A pair of experts in the management of diabetes review the role of insulin therapy and review the approval process for biosimilars, including the FDA's approval of the first interchangeable insulin biosimilar.

Interchangeable Insulin Biosimilars: A Game Changer in Diabetes Management

Hypertension is one of the most common conditions in the world and is a significant risk factor for kidney disease, stroke, and cardiovascular disease. The primary pathophysiological feature seen with prolonged hypertension is a thickening of arterial walls which, over time, can lead to organ damage. 

Maria Luisa Sequeira-Lopez MD, a physician at the University of Virginia, has uncovered a peculiar association between the pathophysiology of hypertension and the long-term use of a ubiquitous class of blood pressure medications.

A primary target in the management of hypertension is the renin-angiotensin-aldosterone system (RAA). The RAA is primarily responsible for maintaining an adequate blood pressure such that organs are perfused and the organism in question is able to survive and function. The pathology of hypertension is linked to an overactive RAA system. As such angiotensin-converting-enzyme inhibitors (ACEi) were developed as a treatment for hypertension. These drugs prevent the conversion of angiotensin to its vasoconstricting form, angiotensin II. The peculiarity Sequeira-Lopez and colleagues found was that long-term use of ACEi’s lead to the same arteriolar thickening and organ dysfunction, in a mouse model and in humans, that long-term hypertension itself produced.

Sequeira-Lopez looked at mice with an ablated renin gene. What they found was a progressive thickening of the afferent arterioles and interlobular arteries in the mouse kidneys.

 Stranger still, the arteriolar thickening was due to an increase in renin cells within the walls.

 This same phenomenon was seen in human kidneys following extended inhibition of the RAA system.

 At closer examination it was found that the invasive renin cells were not the classic endocrine cells but of a matrix-secretory type that is pathological to kidney arterioles.1 In both cases, human inhibition of the RAA system or renin knock-out mice, invasion of the kidney arteriole by pathological renin cells led to reduced blood flow and ischemia.

These findings are both interesting from a basic science perspective and troubling from a clinical viewpoint. Drugs targeting the RAA system are the mainstay of many hypertension treatment regimens. In fact, ACEi’s and angiotensin receptor blockers (ARBs) are often employed to protect the kidneys in diabetic patients with and without hypertension. Not only are these drugs being used by millions of patients worldwide, they have also been shown to reduce the risk of developing major cardiovascular events including heart attacks, strokes, and death.

These conflicting findings present a bit of a dilemma. For Sequeira-Lopez’s part she does not advocate for discontinuation of ACEi or ARB treatments at this time. She does however call for prospective, randomized, controlled investigations aimed at defining the real-life implications of her findings. Ultimately, we as clinicians measure the effectiveness of our treatments based on outcomes. Even though these data indicate that drugs targeting the RAA system cause thickening of renal arterioles the fact that these drugs are associated with better survival and in most cases increased quality of life should be the driving factor. The role of basic science research is to determine what the figuratively microscopic factors are that produce our macroscopic clinical picture. Now that these authors have uncovered a potential problem with a trusted and proven hypertension treatment it will be up to others to examine the clinical implications in the short and long term.

With over a billion people suffering from hypertension worldwide this discovery warrants a closer look. How can it be that the very treatment produces the same pathological sequelae as the disease itself? It is not uncommon for a study to raise more questions than answers. This is the basis of discovery. By building on good science, we find answers and start asking more questions. With a fresh look at an old treatment, we see here that the book isn’t closed on RAA inhibition.

Watanabe, H., Martini, A. G., Sequeira-Lopez, M. L. S., et al. Inhibition of the renin-angiotensin system causes concentric hypertrophy of renal arterioles in mice and humans. 

Dusing R. Mega clinical trials which have shaped the RAS intervention clinical practice. 

Articles

Dr. Gregory Weiss provides perspective on recent data detailing the potential for kidney damage as a result of long-term inhibition of the renin-angiotensin system. 

