Cariprazine Shows High Tolerability and Completion Rates in Major Depressive Disorder Patients

Cariprazine, approved by the FDA as an adjunctive treatment for MDD, has demonstrated positive outcomes in various trials. The analysis focused on its safety profile, leveraging data from five randomized, double-blind, placebo-controlled trials involving patients with inadequate responses to monotherapy antidepressant treatment.

A recent pooled analysis of phase 3 trials has shed light on the safety and tolerability of cariprazine, an adjunctive treatment for major depressive disorder (MDD). This study was published in the International Clinical Psychopharmacology journal. Led by Michael E. Thase, MD, from the Perelman School of Medicine at the University of Pennsylvania, the study aimed to assess the outcomes of patients with MDD receiving cariprazine in conjunction with antidepressant therapy.

A total of 16,825 patients were included in the analysis. 62% of patients were at intermediate or high risk of frailty. In-hospital mortality and any complication rates were primary outcomes. Length of hospital stay and total charges were secondary outcomes. Frailty was assessed using the Hospital Frailty Risk Score, stratified into low, intermediate, and high risk.

  • Patients with high or intermediate frailty had higher in-hospital mortality rates (6.37 and 5.15 times, respectively) compared to those with low frailty.

  • Patients undergoing leadless pacemaker implantation had a 90% completion rate.

  • Only 4.3% discontinued treatment due to mild or moderate treatment-emergent adverse events.

  • PANDO patients showed significant associations with ocular surface, eyelid, upper airway, and systemic inflammatory-related diseases.

  • The Butantan–Dengue Vaccine demonstrated an overall 2-year vaccine efficacy of 79.6% against symptomatic, virologically confirmed dengue.

The pooled analysis underscores the high tolerability and completion rates in MDD patients treated with cariprazine. Despite mild to moderate adverse events, the study supports the safety of cariprazine as an adjunctive therapy for MDD.

Reference:

Thase ME, Yeung PP, Rekeda L, Liu M, Varughese S. Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials. Int Clin Psychopharmacol. Published online January 25, 2024. doi:10.1097/YIC.0000000000000528

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Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

New Delhi: The Union Health Ministry has initiated several initiatives to promote judicious use of antimicrobials, as indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country, the Parliament was recently informed.

Concerns related to overprescription of antibiotics in the country were raised during a Rajya Sabha Session by Minister A D Singh, who inquired whether a survey of nearly 10 thousand hospitals by the National Centre for Diseases Control (NCDC), has found that more than half of the patients were given antibiotics to prevent rather than treat the infection.

In response to the question raised, Prof. Satya Pal Singh Baghel, the Minister of State in the Ministry of Health and Family Welfare confirmed that National Centre for Disease Control (NCDC) conducted Point Prevalence Survey (PPS) on antibiotic use at 20 tertiary care government hospitals (NAC-NET sites). This study was conducted amongst 9653 eligible patients admitted in these 20 hospitals. 71.9% of the patients received antibiotics. Of those who were prescribed antibiotics, 54.8% received antibiotics for prophylactic indications (Surgical Prophylaxis 37.3% and Medical prophylaxis 17.5%).

The Minister further said that indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country. He further shed light on the efforts being made by Government to control the tendency of overprescription of antibiotics. He said that the Health Ministry has taken steps to promote judicious use of antimicrobials which includes launch of Red Line awareness campaign on Antimicrobials Resistance, urging people not to use medicines marked with a red vertical line, including antibiotics, without a doctor’s prescription.

Furthermore, the Indian Council of Medical Research (ICMR) has released treatment guidelines for antimicrobial use in common syndromes, which contain guidelines for the use of antibiotics for viral bronchitis and low-grade fever antibiotics are included in Schedule H and H1 of the Drugs Rules, 1945. These drugs have specific caution labeling requirements and are sold only under the prescription of a Registered Medical Practitioner.

“The supply of a drug specified in Schedule H1 are recorded in a separate register at the time of the supply and such records are maintained for three years and are open for inspection. Central Drugs Standard Control Organisation (CDSCO) has placed 24 hi-end antimicrobials under schedule H1 by issuing notification,” the Minister added.

