A new population-based study from Michigan suggested the associations between glaucoma and cognitive function were “small” and unlikely to be clinically meaningful, with incident glaucoma being associated with higher cognitive function scores but steeper rates of cognitive score decline over time.

Previous studies on these associations have often yielded mix results, but the investigative team led by Ajay Kolli, MD, MPH, of the Department of Ophthalmology & Visual Sciences at the University of Michigan believed their larger, more robust study was able to acturately detail these perceived links between glaucoma and cognitive function.

“To our knowledge, no prior study has provided evidence on whether glaucoma is associated with longitudinal changes in cognitive function in a representative sample,” the authors wrote.

Kolli and colleagues utilized data from the Health and Retirement Study (HRS), which was a longitudinal national survey of US adults 51 years and older that began 3 decades earlier. The survey is home to various sociodemographic, health, and economic data, all of which have been collected regularly since 1992.

The current study included data from HRS as well as Medicare claims recorded from 1998 to 2016 from participants 65 years and older at the time of their glaucoma diagnosis.

Patients were featured in the current study if they were enrolled in Medicare Parts A and B for ≥90% of the months during the study period and had completed the Telephone Interview for Cognitive Status (TICS) assessment. Control subjects were also enrolled if they had 1 or more eye exam claims.

Inclusion criteria for glaucoma cases also included ≥2 eye exams by an ophthalmologist or optometrist within 18 months of the index date. In total, the study featured 1344 cases of prevalent glaucoma and 5729 controls, with analyses of incident glaucoma including 886 cases and 4385 controls.

Fully adjusted models indicated that participants with prevalent glaucoma had similar TICS scores observed in the control group (P=0.86). However, investigators noticed a statistically significant association between incident glaucoma and lower TICS scores (P=0.007).

Regarding per-year rates of change in TICS scores, investigators observed no significant association between either group, and no significant associations were seen when categorizing glaucoma by type and the levels or rates of change in TICS scores.

Kolli and colleagues cited several “worthy strengths” of their study, including their large sample size and the categorization of participants based on the type of glaucoma they had.

In their concluding remarks, the team suggested that- based on the previously documented association between vision impairment, cognitive decline and dementia, glaucoma-related vision loss could be a risk factor for adverse cognitive outcomes.

“Thus, additional research is needed to determine whether the magnitude of glaucomatous vision loss and/or specific type of visual loss due to glaucoma are associate with cognitive outcomes,” the team wrote.

Articles

Incident glaucoma was associated with higher cognitive function scores but steeper rates of cognitive score decline over time.

Associations Between Glaucoma and Cognitive Function Not Substantial 

New advancements in the fields of cataract, cornea, and refractive surgery have transformed 

, Karolinne Rocha, MD, PhD, Director of Cornea and Refractive Surgery, Medical University of South Carolina, discussed her expert work in these areas and innovative advancements in presbyopia and cataract surgery.

Rocha highlighted the sheer amount of advancements, partiucarly for presbyopia, cataract surgery, and lens replacements. Laser surgery in cataract removal can correct for astigmatism when removing the cloudy lens and introacular lenses can then benefit patients even further. 

"When patient comes in for cataract surgery it is not only removing the cloudy lens, but we have the opportunity to fix and correct the focus problem," Rocha said. "Some implants help with the far vision, the reading lesion. The idea is that patient comes in with poor vision, and we can restore that vision, but then they can see distance in here without glasses."

She went on to discuss the interest in intraocular lenses, with new implants being created every year with high level of improvement and quality. 

"It's very interesting when you do one eye, and the patients when they come back, they can tell the difference," Rocha said. "It was like, oh, my gosh, my eye that I just did is like a high resolution TV. They usually want to get the second eye done right away."

Then, Rocha discussed pharmacological approaches for presbyopia. Innovations like eye drops can soften lenses and stop the progression of a stiffer lense. 

Rocha also discussed the patient population she is treating, particuarly for cataract. As a mostly age-related issue, she noted that in fact, patients are coming in for surgery at an earlier stage. The advancements in the technology offered, with micro incision lasers for surgery, have changed the 10-year trends. 

"I remember before we used to wait for the cataract to get really dense and then we would recommend surgery," Rocha said. "But, these days actually we don't want that because the surgery can definitely be a little more complicated."

