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Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Insights from a meta-analysis of nearly a dozen phase 3 trials of SGLT2 inhibitors is providing a comprehensive overview of the effects of the class on 

 and mortality across a multitude of patient populations.

provideAn analysis of 11 phase 3 trials encompassing more than 75,000 individuals, results of the study underline the safety and efficacy of SGLT2 inhibitors in 

 at high risk for atherosclerotic cardiovascular disease (ASCVD), heart failure, 

, suggesting use reduced the risk of major adverse cardiovascular events by 9% relative to placebo therapy, with this effect consistent across all 3 patient populations and all key subgroups.

“Despite the various benefits of SGLT2 inhibitors on cardiovascular-kidney-metabolic diseases, this class of medicine remains under-prescribed,” said lead investigator Brendon Neuen, MBBS, PhD, senior Research Fellow at The George Institute for Global Health.

Beyond the revelations of weight loss and cardiovascular benefits of GLP-1 receptor agonist and other incretin-based therapies, few classes had garnered the same attention from across a breadth of specialties in the last decade in the same manner as the SGLT2 inhibitor class. Once considered an agent with modest anti-hyperglycemic effects, the SGLT2 inhibitor class has thrust itself to the forefront of treatment algorithms for patients with CKD and heart failure, regardless of diabetes status.

Despite the class’s benefit in type 2 diabetes, chronic kidney disease, and heart failure demonstrated in multiple clinical trial programs and further evidenced, less is certain as it pertains to effects on major adverse cardiovascular events among these patient populations. To better elucidate this risk, Neuen and colleagues from the SGLT2 Meta-Analysis Cardio-Renal Trialists' Consortium designed the current study as a meta-analysis of phase 3 trials of SGLT2 inhibitors.

Investigators included phase 3 placebo-controlled, double-blind, randomized trials of SGLT2 inhibitor therapy, which enrolled at least 1000 participants in each arm, with median follow-up of at least 6 months published from January 1, 2012 through December 28, 2023 in their meta-analysis. A total of 11 trials were identified for inclusion.

Of the 78,607 patients from the 11 randomized trials, 42,568 (54.2%), 20,725 (26.4%), and 15,314 (19.5%) included from trials that focused on patients with diabetes at high risk for ASCVD, patients with established heart failure, or patients with chronic kidney disease, respectively.

The primary outcome of interest for the meta-analysis was a 3-point MACE composite of cardiovascular death, myocardial infarction, and stroke. Secondary outcomes of interest included individual components of the composite endpoint, all-cause mortality, and subtypes of death. Risk of the aforementioned outcomes was assessed among the entire meta-analysis cohort and stratified by the 3 primary patient populations as well as predefined subgroups, including ASCVD history, diabetes status at baseline, prior myocardial infarction, albuminuria at baseline, and KDIGO risk groups defined by a combination of eGFR and albuminuria.

Results of the meta-analysis suggested use of SGLT2 inhibitors were associated with a 9% reduction in risk of major adverse cardiovascular disease relative to placebo therapy (Hazard Ratio [HR], 0.91; 95% Confidence Interval [CI], 0.87 to 0.96; 

 < .0001). Further analysis indicated this effect was consistent across all 3 patient populations and key subgroups.

Analysis of individual MACE components suggested the benefit seen in the primary endpoint analysis was driven by, with no significant effect for myocardial infarction in the overall population (HR, 0.95; 95 % CI, 0.87 to 1.04; 

 =.29) and no effect observed on stroke (HR, 0.99; 95% CI, 0.91 to 1.07; 

 = .77). Additionally, the effect on cardiovascular death observed in the meta-analysis was driven by reductions in heart failure death (HR, 0.68; 95% CI, 0.46-1.02) and sudden cardiac death (HR, 0.86; 95% CI, 0.78-0.95), with this effect consistent across subgroups except for being more apparent in those with albuminuria (

“We hope that our findings inform more tailored prescription of SGLT2 inhibitors, particularly in patients with comorbid presentation of diabetes and heart failure or chronic kidney disease, who may experience multiple treatment benefits,” Neuen added.

For more insights from Neuen into evolving landscape of chronic kidney disease management: 

check out this recent episode of Diabetes Dialogue

. In the episode, Neuen joins hosts to discuss FLOW and the concept of a 4-pillared approach to managing kidney risk in type 2 diabetes.

