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Vaccines for IBD patients
Dr KK Aggarwal,  18 September 2018
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Morning MEDtalks with Dr KK Aggarwal 18th September 2018

TEDx Video: Doctor-patient relationship:

Daily low-dose aspirin found to have no effect on healthy life span in older people in a large NIH-funded study, which examined outcomes in United States and Australia

Excerpts from NIH: In a large clinical trial to determine the risks and benefits of daily low-dose aspirin in healthy older adults without previous cardiovascular events, aspirin did not prolong healthy, independent living (life free of dementia or persistent physical disability). Risk of dying from a range of causes, including cancer and heart disease, varied and will require further analysis and additional follow-up of study participants. These initial findings from the ASPirin in Reducing Events in the Elderly (ASPREE) trial, partially supported by the National Institutes of Health, were published online on September 16, 2018 in three papers in The New England Journal of Medicine.

ASPREE is an international, randomized, double-blind, placebo-controlled trial that enrolled 19,114 older people (16,703 in Australia and 2,411 in the United States). The study began in 2010 and enrolled participants aged 70 and older; 65 was the minimum age of entry for African-American and Hispanic individuals in the United States because of their higher risk for dementia and cardiovascular disease. At study enrollment, ASPREE participants could not have dementia or a physical disability and had to be free of medical conditions requiring aspirin use. They were followed for an average of 4.7 years to determine outcomes.

“Clinical guidelines note the benefits of aspirin for preventing heart attacks and strokes in persons with vascular conditions such as coronary artery disease,” said NIA Director Richard J. Hodes, M.D. “The concern has been uncertainty about whether aspirin is beneficial for otherwise healthy older people without those conditions. This study shows why it is so important to conduct this type of research, so that we can gain a fuller picture of aspirin’s benefits and risks among healthy older persons.”

In the total study population, treatment with 100 mg of low-dose aspirin per day did not affect survival free of dementia or disability. Among the people randomly assigned to take aspirin, 90.3 percent remained alive at the end of the treatment without persistent physical disability or dementia, compared with 90.5 percent of those taking a placebo. Rates of physical disability were similar, and rates of dementia were almost identical in both groups.

The group taking aspirin had an increased risk of death compared to the placebo group: 5.9 percent of participants taking aspirin and 5.2 percent taking placebo died during the study. This effect of aspirin has not been noted in previous studies; and caution is needed in interpreting this finding. The higher death rate in the aspirin-treated group was due primarily to a higher rate of cancer deaths. A small increase in new cancer cases was reported in the group taking aspirin but the difference could have been due to chance.

The researchers also analyzed the ASPREE results to determine whether cardiovascular events took place. They found that the rates for major cardiovascular events—including coronary heart disease, nonfatal heart attacks, and fatal and nonfatal ischemic stroke—were similar in the aspirin and the placebo groups. In the aspirin group, 448 people experienced cardiovascular events, compared with 474 people in the placebo group.

Significant bleeding—a known risk of regular aspirin use—was also measured. The investigators noted that aspirin was associated with a significantly increased risk of bleeding, primarily in the gastrointestinal tract and brain. Clinically significant bleeding—hemorrhagic stroke, bleeding in the brain, gastrointestinal hemorrhages or hemorrhages at other sites that required transfusion or hospitalization—occurred in 361 people (3.8 percent) on aspirin and in 265 (2.7 percent) taking the placebo.

As would be expected in an older adult population, cancer was a common cause of death, and 50 percent of the people who died in the trial had some type of cancer. Heart disease and stroke accounted for 19 percent of the deaths and major bleeding for 5%.

CMAAO PENANG RESOLUTION on Universal Health Coverage

The right to health is now generally recognised as a fundamental Human Right by most countries. The Sustainable Development Goal, SDG 3 mandates governments to “ensure healthy lives and promote well-being for all at all stages”.

Universal health coverage (UHC) means that all people and communities can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship. (WHO)

The basis of a universal health coverage is primary health care ideally provided by team of health professionals and health care workers led by a family physician with the health needs of their patients and communities at the centre. This team should be supported by other specialists and provides access to secondary and tertiary care as well as technical and social services.

The funding of such a system can be provided by different means; including tax financing, private or social insurance or health savings accounts, out of pocket expenses or combinations of the above.

Role of governments

Governments should act on the Social Determinants of Health, by enabling a healthy start into life, decent living conditions, quality education, safe and healthy environments including access to healthy nutrition and safe workplaces and transportation.

Regardless of the methodology chosen, the government should ensure that the patients can access timely, competent and quality health care services whenever they need it and without any financial hardship.

The access to health care includes the coverage of essential diagnostics, medications and devices; access to rehabilitation and palliation. The patient should have freedom of choice in the access, especially when it comes to selecting the primary care physician.

While the financing mechanisms may between nations and over time, the government should ensure that a transparent health system is always in place. Such system must cover every member of society and must not discriminate against those with congenital or pre-existing conditions.

Payments and/or reimbursements to health institutions, health professionals and health care workers, must be fair and appropriate.

While disease patterns change from acute episodic illnesses to chronic processes, health care systems must not fall from one silo-structure to another. Universal Health Coverage requires a universal or holistic approach to patients understanding them as persons in their families, groups and communities.

Thus, the role of the physicians extends to be an advocate for healthy living conditions, healthy lifestyles and wellness of all members of the communities. Attentions should be directed to the Social Determinants of Health as well as to identifiable causes of illness, injury and disease; and to general health promotion, health education and specific prevention.

Role of NMAs

NMAs should promote Universal Health Coverage by explaining to their physicians the benefit of UHC for their patients and communities and to encourage the leadership role their physicians should take to make this possible.

