Maggie L. Shaw

Preliminary study results point to a possible connection between increasing global temperatures and an increased risk of hospitalization during the course of 

 that will be presented at this year’s American Academy of Neurology (AAN) 73rd Annual Meeting in April.

This greater risk stems from possible worsening symptoms, the authors noted. They compared visits for each patient during anomalously warm and normal weather periods. Their primary outcome of this retrospective cohort study was annualized warm weather–related risk of out/inpatient and emergency department visits in the United States, and they defined anomalously warm weather as “any month in which local average temperatures were higher than the long-term average temperature for that month by at least 1.5°C, or almost 2°F.”

“We know that heat sensitivity is common in multiple sclerosis, and climate scientists expect that periods of anomalously warm weather will become more frequent with climate change,” lead study author Holly Elser, PhD, of Stanford University School of Medicine and a member of the AAN, said 

. “Our study suggests that warming trends could have serious health implications over the long term for people living with MS.”

Of the 75 million-plus patients identified from a nationwide patient-level commercial and Medicare Advantage claims database, 106,225 (0.14%) had MS (59.0% aged 36-55 years; 76.6% women). Among these patients, the risk of emergency department visits rose the most, at 4%, compared with 3% for inpatient visits and 1% for outpatient visits.

The follow-up period had opposite results. There was an increase of 1960 outpatient and 592 emergency department visits during anomalously warm weather. Inpatient visits remained in the middle, at 1260 more visits.

Overall, although results were similar between men and women, older individuals had the strongest correlation—with results among this group varying by region and season.

“As global temperatures rise, individuals with MS may represent a sub-population uniquely susceptible to associated periods of anomalously warm weather,” the authors concluded, “with implications for both health care providers and systems.”

They emphasized that despite these increases appearing small, “the associated absolute effect on people with MS and the health care system is meaningful,” Elser stated.

All individuals included in the final analysis had at least 3 MS-related in/outpatient or disease-modifying therapy claims in a 365-day period.

The study’s retrospective design and not being able to directly measure symptoms were noted at limitations to these findings. Further study is warranted.

Elser H, Parks R, Moghaven N, et al. Anomalously warm weather and acute care visits in patients with multiple sclerosis: a retrospective study of privately insured individuals in the US. Presented at: the American Academy of Neurology's 73rd Annual Meeting; April 17-22, 2021. Accessed March 5, 2021. https://bit.ly/3eeOC18

Articles

Preliminary study results point to a possible connection between increasing global temperatures and an increased risk of hospitalization during the course of multiple sclerosis (MS).

Study Investigates Link Between Multiple Sclerosis, Warmer Weather 

Study results from Taiwan, conducted among patients with 

, are showing a drop in the risk of renal function decline among patients with heart failure with preserved ejection fraction (HFpEF) administered sacubitril/valsartan. These findings appeared in a recent issue of 

The combination neprilysin inhibitor/angiotensin II receptor blocker, sold as Entresto by Novartis, recently became 

 specifically approved by the FDA to treat HFpEF.

“Sacubitril/valsartan is a combined neprilysin inhibitor/angiotensin II receptor blocker designed for treatment of heart failure,” the study authors wrote. “Nonetheless, its renal protective effect remained an issue of debate.”

In providing background for their study, the researchers noted that a separate study from the United States showed 61.9% of patients with heart failure had at least 1 noncardiovascular-related hospitalization, “showing an important role of noncardiac comorbidities in HF patients.”

Their retrospective cohort study, which took place between January 1, 2016, and October 31, 2018, comprised 274 patients from Wanfang Hospital, Taipei Medical University (sacubitril/valsartan, n = 137; valsartan only, n = 137; mean [SD] age, 72.7 [14.9] years; 65.7% male) matched 1:1 on gender, age, estimated glomerular filtration rate (eGFR), and left ventricular ejection fraction (LVEF). The mean baseline mean eGFR was 70.9 (24.7) mL/min/1.73 m2 and mean LVEF, 54.0% (15.7%). The study end point was sacubitril/valsartan or valsartan stoppage and all-cause death.

