Novel oral intragastric expandable capsules can revolutionize weight loss management in obese patients: Study

China: A recent study published in Diabetes, Obesity and Metabolism has shed light on the safety and efficacy of intragastric expandable oral capsules in adults with overweight or obesity.

The 24-week trial comprising overweight/obese participants showed that 2.24 g of twice-daily intragastric expandable capsules taken before meals led to a clinically meaningful reduction in body weight compared with placebo, with mild gastrointestinal adverse events. 

Obesity is a chronic disease in which body weight exceeds a certain threshold because of the accumulation of adipose tissue, potentially leading to cardiovascular disease, type 2 diabetes, mood disorders, and even malignancy. Among several weight loss therapies, the most common are lifestyle and diet modifications but fail in the long term. Anti-obesity pharmacotherapies have shown efficacy in weight reduction, but side effects occur.

The increasing population of overweight/obese individuals urgently calls for multiple choices of weight management pharmacotherapies. Therefore, Xiaohui Guo, Department of Endocrinology, Peking University First Hospital, Beijing, China, and colleagues aimed to assess the safety and efficacy of 2.24 g intragastric expandable capsules twice per day versus placebo for weight management in adults with overweight or obesity in a double-blind, placebo-controlled study.

The study included adults with a body mass index (BMI) of at least 24 kg/m2 and no more than 40 kg/m2. A total of 280 participants were recruited from six hospitals in China and were assigned in a ratio of 1:1 to receive 2.24 g oral intragastric expandable capsules or placebo for 24 weeks.

Coprimary endpoints were the percentage change from baseline in body weight and the rate of weight reduction of ≥5%, assessed using the full analysis set and per protocol set.

Intragastric expandable capsules comprised two naturally derived components, food-grade carboxymethylcellulose cross-linked with citric acid, producing a three-dimensional polymer matrix that rapidly absorbs water and occupies the volume of the small intestine and stomach, when orally administered with water before a meal, subsequently producing satiety.

The study led to the following findings:

  • At baseline, the mean body weight was 81.8 kg, and the mean BMI was 29.4 kg/m2. The mean body weight change at week 24 was −4.9% with intragastric expandable capsules versus −1.9% with placebo [estimated treatment difference (ETD) −3.0%] using the full analysis set and −6.1% versus −2.5% (ETD −3.6%), respectively, using the per-protocol set.
  • The percentage of participants who had weight loss exceeding 5% was 45.0% in the intragastric expandable capsule group versus 19.7% in the placebo group (ETD 25.3%) in the full analysis set and 55.9% versus 26.2% (ETD 29.6%), respectively, in the per-protocol set.
  • Waist circumference significantly decreased at week 24 (intragastric expandable capsules vs. placebo: −5.6 ± 8.3 cm vs. −2.9 ± 4.8 cm).
  • The most common adverse events associated with the use of intragastric expandable capsules were gastrointestinal disorders (intragastric expandable capsule vs. placebo, 25.0% vs. 21.9%), and most were mild and transient.

In the 24-week trial, including participants with obesity or overweight, 2.24 g twice daily intragastric expandable capsules led to a clinically meaningful reduction in body weight compared with a placebo.

“Our study proved the efficacy of once-daily oral intragastric expandable capsules, in combination with counselling for physical activity and diet, resulting in significantly higher weight reduction at week 24 compared with placebo, with mild gastrointestinal adverse events,” the researchers concluded.

Reference:

Lu D, Yuan Z, Guo X, Zhu L, Zhang F, Li X, Wang W, Lin H, Luo J. Efficacy and safety of intragastric expandable oral capsules in adults with overweight or obesity: A randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2024 Jan 22. doi: 10.1111/dom.15418. Epub ahead of print. PMID: 38253466.

