Weight loss

Type 2 diabetes is not one-size-fits-all: Subtypes affect complications and treatment options

Retrieved on: 
Friday, April 19, 2024
MOD, Hyperinsulinemia, MARD, First Nations, Human, Obesity, Cell, Indigenous peoples, Unique, Disease, Blood transfusion, Insulin, Diabetes, Risk, Patient, Fatty liver disease, Weight loss, Stroke, Research, Fetus, Metabolic disorder, Hope, Pregnancy, Eye disease, Life, Kidney disease, Type 2 diabetes, Pancreas, Paratriathlon, SIDD, Blood, Type, Type 2, Dietary supplement

You may have heard of Ozempic, the “miracle drug” for weight loss, but did you know that it was actually designed as a new treatment to manage diabetes?

Key Points: 
  • You may have heard of Ozempic, the “miracle drug” for weight loss, but did you know that it was actually designed as a new treatment to manage diabetes?
  • In Canada, diabetes affects approximately 10 per cent of the general population.

Locks and keys

  • Every cell in the body needs sugar as an energy source, but too much sugar can be toxic to cells.
  • This equilibrium needs to be tightly controlled and is regulated by a lock and key system.
  • Cells cover themselves with locks that respond perfectly to insulin keys to facilitate the entry of sugar into cells.
  • The body can encounter difficulties producing an adequate number of insulin keys, and/or the locks can become stubborn and unresponsive to insulin.

Severe insulin-deficient diabetes: We’re missing keys!

  • In the severe insulin-deficient diabetes (SIDD) subtype, the key factories — the beta cells — are on strike.
  • Why the beta cells go on strike remains largely unknown, but since there is an insulin deficiency, treatment often involves insulin injections.

Severe insulin-resistant diabetes: But it’s always locked!

  • In the severe insulin-resistant diabetes (SIRD) subtype, the locks are overstimulated and start ignoring the keys.
  • There are many treatment avenues for these patients but no consensus about the optimal approach; patients often require high doses of insulin.

Mild obesity-related diabetes: The locks are sticky!

  • Mild obesity-related (MOD) diabetes represents a nuanced aspect of Type 2 diabetes, often observed in individuals with higher body weight.
  • The locks are “sticky,” so it is challenging for the key to click in place and open the lock.

Mild age-related diabetes: I’m tired of controlling blood sugar!


Mild age-related diabetes (MARD) happens more often in older people and typically starts later in life. With time, the key factory is not as productive, and the locks become stubborn. People with MARD find it tricky to manage their blood sugar, but it usually doesn’t lead to severe complications. Among the different subtypes of diabetes, MARD is the most common.

Unique locks, varied keys

  • In Canada, unique cases of Type 2 diabetes were identified in Indigenous children from Northern Manitoba and Northwestern Ontario by Dr. Heather Dean and colleagues in the 1980s and 90s.
  • Read more:
    Indigenous community research partnerships can help address health inequities

    Childhood-onset Type 2 diabetes is on the rise across Canada, but disproportionately affects Indigenous youth.

  • Acknowledging this distinct subtype of Type 2 diabetes in First Nations communities has led to the implementation of a community-based health action plan aimed at addressing the unique challenges faced by Indigenous Peoples.

A mosaic of conditions

  • Type 2 diabetes is not uniform; it’s a mosaic of conditions, each with its own characteristics.
  • Since diabetes presents so uniquely in every patient, even categorizing into subtypes does not guarantee how the disease will evolve.


Lili Grieco-St-Pierre receives funding from Fonds de recherche du Québec - Santé (FRQS). Jennifer Bruin receives funding from the Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC), JDRF, Diabetes Canada.

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 4/30

      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 7/30

      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 15/30

      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 16/30

      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 17/30

      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 21/30

      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 23/30

      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 24/30

      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 27/30

      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 4/30

      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 7/30

      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 15/30

      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 16/30

      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 17/30

      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 21/30

      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 23/30

      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 24/30

      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 27/30

      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

Drinking apple cider vinegar may help with weight loss but its health benefits are overstated

Retrieved on: 
Wednesday, April 10, 2024
Well, Research, Disease, Overweight, Health, Glucose, Diarrhea, Myocardial infarction, Apple, Cell, Serum, Infection, Appetite, Vegetable, Incidence, Acetic acid, Risk, Physiology, Lipid, Insulin, Diabetes, Weight loss, Internet, Stroke, Blood, Mortality, Cancer, Systematic review, Breakfast, Diet, Cholesterol, Vomiting, Drinking water, Dietary supplement

One day, she explained that she adds apple cider vinegar to improve my health.

Key Points: 
  • One day, she explained that she adds apple cider vinegar to improve my health.
  • Apple cider vinegar is a natural product made of fermented apple juice that has gone sour.
  • I decided to turn medical sleuth and investigate whether apple cider vinegar is as good for health as it sounds.

