Midlife Vitamin D Levels Linked to Later Tau-PET Deposition

 I just exited midlife at age 70, so my stuff is already baked in. But then I have way more than 16 years to go, so maybe still time.

Midlife Vitamin D Levels Linked to Later Tau-PET Deposition

 Higher circulating vitamin D levels in early midlife are associated with lower tau deposition on brain positron emission tomography (PET) imaging in later midlife among adults without dementia, according to a study published in Neurology Open Access. In a prospective cohort study of adults without dementia from the Framingham Heart Study Generation 3 cohort, researchers evaluated whether serum 25-hydroxyvitamin D measured in early midlife is associated with later tau and amyloid burden on brain PET imaging.Serum 25-hydroxyvitamin D levels were assessed at examination cycle 1 between 2002 and 2005. Participants subsequently underwent amyloid PET and/or tau PET imaging between 2016 and 2019. [H]igher vitamin D levels in midlife may offer protection against pathologic tau deposition in the brain, while low vitamin D may represent a potentially modifiable risk factor for healthy middle-aged individuals seeking to reduce dementia risk. A total of 793 participants were included, of whom 53% were women, and the mean [SD] age was 39 [8] years. Of the participants, 424 underwent amyloid PET imaging, and 369 underwent tau PET. The mean (SD) interval between vitamin D measurement and PET imaging was 16.2 (2.4) years. Outcomes included global and composite tau-PET burden and amyloid-PET burden. In fully adjusted models, higher serum 25-hydroxyvitamin D levels were associated with lower global tau-PET burden (β=−0.022; 95% CI, −0.040 to −0.004;P=.010) and lower composite tau-PET burden (β=−0.023; 95% CI, −0.043 to −0.003;P=.016). In contrast, serum 25-hydroxyvitamin D levels were not associated with amyloid-PET burden (β=0.001; 95% CI, −0.024 to 0.024;P=.987). When analyzed using a clinical cutoff (<30 vs ≥30 ng/mL), serum 25-hydroxyvitamin D levels were not significantly associated with tau or amyloid PET outcomes in fully adjusted models. Baseline mean (SD) serum 25-hydroxyvitamin D level was 38 (15) ng/mL, with 34% of participants below 30 ng/mL. Sensitivity analyses excluding individuals taking vitamin D supplements yielded similar findings, with persistent associations between higher serum 25-hydroxyvitamin D and lower tau burden. Study limitations include a lack of repeated vitamin D measurements over time, and the long interval between vitamin D assessment and PET imaging, which may introduce exposure misclassification. This study suggests that higher vitamin D levels in midlife may offer protection against pathologic tau deposition in the brain, while low vitamin D may represent a potentially modifiable risk factor for healthy middle-aged individuals seeking to reduce dementia risk,” concluded the authors.

“Yes, And…” Might Be the Smartest Thing You Say All Week by Super Age

 I normally say yes to most suggested activities. As a friend once commented when he asked me if I wanted to join a trip to Madagascar; 'Dean waited a half second before saying yes'. I'm always up for new experiences. I need as much cognitive reserve as possible since I think I used most of mine up just surviving the stroke. Not quite the improvisation this article recommends but I think similar enough.

“Yes, And…” Might Be the Smartest Thing You Say All Week

Researchers Develop Wearable Sensor to Monitor Vitamin Levels Through Sweat

 How soon will your competent? doctor get this installed on you to verify correct levels? Oh NO, your doctor doesn't know about it!

Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING? Your choice; let them be incompetent or demand action!

Researchers Develop Wearable Sensor to Monitor Vitamin Levels Through Sweat

What Happens To Your Immune System After One Sauna Session by mindbodygreen

 

I'm just got a personal sauna from NuRecover but will use a cold shower instead of a chiller bucket for the cold shock proteins. Still to be put together.

What Happens To Your Immune System After One Sauna Session

 There’s a reason sauna use keeps showing up in longevity research. Regular exposure has been associated with lower risks of cardiovascular disease¹ ,respiratory illness²,dementia³, and even overall mortality⁴ .But those outcomes don’t tell us much about the immediate effects. What actually changes in the body during a single session? And how quickly do those changes happen? A new study⁵set out to answer that by tracking immune responses before, during, and after a 30-minute sauna session, offering a closer look at the body’s short-term reaction to heat. 