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Indian Pharmaceutical Market soars with 9.5% growth in January 2024: Pharmarack Report

New Delhi: The Indian Pharmaceutical Market (IPM) exhibited a robust growth of 9.5% in terms of value and 2.07% in units, reaching a total value of 16,234 Cr in January, 2024, according to a recent report by market research firm Pharmarack.

The Moving Annual Total (MAT) basis showed the market achieving 194,951 Cr with a 7.4% value growth. Significant growth was observed in Respiratory, Pain/Analgesics, Urology, Anti-Neoplastics, and Stomatologicals, with notable performances in Respiratory Therapy, particularly Anti-asthma and COPD combinations. The Pain/Analgesics therapy also exhibited positive attributes, possibly influenced by seasonal trends, while Monoclonal antibodies and Immunosuppressive agents contributed significantly to the Anti-neoplastics therapy.

In the realm of therapy performance, Cardiac treatments exhibited a commendable 11.75% growth in value, coupled with a 3.19% increase in units. Despite a slight dip in unit growth, the Cardiac therapy sector contributed significantly to the overall positive trend in the market. Anti-Infectives demonstrated robust performance, boasting an 11.66% growth in value and a 3.17% increase in units. This strong performance reflects a notable demand for infectious disease management. Gastrointestinal therapies displayed steady growth, recording a 10.28% increase in value and an impressive 7.34% growth in units, indicating a sustained demand for treatments in this category.

Anti-Diabetic therapies showcased positive value growth at 10.78%, though there was a slight decrease in unit growth at 2.39%. Respiratory treatments experienced a 4.02% growth in value, but a decline of -2.59% in unit growth, possibly influenced by specific market dynamics. Pain/Analgesics therapies exhibited consistent growth with a 10.62% increase in value and a 2.46% rise in units, indicating a stable demand for pain management solutions. Anti-Neoplastics emerged as a standout performer with an impressive 20.54% growth in value and a remarkable 24.49% increase in units, pointing to a rising demand for cancer-related treatments. Stomatologicals showcased positive growth with an 8.92% increase in value and a 1.37% rise in units, emphasizing the demand for oral health-related pharmaceuticals.

As per the report, the growth in January ’24 was primarily fueled by price (5.2%) and new products (4.3%). Major therapies such as Cardiac, Anti-infectives, Pain/Analgesics, Neuro/CNS, and Anti-neoplastics experienced substantial volume growth. Remarkably, considerable price growth was observed in Cardiac, Gastrointestinal, Respiratory, Vit/Min/Nutr, Pain/Analgesics, and Neuro/CNS therapies. The new product lever, especially in Anti-diabetic, Blood-related, Hormones, and Stomatologicals, played a crucial role in driving IPM growth.

The top corporates influencing the market included Sun+Ranbaxy, Abbott, Mankind, Cipla, and Zydus. Similarly, the top brands contributing to sales included Augmentin (GSK), Glycomet GP (USV), Manforce (Mankind), Foracort (Cipla), and Mixtard (Abbott*).

In terms of the zonal split in Jan ’24, the IPM exhibited a value skew of S-N-W-E and a unit skew of N-S-E-W. The West zone led with the highest unit growth of 5.5%, and Tamil Nadu and UP-west & Uttarakhand emerged as the highest contributing states. However, Telangana was the only state pan India demonstrating a dip (-5%) in Jan ’24.

In the acute/chronic split, all segments displayed healthy growth, with a stable cyclic trend in the chronic and sub-chronic segments. Acute and chronic therapies contributed an incremental value of ~500 Cr each to the IPM over the Same Period Last Year (SPLY). The acute portfolio, holding ~50% share, contributed 7527 Cr in Jan ’24, with an 8% value growth and 2% unit growth. Sun Pharma* maintained its 1st position, and Fresenius exhibited remarkable performance. In the chronic segment, contributing ~33% to the IPM value, recorded 5463 Cr, growing at 11% by value, with nine corporates sustaining their rank over Jan ’23. The sub-chronic category contributed 19% by value and 15% by units, recording sales of 3239 Cr, growing at 10% by value.