Patel SM, Kang YM, Im K, et al. Sodium Glucose Co-transporter 2 Inhibitors and Major Adverse Cardiovascular Outcomes: A SMART-C Collaborative Meta-Analysis. 

. Published online April 7, 2024. doi:10.1161/CIRCULATIONAHA.124.069568

The George Institute for Global Health. Diabetes drug improves cardiovascular outcomes across a range of heart and kidney conditions. The George Institute for Global Health. April 8, 2024. Accessed April 18, 2024. https://www.georgeinstitute.org/media-releases/diabetes-drug-improves-cardiovascular-outcomes-across-a-range-of-heart-and-kidney.

Campbell P, Iapoce C. 10 years of SGLT2 inhibitors: A Decade of Redefining Cardiometabolic Care. HCP Live. March 29, 2023. Accessed April 18, 2024. https://www.hcplive.com/view/10-years-of-sglt2-inhibitors-a-decade-of-redefining-cardiometabolic-care.

Articles

Meta-analysis of 11 phase 3 trials shows SGLT2 inhibitors reduce cardiovascular event risk by 9% across diverse patient populations.

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SMART-C Meta-Analysis: SGLT2 Inhibitors Reduce Cardiovascular Events

Experts discuss the management of dry eye in the presence of concurrent ocular conditions.

Treating Dry Eye in the Presence of Ocular Comorbidities

Videos

Experts discuss the management of dry eye in the presence of concurrent ocular conditions, as well as managing dry eye before undergoing cataract and refractive surgery.

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Treating Dry Eye in The Presence of Ocular Comorbidities

The publication of results from an online survey of patients with 

 by investigators at the Mayo Clinic is offering new insight into patient perspectives on use of medical cannabis for management of symptoms associated with the chronic condition.

Analysis of survey results, which included more than 1300 respondents with fibromyalgia, indicate nearly half of all patients reported using cannabis since receiving their fibromyalgia diagnosis, with 82% reporting perceived improvements in symptoms for pain with use. Investigators believe these results underscore the growing need for clinician awareness and knowledge on use of medical cannabis for symptom management in fibromyalgia and other 

“Considering that cannabis is a popular choice among patients for managing fibromyalgia symptoms, clinicians should have adequate knowledge of cannabis when discussing therapeutic options for fibromyalgia with their patients,” wrote investigators.

With the changing legality making medical cannabis an accessible option for more and more patients across the US, a team of investigators led by Abhinav Singla, MD, an assistant professor and senior associate consultant at the Mayo Clinic Rochester, sought to better understand contemporary trends in the use of cannabis in symptom management among patients with fibromyalgia. With this in mind, investigators designed their study as an analysis of an electronic, cross-sectional survey administered to patients diagnosed with fibromyalgia.

Outcomes of interest for the analysis included rate reported cannabis use, most common symptoms for reported use, and improvement in symptoms. In total, the survey was administered to 5234 patients with fibromyalgia. A cohort of 1336 patients responded and met the investigators’ inclusion criteria. The group had a median age of 48 (Q1-Q3, 37.5 to 58) years, the majority identified as female, and 49.5% reported use of cannabis since their fibromyalgia diagnosis. Of the 661 patients reporting cannabis use, 38% reported daily use.

Among those using cannabis, treatment of pain (98.9%), fatigue (96.2%), insomnia (93.6%), or stress, anxiety, or depression (93.9%) were the most commonly cited reasons for use. Further analysis indicated 82% of patients reported perceived improvements in pain symptoms with cannabis use, with most patients reporting cannabis use reporting improved symptoms of insomnia as well as stress, anxiety, or depression.

An accompanying editorial from Paula David, MD, Aia Mohsen, MD, and Howard Amital, MD, MHA, all of the Zabludowiz Center of Autoimmune Diseases of the Sheba Medical Center in Israel, offered additional perspective into the growing interest and use of medical cannabis in management of fibromyalgia and other conditions. The trio detail how the potential of medical cannabis in alleviating chronic pain and improving sleep make the study by Singla and colleagues insightful and timely for clinicians to better understand patient perspective on use. However, before concluding their editorial, the group note it is important to move forward with action given the relative lack of well-designed trials on the subject.

