes in metabolites, include activation of inflammatory pathways, neovascularization, capillary loss, fibrosis, endothelial dysfunction, collagen degradation, hemorrhages, and aneurysms.

The study’s limitations were that it included only elderly and middle-aged men and only Finns.

“Therefore, our findings need to be replicated in women and other populations. Finally, our study is an association study that does not allow one to make causal conclusions,” the research team concluded.

Reference:

Lilian Fernandes Silva, Jenna Hokkanen, Jagadish Vangipurapu, Anniina Oravilahti, Markku Laakso, Metabolites as Risk Factors for Diabetic Retinopathy in Patients With Type 2 Diabetes: A 12-Year Follow-up Study, The Journal of Clinical Endocrinology & Metabolism, Volume 109, Issue 1, January 2024, Pages 100–106, https://doi.org/10.1210/clinem/dgad452

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CDSCO panel Rejects Akum Pharma’s FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe

New Delhi: Reviewing the justification presented by the drug major Akum Pharmaceutical with respect to the triple-drug combination of Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected proposal the proposed fixed-dose combination (FDC).

This came after Akum Pharmaceutical presented its proposal for Bempedoic acid plus Atorvastatin Calcium IP eq. to Atorvastatin plus Ezetimibe IP (180mg+20mg+10mg)/ (180mg+ 40mg+10mg) film-coated tablet along with the justification.

Bempedoic acid is a drug used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia.

Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C. The combination of bempedoic and ezetimibe is also indicated with diet management and maximally tolerated statin therapy to treat elevated LDL-C levels in adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease who require further lowering of LDL-C.

Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. This medicine is available only with your doctor’s prescription.

Ezetimibe is used to treat high blood cholesterol. Ezetimibe is available on prescription only. It comes as a tablet.

Earlier, at the 133rd SEC meeting for cardiovascular and renal, regarding the proposed FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe, the expert panel recommended that the firm should present the documents/justification on the following points:

1. The lower dose of statins along with Bempedoic acid is not approved in the country.

2. The firm has not presented adequate justification/rationale for the proposed triple drug combination.

3. More published scientific literature in peer-reviewed journals in support of triple drug combination is to be presented.

4. No global data was presented with respect to the proposed FDC.

In response to the above, at the recent SEC meeting for Cardiovascular on 20th February 2024, Akum Pharmaceutical presented their proposal along with the justification.

In continuation, the expert panel reviewed the proposal along with the justification for the FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe presented by the drug major Akum Pharmaceutical.

After detailed deliberation, the committee opined that the firm could not present a detailed justification with respect to the following:

1. The lower dose of statins along with Bempedoic acid is not approved in the country.

2. The firm has not presented adequate justification/rationale for the proposed triple drug combination.

3. No global data was presented with respect to the proposed FDC.

After detailed deliberation, the committee did not recommend approval of the FDC.

Also Read:Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets

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Registration of hospitals can’t be cancelled under PC PNDT Act unless appropriate authority deems it necessary in public interest: SC

Delivering an interpretation of the powers vested in the appropriate authorities under the Pre-conception and Pre-natal Diagnostic Techniques (Regulation & Prevention of Misuse) PC PNDT Act, 1994, the Supreme Court of India recently clarified that the authorities can only suspend/cancel the registration of hospital/clinic under Section 20(3) of the Act when such an action is believed to be necessary in the public interest.

“…in our view, the power of sub­section (3) of Section 20 of PC&PNDT Act is notwithstanding the power of sub­sections (1) & (2) of Section 20. The said power can only be exercised when the appropriate authority forms an opinion that it is necessary or expedient in public interest to do so. It is incumbent upon the appropriate authority to form its opinion based on reasons expedient or necessary to exercise the power of suspension,” opined the top court bench comprising Justices J.K. Maheshwari and K.V. Vishwanathan.

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WHO issues warning for growing resistance to HIV drug of GSK

The World Health Organization (WHO) has said resistance to GSK’s HIV drug dolutegravir has exceeded levels observed during its trials, citing observational and survey data received from a few countries.

Resistance ranged from 3.9% to 8.6% and reached 19.6% among people who have received and transitioned to a dolutegravir-containing antiretroviral therapy (ART) regimen to combat high HIV viral loads.

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Maha: 45 year old doctor roaming naked inside hospital, inquiry underway

A disturbing incident has come to light in a viral video circulating on social media where a 45-year-old doctor at a government-run hospital in Maharashtra’s Chhatrapati Sambhajinagar district could be seen roaming inside the hospital corridors completely naked.

The video footage captured the doctor’s peculiar behaviour as he wandered unclothed through the corridor of Bidkin Rural Government Hospital, waving a cloth before entering the washroom whose door remained open.
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