The Supergroup Gauger revealed the top 5 corporates in each therapy for Jan ’24, indexed based on overall therapy vs. corporate value growth. Sun* (Cardiac), Aristo (Anti-Infectives), Abbott* (Gastrointestinal), Cipla (Respiratory), and GSK (Pain/Analgesics) emerged as leaders, highlighting their market dominance. In the Indian/MNC Therapy Split, Indian corporates recorded a 10% value growth and a 2.5% unit growth, contributing ~84% across major therapies, while MNCs demonstrated a 6% growth in value, with vaccines being their leading contributor.

Regarding New Introduction Dynamics, in the last 12 months, new SKUs valued at 891 Cr contributed 0.9% to the IPM in Jan ’24. Alkem*, Mankind, Eris LS, Cipla, Sun Pharma, and Abbott* led in launching new introductions, contributing to 16% of the total NIs.

The top 5 therapies leading in new introductions were Anti-diabetic, Cardiac, Pain and Analgesics, Derma, and Neuro/CNS. The average brand value per NI across all supergroups was Rs. 0.30 Cr, with Vaccines (Rs 2.0 Cr/Brand), Antineoplastics (Rs 1.1 Cr/Brand), Blood Related (0.6 Cr/Brand), Gynecological (0.52 Cr/Brand), and VMN (0.50 Cr/Brand) showing relatively higher brand values per NI.

Jan ’24 witnessed one new subgroup launch, with only 4 subgroups crossing a turnover of more than 1 Cr, and 5 subgroups from the OAD Combinations.

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Real-time PCR for Mpox virus highlighted by ICMR

The Indian Council of Medical Research (ICMR) has showcased significant advancements in health research and technology, according to its Annual Report for 2022-23. Under the leadership of Dr. Rajiv Bahl, Secretary of the Department of Health Research (DHR) and Director General of ICMR, the report highlights crucial developments like the Real-time PCR for the Mpox virus and NextGen Sequencing techniques, marking a breakthrough in disease diagnosis and surveillance in India.

ICMR’s role extends beyond research, significantly influencing public health policy with the formulation of nine comprehensive guidelines and policies aimed at combating health hazards and promoting public health awareness. Notable policies include Tobacco Control in India 2022 and the National Injury Prevention strategy.

For more news & updates, check out the link given below:

https://medicaldialogues.in/

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PM Narendra Modi inaugurates AIIMS Jammu

Prime Minister Narendra Modi has inaugurated the All India Institute of Medical Sciences (AIIMS) Jammu. PM Modi also handed over appointment orders to around 1,500 new government recruits of Jammu and Kashmir.

During the event, the prime minister informed that 50 new degree colleges have opened up in Jammu and Kashmir. He added that the number of medical colleges in Jammu and Kashmir has risen to 12 today from four in 2014, there are over 1,300 MBBS seats as opposed to 500 in 2014, and more than 650 PG medical seats as opposed to none in 2014.

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

PM Modi inaugurates AIIMS Jammu campus, now 1300 MBBS seats, 650 PG medical seats in JnK


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10 Early Signs of STDs You Shouldn’t Ignore – Dr Basavaraj S Kumbar

If you’ve had unprotected sex,
it’s important to remember that there’s more at stake than just pregnancy. Not using
protection increases the chances of getting sexually transmitted diseases
(STDs), which can vary from common infections like chlamydia and gonorrhoea to
more serious ones like HIV and herpes.

It’s essential to know that not all STDs
show immediate symptoms. That’s why it’s smart to regularly get tested to catch
any surprises early on. Looking after your sexual health means more than just
avoiding pregnancy – it’s about protecting yourself and your partner from
potential infections.

Sexually transmitted diseases
(STDs) are a big worry because they can harm your health in many ways. While
some infections cause symptoms like itching, pain, or strange discharges,
others don’t show any signs right away.