“Despite growing excitement about using [medical cannabis] to treat [fibromyalgia syndrome], it is important to be cautious. The systematic review of Strand et al. pointed out that there is not enough high-quality evidence, especially from controlled trials, to fully understand how well [medical cannabis] works for [fibromyalgia syndrome],” wrote David, Mohsen, and Amital.

 “This means more research is needed to determine the best doses and composition for each symptom, long-term safety, and whether people might become dependent on [medical cannabis] when using it to manage [fibromyalgia syndrome].”

Singla A, Anstine CV, Huang L, Rosedahl JK, Mohabbat AB, Philpot LM. A Cross-Sectional Survey Study of Cannabis Use for Fibromyalgia Symptom Management. 

. 2024;99(4):542-550. doi:10.1016/j.mayocp.2023.12.018

David P, Mohsen A, Amital H. Is Medical Cannabis a Solution for Controlling Fibromyalgia Symptoms?. 

. 2024;99(4):524-526. doi:10.1016/j.mayocp.2024.02.016

Almost 50% of fibromyalgia patients use cannabis for symptom relief, according to new study. Experts suggest results underline need for clinician awareness, further research.

Fibromyalgia

On the HCPLive fibromyalgia page, resources on the topics of medical news and expert insight into fibrositis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on fibromyalgia, and more.

Survey Finds Many Fibromyalgia Patients Finding Symptom Relief with Medical Cannabis

In roughly 10 years, the prevalence of “deaths of despair” among Black individuals transitioned from trailing far behind to exceeding that of the White population, a new study found.

The “deaths of despair” theory helps society understand the declining health status among people in the US. The term describes midlife deaths from suicide, drug overdose, and alcoholic liver disease.

“The increases have, in part, been associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs,” wrote the team, co-authored by Joseph Friedman, PhD, MPH, of the David Geffen School of Medicine at UCLA and Helena Hansen, MD, PhD, from the department of psychiatry and biobehavioral sciences at UCLA.

Friedman said in a press release the sharp increase in premature mortality is connected to mental health issues and substance use disorders among minority groups.

Previous research found these types of deaths were linked to declining social and economic conditions, as well as a perceived loss of status. White US individuals without a college degree were the ones thought to have deaths of despair the most.

Investigators conducted a cross-sectional study, aiming to assess trends by race and ethnicity in deaths of despair in the years after the seminal analysis on deaths of despair. The seminal analysis ended in 2013. Leveraging data from the Centers for Disease Control (CDC) and Prevention WONDER database, they calculated midlife (ages: 45 – 54 years) mortality from deaths of despair in the US from January 1999 to December 2022.

From 2013 to 2022, the deaths of despair of Black individuals surpassed White individuals.

In 2013, the total midlife mortality rate from these causes among White individuals was 72.15 per 100,000 population, which was 1.99 times greater than the mortality rate of 36.24 per 100,000 Black individuals. Black individuals had a sharp increase in deaths of despair after 2015. By 2022, the deaths of despair of Black individuals (103.81 per 100,000) surpassed White individuals (102.63 per 100,000).

The team also found the midlife mortality rate from deaths of despair among American Indian or Alaska Native individuals was significantly greater than that among White individuals from 1999 to 2022. In 2022, the rate among American Indian or Alaska Native individuals (241.70 per 100,000) was 2.36 times greater than the rate among White individuals.

The findings reveal people among racial and ethnic minority groups, such as American Indian or Alaska Native (104.95 per 100,000) and Black (84.80) have greater rates of drug overdose mortality than White individuals (59.26 per 100,000) in 2022.

In 2022, American Indian or Alaska Native individuals had a 6.06 times greater rate of midlife deaths of alcoholic liver disease compared to White individuals. Rates of midlife suicide deaths stayed high among American Indian or Alaska Native individuals (27.92 per 100,000) and White individuals (24.45 per 100,000) in 2022 but were only 9.21 per 100,000 for Black individuals.

Investigators noted 2 limitations: the possible misclassification of race and ethnicity which could impact the study’s results and the ecological design which makes it difficult to measure the causality of underlying factors.

“The findings reinforce the notion that we need to invest in services that can address these issues and, ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” Friedman said. “…We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality.”