Claim: disinfectant properties

  • But does apple cider vinegar’s decontaminant qualities translate to the human gut?
  • Our stomachs produce acid, which acts as a natural barrier to infection, so how can adding more acid help?

Claim: weight loss and management of type 2 diabetes

  • There are plenty of anecdotal claims that apple cider vinegar can aid weight loss, supported by limited evidence from several small studies.
  • Apple cider vinegar is thought to cause weight loss through its effect on delay of gastric emptying.
  • Reduced calorific intake will lead to weight loss – but how are the metabolic effects on blood glucose and lipids mediated?
  • In type 2 diabetes there is a reduction in sensitivity to insulin which in turn leads to a reduced uptake of glucose by cells.

Claim: reduces risk of heart disease

  • Raised blood lipids are a risk factor for cardiovascular diseases such as myocardial infarction and stroke.
  • Well, I’m afraid there’s no scientific evidence that vinegar consumption of any kind reduces cardiovascular morbidity and mortality in those with or without diabetes.

Claim: cancer treatment and prevention

  • One of the more outrageous claims of benefits of daily apple cider vinegar consumption is that it may prevent or treat cancer.
  • A frequently quoted case-control study from China found that an increased consumption of vinegar was associated with a reduced incidence of oesophageal cancer.


Stephen Hughes does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

No, taking drugs like Ozempic isn’t ‘cheating’ at weight loss or the ‘easy way out’

Retrieved on: 
Wednesday, April 10, 2024
Eating, Reward, Diarrhea, Cardiovascular disease, Obesity, Exercise, Therapeutic Goods Administration, Cell, Hunger, Energy, Half-life, Indigestion, Abdominal pain, Gardening, Insulin, Risk, Diabetes, Weight loss, Stroke, Constipation, Research, Food, Meal, Pharmaceutical Benefits Scheme, Diet, Nausea, Gallbladder disease, Dance, Kidney failure, Hypoglycemia, TGA, BMI, Vomiting, Acute pancreatitis, STEP, Pharmaceutical industry

Hundreds of thousands of people worldwide are taking drugs like Ozempic to lose weight.

Key Points: 
  • Hundreds of thousands of people worldwide are taking drugs like Ozempic to lose weight.
  • As demand for semaglutide increases, so are claims that taking it is “cheating” at weight loss or the “easy way out”.
  • We don’t tell people who need statin medication to treat high cholesterol or drugs to manage high blood pressure they’re cheating or taking the easy way out.

How does it work?

  • GLP-1 gets secreted by cells in your gut when it detects increased nutrient levels after eating.
  • GLP-1 receptor agonist (GLP-1RA) medications like Ozempic help the body’s own GLP-1 work better by mimicking and extending its action.
  • Read more:
    The rise of Ozempic: how surprise discoveries and lizard venom led to a new class of weight-loss drugs

What can users expect? What does the research say?

  • Higher doses of semaglutide are prescribed to treat obesity compared to type 2 diabetes management (up to 2.4mg versus 2.0mg weekly).
  • A large group of randomised controlled trials, called STEP trials, all tested weekly 2.4mg semaglutide injections versus different interventions or placebo drugs.
  • Trials lasting 1.3–2 years consistently found weekly 2.4 mg semaglutide injections led to 6–12% greater weight loss compared to placebo or alternative interventions.
  • Weight reduction due to semaglutide also leads to a reduction in systolic and diastolic blood pressure of about 4.8 mmHg and 2.5 mmHg respectively, a reduction in triglyceride levels (a type of blood fat) and improved physical function.
  • Another recent trial in adults with pre-existing heart disease and obesity, but without type 2 diabetes, found adults receiving weekly 2.4mg semaglutide injections had a 20% lower risk of specific cardiovascular events, including having a non-fatal heart attack, a stroke or dying from cardiovascular disease, after three years follow-up.

Who is eligible for semaglutide?

  • Australia’s regulator, the Therapeutic Goods Administration (TGA), has approved semaglutide, sold as Ozempic, for treating type 2 diabetes.
  • The TGA has approved Wegovy to treat obesity but it’s not currently available in Australia.

What else do you need to do during Ozempic treatment?

  • In addition to taking medication, people had brief lifestyle counselling sessions with dietitians or other health professionals every four weeks as a minimum in most trials.
  • The aim of these trials was to show the effect of adding the medication on top of other lifestyle counselling.


A review of obesity medication trials found people reported they needed less cognitive behaviour training to help them stick with the reduced energy intake. This is one aspect where drug treatment may make adherence a little easier. Not feeling as hungry and having environmental food cues “switched off” may mean less support is required for goal-setting, self-monitoring food intake and avoiding things that trigger eating.

But what are the side effects?