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Inhaled antibiotics may reduce exacerbations and improve QoL in bronchiectasis patients

Inhaled antibiotics  may reduce exacerbations and improve QoL in bronchiectasis patients suggests a new study published in the Chest. 

Inhaled antibiotics are conditionally recommended by international bronchiectasis guidelines for the treatment of patients with bronchiectasis but results of individual studies are inconsistent. A previous meta-analysis demonstrated promising results regarding the efficacy and safety of inhaled antibiotics in bronchiectasis. Subsequent publications have further supplemented the existing body of evidence in this area. Systematic review and meta-analysis of randomised controlled trials of inhaled antibiotics in adult patients with bronchiectasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov for eligible studies. Studies were included if they enrolled adults with bronchiectasis diagnosed by CT and trials had a treatment duration of at least 4 weeks. The primary endpoint was exacerbation frequency, with additional key efficacy endpoints including severe exacerbations, bacterial load, symptoms, quality of life and FEV1. Data were pooled through random-effects meta-analysis.Results: 20 studies involving 3468 patients were included. Inhaled antibiotics were associated with reduced number of subjects with exacerbations (risk ratio 0.85 95%CI 0.75-0.96), a slight reduction in exacerbation frequency (rate ratio 0.78 95%CI 0.68-0.91), a probable reduction in the frequency of severe exacerbations (rate ratio 0.48 95%CI 0.31-0.74) and a likely slight increase in time to first exacerbation (hazard ratio 0.80 95%CI 0.68-0.94). Inhaled antibiotics likely lead to a slight increase in the Quality of Life-Bronchiectasis Respiratory Symptom Score (2.51, 95%CI 0.44 to 4.31) and may reduce scores on the St. George’s Respiratory Questionnaire (-3.13, 95%CI -5.93 to -0.32). Bacterial load was consistently reduced but FEV1 was not changed with treatment. Evidence suggests little to no difference in adverse effects between groups (odds ratio 0.99 95%CI 0.75-1.30). Antibiotic resistant organisms were likely increased by treatment. Inhaled antibiotics result in a slight reduction in exacerbations, a probable reduction in severe exacerbations and a likely slight improvement in symptoms and quality of life in adults with bronchiectasis.

Reference:

Ricardo Cordeiro, Hayoung Choi, Charles S. Haworth, James D. Chalmers. The efficacy and safety of inhaled antibiotics for the treatment of bronchiectasis in adults: Updated systematic review and meta-analysis, CHEST, 2024,ISSN 0012-3692. https://doi.org/10.1016/j.chest.2024.01.045.

(https://www.sciencedirect.com/science/article/pii/S0012369224001399)

Keywords:

Inhaled antibiotics, exacerbations, improve QoL, bronchiectasis patients, bronchiectasis; therapeutics; antibiotics; inhalation; meta-analysis, CHEST, Ricardo Cordeiro, Hayoung Choi, Charles S. Haworth, James D. Chalmers

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Do JAK-STAT Inhibitors confer increased risk of vascular complications in dermatology patients?

Australia: Evolving evidence suggests that dermatology patients receiving Janus kinase–signal transducer and activator of transcription inhibitors (JAK-STATi) may be at increased risk of venous thromboembolism (VTE) and major adverse cardiovascular events (MACE). Most existing literature focused on indications that may confer a higher risk of MACE and VTE than that among patients with isolated dermatological indications.

A recent meta-analysis of randomized clinical trials did not identify a significant rise in the risk of VTE and MACE in dermatology patients receiving JAK-STATi for a median duration of 16 weeks.

The results of the review published in JAMA Dermatology suggest that the evidence is insufficient regarding an increased risk of cardiovascular complications conferred by JAK-STATi in dermatological patients, particularly when used for short time frames.

JAK-STATi include Janus kinase and tyrosine kinase 2 (TYK2) inhibitors, medications that target the JAK-STAT pathway; a series of intracellular mediators that result in amplification and gene transcription through a secondary messenger pathway. Over the past decade, JAK-STATi has revolutionized the management of several dermatological conditions.

