Drug Topics staff

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.

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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

The FDA has granted emergency use authorization (EUA) to Johnson & Johnson for its COVID-19 vaccine following an advisory panel meeting on Friday.

The vaccine, named Ad26.COV2.S, is the first single-dose COVID-19 vaccine and the third vaccine to be authorized in the US for the virus.

The EUA is based on the phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.

As part of its authorization, the FDA noted it is mandatory for Janssen Biotech and vaccination providers to report the following to the Vaccines Adverse Event Reporting System for Janssen COVID-19 Vaccine: serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA, through our open and transparent scientific review process, has now authorized 3 COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

 for more information on the vaccine’s efficacy and safety data. 

1. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. News release. FDA; February 27, 2021. Accessed February 27, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

Articles

The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.

FDA Grants Emergency Use Authorization to Third COVID-19 Vaccine

Several drug approvals made headlines this year, ranging from novel treatments to exciting new indications for existing drug therapies.

 coronavirus disease 2019 (COVID-19) vaccines, both of which were granted emergency use authorization by the FDA in December. In another historic feat, 

remdesivir (Veklury; Gilead) scored an approval

 from the agency as the first drug treatment for COVID-19 on October 22. Remdesivir is indicated for use in hospitalized adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms.

Apart from record-breaking COVID-19 approvals, there were plenty of other noteworthy drug approvals from 2020.

Here are some of the top-read FDA approvals covered by 

10. FDA Approves Oliceridine for Pain Management in Hospitals, Controlled Clinical Settings

Oliceridine (Olinvyk; Trevena Inc), which was approved in August, is an opioid agonist for the management of pain that is severe enough to require intravenous opioid and when alternative treatments are ineffective.

In September, the FDA approved 2 additional doses of dulaglutide (Trulicity; Eli Lilly) for the treatment of type 2 diabetes. Approval of the 3.0 mg and 4.5 mg doses was based on favorable results in regard to A1C and body weight reduction, stemming from the phase 2 AWARD-11 clinical trial comparing the additional doses with 1.5 mg doses in individuals with type 2 diabetes.

8. FDA OKs New Indication for Esketamine Nasal Spray

In August, esketamine (Spravato; Janssen) CIII nasal spray became the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

7. FDA Approves CBD Treatment for Seizures in Rare Genetic Disease

The FDA approved cannabidiol (CBD) (Epidiolex; Greenwich Biosciences Inc) oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.

The latest indication is only the third approval for CBD, and follows the FDA’s recent draft guidance for conducting CBD research to facilitate and support safe and effective study results.

6. FDA OKs First Treatment for Ebola Virus

Regeneron’s Inmazeb became the first FDA-approved treatment 

 (Ebola virus) infection in adult and pediatric patients when it was granted approval in October. The monoclonal antibody mixture is composed of atoltivimiab, maftivimab, and odesivimab-ebgn.

5. FDA Approves Mepolizumab for Hypereosinophilic Syndrome

The FDA approved mepolizumab (Nucala; GlaxoSmithKline) as the first biologic treatment for hypereosinophilic syndrome in adult and pediatric patients aged 12 and older.

4. FDA Approves Tofacitinib for Juvenile Idiopathic Arthritis

The FDA approved tofacitinib (Xeljanz; Pfizer) for the treatment of children and adolescents 2 years of age and older with active polyarticular course juvenile idiopathic arthritis, making it the first and only Janus kinase inhibitor approved in the US for this indication.

3. FDA Approves Baloxavir Marboxil for Post-Exposure Prophylaxis of Influenza

Baloxavir marboxil (Xofluza; Genentech) received FDA approval for the prevention of influenza in individuals aged 12 years of age and older following contact with a person infected with the fly, making it the first single-dose influenza medicine approved for post-exposure prophylaxis. 

2. FDA Approves Dupilumab for Atopic Dermatitis in Children

In May, dupilumab (Dupixent; Sanofi and Regeneron) received approval for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years old. With this approval, dupilumab is the only biologic medicine approved for this patient population.

1. FDA Approves Ozanimod for Relapsing Multiple Sclerosis

The FDA granted approval to ozanimod (Zeposia; Bristol Myers Squibb) in March for the treatment of relapsing multiple sclerosis. The approval includes indicated uses for clinically isolated syndrome, relapsing-remitting disease, and active secondary disease.

Here are some of the top-read FDA approvals covered by Drug Topics® from this year.

Top FDA Approvals of 2020

The coronavirus disease 2019 (COVID-19) pandemic has dominated headlines and remained a centerpiece of much of our coverage this year. However, there were plenty of other news topics that resonated with readers––from product recalls and FDA approvals to new and exciting medical research.

As we look back at 2020 and ahead to 2021, the 

® team rounded up some of our top-read articles from the last year.

10. New Diabetes Medications, Technologies You Should Know

With new drugs and technologies available, pharmacists are at the forefront of the effort to educate patients and health care professionals about diabetes treatments, monitoring options, and pipeline drugs.

9. USPSTF Issues Draft Recommendation on Vitamin D Screening in Adults

The US Preventive Services Task Force concluded that the current evidence is insufficient to make a recommendation for or against vitamin D deficiency screening in asymptomatic adults.

8. Psychedelic Medicines for Pain Go Mainstream

This article, published in July, provides an overview of certain illicit drugs being researched as potential alternatives to opioids in pain management. Substances including cannabis, psilocybin, and kratom are discussed.

7. All Pharmacists Now Authorized to Administer Childhood Vaccines

In August, the Department of Health and Human Services authorized all state-licensed pharmacists to order and administer childhood vaccinations amid the COVID-19 pandemic.

6. Premature Testing More Likely to Result in False Negative for COVID-19

In June, a Johns Hopkins research team of investigators suggested that testing infected individuals too early for COVID-19 may result in a false negative, even though they may test positive for the virus later.

5. Study Suggests Digestive Symptoms May Be Associated with COVID-19

Early on in the pandemic, a study from China reported that approximately half of patients in the Wuhan outbreak presented with digestive symptoms as their chief complaint. The findings suggested that digestive symptoms, such as diarrhea, could be a presenting feature of COVID-19.

4. 8 Things to Know About the Spanish Influenza Pandemic of 1918-1919

As the world grappled with the COVID-19 pandemic this year, our 2018 article on the Spanish flu pandemic resurfaced among readers. Take a look back at one of the worst pandemics in global history with this article.

3. FDA Approves Oliceridine for Pain Management in Hospitals, Controlled Settings

In August, the FDA approved olicieridine (Olinvyk; Trevena Inc), an opioid agonist for the management of pain that is severe enough to require an intravenous opioid and when alternative treatments were ineffective.

2. First Big Metformin Product Recalled, More on the Way

In more big news from the year, an FDA investigation identified elevated levels of the carcinogenic ingredient N-nitrosodimethylamine in certain extended-release (ER) metformin products, spurring a number of product recalls. 

In May, Apotex Corp and Amneal Pharmaceuticals both issued voluntary recalls of their metformin hydrochloride ER tablets.

COVID-19–related news dominated headlines for many reasons, but this article on the virus’ effect on shingles was the top-read piece on the 

The article discusses the effect of coronavirus-related stress on the human body and the potential triggering effects for individuals with underlying health conditions.

The Drug Topics® team rounded up some of our top-read articles from the last year. 