Patients additionally don't have the same confusion or fear regarding the procedure as it becomes more commonly performed, as Rocha noted. As an outpatient procedure, it is crucial to have a quality care team helping patients through their journey. 

"The patients feel really comfortable going through the procedure, it doesn't hurt," Rocha said. "And again, it's an in and out procedure." 

With an aging population, rates of conditions such as presbyopia are increasing substantially. But, Rocha additionally noted that the numbers of myopia are also increasing, particuarly in children who are spending the majority of their time using technology. 

She concluded with the note that the procedures themselves are safe and have advanced substantially within the past decade. 

"Especially at what's exciting is to be able to offer the introacular lens implants with really high quality and be able to address the patient's visual needs for distance and near and be able to eliminate the glasses," Rocha said. 

Videos

Dr. Rocha discusses treatment options, overall safety, and patient populations undergoing surgery. 

Karolinne Rocha, MD: Advancements in Cataract, Refractive Surgery 

A recent study suggested that a causal relationship could not be established between COVID-19 infection and 

, despite the high seroprevalence of COVID-19.

However, study investigators noted that they reported these findings to raise awareness of the potential future risk of retinal vascular events.

“We reported this series to raise awareness regarding the potential risk of retinal vascular events due to a heightened thrombo-inflammatory state associated with COVID-19 infection,” wrote study author Noy Ashkenazy, MD, University of Miami Bascom Palmer Eye Institute.

Ashkenazy and colleagues performed the multicenter, retrospective, nonconsecutive case series to raise awareness regarding a potential temporal association between infection from COVID-19 and retinal vein occlusion.

The population included in the study were patients presenting with hemi-RVO (HRVO) or central RVO (CRVO) between March 2020 and March 2021, with a confirmed COVID-19 infection. Exclusion criteria consisted of an age younger than 50 years, or a confirmed case of hypertension, diabetes, glaucoma, obesity, and underlying hypercoagulable states, as well as those requiring intubation during hospitalization.

Investigators identified the mean outcome measures as any ophthalmic findings, including presenting and final visual acuity, imaging findings, and clinical course. They included a total of twelve eyes of 12 patients with CRVO (9 of 12) or HRVO (3 of 12) after COVID-19 infection.

The data identified the median age as 32 years (range, 18 - 50 years), with 3 patients hospitalized, but none intubated, according to investigators. Moreover, the median time from diagnosis of COVID-19 to ophthalmic symptoms was 6.9 weeks.

Investigators noted the presenting visual acuity ranged from 20/20 to counting fingers, while over half of patients (7 of 12) had a visual acuity of ≥20/40. Optical coherence tomography found macular edema in 42% of the eyes. Of this number, data show 80% (4 of 5) were treated with anti-VEGF injections.

Further, the findings show 92% of patients (11 of 12) had partial or complete resolution of ocular findings at final follow-up. Additionally, 4 eyes (33%) had retinal thinning, determined using optical coherence tomography, at the end of the study interval.

Investigators noted the final visual acuity ranged from 20/20 to 20/60 with 11 of the 12 eyes (92%) achieving a visual acuity of ≥20/40 at a median final follow-up period of 13 weeks (range, 4 - 52 weeks).

Hemi- and Central Retinal Vein Occlusion Associated with COVID-19 Infection in Young Patients without Known Risk Factors

Study investigators aimed to raise awareness of the potential risk of retinal vascular events associated with COVID-19 infection. 

Causal Relationship Not Established Between COVID-19 Infection, Retinal Vein Occlusion

A team of investigators from the Netherlands suggested that the current Dutch retinopathy of prematurity (ROP) could be improved through the implementation of new screening inclusion criteria, with the most effective strategy detailed in the study being able to reduce the number of screened infants by 24% compared to the current guideline.

These strategies could also reduce overall annual costs of current ROP screening, which was estimated at €59454, or roughly $62,600.

The team, led by Kasia Trzcionkowska, PhD, of Leiden University, defined ROP as “the most important cause of visual impairment and blindness” in premature infants. Though most cases are mild and regressive, early detection and treatment of ROP has been advised to prevent severe and permanent loss of sight.