What happens to your immune system during a 30-minute sauna

Researchers studied 51 adults, both men and women, during a standard Finnish sauna session set to about 73°C (roughly 163°F). Each participant spent 30 minutes in the sauna, with blood samples taken before, immediately after, and 30 minutes post-session. The goal was to track how immune cells and inflammatory signals changed in response to heat stress. Participants were allowed to drink water throughout, which helped control for dehydration and made the setup closer to a typical real-world sauna experience. Instead of just looking at overall immune activity, the researchers zoomed in on specific white blood cells and a wide range of cytokines, which are signaling molecules involved in inflammation and immune response. This gave a more detailed picture of how the body reacts in the short term. 

Sauna’s immediate effect on immune cells

The biggest shift came down to your white blood cells, which are a key part of your immune system. After the sauna session, those levels went up, including important types like neutrophils and lymphocytes. These are the cells that help your body spot and respond to anything that doesn’t belong, whether that’s a virus or another kind of threat. What stands out is how quickly this happens. The increase shows up right after the sauna, then goes back down within about 30 minutes. So this isn’t a long-lasting spike; it’s more like a short window where your immune system is a bit more alert. This pattern mirrors what happens during exercise. When you work out, immune cells move out of tissues and into your bloodstream, where they’re more ready to respond if needed. A sauna seems to trigger a comparable response, just through heat instead of movement. 

What about inflammation & body temperature?

One thing the researchers looked at closely was inflammation, since that’s often what people think of when they hear the body is under “stress.” But in this case, there weren’t big changes across most inflammatory markers. Out of dozens of signals they measured, only a few shifted in a meaningful way. That suggests your body isn’t going into a full inflammatory response during a sauna. Instead, the response seems more about mobilization than inflammation. Your immune cells are being redistributed and activated, not necessarily pushed into an inflammatory state. Body temperature did play a role, though. On average, people’s temperature rose by about 2°C (roughly 3.6°F) during the session. And the more it increased, the more certain immune-related signals shifted alongside it. 

Adding sauna use to your routine

 So what does this mean for your day-to-day routine? It doesn’t mean a single sauna session will prevent illness or replace other foundational habits. But it does suggest that sauna use can act as a short-term stimulus for your immune system, similar to a workout.If you already use a sauna, this adds another layer of context. That post-sauna feeling isn’t just relaxation. Your body is actively responding, mobilizing immune cells in a way that may support overall immune surveillance over time. 

If you’re considering adding it in, consistency matters more than intensity. This study looked at one session, but previous research has linked regular sauna use to broader health benefits, including a lower risk of certain chronic conditions.

It’s also worth paying attention to how you personally respond. Hydration, heat tolerance, and recovery all play a role in how beneficial the experience feels.

The takeaway

This study doesn’t suggest that sauna use is a cure-all. But it does offer a clearer picture of what’s happening in the body during a session. Your immune system isn’t passive in that environment. It’s responding, adapting, and briefly shifting into a more active state.

Efficacy of radial shock wave therapy for ankle spasticity in patients with stroke within 3 months of onset: a prospective quasi-experimental study

So, still a failure; no cure for spasticity. The goal is to cure spasticity, not just reduce it.

When you are the 1 in 4 per WHO that has a stroke with spasticity, you'll want your spasticity cured. You better start solving that now.

Since you are using a subjective measurement scale(Modified Ashworth Scale) nothing here inspires any sort of confidence. In fact I would assume that the participants are using the Hawthorne effect to please the researchers. 

