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A growing body of research shows that exposure to air pollution, especially during pregnancy and childhood, may have a negative impact on brain development. Now a study led by the Barcelona Institute for Global Health (ISGlobal), a centre supported by the “la Caixa” Foundation, has found that exposure to nitrogen dioxide (NO2) during the first two years of life is associated with poorer attention capacity in children aged 4 to 8, especially in boys. NO2 is a pollutant that comes mainly from traffic emissions.

The study, published in Environment International, shows that higher exposure to NO2 was associated with poorer attentional function in 4- to 6-year-olds, with increased susceptibility to this pollutant observed in the second year of life. This association persisted at an age of 6 to 8 years of age only in boys, with a slightly greater susceptibility period from birth to 2 years of age.

The researchers used data from 1,703 women and their children from the INMA Project birth cohorts in four Spanish regions. Using the home address, the researchers estimated daily residential exposure to NO2 during pregnancy and the first 6 years of childhood. In parallel, they assessed the attentional function (the ability to choose what to pay attention to and what to ignore) at 4-6 years and 6-8 years, and working memory (the ability to temporarily hold information) at 6-8 years, using validated computerised tests.

Periods of higher susceptibility to air pollution

A previous INMA study reported that exposure to NO2 during pregnancy and childhood was associated with impaired attentional function in children at 4-5 years of age. The present study found that:

• Higher exposure to NO2 between 1.3 and 1.6 years of age was associated with higher hit reaction time standard error, an indicator of speed consistency, in the attentional function test at 4–6 years of age.
• Higher exposure to NO2 between 1.5 and 2.2 years of age was associated with more omission errors.
• Higher exposure to NO2 between 0.3 and 2.2 years was associated with higher hit reaction time standard error at 6–8 years only in boys.
• No associations were found between higher exposure to NO2 and working memory in children aged 6 to 8 years.

“These findings underline the potential impact of increased traffic-related air pollution on delayed development of attentional capacity and highlight the importance of further research into the long-term effects of air pollution in older age groups”, explains Anne-Claire Binter, last author of the study and postdoctoral researcher at ISGlobal.

As the brain matures

Attentional function is crucial for the development of the brain’s executive functions, which manage and control actions, thoughts and emotions to achieve a goal or purpose. “The prefrontal cortex, a part of the brain responsible for executive functions, develops slowly and it is still maturing during pregnancy and childhood,” adds Binter. This makes it vulnerable to exposure to air pollution, which has been linked in animal studies to inflammation, oxidative stress, and impaired energy metabolism in the brain.

“In boys, the association between exposure to N02 and attentional function may last longer because their brains mature more slowly, which could make them more vulnerable”, she points out. To understand this better, future studies should follow people over time to see how age and gender affect the relationship between air pollution and attention span, especially in older age groups.

In conclusion, “this study suggests that early childhood, up to the age of 2, seems to be a relevant period for implementing preventive measures,” says Binter. “Even a small effect at the individual level from relatively low levels of exposure, as in this study, can have large consequences at the population level. Exposure to traffic-related air pollution is therefore a determinant of the health of future generations.”

Reference:

Kellie L.H.A. Crooijmans, Carmen Iñiguez, Kristina W. Withworth, Marisa Estarlich, Aitana Lertxundi, Ana Fernández-Somoano, Adonina Tardón, Jesús Ibarluzea, Jordi Sunyer, Mònica Guxens, Anne-Claire Binter, Nitrogen dioxide exposure, attentional function, and working memory in children from 4 to 8 years: Periods of susceptibility from pregnancy to childhood, Environment International, https://doi.org/10.1016/j.envint.2024.108604.

Tirzepatide significantly reduced the apnea-hypopnea index (AHI) relative to placebo therapy—paving the way for the company to submit a mid-year application for approval in moderate-to-severe OSA and obesity.

Tirzepatide is the only approved GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) treatment for chronic weight management, commercialized as Zepbound in the U.S. and Mounjaro in some global markets outside the U.S.

A combination of 2 studies investigating tirzepatide in adults with OSA, results indicate tirzepatide use reduced AHI in patients with OSA, with this benefit observed regardless of positive airway pressure (PAP) therapy. Further analysis of both studies showed that tirzepatide provided benefits for secondary outcomes, including mean AHI percentage reduction and body weight reduction from baseline to week 52.

“OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated,” Jeff Emmick, senior vice president of product development at Lilly, said in a press release.

“Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease.”

SURMOUNT-OSA Study 1 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were not on positive airway pressure (PAP) therapy for 52 weeks.

For the efficacy estimands, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to a mean AHI reduction from baseline of 4.8 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 55.0% compared to 5.0% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.

SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on and planned to continue to use PAP therapy for 52 weeks.

In this population for the efficacy estimand, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction from baseline of 6.0 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 62.8% compared to 6.4% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 20.1% from baseline, compared to 2.3% from baseline for placebo.

The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20% in a patient population comprising approximately 70% males, who are known to achieve less weight loss with incretin therapy than females.

New Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by Akums Drugs and Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to modify inclusion criteria by reducing the Prostate-Specific Antigen (PSA) level to less than 4 and to include more geographically distributed sites.

In addition to the above, the expert panel suggested that PSA should be done at baseline and at the end of the study after 3 months. Furthermore, the committee advised to include more geographically distributed sites so that there should be 50% each from government and private sites.

This came after Akums Drugs and Pharmaceuticals presented the active post-marketing surveillance (PMS) protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 09.12.2022.

Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate gland to grow. Dutasteride will cause the size of the prostate to decrease, but the effect lasts only as long as the medicine is taken.

Silodosin is in a class of medications called alpha-blockers. It relieves the symptoms of BPH by relaxing the muscles of the bladder and prostate. Silodosin is used to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder.

At the recent SEC meeting for Urology held on 27th March 2024, the expert panel reviewed the active PMS protocol of the Dutasteride plus Silodosin (0.5mg/0.5mg + 4mg/8mg) uncoated bilayered tablet.

After detailed deliberation, the committee opined the following modification:

1. Inclusion criteria should be modified by reducing the PSA level to less than 4.

2. PSA should be done at baseline and at the end of the study after 3 months.

3. More sites to be included which should be geographically distributed so that there should be 50% each from Government and Private sites.

Accordingly, the expert panel stated that a revised Active PMS protocol should be submitted to CDSCO for further review by the committee.

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