In 2022, the ORAL study, a large open-label randomized clinical trial, suggested that rheumatoid arthritis patients receiving JAK-STATi may be at higher risk of MACE and VTE. This prompted a classwide black box warning counselling against their use in patients above 65 years or with preexisting cardiovascular risk factors. Similarly, dermatological guidelines have recommended against JAK-STATi use in certain population groups, or only in patients who have failed trials of more established therapies, including TNF inhibitors.

Against the above background, Patrick A. Ireland, Prince of Wales Hospital, Randwick, New South Wales, Australia, and colleagues aimed to evaluate the risk of VTE, MACE, serious adverse events (SAEs), and tolerability of systemic JAK-STATi compared with placebo, in those with a dermatologic indication.

For this purpose, the researchers carried out a systematic review of the literature from June 2023 using online databases. The analysis was reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines.

The eligibility criteria of the studies were placebo-controlled randomized clinical trials that compared systemic JAK-STATi with placebo and investigated the safety in patients with atopic dermatitis, vitiligo, psoriasis, alopecia areata, lichen planus or hidradenitis suppurativa. Study selection and data extraction were carried out by two authors working independently using a standardized template.

The main outcomes were the incidence of VTE, SAE, MACE, and study discontinuation due to TEAEs. Analysis of these values was done against person exposure years to determine the incidence rate (IR). Risk ratios (RRs) compared incidence rates among treatment and placebo comparator arms.

The researchers reported the following findings:

  • Forty-five randomized clinical trials were eligible for inclusion, with 12 996 patients receiving active JAK-STATi therapy and 4925 allocated to placebo treatment.
  • There was no significant increase in MACE (I2 = 0.00%; RR, 0.47) or VTE (I2 = 0.00%; RR, 0.46) between placebo and JAK-STATi comparator arms.
  • There was also no significant difference in SAEs (I2 = 12.38%; RR, 0.92) and discontinuations between JAK-STATi and placebo (I2 = 23.55%; RR, 0.94).

“We did not identify a significant increase in the risk of MACE and VTE in dermatology patients receiving JAK-STATi in the short term,” the researchers wrote.

The results aid in reassuring clinicians that prescribing these medications in short intervals to patients with low CV risk profiles appears to be both well tolerated and safe in this cohort.

“Given the limited evidence, clinicians must remain judicious in their use of these medications for long durations and in high-risk patient populations,” the research team concluded.

Reference:

Ireland PA, Jansson N, Spencer SKR, Braden J, Sebaratnam D. Short-Term Cardiovascular Complications in Dermatology Patients Receiving JAK-STAT Inhibitors: A Meta-Analysis of Randomized Clinical Trials. JAMA Dermatol. Published online January 31, 2024. doi:10.1001/jamadermatol.2023.5509

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Predictive Model using AI may detect Hyperuricemia Risk Early among those on low dose Aspirin

Hyperuricemia is primarily attributed to increased serum uric acid (SUA) concentration, considered the primary gout factor. In the US, approximately 38 million adults, up to 16.9% of the population, are affected by hyperuricemia.

According to an original research article published in Frontiers in Pharmacology, researchers concluded that a predictive model established by XGBoost algorithms could help clinicians detect hyperuricemia risk early in people taking low-dose aspirin.
Hyperuricemia is a severe condition related to gout and cardiovascular diseases. Low-dose aspirin was reported to inhibit uric acid excretion, leading to hyperuricemia. To decrease hyperuricemia-related CVD, this study identified the risk of hyperuricemia in people taking aspirin.
The data for this study were collected from the NHANES between 2011 and 2018. The analysis included participants who answered the “Preventive Aspirin Use” questionnaire with positive answers. The study used six machine learning algorithms, and the eXtreme Gradient Boosting (XGBoost) model was selected to predict the risk of hyperuricemia.
Key findings from the study are:
  • Out of 805 participants enrolled, 190 participants had hyperuricemia.
  • The participants were divided into a training set and a testing set (ratio of 8:2).
  • The area under the curve for the training and testing set was 0.864 and 0.811, respectively.
  • The SHapley Additive exPlanations (SHAP) method evaluated the modelling performance.
  • The feature ranking interpretation presented that eGFR, BMI, and waist circumference were the three most essential features for hyperuricemia in those taking aspirin.
  • The factors correlated with the development of hyperuricemia are triglyceride, hypertension, total cholesterol, HDL, LDL, age, race, and smoking.
Study limitations include a cross-sectional study, small sample size, and the duration of people taking low-dose aspirin was not known.
They said we leveraged an ML model trained on NHANES data to develop a hyperuricemia model for those taking aspirin. XGBoost model can p help clinicians detect hyperuricemia risk early.
Reference
Zhu, B. et al. Prediction of hyperuricemia in people taking low-dose aspirin using a machine learning algorithm: a cross-sectional study of the National Health and Nutrition Examination Survey. Frontiers in Pharmacology, 14. https://doi.org/10.3389/fphar.2023.1276149