Efficacy of radial shock wave therapy for ankle spasticity in patients with stroke within 3 months of onset: a prospective quasi-experimental study

• Yuichi Hiramatsu,
• Hajime Yagura,
• Hiroaki Fujimoto,
• Megumi Hatakenaka,
• Teiji Kawano,
• Shota Segawa,
• Makiko Rai,
• Ryutaro Hayashi,
• Akihiko Nakae,
• Haruka Asano,
• Takuya Ogawa &
• Ichiro Miyai 

We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Abstract

Background

Extracorporeal shock wave therapy (ESWT) is widely used to reduce poststroke spasticity (PSS). However, limited evidence exists regarding its efficacy in patients with stroke within 3 months of onset. Therefore, this study aimed to investigate the association between ESWT administered 1 to 3 months after stroke and changes in spasticity and joint mobility in patients with PSS.

Methods

Prospective quasi-experimental study. Fifty-two patients with PSS affecting the ankle joint were enrolled from March 2023 to March 2025, and allocated into three groups based on the time elapsed from stroke onset: 1, 2, or 3 months. All patients underwent radial ESWT to the gastrocnemius and soleus muscles once weekly for 3 consecutive weeks. Spasticity and joint mobility were evaluated using the Modified Ashworth Scale (MAS) and passive range of motion (PROM) measurements before and after each session, and at 1 and 5 weeks post-treatment.

Results

Except for the MAS score obtained after the first session, significant immediate reductions in the MAS scores and PROM measurements were observed after all shock wave therapy sessions. Compared to baseline, cumulative changes were greatest after the third session, with a mean reduction of 0.6 points in the MAS score and a 6.4° increase in the PROM. These changes were maintained for 5 weeks. No serious adverse events related to shock wave therapy were reported.

Conclusions

ESWT during the early subacute stage was associated with improvements(NOT GOOD ENOUGH!) in spasticity and joint mobility in patients with PSS. Repeated sessions showed greater cumulative changes compared with a single session.

Trial registration UMIN-CTR000050477.

Watch: Can making movement ‘worse’ actually speed up recovery after stroke?

 Well, gee, that knowledge has been out there a while. Is your doctor incompetent in not knowing about this? Getting close to nine years and your doctor hasn't been fired for incompetency yet? I guess the board of directors is so incompetent they have no standards for staff!

• error-based learning (8 posts to November 2017)

Watch: Can making movement ‘worse’ actually speed up recovery after stroke?

Here, we speak to Eyal Samuel Shachar, CEO of BioXtreme, about the company’s counterintuitive approach to neurorehabilitation: using error augmentation in robotics to help stroke and other neurological injury patients recover faster.

Watch the exclusive interview now on YouTube or listen on your chosen podcast platform.

Hemiparesis Patterns Help Explain Heterogeneous Gait Asymmetries in People Post-Stroke

 This doesn't help survivors recover since NO recovery protocols were created! In case you didn't know, stroke research should get survivors recovered!

Hemiparesis Patterns Help Explain Heterogeneous Gait Asymmetries in People Post-Stroke

Presenter Information

• Dhivya Dharshne Kamaraj,, Illinois math and

Session Number

2

Advisor(s)

Russell T. Johnson, Department of Physical Medicine and Rehabilitation Northwestern University

Location

A121

Discipline

Medical and Health Sciences

Start Date

15-4-2026 11:10 AM

End Date

15-4-2026 11:55 AM

Abstract

A stroke can damage the brain and cause hemiparesis, which is weakness on one side of the body. Many people with hemiparesis have difficulty walking. Their steps may be uneven, slower, and require more energy than typical walking due to muscle weakness, reduced coordination, and altered neural control. Testing every possible treatment directly on patients is difficult, so computer simulations provide another way to study possible treatments options. Here, we use OpenSim, a musculoskeletal modeling program, and Moco, an optimization tool, to simulate walking in people with post-stroke hemiparesis. This toolbox allows us to isolate the effect of muscle weakness from other types of impairment common after a stroke to predict gait changes. Using MATLAB, I analyzed simulations based on muscle group data and weakness from a prior study of nine participants with post-stroke hemiparesis. I compared three conditions: without intervention, with an ankle strengthening intervention, and with a rigid ankle-foot orthosis (AFO). Step time and step length asymmetries and metabolic cost results were computed and compared to assess differences between simulated interventions. These results help us understand how different types of therapeutic interventions can improve gait in people with post-stroke and provide a basis for personalized rehabilitation

Measuring arm function early after stroke: is the DASH good enough?