This means you might not even realize
you have something wrong inside you. It’s really important to get tested
regularly to catch any problems early.

The symptoms of these infections can
vary a lot, from sores and painful urination to unusual discharge and swollen
lymph nodes. If left untreated, STDs can cause serious issues like trouble
getting pregnant, damage to your organs, or even cancer. So, it’s not just
about you – it’s about taking care of your health and thinking about your
future self.

10 Early Signs of STDs You Shouldn’t Ignore

  1. Unusual
    Discharge:     Keep an eye out for any unusual discharge from the genital
    area. Discharge that is different in colour, consistency, or odour than
    usual could indicate an STD like Chlamydia, Gonorrhoea, or Trichomoniasis.
  2. Genital
    Sores or Ulcers:     Pay attention to the presence of sores or ulcers on
    the genitals. These can be a sign of herpes or syphilis and should be
    examined by a healthcare professional promptly.
  3. Painful
    Urination:     If you experience pain or discomfort while urinating, it
    could be a symptom of various STDs, including Chlamydia, Gonorrhoea, or
    even a urinary tract infection (UTI) caused by an STD.
  4. Flu-Like
    Symptoms:     Feeling flu-like symptoms such as fever, fatigue, and body
    aches might be an early indication of HIV infection. If you’ve engaged in
    unprotected sex and experience these symptoms, it’s essential to get
    tested.
  5. Changes
    in Vaginal Discharge:     Women should be aware of any changes in vaginal
    discharge, such as increased volume, unusual colour, or foul odour. These
    changes could signal an infection like Bacterial Vaginosis,
    Trichomoniasis, or even a yeast infection caused by an STD.
  6. Pelvic
    Pain:     Persistent pelvic pain or discomfort, especially during
    intercourse, could be a symptom of various STDs, including Chlamydia,
    Gonorrhoea, or pelvic inflammatory disease (PID) caused by untreated
    infections.
  7. Visible
    Warts:     Warts appearing on the genital area could be a sign of Human
    Papillomavirus (HPV) infection. These warts may be flesh-coloured, raised,
    or clustered and should be evaluated by a healthcare provider.
  8. Itching
    or Burning:     Unexplained itching or burning sensations in the genital
    area could indicate an STD like Trichomoniasis or a yeast infection. These
    symptoms may also accompany other STD-related conditions.
  9. Abdominal
    Pain:     Persistent abdominal pain, particularly lower abdominal pain,
    could be a sign of a more serious STD-related complication, such as PID.
    Seek medical attention if you experience this symptom.
  10. Lack
    of Symptoms:     Remember that not all STDs present immediate symptoms.
    Some infections, such as Hepatitis B or HIV, may not show signs early on.
    Regular testing, especially after unprotected sex or with multiple sexual
    partners, is crucial for early detection and treatment.

Treatment and Prevention

Treatment and prevention methods
for sexually transmitted diseases (STDs) vary depending on the type of
infection. Antibiotics can effectively treat bacterial STDs, while viral
infections cannot be cured but can be managed with proper medical care. Vaccines
against hepatitis A, hepatitis B, and HPV offer an extra layer of protection
against certain infections.

Making smart lifestyle choices
like abstaining from sex, limiting sexual partners, practising mutual
monogamy,
and consistently using condoms significantly lower the risk of getting
an STD.
Untreated STDs can lead to serious health problems such as infertility,
organ
damage, illness, cancer, and the spread of other diseases. Routine
gynaecological check-ups are key for early detection of sexually
transmitted
diseases (STDs).

Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.

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Faulty intubation during anaesthesia: SC slaps Rs 10 lakh compensation on Manipal Hospital

New Delhi: The Supreme Court recently directed Manipal Hospital to pay Rs 10 lakh compensation to the widow of a patient who developed hoarseness in his voice as a result of faulty insertion of a double lumen tube while administering anaesthesia.