Several updates and risk-based screening criteria for the Netherlands’ first national ROP inventory, NEDROP, in 2013 and 2017, resulting in a second national ROP inventory called NEDROP 2. In both instances, the number of infants required for ROP screening was reduced.

Trzcionkowska and colleagues evaluated the effects and costs of current and alternative ROP screening strategies and considered whether the number of infants who would require ROP screening could be reduced.

The team utilized data from an earlier prospective population-based study, the NEDROP-2 study, which featured data from all infants born in 2017 and referred for ROP screening in the Netherlands.

A variety of screening strategies were featured in the study and evaluated based on gestational age (GA), birth weight (BW), and the presence of 1 or more specific risk factors including mechanical ventilation, sepsis, necrotizing enterocolitis, postnatal corticoids and/or hypotension treated with inotropic agents.

The investigators considered the cost and effects of all available strategies.

Screening was performed in a total of 1088 patients, and ROP was found in 305, with 259 being considered mild and 47 deemed severe.

Investigators determined that the most efficient strategy in detecting infants treated for ROP included infants with GA < 30 weeks and BW < 1250 g 

 GA 30–32 weeks and/or BW 1250–1500 g in addition to 1 or more risk factors.

This particular strategy would require that 744 children were screening, which represented a 23.8% reduction in comparison to the current screening guideline.

Likewise, only 2662 screening examinations would be done if this strategy was applied to the NEDROP population, representing a 18.7% reduction in screening done under the current guideline.

Costs varied from €137 966 to €492 689 depending on the strategy, with the total annual costs of the current Dutch guideline treatment for ROP amounting to €552 143.

The investigative team suggested that the Dutch national screening guideline would be adjusted according to the cost-effective strategies detailed in the study.

“This will reduce healthcare costs further by about 60 000 euro per year,” the team wrote. “Marginal costs for detecting all these infants might be acceptable for society when QALY gain and savings for society as a result of improved vision are incorporated in the decision.”

The most effective strategy reduced the number of screened infants by 24% compared to the current guideline.

Investigators Suggest New, Cost-Effective Screening Strategies for ROP

A quarterly dose of 0.5 mg ranibizumab was not associated with reduced incidence of 

neovascular age-related macular degeneration (nAMD)

 versus sham injections among patients with intermediate AMD, according to new findings.

In research seeking to interpret the potential prophylactic benefits of the anti-VEGF injection therapy, a team of investigators from the PREVENT Study Group reported that an altered dose regimen of ranibizumab intravitreal injection did not provide neither reduction in patient progression to nAMD nor benefit of visual acuity over 2 years.

That said, the team also observed data indicating the PREVENT findings may have been underpowered.

Led by Clement K. Chan, MD, of Southern California Desert Retina Consultants, investigators sought to interpret the preventive effect of ranibizumab on nAMD development in eyes with intermediate AMD for patients patients with preexisting nAMD in their contralateral eye. They conducted a multi-center, randomized trial involving patients ≥50 years old with eligible nAMD and AMD disease; eligible eyes required multiple intermediate drusen of ≥63 μm and <125 μm, or ≥1 large drusen of ≥125 μm, plus pigmentary changes.

Patients were randomized to either intravitreal ranibizumab 0.5 or sham injections every 3 months for 24 months. Chan and colleagues sought a primary outcome of conversion of eyes from AMD to nAMD, and a secondary outcome of change in best corrected visual acuity (BCVA), each from baseline to 24 months.

The final trial population included 108 participants split 1:1 to either treatment arm. Mean patient age was 78 years old at baseline, with a majority (56%) being female; 106 (98.1%) patients were non-Hispanic White. Mean BCVA score was 77.7 letters.

Investigators observed 7 eyes (13%) convert from AMD to nAMD in both treatment arms from baseline to 24 months, indicating no observed benefit of ranibizumab in preventing disease progression (hazard ratio [HR], 0.91; 95% CI, 0.32 - 2.59; 

 = .86). Even after adjusting for patients lost to treatment follow-up, cumulative nAMD indigence was 14% in the ranibizumab arm (95% CI, 4 - 23) versus 15% in the sham injection arm (95% CI, 4 - 25) at 24 months.

Chan and colleagues observed only an -0.8 adjusted difference in BCVA letter change (95% CI, -3.7 to 2.2; 

 = .62) in the ranibizumab arm (mean change, -2.1 letters; SD, 5.4) versus sham injection arm (mean change, -1.4 letters; SD, 7.7).