Friedman J, Hansen H. Trends in Deaths of Despair by Race and Ethnicity From 1999 to 2022. 

. Published online April 10, 2024. doi:10.1001/jamapsychiatry.2024.0303

‘Deaths Of Despair’ Among Black Americans Surpassed Those of White Americans In 2022. EurekAlert! April 10, 2024. 

https://www.eurekalert.org/news-releases/1040516

A recent study found Black individuals had a sharp increase in midlife deaths from suicide, drug overdose, and alcoholic liver disease after 2015.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Addiction

Addiction medicine condition center page, resources on the topics of medical news and expert insight into clinical addiction can be found. Content includes articles, interviews, videos, podcasts, and breaking news on addiction therapy research, treatment, and drug development.

2022 Spike in “Deaths of Despair” Among Black Population Surpasses White People

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Findings from a recent study are providing an overview of changes in direct-acting antiviral (DAA) use following modifications to state Medicaid program 

 treatment coverage restrictions, highlighting greater DAA uptake after states relaxed their policies related to liver disease severity, sobriety, or prescriber specialty.

 allude to the potential to improve access to curative HCV treatment by further loosening or eliminating such restrictions, supported by evidence of a significant increase in the number of patients treated for HCV across 32 state Medicaid programs that eased or eliminated their coverage restrictions compared to those that maintained restrictions.

“To our knowledge, this study is the first to comprehensively evaluate the effect of easing DAA Medicaid coverage restrictions across the US,” Sonya Davey, MD, resident physician in internal medicine at Harvard Medical School/Brigham and Women's Hospital, and colleagues wrote.

The World Health Organization (WHO) estimates 50 million people have chronic HCV infection, with about 1 million new infections occurring every year.

 In 2016, the WHO set a goal to eliminate viral hepatitis as a public health problem by 2030, including a 90% reduction in incidence and a 65% reduction in mortality compared with a 2015 baseline. Although DAAs offer an effective cure for HCV, access to treatment and care remains an issue hindering their uptake, attributed partially to their high cost.

To better understand the extent to which state Medicaid program restrictions limited treatment of HCV among Medicaid beneficiaries, investigators performed a difference-in-differences analysis to measure whether the use of DAAs increased in states that lifted or eased restrictions compared to states with no changes. They examined DAA prescriptions among Medicaid beneficiaries from 39 state Medicaid programs, measuring DAA coverage restrictions based on a series of cross-sectional assessments performed from 2014 through 2022 by the US National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation.

Quarterly use of DAAs in each Medicaid program was examined from January 1, 2015, to December 31, 2019. Investigators noted this period was selected to begin after the first combination DAA therapy (ledipasvir/sofosbuvir) was introduced during the last quarter of 2014 and national hepatology and infectious disease associations recommended treatment of all individuals with chronic HCV with DAAs, ending the study before 2020 to avoid confounding by changes in access to treatment that occurred during the COVID-19 pandemic.

Coverage restrictions were measured in 3 domains: requirements for minimum disease severity measured with the liver fibrosis score, requirements for periods of sobriety before treatment, and limited prescribing to certain specialists. For each domain, investigators stratified each state’s policies as strict, lenient, or no restriction.

Among the 39 Medicaid programs included in the study, 7 (18%) states eliminated all 3 DAA coverage restrictions, 25 (64%) eased restrictions, and 7 (18%) maintained the same restrictions from 2015 to 2019. Compared to the states with no changes, investigators pointed out those that eased or eliminated restrictions were more likely to have strict baseline restrictions for disease severity (75% vs 43%), but there were no other significant differences for baseline prescriber or sobriety restrictions, source of Medicaid reimbursement, state HCV prevalence, Medicaid expansion status, and US region.

The mean use of HCV treatment in all states increased from 669 to 3601 treatment courses per 100,000 Medicaid beneficiaries from the first quarter of 2015 to the last quarter of 2019. After states eased or eliminated restrictions, the use of DAAs increased by 966 (95% CI, 395 to 1537) treatment courses per 100,000 Medicaid beneficiaries each quarter compared with states that did not ease or eliminate restrictions.