While the District Consumer Court had granted Rs 5 lakh Compensation and the National Consumer Disputes Redressal Commission (NCDRC) upheld the same, the Supreme Court bench comprising Justices Hima Kohli and Ahsanuddin Amanullah enhanced the amount of compensation to Rs 10 lakhs.

“Having regard to the fact that the appellant expired during the pendency of the proceedings before the NCDRC, no useful purpose would be served in remanding the matter back for reappreciation of the evidence to arrive at a just and fair compensation. Instead, it is deemed appropriate to direct that the compensation awarded by the District Forum be doubled from ₹5,00,000/- (Rupees Five lakhs only) to ₹10,00,000/- (Rupees Ten lakhs only) with simple interest calculated @ 10% per annum from the date of filing of the claim petition till the amount is paid, subject to the adjustment of the amounts already released in favour of the deceased – appellant,” the Apex Court bench ordered.

The appellant approached the Supreme Court bench being aggrieved by the NCDRC order, which upheld the Karnataka State Commission order that confirmed the ruling of the District Consumer Court, Bangalore directing the hospital to pay Rs 5 lakh as compensation and Rs 5,000 as litigation expenses. However, the complaint against the concerned doctors was dismissed.

It was submitted by the counsel for the appellants that despite the deficiency of services being proved against the hospital and the deceased patient having claimed Rs 18 lakh as compensation with interest, the District Forum had suo moto arrived at a rough and ready figure of Rs 5 lakh payable as compensation without furnishing any reasons for arriving at the said figure.

The matter goes back to 2003 when the patient had undergone surgery on the left lung and after the surgery, he developed hoarseness in his voice. Even though the operating surgeon had assured the patient that the hoarseness could be due to the operation involving the complete removal of the tumor along with lymphnodes around the Recurrent Laryngeal Nerve and assured that the patient could regain his voice within 6-8 months with nebulization and voice therapy, the patient’s voice was not restored and remained hoarse all through. 

Subsequently, the appellant took opinions from two other expert doctors in the field and both doctors opined that there was subluxation of the left arytenoid process, which happened due to wrong intubation during the anaesthesia procedure at the hospital.

The appellant’s counsel argued that it is not in dispute that the surgery relating to cancer of the lung is a specialized surgery and requires a specialized anaesthetist. It was contended that even though the Head of the Department of Anaesthesia was to administer anaesthesia to the deceased patient, the same was administered by a doctor who was qualified but was a trainee anaesthetist in the Cardiac Anaesthesia Department.

While considering the matter, the NCDRC bench frowned on the delegation of such a critical duty on a trainee anaesthetist and treated the same as a breach of duty of care. After perusing the material on record, the NCDRC bench observed that the dislocation of the left Arytenoid was on account of the trauma caused leading to the paralysis of the vocal cord of the deceased-appellant and that the RLN injury does not cause dislocation of Arytenoid. The top consumer court opined that the paralysis of the left vocal cord of the deceased-appellant was attributed to the faulty insertion of the Double Lumen Tube in the course of administering anaesthesia to him for undergoing the surgery.

Meanwhile, the counsel for the hospital submitted that the District Forum erred in discarding the evidence of the doctors who stated that there was nothing wrong in giving anaesthesia through a double-lumen tube. He also sought to question the reliance placed by the District Forum on the testimony of two expert doctors produced by the deceased-appellant during the course of evidence.

However, the records revealed that the Hospital did not object to the said expert doctors deposing in the case, nor did the Hospital file an application for an expert appointed by the District Forum for giving an opinion in the instant case, argued the hospital’s counsel.

“Mere reliance on medical literature would not be sufficient to exonerate the Hospital from its duty of ensuring that the Head of the Department, Anaesthesia ought to have inserted the Double Lumen Tube. Instead, he was not available and the task was delegated to a trainee anaesthetist,” noted the bench.