The team also observed 2 of 39 (5%) eyes from the ranibizumab arm that lost ≥10 letters in VA from baseline to 24 months, versus 4 of 40 (10%) eyes from the sham arm. No serious ocular adverse events were observed in either group.

The team concluded that both primary and secondary endpoints were not met with preventive ranibizumab in eyes with AMD versus sham injection. They stressed the need for other strategies that may reduce progression from AMD to nAMD in this vulnerable population, while also pointing to weaknesses in the PREVENT trial.

“Quarterly dosing of 0.5 mg ranibizumab in eyes with intermediate AMD did not reduce the incidence of nAMD compared with sham injections; however, the study was likely underpowered given the 95% CI, and a clinically meaningful effect cannot be excluded,” they wrote.

The study, “Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration in Vulnerable Fellow Eyes: A Randomized Clinical Trial,” was published online in 

Investigators did not observe a benefit with the anti-VEGF in preventing intermediate AMD eyes from converting to neovascular disease versus sham.

Quarterly Ranibizumab Injections Do Not Prevent Progression to nAMD

 (DR) is not often utilized by primary care professionals (PCP) and largely ineffective when used. 

A team, led by Ailin Song, MHS, Duke University School of Medicine, assessed the practice patterns of fundoscopic examination for diabetic retinopathy screening in a large primary care network and evaluated the sensitivity and accuracy of PCP fundoscopy for detecting the disease.

Primary care physicians are critical in diabetic retinopathy screenings, particularly where there is limited access to specialty eye care.

However, there is also limited data on current diabetic retinopathy screening practice patterns within the primary care setting.

In the retrospective cohort study, the investigators used a random sampling and manual review of electronic health records for PCP fundoscopic examination documentation. The team compared this data with documentation of an examination performed by either an ophthalmologist or optometrist within 2 years before and after primary care visits.

The data was derived from a network of 28 clinics with 7449 adult patients with diabetes seen by at least one primary care network in 2019.

The team also abstracted data from 2001 encounters from the electronic health record for a random sample of 767 patients.

The investigators sought main outcomes of the frequency of PCPs performing fundoscopy at least once in the calendar year for patients with diabetes. They also identified patient, clinician, and clinic factors linked to PCPs performing fundoscopy at least once in the calendar year using univariate and multivariable logistic regression analyses.

Finally, they compared the PCP examination results with diagnoses made by eye care professionals to assess the sensitivity and accuracy of the findings from the PCP examinations.

The results show primary care professionals documented a fundoscopic examination for 12.1% (n = 93) of this patient population. All of these results were classified as normal.

After using eye care examination results as a reference standard, the accuracy of PCP fundoscopic examination was 62.7% (95% CI, 50.0%-73.9%). There was also a sensitivity for detecting disease of 0.0% (95% CI, 0.0%-14.9%).

In addition, patient demographics and clinical characteristics were not associated with PCPs performing fundoscopy.

However, after conducting a multivariable logistic regression analysis, the investigators connected the number of PCP years in practice with a greater odds of patients receiving fundoscopy at least once in the year (aOR per 10 years in practice, 1.26; 95% CI, 1.01-1.59; 

Nurse practitioner credentials was also linked to a lower odds of receiving fundoscopy (aOR, 0.23; 95% CI, 0.04-0.79; 

 = .049; compared with having physician credentials), after adjusting for rural clinical location, clinic location in a primary care shortage area, and documentation of an up-to-date eye care professionals examination by a PCP in the study year.

“In this cohort study, fundoscopic examination was rarely performed and was not sensitive for detecting DR in primary care practice,” the authors wrote. “Because the rate of DR screening by eye care professionals remains low, research to explore and break down barriers to the implementation of effective primary care–based DR screening strategies, such as teleretinal imaging, is needed to prevent vision loss from undiagnosed DR.”

Practice Patterns of Fundoscopic Examination for Diabetic Retinopathy Screening in Primary Care

After using eye care examination results as a reference standard, the accuracy of PCP fundoscopic examination was 62.7%.

Fundoscopy Examination for Diabetic Retinopathy Remains Low in Primary Care Practices

New findings suggest the profile of patients referred for 

 has undergone an evolution over the past decade.