Look at it yourself, you can see it has no objectivity at all and nothing that could generate an EXACT RECOVERY PROTOCOL! In my opinion; TOTALLY WORTHLESS!

Free online DASH score calculator

You need to determine which of these nine options is causing your problems.

The exact same deficit could have 9 causes.

See this example of nine reasons for a movement disability:

 

You can't tell me these all have the same solution, I'm not that stupid.
1. Penumbra damage to the motor cortex.
2. Dead brain in the motor cortex.
3. Penumbra damage in the pre-motor cortex.
4. Dead brain in the pre-motor cortex.
5. Penumbra damage in the executive control area.
6. Dead brain in the executive control area.
7. Penumbra damage in the white matter underlying any of these three.
8. Dead brain in the white matter underlying any of these three.
9. Spasticity preventing movement from occurring.

The latest here: 

 Measuring arm function early after stroke: is the DASH good enough?

Karen Baker1, 

Louise Barrett2, 

E Diane Playford1, 

Trefor Aspden3, 

Afsane Riazi3, 

Jeremy Hobart2

1. Correspondence to Professor Jeremy Hobart, Clinical Neurology Research Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Room N13 ITTC Building, Plymouth Science Park, Derriford, Plymouth PL6 8BX, UK; jeremy.hobart@plymouth.ac.uk

Abstract

Objective Despite a growing call to use patient-reported outcomes in clinical research, few are available for measuring upper limb function post-stroke. We examined the Disabilities of the Arm, Shoulder and Hand (DASH) to evaluate its measurement performance in acute stroke. In doing so, we compared results from traditional and modern psychometric methods.

Methods 172 people with acute stroke completed the DASH. Those with upper limb impairments completed the DASH again at 6 weeks (n=99). Data (n=271) were analysed using two psychometric paradigms: traditional psychometric (Classical Test Theory, CTT) analyses examined data completeness, scaling assumptions, targeting, reliability and responsiveness; Rasch Measurement Theory (RMT) analyses examined scale-to-sample targeting, scale performance and person measurement.

Results CTT analyses implied the DASH was psychometrically robust in this sample. Data completeness was high, criteria for scaling assumptions were satisfied (item-total correlations 0.55–0.95), targeting was good, internal consistency reliability was high (Cronbach's α=0.99) and responsiveness was clinically moderate (effect size=0.51). However, RMT analyses identified important limitations: scale-to-sample targeting was suboptimal, 4 items had disordered response category thresholds, 16 items exhibited misfit, 3 pairs of items had high residual correlations (>0.60) and 84 person fit residuals exceeded the recommended range.

Conclusions RMT methods identified limitations missed by CTT and indicate areas for improvement of the DASH as an upper limb measure for acute stroke. Findings, similar to those identified in multiple sclerosis, highlight the need for scales to have strong conceptual underpinnings, with their development and modification guided by sophisticated psychometric methods.

https://doi.org/10.1136/jnnp-2015-310557

Study uncovers a downside of Medicare Advantage plans for stroke patients

Be careful out there. Luckily I didn't fall for the advertising.

Study uncovers a downside of Medicare Advantage plans for stroke patients

Medicare Advantage plans have a lot of appeal compared to Original Medicare since they tend to offer more perks and coverage. But those plans may not be all they’re cracked up to be when it comes to patients recovering from stroke.A recent study suggests that stroke patients enrolled in Medicare Advantage plans might get lower-quality post-acute care than those with Original Medicare. That gap seems to widen for patients who also qualify for Medicaid.

The research, published in JAMA Network Open, analyzed national data from more than 44,000 Medicare beneficiaries ages 65 and older who were hospitalized for stroke.

Researchers examined patients discharged to inpatient rehabilitation facilities, skilled nursing facilities or home health agencies. They measured quality using the five-star rating systems from the Centers for Medicare and Medicaid Services (CMS).

Medicare Advantage versus Original Medicare

Medicare Advantage is one of the two main types of Medicare. The other is Original Medicare, aka traditional Medicare.

Original Medicare is offered directly by the federal government, while private insurers that contract with the government offer Medicare Advantage plans.