Further, the Court also took note of the submission made by the appellant’s counsel that the deceased was working as an Area Sales Manager in the private sector and his career nosedived due to the hoarseness of his voice. The counsel submitted that the patient had virtually lost his voice and continued on the same post from the year 2023 onwards without promotion till he expired at the end of 2015. He was working on the same salary that was being paid to him at the time of his initial engagement i.e. Rs 30,000. per month.

Taking note of these facts, the Supreme Court bench observed, “…we are of the opinion that the District Forum ought to have taken all the aforesaid aspects into consideration for arriving at a rightful compensation payable to the deceased which in the instant case, has not been done.”

Therefore, the bench enhanced the amount of compensation from Rs 5 lakh to Rs 10 lakh and ordered, “As requested by learned counsel for the appellants, the amount awarded as above be released by the Hospital in favour of the widow of the deceased complainant … within a period of four weeks from today.”

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/supreme-court-rs-10-lakh-compensation-232650.pdf

Also Read: Not carrying out pre-operative investigations amounts to gross negligence: Consumer Court slaps Rs 10 lakh compensation

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Dangal actor Suhani Bhatnagar dies of rare disease called Dermatomyositis

Dermatomyositis, a rare and challenging autoimmune disorder, recently claimed the life of Suhani Bhatnagar, a young and talented actress best known for her portrayal of young Babita Phogat in Aamir Khan’s acclaimed wrestling film, “Dangal”. At just 19 years old, Suhani’s untimely passing in Delhi has cast a spotlight on this uncommon disease, following a brief battle that began with symptoms emerging just two months ago and a diagnosis confirmed merely ten days before her tragic demise.

This condition is marked by the immune system erroneously attacking the body’s own tissues, leading to inflammation and consequent damage, predominantly affecting the skin and muscles. Individuals with dermatomyositis experience a variety of symptoms, most notably a distinctive skin rash that manifests as reddish or purplish discoloration on the face, neck, shoulders, chest, and sometimes extends to the elbows, knees, and knuckles. The disease also causes muscle weakness and fatigue, severely impacting the ability to perform daily tasks and activities.

While the exact cause of dermatomyositis remains elusive, it is believed to result from a mix of genetic susceptibilities, environmental factors, and immune system irregularities, with certain medications or infections potentially triggering its onset.

Treatment strategies for dermatomyositis focus on controlling the immune system’s overactivity through medications and employing physical therapy to maintain muscle strength and flexibility. Proper management enables many individuals diagnosed with this condition to lead active and fulfilling lives, despite the need for ongoing care and vigilance to prevent further complications.

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Parliamentary Committee recommends multiple measures to make medical education more affordable

Taking note of the problems faced by medical aspirants due to the huge cost of medical education in private medical colleges in India, a Parliamentary Committee on Health has recommended multiple measures to the Government to deal with the issue.

The panel has opined that running medical colleges and hospitals on a PPP model and giving tax benefits to the company/group could also help make medical education more affordable.

Apart from these, the panel has recommended the Ministry formulate a comprehensive framework to address the bureaucratic hurdles and effectively implement the partnership of the private medical colleges with the district hospitals.

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

How Can Medical Education Be Made More Affordable? Here Is What Parliamentary Committee Said

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Remission of Cushing’s disease associated with higher risk of developing autoimmune disease

A study of more than 250 persons undergoing surgical therapy for Cushing’s disease (CD) or nonfunctioning pituitary adenomas (NFPAs) found that patients who achieved remission of CD were more likely than those with surgically treated NFPAs to develop new-onset autoimmune disease within three years after remission. The study is published in Annals of Internal Medicine.

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Health care inequities behind shorter life spans for Inuit from Nunavik, Quebec, with lung cancer

People living in the Inuit region of Nunavik in northern Quebec die earlier after a diagnosis of lung cancer than Montreal residents receiving treatment at the same cancer center, according to new research published in theCanadian Medical Association Journal.

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