During the 18-month follow-up period—with measures taken at 3, 6, 12, and 18 months—the primary outcomes were end eGFR, renal function decline (drop of ≥ 20% in eGFR), mortality, and heart failure–related hospitalization. There was a significantly greater improvement overall in eGFR in the sacubitril/valsartan group vs the valsartan-only group (

< .01) and among the subgroup of patients with HFpEF (LVEF ≥ 40%) or the participants who had a baseline eGFR of ≥ 60 mL/min/1.73 m2.

Risks of cardiovascular mortality, all-cause mortality or heart failure–related did not change.

However, renal function decline risk was halved (HR, 0.5; 95% CI, 0.3-0.9), and the authors called this a significant reduction, following a multivariate Cox regression analysis.

Analyses produced the following results by the 18-month mark:

eGFRs of 69.4 and 63.9 mL/min/1.73 m2 in the sacubitril/valsartan and valsartan-only groups

7.2 mL/min/1.73 m2 (95% CI, 2.9-11.5) higher eGFR, via generalized estimating equation, in the sacubitril/valsartan group compared with the valsartan-only group (

Among patients with HFpEF, an 8.2 mL/min/1.73 m2 (95% CI, 3.8-12.6) higher eGFR compared with the valsartan-only group (

For patients with a baseline eGFR of ≥ 60 mL/min/1.73 m2, an 8.0 mL/min/1.73 m2 (95% CI, 1.3-14.6) higher eGFR in the sacubitril/valsartan vs the valsartan-only group (

For patients with a baseline eGFR of < 60 to ≥ 30 mL/min/1.73 m2, a 12.7 mL/min/1.73 m2 (95% CI, 5.7-19.8) higher eGFR in the sacubitril/valsartan vs the valsartan-only group (

No change in LVEF, hemoglobin, or serum creatinine levels between the groups for the duration of the study.

No significant improvement in eGFR among patients with heart failure with reduced ejection fraction (LVEF < 40%) or a baseline eGFR < 30 mL/min/1.73 m2

The authors attribute the renal protective effect seen to neprilysin inhibition, and they highlight that this “may be restricted to patients with HF, especially in those with HFpEF,” but that future studies should confirm these findings among patients susceptible to the benefits of sacubitril/valsartan.

The retrospective study design, lack of data on albumineria as an outcome variable, small case number, and including only patients of Asian ethnicity mark limitations to these findings.

Hsieh H-L, Chen C-Y, Chen C-H, et al. Renal protective effect of sacubitril/valsartan in patients with heart failure. 

Published online February 25, 2021. doi:10.1038/s41598-021-84118-8

Study results from Taiwan of patients with heart failure and comorbid chronic kidney disease show a drop in the risk of renal function decline among patients with heart failure with preserved ejection fraction (HFpEF) administered sacubitril/valsartan.

Patients With HFpEF Administered Sacubitril/Valsartan Gain Renal Benefits

 and who had commercial health insurance coverage adhered to their pre-exposure prophylaxis (PrEP) regimens more than twice as long as persons covered by Medicaid, according to study findings in 

Persistence was also shown to be highest among men, White individuals, and those aged 55 to 64 years.

“The United States Preventive Services Task Force recommends clinicians offer PrEP to persons at high risk of acquiring HIV,” the study authors wrote. “It is estimated that approximately 1.1 million persons in the United States are at risk of HIV acquisition and could benefit from taking PrEP, yet only 7% received a PrEP prescription in 2016.”

Consistent weekly PrEP use (at least 4 doses/week) is over 90% effective at preventing HIV in men who have sex with men alone, but this high rate starts to drop in the week after PrEP stoppage, they added, “and persons can acquire HIV infection soon after PrEP is discontinued.”

Whereas similar previous studies have zeroed in on PrEP adherence in closed health care systems, this study sought results generalizable to wider patient populations.