Medicare Advantage plans must cover the same services that Original Medicare covers but also can cover other expenses as well. So, Medicare Advantage plans can differ vastly when it comes to coverage and costs — and thus customer satisfaction.Medicaid is a joint federal and state program that provides health coverage for those with low incomes.

A difference in care

A stroke can dramatically alter a person’s cognitive and physical abilities. That’s why quality rehab care is so critical — for both recovering from a stroke and reducing the risk of another stroke.

Amol Karmarkar, a professor at VCU School of Medicine’s Department of Physical Medicine and Rehabilitation and one of the study’s lead researchers, explains in a summary of the findings:

“Having access to high-quality post-acute care is vital for functional recovery and positive health outcomes for stroke patients, so that they can return to their lives and communities.”

According to the study, among patients who weren’t eligible for Medicaid, those with Medicare Advantage plans were less likely to receive care from highly rated facilities than Original Medicare enrollees:

• Skilled nursing facilities: 53% of Medicare Advantage patients went to highly rated facilities, compared to 58% with Original Medicare
• Home health agencies: 19% of Medicare Advantage patients used highly rated agencies, compared to 22% with Original Medicare

The disparities were more pronounced for “dual-eligible” patients (those on both Medicare and Medicaid), who tend to have higher stroke severity and greater health care needs. Here’s what the study found for skilled nursing facilities:Only 42% of dual-eligible Medicare Advantage patients received highly rated care

• Only 44% of dual-eligible Original Medicare patients received highly rated care

Researchers found no statistical difference in care quality for patients discharged to inpatient rehabilitation facilities.

Read Next: 9 Ways to Take Care of Your Pennies so Your Dollars Take Care of Themselves

What’s driving the gap?

Researchers point to several potential factors. Medicare Advantage plans often use narrow provider networks to keep costs down, which could limit patient access to more highly rated facilities. Geography may also play a role if higher-rated facilities are farther from where patients live.Another issue is that many patients, caregivers and providers simply aren’t aware of CMS’ quality rating tools.

“[U]nderstanding these publicly available rating systems is critical because the quality of post-acute care services may ultimately influence a patient’s short-term experience and long-term recovery patterns,” Karmarkar noted.

The bigger picture for Medicare enrollees

Medicare Advantage plans now cover more than half of all Medicare-eligible beneficiaries. Nearly 35.5 million people were enrolled as of Feb. 1. These plans often appeal to seniors with lower premiums, reduced copays and extra benefits.

Unlike Original Medicare, however, they typically require prior authorization for services and restrict enrollees to specific networks of doctors, hospitals and rehab facilities.

For anyone weighing Medicare options, particularly those with health conditions that could increase stroke risk, this research suggests it’s worth investigating what falls within a plan’s network before enrolling.

Taking the time to check the quality ratings of in-network facilities now could make a significant difference in your recovery options later.

Learn more about what to expect from Medicare coverage in “Retirees, Beware: Medicare Will Not Cover These 11 Medical Costs” and “Many People on Medicare Advantage Are Losing Out Because of This Mistake.”

The Most Dangerous Words in Medicine: ‘Your Labs Are Normal’ by Super Age

 In case you really want to get into the weeds with your doctor and tell them what to do. 

The Most Dangerous Words in Medicine: ‘Your Labs Are Normal’

Effect of repeated hot water immersion on cognitive performance, cerebrovascular function, sleep and biomarkers of neurodegeneration in older adults

 Ask your competent? doctor if saunas are better than this. And when EXACTLY THEY WILL GET TESTING GOING IN STROKE SUBJECTS!

Effect of repeated hot water immersion on cognitive performance, cerebrovascular function, sleep and biomarkers of neurodegeneration in older adults

Daniel D. Piccolo, Jo Corbett, Thomas B. Williams, Thomas J. James, Janis K. Shute, Mohammad G. A. Alnajjar, Luke C. Hudson, Poppy A. Marsh, Veronika Praskacova See all authorsFirst published:

29 April 2026 

https://doi.org/10.1113/EP093500Digital Object Identifier (DOI)

 

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Handling Editor: Toby Mundel

Funding information:

The authors gratefully acknowledge funding by SPATEX and the British and Irish Spa and Hot Tub Association (BISHTA) Grant Number: 00229288; and the Ceperich Educational Trust.