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Postoperative antibiotics may not improve outcomes among kids with nonperforated appendicitis with gangrenous, suppurative, or exudative findings: JAMA

A recent study published in the Journal of American Medical Association investigated the efficacy of postoperative antibiotics in children with nonperforated appendicitis who exhibit gangrenous, suppurative or exudative (GSE) findings.

This retrospective cohort study was conducted across 16 hospitals that participated in a regional research consortium and analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP)–Pediatric Appendectomy Targeted dataset. The research compared the surgical site infection (SSI) rates between children who received postoperative antibiotics with those who did not. 

This research included a total of 958 children with nonperforated appendicitis in the hospital-level analysis, with 573 (59.8%) receiving postoperative antibiotics. No correlation was found between the use of postoperative antibiotics and SSI rates when analyzed at hospital and patient levels.

The hospital-level analysis explored the association between postoperative antibiotic use and SSI rate ratios and found no significant correlation regardless of the overall rate of antibiotic use or the duration of antibiotic treatment.

Further analysis at the patient level included 404 patients who were propensity-matched who showed similar rates of SSI between those who received postoperative antibiotics and those who did not.

These findings suggest that the postoperative antibiotics use may not provide any added benefit in preventing SSIs in children with nonperforated appendicitis showing GSE findings. Furthermore, unnecessary antibiotic use contributes to antibiotic resistance and the risk of adverse reactions which highlights the importance of evidence-based approaches to prescribe antibiotics.

Reference:

Cramm, S. L., Graham, D. A., Blakely, M. L., Kunisaki, S. M., Chandler, N. M., Cowles, R. A., Feng, C., He, K., Russell, R. T., Allukian, M., Campbell, B. T., Commander, S. J., DeFazio, J. R., Dukleska, K., Echols, J. C., Esparaz, J. R., Gerall, C., Griggs, C. L., … Hanna, D. N. (2024). Postoperative Antibiotics, Outcomes, and Resource Use in Children With Gangrenous Appendicitis. In JAMA Surgery. American Medical Association (AMA). https://doi.org/10.1001/jamasurg.2023.7754

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2278 Nursing colleges in India: MoS Health informs parliament

New Delhi- As per the data presented in the Lok Sabha by Minister of State for Health Dr Bharati Pravin Pawar, there are a total of 2278 government and private nursing colleges in India.

Of these 2278 nursing colleges, 234 are government nursing colleges and 2044 are private nursing colleges. Apart from this, a fund of about Rs 7 crore has also been released for 48 colleges in 16 states of India.

State-wise total nursing colleges are mentioned below-

S No.