The investigators from the CDC compared data on insured Americans between January 1, 2012, and December 31, 2017, from the IBM MarketScan Commercial Claims and Encounter (commercial coverage group; n = 11,807) and the IBM MarketScan Multi-State Medicaid (Medicaid coverage group; n = 647) databases. Most patients were male (97.7% and 77.6%, respectively) and aged 25 to 44 years (60.8% and 63.2%). All had to have at least 1 filled PrEP prescription.

Uninterrupted PrEP use was 13.7 (95% CI, 13.3-14.1) months among the commercial group vs 6.8 months (95% CI, 6.1-7.6; 

PrEP use for at least 12 continuous months was more common in the commercial group than the Medicaid group (54.0% vs 29.9%) and in male vs female patients (54.4% vs 36.7%).

Persistent PrEP use was more than twice as long in male compared with female patients (13.9 [95% CI, 13.4-14.3] vs 6.9 [95% CI, 5.6-8.7] months) and in older (45-64 years) vs younger (18-44 years) women (12.2 [95% CI, 10.2-16.1] vs 5.6 [95% CI, 4.5-6.9] months).

Female patients with Medicaid coverage had reduced PrEP persistence overall compared with male patients: 5.8 (95% CI, 4.1-7.1) vs 7.1 (95% CI, 6.2-8.1) months.

Female patients with Medicaid coverage were less likely to continue PrEP after 12 months compared with male patients: 20.8% vs 32.4%.

In the commercial and Medicaid groups, older (45-54 years) users had longer median PrEP persistence than younger (18-24 years) users:

Commercial: 18.9 (95% CI, 17.6-20.6) vs 7.4 (95% CI, 6.9-8.2) months

Medicaid: 8.9 (95% CI, 7.3-10.6) vs 5.1 (95% CI, 4.0-6.7) months

In the Medicaid group, Black individuals had the shortest PrEP persistence compared with White and other race/ethnicity users: 4.7 vs 7.3 vs 8.0 months, respectively.

For this study, PrEP was considered discontinued on the 31st day after a prescription should have been refilled and persistence defined as “the length of time that a person continued to refill PrEP prescriptions without an interruption of more than 30 days.”

The authors note how their findings add to the current body of evidence of disparities in PrEP uptake and persistence.

“Previous studies have identified similar patient factors associated with PrEP discontinuation, including female sex, younger age, black race/ethnicity, and uninsured status,” they said. “A recent study of PrEP prescriptions dispensed by a national pharmacy chain also found that more than half of PrEP users persisted for a year, with women and younger persons persisting with PrEP the shortest time.”

Possible causes of these disparities include stigma, financial issues, and lack of both health care access and support. Solutions to close these care gaps include tailoring PrEP interventions for younger patients (eg, more frequent visits, more intensive counseling, long-acting injectables) and for Black individuals (by addressing social determinants of health).

“PrEP will only be effective in preventing new HIV infections if it is used adherently and persistently by persons who are at risk of acquiring HIV,” the authors concluded. “A better understanding of reasons for discontinuing PrEP will inform interventions to support PrEP use by persons with substantial risk of HIV acquisition.”

Huang Y-LA, Tao G, Smith DK, Hoover KW. Persistence with human immunodeficiency virus pre-exposure prophylaxis in the United States, 2012–2017. 

 2021;72(3):379-385. doi:10.1093/cid/ciaa037

Individuals at high risk of contracting HIV and with commercial health insurance adhered to their pre-exposure prophylaxis (PrEP) regimens more than twice as long as persons covered by Medicaid.



PrEP Rates Lowest Among Persons at Highest Risk of HIV With Medicaid Coverage

A systematic review and meta-analysis of studies of patients with 

 (MS) found that mindfulness- and acceptance-based interventions (MABIs) did not have a significant effect on mindfulness among these patients. Quality of life (QOL), coping skills, cognition, and mindfulness were shown to have just moderate gains.