The data show a decrease in the raw number of endophthalmitis cases after cataract surgery in opposition to an increase in the number of patients who presented with endophthalmitis after intravitreal injections.

“The overall incidence of acute endophthalmitis was 1 per 1920 procedures,” wrote study author Catherine Creuzot-Garcher, MD, PhD, Department of Ophthalmology, University Hospital, Dijon, France.

Alongside colleagues, Creuzot-Garcher set out to describe the causes of postoperative acute endophthalmitis longitudinally, on the national scale. The cohort study occurred from 2009 to 2018 in France.

The included participants were individuals diagnosed with acute endophthalmitis after intraocular procedures. Investigators collected information on patients from the French medical-administrative database.

They identified endophthalmitis cases and intraocular procedures based on billing codes in all French hospitals and private practices. The study’s main outcome was the incidence of acute endophthalmitis within 42 days of the procedure.

Over January 2009 to October 2018, a total of 7522 cases of acute endophthalmitis occurred after 14,438,854 intraocular procedures. The majority of cases were found to occur after standalone cataract surgery (4808 cases for 7,316,077 procedures; 63.92%), followed by after intravitreal injections (1296 cases for 5,455,631 intravitreal injections; 17.23%).

These were then followed by vitreoretinal surgery (698 for 442,263 procedures; 9.28%), anterior segment surgery (245 cases; 3.26%), combined cataract and vitreoretinal surgery (698 for 442,263 procedures; 9.28%), anterior segment surgery (245 cases; 3.25%), combined cataract and vitreoretinal surgery (191 cases, 2.54%), cornea surgery (142 cases, 1.89%), and glaucoma surgery (80 cases, 1.06%).

Investigators saw the overall incidence rate of acute endophthalmitis was 0.0521% (95% confidence interval [CI], 0.0520 - 0.0522). The surgery with the highest incidence of endophthalmitis was scleral and globe surgery, at an incidence of 0.1827% (95% CI, 0.1757 - 0.1898).

The next highest incidence was vitreoretinal surgery combined with cataract surgery, at an incidence of 0.1685% (95% CI, 0.1663 - 0.1706). Data show the incidence of endophthalmitis after intravitreal injection was stable throughout the stable period, and those receiving intravitreal injections were the oldest at an age of 75.4 years (standard deviation, 12.0 years; 

Moreover, the onset of endophthalmitis after intravitreal procedures, including injection or undergoing vitreoretinal surgery, was earlier than after the other procedures (

Epidemiology of Acute Endophthalmitis after Intraocular Procedures: A National Database Study

The numbers show a decrease in endophthalmitis cases after cataract surgery and an increase in endophthalmitis after intravitreal injection. 

Patient Profile in Acute Endophthalmitis Referral Evolved Over a Decade 

If you’ve been keeping an eye on recent developments in ophthalmic care, then you’ll know that several new therapeutic agents that had been approved by the US Food and Drug Administration (FDA) in recent months, including ranibizumab delivered via Port Delivery System (PDS) and 

, the latter of which became the first-of-its-kind intravitreal bispecific biologic therapy for both age-related macular degeneration (AMD) and diabetic macular edema.

But the recent advancements in ophthalmology don’t stop there. As Veeral Sheth, MD, Director of Clinical Trials at University Retina would explain, there is so much going on in the world of eye care that it’s been “hard to keep track of all the work”.

“That's exciting, because that means we get new therapies for patients, and we get to give them additional hope and reduce treatment burden and give them better results,” Sheth said. “Patients ask all the time, ‘Doc, am I going to be doing these injections forever and ever?’, and the answer is only if nothing changes from the standpoint of what becomes available. So, the fact is that we do have a lot on the horizon.”

Sheth spoke of the promise of “game changing technology” being developed with gene therapy and tyrosine kinase inhibitors (TKIs), the former of which has been utilized in early trials involving geographic atrophy (GA), which he considered to be “one of the most frustrating” conditions for patients and doctors alike.

However, Sheth noted that gene therapy is still “years away” from being applied in daily practice, and that larger and more pivotal studies are needed.

But while gene therapy might not be applied in the immediate future, Sheth was optimistic about what rollout would look like in the intervening years.

