Recently I came across an FDA website that peaked my curiosity and interest.  After dabbling with its interactive format, I thought this would be interesting to share because it is one of the few places where one can find demographic information about recently approved medications.  Although the site, Drug Trials Snapshots, is principally designed to provide consumers with information about subjects who participated in clinical trials that supported the FDA approval of new drugs, it might also be useful for healthcare professionals.  This is because the information highlights whether there were any differences in the benefits and side effects among sex, race and age groups – something that is long overdue and may be helpful when assessing the appropriateness of prescribing medications for different patient types.  We are all aware of the fact that certain drugs work better in certain types of patients and not others.  Conversely, dosing requirements and side effects may differ depending on age, race and sex.

In addition to information about what the drug is used for, potential benefits and side effects, who participated in the clinical trials, and trial design, each drug has a section that provides subgroup analyses conducted for sex, race, and age.                            

Here are two randomly chosen examples:

ENTRESTO is a drug to be taken in conjunction with other heart failure therapies for the long-term treatment of chronic heart failure.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: ENTRESTO worked similarly in men and women.
• Race: ENTRESTO worked similarly in all races studied.
• Age: ENTRESTO worked similarly in all age groups studied

Were there any differences in side effects among sex, race and age?

• Sex:  The risk of side effects appeared to be similar in men and women.
• Race:  There was an increased risk of an allergic reaction called angioedema in black patients.
• Age: The risk of low blood pressure was higher in patients 65 years and older.                                             

OCREVUS is used for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: OCREVUS worked similarly in men and women with RMS, but better in men with PPMS.
• Race: Most of the patients were White. The number of patients of other races was limited; therefore, differences in response to OCREVUS among races could not be determined.
• Age: OCREVUS worked similarly in age groups studied. The number of patients above 65 years of age was limited, however, so that differences in response between patients above and below 65 years of age could not be determined.

Were there any differences in side effects among sex, race and age?

• Sex: The risk of side effects was similar in in men and women.
• Race: Majority of the patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
• Age: The risk of side effects was similar in age groups studied. The number of patients above 65 years of age was limited; therefore, differences in response between patients above and below 65 years of age could not be determined.
  

  
  

  Though limited in the amount of detail provided, Drug Trials Snapshots is definitely a step in the right direction for patients and providers alike.   Check it out! 

                           https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots

Judith Wolf, MD   Associate Director, WHEP

 

PrEP’d? I was NOT ready!

Before starting the college health rotation with Drexel student health, my knowledge about PrEP (HIV Pre-exposure Prophylaxis) was fairly limited. I knew that it was marketed to populations at higher risk of HIV infection and that was about it. I could have never guessed how frequently I would have come across its prevalence in Student Health at Drexel University and needless to say, I was relatively unprepared. I knew working in college health, addressing sexual health would be well within my responsibilities. I was ready to comfortably ask questions about sexual health: are you sexually active? Do you prefer men, women or both? How many partners do you have/is this an exclusive or casual relationship? Do you engage in oral, vaginal, anal sex? Do you use toys? Do you use condoms? Are you on birth control if so, which one? I even got to the point where I knew it was better to ask if someone was top, bottom or verse as opposed to anal-receptive, penetrative or both (terminology I felt to be a little too sterile, especially with this younger population). These questions helped steer the conversation during the visit. I was ready to discuss safe sexual practice, nudge an STI check, and engage in one size does not fit all conversation (both figuratively and literally). But I missed the mark when it came to discussing PrEP.  By my fourth year of medical school, I had a solid understanding about interventions if a patient were to become infected, but I was missing a key component of infection prevention. As I was fairly ignorant of its uses and contraindications, I found that I could not properly engage in the conversation.

As I have seen first-hand, HIV Pre-exposure Prophylaxis has gained an increasing presence in college health. This is largely due to the American College Health Association (ACHA) and their push to address college sexual health and improve its practices. The ACHA is a large supporter of broad access to PrEP in college and university health services. This makes sense when considering the ages of newly diagnosed patients and the average aged college individual. According to the CDC, “young adults ages 13–24 accounted for 21% of new HIV infections in the United States in 2016”. This incidence is not lost on the ACHA. They make the point that “college health is uniquely positioned to make a significant impact in the health of young adults in the U.S. by offering PrEP as a standard health care service.” PrEP can reduce the risk of HIV infection by 90% when taken as prescribed and used in conjunction with condoms and other prevention strategies.

It is imperative that as a healthcare provider, we should be proactive about addressing the benefits of PreP to whom it is recommended. Whether in college health or not, chances are that our paths will cross with individuals who could benefit from being on PrEP.  A 90% reduction of infection is nothing to sneeze at and so, arming ourselves with knowledge about this drug is absolutely required. 

Brittney Bruno    DUCOM 2020