Inhibition of the Renin-Angiotensin System and the Potential for Kidney Damage

A man in his mid-70’s with a recent UTI is brought to the hospital by ambulance with a glucose of 30 after family called 911 for generalized weakness. Medics gave an amp of D50 and he gradually became less weak. He is 4 days into the second course of antibiotics for a UTI but denies any fever, pain, or other complaints. He has a history of Parkinson’s and HTN, but no diabetes or other endocrine conditions.

Vital signs are normal. Physical exam is non-focal

The latest endocrine case report from Brady Pregerson, MD, features a man in his mid-70’s with a recent UTI brought to the hospital with a glucose of 30 mg/dL and reports of generalized weakness. Can you determine the correct diagnosis?

Endocrine Case Report: Glucose of 30 mg/dL

Patrick Campbell is the senior editor of Endocrinology Network, as well as its sister publication Practical Cardiology. Prior to joining these brands, he led coverage of cardiology and diabetes with HCPLive. Before joining parent company 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 freelance multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. In his free time, he enjoys traveling, sports, and exploring the great outdoors. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

This article was originally published on 


A new study has returned surprising results, suggesting elevated NT-proBNP in early pregnancy was associated with a lower risk of hypertensive disorders and future hypertension.

An analysis of data from more than 4000 women, results of the study suggest higher NT-proBNP concentrations were associated with a lower risk of HDP and hypertension 2-7 years post partum, even after adjustment for variables including age, race, BMI, and lifestyle facts.

“Contrary to our hypothesis, we demonstrated that higher NT-proBNP concentrations in early pregnancy were associated with a lower risk of HDP. This association was present after controlling for early-pregnancy blood pressure and traditional risk factors,” wrote investigators.

Few conditions are associated with as substantial of an increase for risk of future cardiovascular disease as HDPs. With this in mind, investigators sought to determine whether measurements of NT-proBNP could serve as useful markers for subclinical cardiac dysfunction and a predictor of HDP as well as future hypertension risk. Performed on behalf of the NICHD nuMoM2b and NHLBI nuMoM2b Heart Health Study Networks, the study was designed to assess potential associations of NT-proBNP and HDP and future hypertension risk in a cohort of patients from The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be Heart Health study.

From the prospective multicenter observational study, investigators were able to identify a cohort of 4103 nulliparous women with complete data and no pregnancy hypertension or diabetes at baseline who were treated at 8 clinical sites in the US. As part of their participation in the study, women provided a nonfasting blood sample in the first trimester, attended study visits at 3 time points prior to delivery, allowed medical records access, and agreed to postpartum follow-up. Follow-up was performed via telephone or email at 6-month intervals beginning at least 6 months after delivery and required patients to undergo an in-person cardiovascular assessment visit at least 2 years after delivery.

The study cohort had a mean age of 27 (SD, 5.6) years. Of the 4103 included in the study, 909 (22.2%) had an adverse pregnancy outcome and 817 (19.9%) had stage 1 hypertension or greater at the follow-up visit. Compared to women without hypertension at follow-up, women who had hypertension were older at baseline, more likely to self-report being non-Hispanic Black, and had higher early-pregnancy BMIs.

Results demonstrated higher NT-proBNP concentrations were associated with a lower risk of HDP (aOR per doubling, 0.81 [95% CI, 0.73-0.91]), which investigators noted persisted after adjustment for age, self-reported race and ethnicity, early-pregnancy BMI, smoking, and aspirin use. When assessing NT-proBNP and hypertension risk 2-7 years after delivery, results indicated higher NT-proBNP concentrations were associated with a Lowe risk of incident hypertension (aOR per doubling, 0.84 [95% CI, 0.770.93]), which investigators pointed out was an association that persisted after adjustment for confounders, including HDP.

“Findings from this cohort study support the importance of early-pregnancy cardiovascular adaptation not only for healthy pregnancy outcomes but also as a marker of future cardiovascular health. Taken together, these findings suggest that early-pregnancy cardiovascular physiology, as assessed with NT-proBNP concentration, may be an important determinant of both pregnancy outcome as well as future CVD,” wrote investigators.