  • In on study these led to discontinuation of medication in 6% of people, but interestingly also in 3% of people taking placebos.
  • More severe side-effects included gallbladder disease, acute pancreatitis, hypoglycaemia, acute kidney disease and injection site reactions.
  • Here are some potential risks and benefits

    To reduce risk or severity of side-effects, medication doses are increased very slowly over months.

  • Health, Meat and Livestock Australia, and Greater Charitable Foundation.
  • She has consulted to SHINE Australia, Novo Nordisk, Quality Bakers, the Sax Institute, Dietitians Australia and the ABC.

Biophytis launches OBA phase 2 clinical study in obesity with BIO101 (20-hydroxyecdysone)

Retrieved on: 
Wednesday, April 10, 2024
Notifiable disease, Metabolism, Obesity, Euronext Growth, Skeletal muscle, Patient, Nature Biotechnology, Weight loss, Trial of the century, OBA, Facial muscles, Sarcopenia, Therapy, MAS, Pharmaceutical industry

These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study.

Key Points: 
  • These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study.
  • We believe that our leadership in developing drugs for muscular diseases and promising results obtained in obesity will be a strong accelerator of the OBA clinical plan."
  • The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024.
  • Further information on the OBA program and the clinical study is expected to be provided through the coming weeks.

Current constipation medications don't provide relief for some patients with Chronic Idiopathic Constipation, per Gastroenterologist survey

Retrieved on: 
Tuesday, April 9, 2024
Adverse, Laxative, Gastrointestinal disease, Defecation, Patient, Human, American Journal, Weight loss, Constipation, News, Quality of life, Vibrant consonant, Hope, Invention, FDA

The survey of roughly 100 high-volume gastroenterology providers found that 74 percent of those interviewed are either unsure or positive that the medications they prescribe for patients with chronic constipation are not working.

Key Points: 
  • The survey of roughly 100 high-volume gastroenterology providers found that 74 percent of those interviewed are either unsure or positive that the medications they prescribe for patients with chronic constipation are not working.
  • Disrupting the U.S. $4.6 billion constipation treatment market, Vibrant Gastro’s first-in-class technology offers providers and patients with a new, non-pharmaceutical alternative to address this issue.
  • Patients track the progress of the treatment on their phone with an app to increase compliance, consistency and to monitor results.
  • A study presented at Digestive Disease Week in 2023 found significant symptomatic relief in patients and a substantially improved quality of life.

UMeWorld to Debut the World's First & Only Weight Loss Cooking Oil in the US

Retrieved on: 
Tuesday, April 9, 2024
DAG, Soybean, Weight loss, Leg, Obesity, Insulin resistance, OTC

In order to capitalize on the exclusive license, UMeWorld plans on constructing a state-of-the-art DAG cooking oil pilot plant in Miami Florida which is slated to break ground in 2024.

Key Points: 
  • In order to capitalize on the exclusive license, UMeWorld plans on constructing a state-of-the-art DAG cooking oil pilot plant in Miami Florida which is slated to break ground in 2024.
  • This revolutionary cooking oil not only promises to redefine culinary standards but also promotes healthy living because Diacylglycerol (DAG) oil can actually help people lose weight making DAG the world's only ‘weight loss cooking oil’.
  • DAG oil boasts superior digestibility which ensures minimal fat storage, aligning perfectly with weight loss dietary guidelines established to treat lifestyle diseases such as obesity and insulin resistance.
  • “We’re going after a huge segment of the market with our exclusive DAG weight loss cooking oil and enzymatic refining process.

US Gastroenterologists Project Swift Uptake of Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Retrieved on: 
Friday, April 5, 2024
Launch, Benchmarking, Liver, Patient, Gastroenterology, Weight loss, Market, Pulse, Fibrosis, NASH, FDA, Pharmaceutical industry

As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.

Key Points: 
  • As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.
  • Furthermore, 70% of gastroenterologists in the March 2024 pulse now report they are at least moderately familiar with Rezdiffra, a significant increase compared to April 2023.
  • When discussing the primary benefits of Rezdiffra, gastroenterologists highlight its distinction as the first indicated product for MASH, alongside its prospective efficacy in improving fibrosis.
  • Furthermore, gastroenterologists indicate that over one-third of MASH patients under their care would be suitable candidates for Rezdiffra, further bolstering the likelihood of swift uptake and utilization.

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Tuesday, April 2, 2024
Neutropenia, Prostate cancer, Survival, RECIST, Prostate-specific antigen, Patient, SAN, Neoplasm, MMAE, Weight loss, Publishing, Peripheral neuropathy, University, CD46, Spacecraft, Society, Safety, ASCO, Adenocarcinoma, Fatigue, ADC, PSA, FDA, Fortis, Lead, Food, Pharmaceutical industry

“We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
  • The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
  • These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.