“Ultimately, if you can use gene therapy and leverage, the eye as a factory for the medication- in other words, treating these patients with a surgical treatment or a super choroidal treatment or maybe even an intraperitoneal treatment, but then the eye does the heavy lifting and actually produces the therapeutic to neutralize the disease, then you're talking about reducing that treatment burden,” he said.

To hear more from Dr. Sheth on additional developments in the management of pigment dispersion syndrome and the benefits of home-based optical coherence tomography, please listen to the full episode of DocTalk.

Podcasts

Exploring New Horizons in Ophthalmology Care with Gene Therapy

Although men are known to have higher rates of diabetes and cardiovascular disease (CVD), women with diabetes often have a greater risk profile regarding adverse events. 

A recent presentation given at the 6th Annual Heart in Diabetes meeting, accumulated the known data on these sex differences, from observations on less controlled LDL-C and blood pressure in women to the potential for achieve greater benefit from GLP-1 receptor agonist treatment in women. 

, the presenting author, Erin Michos MD, Division of Cardiology, Johns Hopkins School of Medicine, discussed what these data may mean for women with diabetes and what can be done to address these sex-specific issues.   

This transcription has been edited for clarity.

: Can you provide a summary of your discussion on the sex differences in diabetes impact on atherosclerotic cardiovascular disease (ASCVD) and heart failure and note any key highlights?

At this meeting, I'm talking about sex differences in the risk that diabetes confers in heart failure and ASCVD. While there's a greater prevalence of diabetes in men, diabetes confers a greater relative risk of cardiovascular outcomes in women.

In the risk for myocardial infarction, diabetes confers a fourfold increased risk in women compared to a twofold increase in men. Women at the time of diabetes diagnosis have a higher body mass index (BMI) and they tend to have more cardio metabolic risk factors. They have dyslipidemia, and elevated blood pressure at the time of diabetes diagnosis, which may be why they are at greater risk for cardiovascular complications.

But, the good news is that these novel agents that we have, SGLT2 inhibitors and GLP-1 receptor agonists seem to have equal efficacy in both men and women. Similar glucose control, but also similar reduction in major adverse cardiovascular outcomes. Women benefit equally as men do for these important therapies, so we need to prescribe them for appropriate patients irregardless of sex.

Actually, there's even real world data, not from the trials, but real world data suggesting that GLP-1 receptor agonists may even benefit women even more than men. They can seem to confer greater weight loss in women than in men. With a similar glycemic control, women do tend to have a few more side effects, gastrointestinal side effects with GLP-1’s than men do. But again, most of the time, the side effects can be managed with appropriate counseling and with the GLP-1’s, starting slow and working your way up.

: What is the larger importance of including more women in clinical trials?

It's really, really important because we've shown this and demonstrated this over and over again, that women are underrepresented in cardiovascular clinical trials relative to the disease burden in the population. We examine this for both lipid lowering studies and cardiometabolic studies. And it is true for certain conditions like acute coronary syndrome, the prevalence is less in women than in men.

But if you benchmark enrollment and trials to the burden of disease in the population, women are underrepresented. Historically, only like 25% of trial participants are female. So, you can look for interactions by sex, but if there's not enough women in the trial, you're not going to have enough statistical power to see if there's an effect modification, not only for efficacy, but for safety.

Clinical trials serve as the backbone of how we get FDA approvals and implement these into our guidelines. If we're going to disseminate this in our clinical population, we want to make sure that trial results are representative of the patients we see every day in clinic, so not only women, but we also need to make sure we have adequate enrollment of older adults and adults that come from underrepresented minority, racial ethnic groups.

: How does gestational diabetes play into this conversation?

Unfortunately, gestational diabetes is on the rise both in the United States and globally. It’s kind of mirroring the trends and rise in obesity. Obviously, obesity pre pregnancy is a big risk factor for these adverse pregnancy outcomes, including gestational diabetes.

We have an oral presentation here at Heart in Diabetes being presented by one of my mentees, Dr. Sam Anza. He's a medicine resident at Rochester General. And what we showed in a national sample of over 15 years of delivery hospitalizations was that women with GDM compared to controls had increased risk of acute cardiovascular complications, so they were nearly twofold more likely to have preeclampsia. And they were also at increased risk for having stroke, peripartum cardiomyopathy, and acute kidney injury.