Association of N-Terminal Pro–Brain Natriuretic Peptide Concentration in Early Pregnancy With Development of Hypertensive Disorders of Pregnancy and Future Hypertension

New data suggests higher concentrations of NT-proBNP in early pregnancy could help predict women at a lower risk for developing hypertensive disorders of pregnancy and future hypertension.

High NT-proBNP in Early Pregnancy Could Signal Lower HDP, Future Hypertension Risk

An analysis of Medicare claims data is providing clinicians with new insight into the rate of long-term discontinuation of medications for obesity-related comorbidities following sleeve gastrectomy or gastric bypass.

A comparative effectiveness study of adult Medicare beneficiaries with up to 5 years of follow-up data, results of the study suggest both procedures were associated with medication discontinuation, but gastric bypass was associated with a greater cumulative incidence of medication discontinuation and a lower incidence of medication restart. 

“We believe these results demonstrate that both procedures are associated with long-term discontinuation of obesity-related medication and suggest that patients who underwent gastric bypass may be slightly more likely to remain free from their diabetes, antihypertensive, and lipid-lowering medications,” wrote investigators.

 has grown, so has the role of bariatric surgery in obesity management. To better inform clinical decision-making in patients with obesity, a team led by Ryan Howard, MD, of the Department of Surgery at the University of Michigan, designed their study to compare rates of medication discontinuation and restart of diabetes, hypertension, and lipid-lowering medications up to 5 years after gastric bypass or sleeve gastrectomy.

Using fee-for-service Medicare claims for patients who underwent laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass from 2012-2018. For the purpose of analysis, investigators created 3 study cohorts to assess effects on medication discontinuation in cohorts defined by use of diabetes, hypertension, and lipid-lowering medications, respectively.

The primary outcome of interest for the study was the discontinuation of diabetes, hypertension, or hyperlipidemia medications, with discontinuation defined as a lapse in claims for a medication refill of 6 months or longer. The secondary outcome of interest was the restart of medication after discontinuation.

Investigators identified a cohort of 95,405 patients for inclusion in their analyses. This cohort had a mean age of 56.6 (SD, 11.8) years and 74.8% (n=71,348) were female. Of the 95,405 patients in the overall study cohort, 30,588 were included in the diabetes cohort, 52,081 were included in the hypertension cohort, and 35,055 were included in the hyperlipidemia cohort.

In the diabetes cohort, the median follow-up time was 307 (IQR, 160-795) days for 16,809 patients who underwent sleeve gastrectomy and 260 (IQR, 158-702) days for 13,779 patients who underwent gastric bypass. In the hypertension cohort, the median follow-up time was 545 (IQR, 250-1091) days for 31,126 patients who underwent sleeve gastrectomy and 613 (IQR, 265-1349) days for 20,955 patients who underwent gastric bypass. In the hyperlipidemia cohort, the median follow-up time was 487 (IQR, 218-963) days for 20,654 patients who underwent sleeve gastrectomy and 419 (IQR, 172-1006) days for 14,401 patients who underwent gastric bypass.

Results of the analysis suggested gastric bypass, when compared with sleeve gastrectomy, was associated with a greater 5-year cumulative incidence of medication discontinuation in the diabetes cohort (74.7% [95% CI, 74.6-74.9] vs 72.0% [95% CI, 71.8-72.2]), the hypertension cohort (53.3% [95% CI, 53.2-53.4] vs 49.4% [95% CI, 49.3-49.5]), and the hyperlipidemia cohort (64.6% [95% CI, 64.5-64.8] vs 61.2% [95% CI, 61.1-61.3]). Similarly, further analysis indicated gastric bypass, when compared with sleeve gastrectomy, was associated with a lower incidence of medication restart in the diabetes cohort (30.4% [95% CI, 30.2-30.5] vs 35.6% [95% CI, 35.4-35.9]), the hypertension cohort (67.2% [95% CI, 66.9-67.4] vs 70.6% [95% CI, 70.3-70.9]), and the hyperlipidemia cohort (46.2% [95% CI, 46.2-46.3] vs 52.5% [95% CI, 52.2-52.7]).