State

Total

1

Andhra Pradesh

138

2

Arunachal Pradesh

5

3

Assam

21

4

Bihar

15

5

Chandigarh

2

6

Chhattisgarh

114

7

Dadra & Nagar Haveli

1

8

Daman & Diu

1

9

Delhi

15

10

Goa

6

11

Gujarat

98

12

Haryana

39

13

Himachal Pradesh

34

14

Jammu & Kashmir

18

15

Jharkhand

28

16

Karnataka

367

17

Kerala

155

18

Lakshadweep

1

19

Madhya Pradesh

156

20

Maharashtra

101

21

Manipur

12

22

Meghalaya

4

23

Mizoram

4

24

Nagaland

1

25

Odisha

48

26

Pondicherry/Puducherry

12

27

Punjab

120

28

Rajasthan

166

29

Sikkim

4

30

TamilNadu

196

31

Telangana

88

32

Tripura

5

33

Uttar Pradesh

170

34

Uttarakhand

31

35

West Bengal

102
Also Read: India has 108940 MBBS seats in 706 Medical Colleges, MoS Health Provides State/UT wise Breakup
The data was presented in response to the question raised by the Member of Parliament Omprakash Rajenimbalkar, Vinayak Raut and Advocate Adoor Prakash in the Lok Sabha to the MoS Health Dr Bharati Pravin Pawar. The MP also asked about the steps taken by the government to meet the needs of the colleges. Consequently, the proposal by the Government to establish Government/Private Nursing Colleges in all the districts of Maharashtra was also asked. Additionally, the status of upgrading existing nursing schools to Colleges of Nursing under the Central Sector Scheme for upgradation was also sought.
Also Read: 485 MBBS, 247 PG Medical Seats Still Went Vacant in 2023: MoS Health tells parliament

In response, MoS Health answered that the government has taken several steps to meet the needs of nursing colleges.

The steps include-

1 In the budget speech 2023-24 establishment of 157 nursing colleges has been announced under the Centrally Sponsored Scheme (CSS).

2 For Nursing Educational Programmes Student patient ratio has been relaxed from 1:5 to 1:3.

3 The land requirement for Nursing Educational Institutes has been relaxed to construct a building of 54,000 sq. ft. for the School/College of Nursing including a Hostel.

4 To open GNM and B.Sc. (Nursing) programme 100 bedded parent hospital is essential since 2013-2014. However, this is relaxed for hilly and tribal areas.

5 Relaxed norms for teaching faculty to start B.Sc. (N) Programme.

6 Super speciality Hospitals can start M.Sc. (N) without having under graduate programme.

7 Maximum of 100 seats will be granted to the institutions for B.Sc.(N)/GNM programmes which have parent hospitals with 300 beds without insisting on Medical College.

8 Distance from school to hospital has been relaxed.

9 Eligibility Criteria for admission to nursing programmes relaxed.

Also Read: MoS Health Counts 13 lakh Allopathic Doctors, 36.14 lakh Nursing Personnel in India, Check Details

Further, Dr Bharati Pravin Pawar also added that Under the Centrally Sponsored Scheme (CSS) for “Augmenting Nursing EducationEstablishment of new College of Nursing (CoN) in co-location with Medical College” 157 nursing colleges have been approved of which two are in Maharashtra at Gondia and Nandurbar districts.

He also stated, “Under the Central Sector Scheme “Development of Nursing Services”, funds to the tune of Rs.7.00 crore is released for Upgradation of each School of Nursing into College of Nursing. So far, 48 Institutes have been allocated funds for the upgradation of the School of Nursing into the College of Nursing. List of these 48 institutions along with funds released so far”.

To view the document, click on the link below:

https://medicaldialogues.in/pdf_upload/loksabhaquestionsannex1715au105-231769.pdf
https://medicaldialogues.in/pdf_upload/loksabhaquestionsannex1715au205-231770.pdf

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NMC 75 percent attendance rule for medical college faculties opposed by doctors

Opposing the National Medical Commission’s (NMC) rule of insisting on 75% attendance for the medical college faculties, and resident doctors, the Tamil Nadu Government Doctors’ Association (TNGDA) has recently written to the President of the Undergraduate Medical Education Board (UGMEB) of NMC.

The association highlighted that such a mandatory requirement regarding the percentage of attendance deprives the faculties and residents in medical colleges of their leave rights. Therefore, TNGDA urged NMC to withdraw the concerned rule and instead insist on the maximum limit of vacancy-days for each post and each cadre in all departments. The association has also opposed the enforcement of AEBAS.

As per the NMC rules, the undergraduate and postgraduate medical colleges imparting medical education must ensure that their faculties have 75% attendance of the total working days.