The author searched PubMed (1966-2020), CINAHL (1981-2020), PsycINFO (1935-2000), and SCOPUS (1966-2020) from their inception through July 3, 2020, including 18 randomized controlled trials in her final analysis. Search terms used included 

. Among qualifying criteria, the 18 trials had to be written in English, provide a comparison of before and after results, and test sole or multicomponent interventions “involving MABIs at least 50% of the whole intervention time.”

Of the 18 studies included, in-person interventions were tested in 15 and web- or phone-based interventions in 3, among a mean (SD) cohort size of 61.2 (37.5) patients, with the smallest trial including 24 individuals and the largest, 150. The mean (SD) patient age was 42.4 (8.6) years, and 78.7% of patients were female.

“Interventions involving mindfulness training have shown growing evidence for improving cognitive functions, including attention and memory,” said Areum Han, PhD, the study’s author. “But the scientific investigation regarding effects of mindfulness training on cognition is still relatively new with a limited number of studies.”

Her analysis revealed these findings of the MABIs tested:

They had a moderate effect on QOL in 12 of the trials, which covered 547 participants (standardized mean difference [SMD], 0.56; 95% CI, 0.15-0.97). This was seen immediately following the interventions.

QOL improved more with follow-up in 7 of the trials, which covered 390 participants (SMD, 0.81; 95% CI, 0.21-1.40).

Coping skills had slight improvements in 4 of the trials, of 214 participants (SMD, 0.45; 95% CI, 0.02-0.87), immediately following the interventions.

Coping skills did not have statistically significant increases in 3 of the trials, among 170 participants (SMD, 0.63; 95% CI, –0.15 to 1.42), at follow-up.

Cognition (memory) moderately improved in just 4 trials, covering 170 participants (SMD, 0.49; 95% CI, 0.19-0.80), a finding seen right after the MABIs concluded.

Memory was shown to greatly improve in 3 of the trials, covering 137 participants (SMD, 1.12; 95% CI, 0.06-2.17), but this was only seen at follow-up.

No statistically significant improvements from MABIs were noticed for mindfulness, both immediately following interventions (SMD, 0.22; 95% CI, –0.34 to 0.77) and at a more distanced follow-up (SMD, 0.59; 95% CI, –0.26 to 1.44).

“The present meta-analysis paper found new information by conducting meta-analyses regarding effects on coping, attention, memory, and mindfulness,” Han noted. “Previous meta-analyses for people with MS were not conducted in these outcomes.”

These previous studies, she added, have primarily focused on symptom reduction for depression, anxiety, stress, fatigue, and pain.

Because the present meta-analysis did not include subgroup analyses on individual MABI features and only studies written in English were included, these findings may be limited in their generalizability.

Future studies on the effects of MABIs on QOL, coping, cognition, and mindfulness should include subgroup analyses for contributions of mindfulness-based cognitive therapy, acceptance and commitment therapy, and dialectical behavior therapy among patients with MS, Han concluded.

“High-quality studies with follow-up evaluations are needed to support effects of MABIs on QOL, coping, cognition, and mindfulness in people with MS and examine intervention features that increase and maintain effects,” she emphasized.

Han A. Effects of mindfulness-and acceptance-based interventions on quality of life, coping, cognition, and mindfulness of people with multiple sclerosis: a systematic review and meta-analysis. 

2021;1-18. doi:10.1080/13548506.2021.1894345

A systematic review and meta-analysis of studies of patients with multiple sclerosis (MS) found that mindfulness- and acceptance-based interventions did not have a significant effect on mindfulness among these patients.

Maggie L. Shaw

Articles

Study Investigates Link Between Multiple Sclerosis, Warmer Weather

Patients With HFpEF Administered Sacubitril/Valsartan Gain Renal Benefits

PrEP Rates Lowest Among Persons at Highest Risk of HIV With Medicaid Coverage

Mixed Improvements Seen Among Patients With MS Practicing Mindfulness