“Long-term prospective trials are needed to explain the mechanisms and factors associated with the differences in medication discontinuation and comorbidity resolution after bariatric surgery,” noted investigators in their conclusion.

Medication Use for Obesity-Related Comorbidities After Sleeve Gastrectomy or Gastric Bypass

A comparative effectiveness study of Medicare claims data suggests gastric bypass surgery was associated with a greater rate of discontinuation of medications for obesity-related comorbidities than sleeve gastrectomy. 

Gastric Bypass Associated with Greater Medication Discontinuation than Sleeve Gastrectomy

Data from an analysis of the Avon Longitudinal Study of Parents and Children (ALSPAC) suggests arterial stiffness in adolescence could cause insulin resistance and dyslipidemia in young adulthood.

The study, which investigators suggest is the largest of its kind to date, provide an overview of the associations between arterial stiffness, as measured by carotid-femoral pulse wave velocity (cfPWV), and carotid item-media thickness (cIMT) progression on the risk of dysglycemia, insulin resistance, and dyslipidemia.

“Our novel findings are clinically significant for pediatric and adolescent health, in that preventing and treating insulin resistance, young-onset type 2 diabetes mellitus, and dyslipidemia may necessitate strategies to concurrently reduce arterial stiffness, particularly from adolescence,” said Andrew Agbaje, MD, MPH, a physician and clinical epidemiologist at the University of Eastern Finland, 

As the diabetes epidemic continues to balloon in the US and abroad, understanding factors associated with increased risk of incident type 2 diabetes could prove beneficial in alleviating the burden of diabetes on individuals and health systems. Citing recent evidence suggesting arterial stiffness could be a novel risk factor in the causal pathway of type 2 diabetes, Agbaje and a team of investigators sought to further investigate potential associations using data from the ALSPAC birth cohort.

A cohort of more than 14,901 children surviving beyond 1 year, the ALSPAC cohort contained data from 3862 participants with data from cfPWV and cIMT assessments performed at 17.7 years. Using this cohort, investigators designed their study to assess temporal causal longitudinal associations of cfPWV and cIMT with fasting LDL-C, HDL-C, triglyceride, glucose, insulin, insulin resistance, and pancreatic beta-cell function at the 24.5-year follow-up.

Compared to their male counterparts, women included in the study had higher fasting total cholesterol, HDL-C, and insulin but lower glucose at both the 17.7-year and 24.5-year follow-up. Investigators noted 9.2%, 41.6%, 24.5%, 7.5%, and 10.3% of 3862 participants were at risk of high glucose, insulin, LDL, triglyceride, and low HDL, respectively, at 24.5 years.

Upon analysis, results suggested a higher cfPWV at 17.7 years was associated with increased insulin at 24.5 years, which investigators pointed out was slightly attenuated after adjustment for covariates. Higher cIMT at 17.7 years was associated with lower insulin at 24.5 years after adjustment for covariates.

In mixed-effect models, results indicated the 7-year progression of cfPWV was directly associated with an increase in triglycerides. Further analysis demonstrated cIMT progression was associated with increases in LDL-C, triglycerides, and glucose. In cross-lagged models suggested higher cfPWV at 17.7 years was associated with higher insulin (β=.06, SE, 0.12, 

=.014), HOMA of insulin resistance, and HOMA-percent pancreatic beta-cell function at 24.5 years. However, in the same models, insulin, HOMA of insulin resistance, and HOMA-percent pancreatic beta-cell function at 17.7 years were not associated with cfPWV at 24.5 years.

Investigators pointed out higher cIMT at 17.7 years was associated with reduced insulin HOMA of insulin resistance, and HOMA-percent pancreatic beta-cell function at 24.5 years, but not vice versa. Additionally, higher glucose at 17.7 years was associated with higher cfPWV and cIMT at 24.5 years.