NMAs should analyse current and foreseeable health demands of the people and thereafter target appropriate educational programs for health professionals on prevention, health promotion and nutrition.

NMAs should reach out to politicians, the media and other influencers to advocate for Universal Health Care and to explain that expenditure for health care is not just a cost, but an investment in the future of every society.

The hip implant class action law suit against the pharma major Johnson and Johnson in the US, began in 2011. Two years later, in 2013, the firm agreed to pay an estimated $2.5 billion to settle thousands of lawsuits from affected patients. A petition has been filed by 52-year-old Jyoti Sharma, who moved the National Consumer Disputes Redressal Commission (NCDRC) in 2016 suing Johnson & Johnson for Rs 2 crore in damages. Sharma underwent a hip replacement surgery in New Delhi in September 2006. She claims she visited the hospital on multiple occasions complaining of pain but wasn’t informed about the global recall.

Early 2011, when her doctor advised her to undergo tests to determine the cobalt-chromium level in the blood, they found that her cobalt levels were as high as 3.69 (the normal range is between 0.08 and 0.09). She says she was first informed of the global recall in March 2012 after which, in June 2012, her implant was removed and she underwent a revision hip replacement surgery. When the pain persisted, she moved court.

Continuous calorie restriction group: 1200 to 1500 kcal a day (30% protein, 45% carbohydrate, and 25% fat), for a total of 10,300 kcal a week.

Intermittent-fasting group: 500 to 600 kcal a day (including a minimum of 50 g of protein) on two consecutive or non-consecutive days of the week, and to consume their usual diet on the other 5 days, for a total of 11,500 kcal a week.

Levels of immunosuppression associated with IBD treatment regimens

  1. Low-level immunosuppression: Lower daily doses of corticosteroids than those in high-level immunosuppression for more than 14 days
  1. Methotrexate (0.4 mg/kg/week), azathioprine (<3.0 mg/kg/day), or mercaptopurine (<1.5 mg/kg/day)

   2. High-Level Immunosuppression

  1. Glucocorticoids (prednisone >20 mg/day for at least 2 weeks and within 3 months of stopping therapy)
  2. 6-mercaptopurine, azathioprine, or methotrexate at doses higher than those associated with low-level immunosuppression or discontinuation within 3 months
  3. Adalimumab, certolizumab pegol, golimumab, infliximab, natalizumab, or vedolizumab, or discontinuation within 3 months

अनशनमायुषो ह्रासकराणां, प्रमिताशनं कर्शनीयानाम्, अजीर्णाध्यशनं ग्रहणीदूषणानां, विरुद्धवीर्याशनं निन्दितव्याधिकराणां: It is said that: Not eating or long fasting reduces life span, eating less causes emaciation, eating when the previous meal is not digested causes diseases of duodenum and eating foods with opposite potencies may cause obesity, diabetes, skin diseases etc.

Inactivated vaccines for patients with inflammatory bowel disease

  1. Influenza: All patients with IBD should be vaccinated seasonally with the intramuscular/intradermal inactivated influenza vaccine prior to starting immunosuppressive therapy.
  2. Pneumococcal pneumonia: All patients with IBD should be vaccinated once with the PCV13 followed by the PPSV23 (first dose after 8 weeks if immunocompromised, or after ≥1 year if immunocompetent; second dose after 5 years; and third dose after 65 years of age). If previously vaccinated with the PPSV23, then the PCV13 should be administered at least 1 year after the PPSV23 in both immunocompromised and immunocompetent adults.
  3. Hepatitis A: Check hepatitis A immune status at the patient’s initial visit. If nonimmune to hepatitis A, vaccinate the patient with a 2-dose series (0 months and 6-12 months).
  4. Hepatitis B: Check hepatitis B immune status at the patient’s initial visit. If nonimmune to hepatitis B, vaccinate the patient with a 3-dose series (0 months, and 1 and 6 months after first dose) and recheck titers 1 to 2 months after last vaccination. If the patient remains nonimmune, offer booster with a double dose of hepatitis B vaccine or offer combined hepatitis A/B vaccination.
  5. Human papilloma virus: All male and female IBD patients between the ages of 11 and 26 years should be vaccinated with the human papilloma virus vaccine.
  6. Meningococcal disease: Patients with IBD should be vaccinated with the meningococcal vaccine according to standard ACIP recommendations for the general population.
  7. Tetanus, diphtheria, and pertussis: All patients with IBD should be vaccinated with Td every 10 years. TDap should be substituted once for the Td vaccine to provide additional coverage for pertussis.

Live vaccinations for patients with IBD

  1. Measles, mumps, rubella (MMR): Vaccinate all nonimmune patients with the MMR vaccine as long as they have not been on immunosuppressive therapy within the previous 3 months and there are no plans to start immunosuppressive therapy within the next 6 weeks.
  2. Varicella zoster: Vaccinate all nonimmune patients with the varicella zoster vaccine as long as they have not been on immunosuppressive therapy within the previous 3 months and there are no plans to start immunosuppressive therapy within the next 6 weeks.
  3. Herpes zoster: Vaccinate all patients over the age of 60 years with the herpes zoster vaccine. Vaccination is safe in patients on low-dose immunosuppression but contraindicated in patients on biologic therapy or on corticosteroids. Do not vaccinate patients on high-dose immunosuppressive therapy within the past 3 months or who plan to start high-dose immunosuppressive therapy within the next 6 weeks.

Dr KK Aggarwal

Padma Shri Awardee

President Elect CMAAO

President HCFI


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