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Abstract

Ageing is associated with cognitive decline and increased risk of developing neurodegenerative disease. Repeated passive heating, using hot water immersion (HWI), may improve cognitive performance via improved cerebral oxygenation, but this is yet to be examined in older adults. Twelve healthy older adults (aged: 69.2 ± 10.0 years; body mass index: 25.2 ± 4.1 kg m−2) completed a 6-week pre–post intervention study consisting of two to three weekly 1 h HWIs in 40°C water. Rectal temperature was maintained in a target range of 38.5–39.0°C during HWI. Cognitive performance (working memory via 1 and 2-back, inhibition via 2-choice reaction time, logical reasoning via logical relations) and cerebral oxygenation (Δoxyhaemoglobin, Δdeoxyhaemoglobin, Δtotal haemoglobin and Δtissue saturation index) were assessed during the first and final HWI sessions (pre-, immediately post- and 3 h post-HWI). Common carotid artery blood flow (CCA-BF), sleep quality (7-day baseline and final week), plasma [amyloid-β] 42 (Aβ42), and [phosphorylated tau] (p-tau), were measured pre- and post-intervention. Repeated HWI improved 1-back (P = 0.023) and logical reasoning (P = 0.002) performance, but not 2-back or 2-choice reaction time (P > 0.05). Cerebral oxygenation was acutely reduced immediately post-HWI (all parameters P < 0.05), but returned to baseline 3 h post-HWI, with no chronic adaptation. CCA-BF, sleep quality, [Aβ42] and [p-tau] all remained unchanged at 6 weeks (P > 0.05). Repeated HWI improves cognitive domains of logical reasoning and working memory without altering cerebral oxygenation, CCA-BF, sleep or neurodegenerative biomarkers. Further investigation into the underlying mechanisms for cognitive performance improvements via HWI is warranted.

ageing, exercise mimetic, passive heat therapy, working memory

Highlights

• What is the central question of this study?

  Can 6 weeks of hot water immersion improve cognitive performance, cerebrovascular function, sleep and neurodegenerative biomarkers in healthy older adults?

• What is the main finding and its importance?

  Six weeks of two to three hot water immersions per week improved working memory and logical reasoning in healthy older adults, but did not alter common carotid artery blood flow or oxygenation, sleep, or neurodegenerative biomarkers. The results suggest that hot water immersion may offer a simple, non-pharmacological, therapeutic approach to support cognitive performance in older adults, though mechanisms remain to be clarified.

Spicy food consumption and risk of vascular disease: Evidence from a large-scale Chinese prospective cohort of 0.5 million people

Your competent? doctor already had you consuming this Szechuan pepper (March 2020)that sends the equivalent of 50 light taps to the brain per second. So updating your diet protocol will be a no-brainer(I know your doctor doesn't have any brains since s/he has NO STROKE RECOVERY POROTOCOLS AT ALL!)

Spicy food consumption and risk of vascular disease: Evidence from a large-scale Chinese prospective cohort of 0.5 million people

Dongfang You youdongfang@njmu.edu.cn, Dianjianyi Sun, Ziyu Zhao, Mingyu Song, Lulu Pan, Yaqian Wu, Yingdan Tang, … Show All … On behalf of the China Kadoorie Biobank Collaborative GroupAuthors Info & Affiliations

Published Online: 19 July 2024

Abstract

Background:

Spicy food consumption has been reported to be inversely associated with mortality from multiple diseases. However, the effect of spicy food intake on the incidence of vascular diseases in the Chinese population remains unclear. This study was conducted to explore this association.