Effect of Arterial Stiffness and Carotid Intima-Media Thickness Progression on the Risk of Dysglycemia, Insulin Resistance, and Dyslipidemia: a Temporal Causal Longitudinal Study,

The largest study of its kind to date provides evidence suggesting a causal relationship between cfPWV and cIMT in adolescence with increased insulin resistance and dyslipidemia in young adulthood. 

Arterial Stiffness Could Cause Insulin Resistance, Dyslipidemia

The US Food and Drug Administration has approved the Omnipod 5 Automated Insulin Delivery System for use in individuals aged 6 years and older with type 1 diabetes, according to a 

Announced on January 28, Insulet suggests the approval Omnipod 5 the first tubeless automated insulin delivery system with the ability to integrate with the Dexcom G6 continuous glucose Monitoring System and a compatible smartphone to automatically adjust insulin and protect against glycemic events.

“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, President and CEO of Dexcom, in the aforementioned statement. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”

The Omnipod 5 system includes a tubeless pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app, which includes a SmartBolus calculator. When in use, the Pod with SmartAdjust technology receives a CGM value and trend every 5 minutes which is used to predict glucose levels an hour in the future.

In their statement, Insulet noted the Omnipod 5 will launch in a limited market release initially to allow them to incorporate learnings and improve user experience, but the Omnipod 5 will become broadly available shortly after the limited market release.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”

Announced on Jan. 28, the Omnipod 5 AID becomes the first tubeless automated insulin delivery system with the ability to integrate with the Dexcom G6 continuous glucose Monitoring System and a compatible smartphone to automatically adjust insulin and protect against glycemic events

FDA Approves Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes in Ages 6 and Older

New research from the University of Boston and the National Center for Posttraumatic Stress Disorder at the US Department of Veterans Affairs is providing clinicians with insight into the impact of anxiety and mental stress on cardiovascular and diabetes risk in men.

An analysis of data from an ongoing 40-year study of male patients suggests higher anxiety levels in middle adulthood were associated with stable differences in cardiometabolic risk trajectories that were maintained into older ages and also suggests anxious individuals might experience earlier deteriorations in cardiometabolic health.

“While the participants were primarily white men, our findings indicate higher levels of anxiousness or worry among men are linked to biological processes that may give rise to heart disease and metabolic conditions, and these associations may be present much earlier in life than is commonly appreciated – potentially during childhood or young adulthood,” said Lewina Lee, PhD, lead author of the study, an assistant professor of psychiatry at Boston University School of Medicine, and an investigator and clinical psychologist at the National Center for Posttraumatic Stress Disorder at the U.S. Department of Veterans Affairs, 

Although anxiety has been linked to an increased risk of cardiometabolic disease, evidence gaps prevent clinicians from achieving a complete understanding of the mechanisms behind the association. With this in mind, Lee and fellow investigators sought to assess the prospective association of neuroticism and worry with cardiometabolic risk trajectories over a long-term period.

Leveraging data from the Normative Aging Study, investigators identified a sample of 1561 for inclusion in their final analyses. The Normative Aging Study was a longitudinal study of aging processes in men established by the VA Boston Outpatient Clinic that enrolled 2280 men between the ages of 21-80 years between 1961 and 1970. Investigators considered examination data from these patients through December 31, 2015.

As part of the Normative Aging Study, neuroticism and worry were assessed in a pair of mail surveys administered in 1975 that assessed neuroticism with 9 dichotomous items of the EPI-Q and worry using a content-based paper-and-pencil scale asking patients to rate how much they worry about various issues using 20 items on scale of 0-4. For inclusion in the investigators’ final analyses, patients need to complete at least 1 of the 2 mail surveys and have no missing data related to comorbidities or follow-up examinations.

At baseline, the analytic sample had a mean age of 53 years (SD, 8.4 years; range, 33–84 years), 91% were married, 97% were White, and the mean follow-up time was 22.9 (SD, 11.2) years. During the follow-up period, the mean number of examinations was 6.6 (SD, 3.4; range, 1-15), 219 men were seen within 3 years of the end of follow-up, and 1067 died.