For the full story, check out the link given below:

75 Percent Attendance Deprives Faculties Of Legitimate Leave Rights: Doctors Oppose NMC Rules

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Age at natural menopause linked to Polycystic Ovary Syndrome

In
a pioneering effort to understand the intricate relationship between polycystic
ovary syndrome (PCOS) and the age at natural menopause (ANM), a
population-based study has unfolded compelling findings. The study found a significant
association between PCOS and ANM in women, with potential implications for
fertility and reproductive health.

The
study results were published in the journal Menopause.

Also Read: Cold water swimming may reduce anxiety and symptoms of menopause

Conducted
over approximately two decades, the Tehran Lipid and Glucose Study enrolled
1,696 reproductive-aged participants, embarking on a quest to discern the
association between PCOS and ANM. The research cohort comprised 348 women
diagnosed with PCOS based on the Rotterdam criteria and 1,348 non-PCOS
controls. Employing an accelerated failure time survival regression model, the
study meticulously adjusted for numerous potential confounders, including age
at baseline, menarche age, medical history, parity, oral contraceptive use,
body mass index, education level, physical activity, and smoking.

Findings:

  • The
    unadjusted analysis unveiled a significant positive association between PCOS
    and ANM, revealing that women with PCOS experienced 1.05 times longer time to
    menopause compared to their non-PCOS counterparts (95% confidence interval,
    1.02-1.06; P < 0.001).
  • Even
    after adjusting for the multifaceted factors influencing menopausal age, the
    results remained significant, indicating 1.03 times longer time to menopause
    for PCOS-affected women (95% confidence interval, 1.01-1.06; P = 0.002).
Also Read: Women with late menarche and early menopause may demonstrate higher risk for Rheumatoid arthritis

These
findings carry noteworthy implications for women grappling with PCOS,
suggesting a potential impact on their fertility and reproductive health. The
study not only establishes a robust association between PCOS and ANM but also
prompts further inquiry into the underlying mechanisms governing this
relationship. This
groundbreaking research opens avenues for future investigations, ultimately
aiming to empower women with valuable insights into their reproductive journey. 

Further reading: Amiri M, Rahmati M, Firouzi F, Azizi F, Ramezani Tehran F. A prospective study on the relationship between polycystic ovary syndrome and age at natural menopause. Menopause. 2024;31(2):130-137. doi:10.1097/GME.0000000000002261

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District Consumer Commission directs Insurance company to reimburse over Rs 1.88 lakh medical claim of Delhi man

New Delhi: The District Consumer Disputes Redressal Commission directed Oriental Insurance Company to reimburse a medical claim amount of more than Rs 1.88 lakh along with a compensation of Rs 7,500 for deficiency in services to a policyholder.

The direction of the District Consumer Disputes Redressal Commission (East Delhi) came on the man’s complaint that the amount was not paid to him despite submitting a claim of Rs 1,88,729 along with requisite documents to Oriental Insurance Company Ltd in 2017.

The commission, comprising President S S Malhotra and Members Rashmi Bansal and Ravi Kumar, in a recent order, noted that the complainant’s wife was taking treatment at AIIMS and the raised claim was not disputed by the insurer.

Also Read:Medical Claims cannot be denied only because hospital not mentioned in Govt order: HC

It rejected the company’s arguments that the complainant did not submit the requisite documents.

“Fact otherwise is well proved that the complainant has filed all the necessary documents along with the complaint and exhibited all the documents. Therefore, it appears to the commission, that the contention that the complainant did not cooperate or did not furnish the document/details appears to be an afterthought,” the commission said.

Stating that not reimbursing the claim amounted to deficiency in services, the commission directed Oriental Insurance to pay the amount with interest along with Rs 7,500 as compensation and Rs 5,000 as litigation costs.

Medical Dialogues team had earlier reported that the Madurai bench of Madras High Court reiterated that a claim for medical reimbursement cannot be rejected merely because the treatment was undertaken in a non-networking hospital. “The issues regarding the settlement of the medical claim are no more res-integra in respect of the treatment undertaken in a non-network hospital. Several orders have been passed by the Courts to settle the medical reimbursement claim and not to reject the same merely on the ground that the hospital is not falling under the list of network hospitals,” noted the HC bench comprising Justices SM Subramaniam and V Lakshminarayanan. 

Also Read:Mediclaim cannot be rejected citing existing illness: SC

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