When investigators examined each of the 3 domains separately, they found easing or eliminating restrictions related to liver disease severity (986; 95% CI, 512 to 1460) and prescriber specialty (869; 95% CI, 283 to 1456) were associated with increased use of DAAs, while changes in sobriety restrictions were not associated with a change in DAA use (53; 95% CI, −321 to 427).

Investigators highlighted several potential limitations to these findings, including the fact they did not account for changes in other Medicaid coverage restrictions, possible lack of generalizability to those with private insurance or Medicare part D plans, and use of calculations based on the FDA-recommended duration for treatment-naive patients without decompensated cirrhosis that may not account for patients who did not fit this assumption.

“In this study, from 2015 to 2019, treatment of HCV with DAAs increased after state Medicaid programs eased coverage restrictions compared with states that did not ease restrictions,” investigators concluded.

 “Further reductions or eliminations of these restrictions may maximize the public health effect of these safe and effective treatments for HCV.”

Davey S, Costello K, Russo M, et al. Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs. 

 2024;5(4):e240302. doi:10.1001/jamahealthforum.2024.0302

World Health Organization. Hepatitis C. Newsroom. April 9, 2024. Accessed April 17, 2024. 

https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

World Health Organization. WHO releases first-ever global guidance for country validation of viral hepatitis B and C elimination. June 25, 2021. Accessed April 17, 2024. 

https://www.who.int/news/item/25-06-2021-who-releases-first-ever-global-guidance-for-country-validation-of-viral-hepatitis-b-and-c-elimination

The modified difference-in-differences analysis found notable increases in DAA use after state Medicaid programs relaxed certain coverage restrictions.

Hepatitis C

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Hepatology

DAA Use Increased After State Medicaid Programs Eased HCV Treatment Restrictions

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

NSAID use decreased the odds of a cardiovascular event by 12% in patients with gouts

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

NSAIDs Decreased the Odds of Adverse Cardiovascular Events in Gout

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Patient-led urate monitoring supports adherence to urate-lowering therapy and helps attain target concentrations among individuals with gout.

Self-Monitoring of Urate Concentration Could Benefit Gout Management 

Podcasts

In this episode, hosts discuss the STEP HFpEF DM trial and the need for fair allocation of incretin-based therapies with ongoing shortages and overwhelming demand.

Obesity Management

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Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, Rare Disease Report, and Heart Trials.

Diabetes Dialogue: STEP HFpEF DM and Fair Allocation of Incretin-Based Therapies

Vision issues were linked to an increased risk of suicidal ideation, suicidal behavior, and suicide death, particularly among adolescents.

Visual Impairment Associated with Heightened Risk of Suicidal Tendencies

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

In this analysis, investigators sought to assess PsA development probability in subclinical PsA as well as to characterize symptoms and patterns of subclinical PsA.


Plaque Psoriasis

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Psoriasis Patients with Arthralgia At Increased Risk of Psoriatic Arthritis Development

Participants described the intervention as complete and coherent and would recommend this intervention to other patients. 

Rheumatoid Arthritis

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Osteoarthritis

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Plant-Based Diet Intervention Improves Disease Activity, Symptoms in RA, Osteoarthritis 

A pooled analysis revealed a loading-dose regimen, especially for patients receiving secukinumab 150 mg for PsA, increases the odds of disease improvement.

Rheumatology

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Psoriatic Arthritis

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Secukinumab 300 mg May Improve PsA or Active Psoriasis More Than 150 mg

The consensus calls for the recognition of kidney disease as a major non-communicable disease driver of premature mortality by the World Health Organization.

International Consensus Statement Calls for Prioritization of Kidney Disease by the WHO

This analysis looked at the potential connection between SARS-CoV-2 test positivity and new asthma diagnoses.


Asthma

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No Association Identified Between COVID-19, Development of Asthma Among Children

In an interview with HCPLive, Rishi Kakar, MD, discussed the positive long-term xanomeline-trospium data from EMERGENT-4.

Schizophrenia

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Latest News

SMART-C Meta-Analysis: SGLT2 Inhibitors Reduce Cardiovascular Events

Treating Dry Eye in The Presence of Ocular Comorbidities

Survey Finds Many Fibromyalgia Patients Finding Symptom Relief with Medical Cannabis

2022 Spike in “Deaths of Despair” Among Black Population Surpasses White People

DAA Use Increased After State Medicaid Programs Eased HCV Treatment Restrictions