For the purpose of analysis, investigators used mixed-effects regression to model cardiometabolic risk trajectories over age and assessed their associations with neuroticism and worry. Additionally, Cox regression was used to assess associations of neuroticism and worry with risk of having 6 or more cardiometabolic risk biomarkers through 2015.

Upon analysis, results indicated cardiometabolic risk increased at a rate of 0.8 markers per decade from age 33-65 years, at which point men had a mean of 3.8 high-risk factors. After 65 years, the rate of cardiometabolic risk factors increased at a rate of 0.5 markers per decade. Investigators pointed out higher neuroticism (B=0.08; 95% CI, 0.02-0.15) and worry levels (B=0.07; 95% CI, 0.001-0.13) were associated with increased risk over time. In adjusted analyses, this translated to 13% (95% CI, 1.03–1.23) and 10% (95% CI, 1.01–1.20) greater risks of having 6 or more cardiometabolic risk markers for higher neuroticism and worry, respectively.

“It would be important for future studies to evaluate if these associations exist among women, people from diverse racial and ethnic groups, and in more socioeconomically varying samples, and to consider how anxiety may relate to the development of cardiometabolic risk in much younger individuals than those in our study,” Lee added.

Neuroticism, Worry, and Cardiometabolic Risk Trajectories: Findings From a 40‐Year Study of Men,

Journal of the American Heart Association.

An analysis of data from the Normative Aging Study provides insight into associations of neuroticism and worry with risk of cardiometabolic disorders in men over a 40-year period.

Stress, Anxiety Linked to Greater Risk of Cardiovascular Disease, Diabetes in Aging Men

I’d be interested in what Dr Bhatt says his screening would be in the patient who hasn’t had an event before, who has all their factors controlled, their diabetes, their blood pressure and lipids are controlled by the referring doctor. Some of our doctors do cardiac calcification scores, scares the patient, but they’re already on a statin and their LDL [low-density lipoprotein] is below 70 mg/dL, and I have them on the works of heart-smart drugs and all that. Some of them do stress tests, so I’d be interested in what screening is done. The cardiologists tend to do different things, so I’d be interested in what the guru does.

Dhiren Patel, PharmD, CDCES, BC-ADM, BCACP:

Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC:

 I think if it’s a tough situation, I just send them to an endocrinologist. That’s what I do. But assuming it’s not too challenging, generally speaking, the guidelines are pretty firm about what things to test for. It’s usually the simple stuff: LDL, cholesterol, blood pressure, glucose, weight. I actually prefer waist circumference, but I think weight or BMI [body mass index] are the more standard ones. Screen for smoking. Beyond that, everything else really is supposed to be symptom-driven. These days, the annual stress test per the guidelines is out, even though that remains a common practice. Any sort of imaging testing or invasive testing, in general, is meant to be driven by the presence of symptoms, such as suspected angina. Though coronary calcium you mentioned; there, that has been promoted in recent years as a way, if there’s really a question to be answered in terms of figuring out if a patient is at high risk. For example, a patient where maybe you think they need to be on a statin but there’s statin hesitancy. There perhaps getting coronary calcium can help tip things over where the patient says, “Oh yeah, I do have plaque in the coronaries. Maybe it’s time to go and start that statin.” I think there’s a role, but I suspect in years to come, there’s going to be a much more prominent role played by imaging tests, even in people who are asymptomatic. But at least per the guidelines, we’re not quite there yet.

 Thank you. Jen, how are you guys classifying this risk and screening?

Jennifer Goldman, RPh, PharmD, CDCES, BC-ADM, FCCP:

 Community pharmacists are highly accessible, and almost every human being goes into a pharmacy at some point. I think that they also get to know their patients, just like in primary care, so they’re in a unique position to be able to say, “Hey, have you seen the doctor? Hey, have you been screened for this? Have you considered this? Have you talked about this?” I think that pharmacists in the community can help answer those questions or at least put it into patients’ minds that, “You need to go see your doctor. Have you had your blood pressure checked? Have you had your cholesterol checked? Have you considered these things?” Even to just make those suggestions, to make sure they’re seeing the appropriate providers. Then clearly the pharmacists who are within primary care or within cardiology and endocrinology are working with the team in terms of drug therapy management, but the community pharmacist is in that unique position.