Methods:

This study was performed using the large-scale China Kadoorie Biobank (CKB) prospective cohort of 486,335 participants. The primary outcomes were vascular disease, ischemic heart disease (IHD), major coronary events (MCEs), cerebrovascular disease, stroke, and non-stroke cerebrovascular disease. A Cox proportional hazards regression model was used to assess the association between spicy food consumption and incident vascular diseases. Subgroup analysis was also performed to evaluate the heterogeneity of the association between spicy food consumption and the risk of vascular disease stratified by several basic characteristics. In addition, the joint effects of spicy food consumption and the healthy lifestyle score on the risk of vascular disease were also evaluated, and sensitivity analyses were performed to assess the reliability of the association results.

Results:

During a median follow-up time of 12.1 years, a total of 136,125 patients with vascular disease, 46,689 patients with IHD, 10,097 patients with MCEs, 80,114 patients with cerebrovascular disease, 56,726 patients with stroke, and 40,098 patients with non-stroke cerebrovascular disease were identified. Participants who consumed spicy food 1–2 days/week (hazard ratio [HR] = 0.95, 95% confidence interval [95% CI] = [0.93, 0.97], P <0.001), 3–5 days/week (HR = 0.96, 95% CI = [0.94, 0.99], P = 0.003), and 6–7 days/week (HR = 0.97, 95% CI = [0.95, 0.99], P = 0.002) had a significantly lower risk of vascular disease than those who consumed spicy food less than once a week (P_trend <0.001), especially in those who were younger and living in rural areas. Notably, the disease-based subgroup analysis indicated that the inverse associations remained in IHD (P_trend = 0.011) and MCEs (P_trend = 0.002) risk. Intriguingly, there was an interaction effect between spicy food consumption and the healthy lifestyle score on the risk of IHD (P_interaction = 0.037).

Conclusions:

Our findings support an inverse association between spicy food consumption and vascular disease in the Chinese population, which may provide additional dietary guidance for the prevention of vascular diseases.

Neils Bohr who famously said science progresses one funeral at a time.

It is the same in stroke? How many and who have to die before we get 100% recovery protocols?

FDA Declines Stroke Drug Over Manufacturing and Packaging Issues

 Have your doctor and hospital follow this research. They won't know about it or follow it unless YOU put their feet to the fire.

FDA Declines Stroke Drug Over Manufacturing and Packaging Issues

Jump to Key Points

April 23 (Reuters) - Grace Therapeutics said on Thursday the U.S. Food and Drug Administration declined to approve its drug ⁠for a rare type of stroke, citing deficiencies in chemistry, manufacturing and controls and non-clinical data.

Shares of the ⁠Princeton, New Jersey-based company were down 43%.

In its complete response letter, the FDA referenced specific ⁠issues in the chemistry, manufacturing ‌and controls (CMC) and non-clinical sections of the company's application. Grace said it can address these in a resubmission.

Those issues relate to leachables data for product packaging, non-clinical product toxicology risk assessments and product manufacturing deficiencies at the contract manufacturing organization, ‌the company said.

Article Key Points

The FDA declined Grace Therapeutics' stroke drug approval due to manufacturing and packaging issues. The company plans to address these concerns and seek further guidance from the FDA. Shares dropped 43% following the announcement.

Leachables are chemical compounds that migrate from packaging, manufacturing equipment ​or delivery ‌systems into a drug.

The company said ‌it intends to request a meeting with the FDA to clarify the path forward and determine ⁠the appropriate next steps.

"Potential FDA approval of ... GTx-104 ‌for the treatment of ⁠aSAH would represent the first ​meaningful innovation in the standard of ‌care for these patients in more than 40 years," said Prashant Kohli, Grace's CEO.

The drug GTx-104 is for the treatment of aneurysmal subarachnoid hemorrhage, a critical, ​often fatal form of stroke caused by a ‌ruptured ‌brain aneurysm.

Grace said it is a relatively uncommon type of stroke that accounts for ‌about 5% of all ​strokes and an estimated 42,500 hospital-treated patients in the U.S.

GTx-104 is an injectable formulation of nimodipine, the only FDA-approved drug for aneurysmal subarachnoid ⁠hemorrhage, for intravenous infusion. The IV delivery has the potential to ‌lower drug-to-drug interactions and eliminate potential dosing errors, Grace added.

(Reporting by Puyaan Singh ​in Bengaluru; Editing by Tasim Zahid)

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