This is really, really important and why we need to try to prevent gestational diabetes in the first place, but also make sure that they're closely followed. But even if we get women through the pregnancy and delivery, that we know that gestational diabetes is associated with a tenfold increased risk of developing type 2 diabetes, and there's a lot of emerging area whether this some of these agents like GLP-1 receptor agonists may potentially be useful in this group.

But not only that, it's associated with a twofold increased risk of developing cardiovascular events and this could be even more 10 years out from their index pregnancy. Even if you look at women who had GDM, but didn't develop interim type 2 diabetes, they still have an elevated risk of developing coronary artery calcium that was shown in the CARDIA study and about a 60% increased risk of a clinical cardiovascular event, even if they're euglycemia after delivery, it'll still have long term complications.

: As a multidisciplinary issue, how does a care team need to be shaped to be able to address these issues?

For women who have had adverse pregnancy outcomes like gestational diabetes, it's really important that they're taken care of by a multidisciplinary team, and postpartum in the fourth trimester, you know that there's this appropriate handoff between OB/GYN to primary care.

Outside of this, one of the conversations we've been having at this meeting is around obesity management. Obviously, obesity is one of the big drivers of diabetes and other comorbidities such as heart failure, particularly heart failure with preserved ejection fraction, atrial fibrillation.

One of the big messages, I think, is that cardiologists need to be in this space of managing diabetes. There’s just not enough obesity medicine specialists, and there's more than double cardiologists and endocrinologists. Because obesity can lead to so many downstream cardiovascular complications cardiologists need to get involved in this space.

We have new agents now, because many patients still struggle with their weight, even after counseling them about diet and lifestyle. You know, obesity is skyrocketing. 42% of US adults are obese and 70% are overweight and obese. Now we have agents like semaglutide, that can confer a 28 pound weight loss at the maximum dose.

Just released was the results from SURMOUNT-1, a trial of tirzepatide. I mean, it's unbelievable, they showed at the highest dose of 50 milligrams, there was a 22% relative weight loss, which translates to 52 pounds. 52 pounds of weight loss with a pharmacological agent is bariatric surgery levels of weight loss, and this should have substantial impact on our patients, preventing these long term comorbidities that we see from obesity.

I think cardiologists really need to get involved in obesity medicine management, or at least know how to appropriately refer and counsel their patients about these new therapeutic options.

Erin Michos, MD: Sex Specific Differences in Risk Factor Profiles in Diabetes Care

The US Food and Drug Administration (FDA) approved a supplemental indication for phentermine and topiramate extended-release capsules (Qsymia) for chronic weight management in pediatric patients 12 years and older who defined as having a body mass index (BMI) of 95th percentile or greater when standardized for age and sex.

The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended capsules be used in conjunction with a reduced-calorie diet and increased physical activity.

A total of 54 patients were randomly assigned to the Qsymia 7.5 mg group, while 15 were enrolled in the 15 mg group and 56 in the placebo group.

All participants were counselled in lifestyle modification, which included reducing calories and increasing physical activity.

Overall, participants in the 7.5 mg and 15 mg treatment groups lost an overage of 4.8% and 7.1% of their BMI, respectively. Meanwhile, those who were on placebo gained an average of 3.3% of their BMI.

Back in 2012, the FDA approved phentermine and topiramate extended-release capsules for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater with at least 1 weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia, as an adjunct to a reduced-calorie diet and increased physical activity.

The capsules are only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS), due to the increased risk for birth defects with fetal exposure to Qsymia during pregnancy,

Phentermine and topiramate extended-release capsules are also associated with increased heart rate, suicidal behavior and ideation, depression, the slowing of linear growth, acute myopia, secondary angle closure glaucoma, mood and sleep disorders, cognitive impairment, metabolic acidosis, and decrease in renal function.

The most common adverse reactions reported in the pediatric clinical trial included depression, dizziness, joint pain, fever, flu, and ankle sprain.

The approval, which was was supported by data from a 56-week trial involving 223 obese individuals 12-17 years old, recommended the capsules be used in conjunction with a reduced-calorie diet and increased physical activity.

FDA Approves Phentermine and Topiramate Capsules for Pediatric Chronic Weight Management

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