Videos

Criteria and types of health care professionals who may screen patients at high risk for cardiovascular disease.

Screening for Cardiovascular Disease

 Dr Busch, when you think about some of these risk factors that are associated with what Dr Bhatt just mentioned, how are you talking to your patients about these risk factors? I sometimes think about them as modifiable, nonmodifiable. And then, what are the efforts that you are doing, and we’ll maybe go around, of screening these cardiovascular risks? You’re very involved in clinical trial research. I feel like you’re constantly looking at panels and seeing who could potentially be at risk. So maybe talk to us a little about those risk factors and how your practice takes on the screening of these cardiovascular risks.

 For an endocrinologist, most of our patients have diabetes and mainly type 2 diabetes, but they don’t just come in with a diabetes, as Jen and others have said. They come in with diabetes, hypertension, hyperlipidemia, and obesity; they come in with hypertriglyceridemia. So, which one are we going to tackle first? Say they’ve done the lifestyle stuff, they’ve met with the diabetes educator, and you know they’re going to end up on 6 or 7 drugs down the line. Well, visit 1, you’re not giving them the works. You could, but then the patient will put their shoes and socks on and run away. You have to choose your battles first, and what you’re going to be successful with early. Oftentimes, the LDL [low-density lipoprotein] is the easiest thing to control because the statins work, and if they can tolerate the statin, at least you could show success after the first visit, that you got their LDL at a target, and then try to address the other things.

If they come in with an A1C [glycated hemoglobin] over 7.5%, you’re going to give them 2 drugs for diabetes and heart-smart drugs. You give them a statin, or a statin plus something else to get their LDL down. Now we have the REDUCE-IT trial that Dr Bhatt is famous for. You’re going to look at the triglycerides and do something about that as an additional marker. And then of course, their blood pressure. And even if their blood pressure is good, congratulations, you have good blood pressure, here’s your ACE [angiotensin-converting enzyme inhibitor] or ARB [angiotensin receptor blocker] based on the HOPE trial. Congratulations, your LDL is 92 mg/dL, here’s your statin based on the CARDS study, that statins should be in the drinking water of diabetes.

You have to roll out the regimen for the patient, and most of our patients, if you ask them what did they have for breakfast? Their answer is pills, because after a year, they’re on 6 or 7 medications and some injectables as well. So, each thing has to be addressed, because these are risk multipliers, and you want to address each thing. But it takes about 6 months to a year to roll out the full regimen that the patient is going to be on. But you’re not telling them day 1, especially if they come in saying, “I don’t want medications, I want to treat things the natural way,” and you know what you have cooking down the line.

 Absolutely. It’s a lot, especially as some of these medications start blurring and have cardiac benefits, you have different specialties that normally didn’t use them that are now using them. And we’re going to get to that. Joyce, when we started, you mentioned you spent a lot of time on both preventive cardiology and secondary prevention. From where you sit in the specialty arena, where you get to interact with endocrinologists and pharmacists and cardiologists, how do you go about what Dr Busch just mentioned, with primary prevention and secondary prevention? How do you tackle each of those?

Joyce Ross, MSN, RNC, CRNP, CS, FNLA, FPCNA:

 Well, I think the first thing I want to say is, I totally agree with Dr Busch that we really can’t just throw everything at the patient the first time we see them. They will run and they won’t come back. And the idea of multiple medications all at one time is something that me is a nurse practitioner, a person who sees the patient on a regular basis, even more than perhaps the physicians in the various settings, I’m kind of a gatekeeper in a lot of ways. At least for our practice, I would be able to make sure that everybody was getting the information. I think communication between the health care providers is critically important, because this is a team. And of course, the most important part of the team is that patient. So, for me, every time a patient is seen by any of a group, and it’s wonderful if you’re all in the same health system, and you can just pick up where you where you want to, but that’s not always ideal. But what happens, what is very important, is for you, as a provider, no matter what your entity is, to communicate with the others about what you saw, what you did, how the patient is doing.

