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