And you know what? The most important thing to me is that patient gets that same letter, because they need the congratulations, they need that idea that, “look what we did.” Again, to go back to what Dr Busch was saying, we’re helping them and supporting them in the decision that they have to make to take a lot of medication. I think that the most important thing is to depend on all the team, communicate, but communicate first with the patient. My opportunities have always been to develop long-term relationships with the patients, because dyslipidemia is not something that’s going to go away. And I’ve taken care of patients from the time they’ve been 6 years old until out of college, married and have children. This long relationship that you have with them is critically important. As a nurse practitioner, I’ve been fortunate to do that, where many specialists don’t have that opportunity. When others communicate with me, I have a great chance of weaving their thoughts and plan into the overall plan. That’s how the team works.

Recommendations for establishing relationships and talking with patients about primary and secondary prevention against cardiovascular events.

Counseling Patients on CVD Risk Factors

A new study from John Hopkins University is drawing attention to the need for regular screenings as well as interventions to address 

Results of the study, which leveraged data from all patients with 

 in the Geisinger Health System over a 15-year period, suggests rates of obesity among patients with type 1 diabetes had were similar to that of the general population and patients with type 1 diabetes had a greater risk of kidney disease in an age-adjusted analysis.

“Our study shows that obesity rates in adults with type 1 diabetes are increasing and mirror the rates in the general adult population,” said Elizabeth Selvin, PhD, MPH, of Johns Hopkins Bloomberg School of Public Health and John Hopkins University, 

. “Our research also highlights the high risk of kidney disease in people with type 1 diabetes. Kidney disease is often considered more common in people with type 2 diabetes, but our data shows adults with type 1 diabetes actually had a higher risk of kidney disease than those with type 2.”

Funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, the current study  was designed by Selvin and a team of colleagues to better understand the impact of obesity and chronic kidney disease in populations with type 1 diabetes compared with patients with type 2 diabetes. Using data from the Pennsylvania-based Geisinger Health System from 2004-2018, investigators identified 4060 patients with type 1 diabetes and 135,458 patients with type 2 diabetes for inclusion in their analysis.

The primary outcomes of interest for the study included trends in obesity, low eGFR, and albuminuria. Investigators defined low eGFR as below 60 mL/min/1.73m2, and albuminuria as a urine albumin-to-creatinine ratio of 30 mg/g or more. For the purpose of analysis, investigators used multivariable logistic regression to evaluate the independent association of obesity with chronic kidney disease in 2018.

Compared to their counterparts with type 2 diabetes, patients with type 1 diabetes were younger (median age: 62 vs 39 years) and had a lower crude prevalence of low eGFR across all study years (2018: 30.6% vs 16.1%). However, after adjustment for age differences, prevalence of chronic kidney disease was greater in type 1 diabetes than type 2 diabetes in all study years (2018: 16.2% vs 9.3%).

Analysis of obesity rates suggested the rates of obesity increased over the study period among patients with type 1 diabetes, with rates increasing from 32.6% in 2004 to 36.8% in 2018. In comparison, rates of obesity remained stable in patients with type 2 diabetes throughout the study period. Additionally, results indicated a diagnosis of obesity was associated with increased odds of low eGFR in both type 1 (aOR, 1.52 [95% CI, 1.12-2.08]) and type 2 diabetes (aOR, 1.29 [95% CI, 1.23-1.35]).

“Our results highlight the need for interventions to prevent weight gain and end-stage kidney disease in people with type 1 diabetes,” Selvin added.

Obesity and Chronic Kidney Disease in US Adults With Type 1 and Type 2 Diabetes Mellitus

The Journal of Clinical Endocrinology & Metabolism.

An analysis of data from more than 135k patients with type 1 and type 2 diabetes indicates the age-adjusted rate of chronic kidney disease was greater in type 1 diabetes and also sheds light on the rising rate of obesity in type 1 diabetes.

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