Wednesday, November 8, 2023

I'm a little pill with a big story to tell

O

nce upon a time, I was called empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated, among other things, for reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease, and also an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

 

I was just enjoying life, content with my lot as an SGLT2 inhibitor, when the good people from Boehringer Ingelheim showed up. They ran all sorts of trials on me—phase I, phase II, and even phase III. They were randomized, they were controlled, they were double-blind, they were multicenter, they were placebo-controlled. All in an effort to help people with diabetes lower their A1c. Along the way, I was honored and humbled to receive approval from the Food and Drug Administration (FDA).

 

Boehringer Ingelheim baptized me and called me Jardiance. I wasn’t just hard-to-pronounce generic empagliflozin anymore. I had a name! A real name! Something musical that just rolled off the tongue.

 

Then, late last year, a breakthrough! The DINAMO phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c compared with placebo for children and adolescents aged 10–17 years living with type 2 diabetes!1 It turns out that when Jardiance was added to other baseline treatments (diet, exercise, metformin and/or insulin) HbA1c was reduced by 0.84% compared with placebo at week 26 (95% CI –1.50 to –0.19; P=0.012).

 

Woo-hoo!

 

You might have seen me around. Sometimes I’m 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with “S 10” on one side and the Boehringer Ingelheim company symbol on the other side. But sometimes I’m 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with “S 25” on one side and the Boehringer Ingelheim company symbol on the other side.

 

Be careful with me, though—there have been reports of urosepsis, genital mycotic infections, and necrotizing fasciitis of the perineum. But let’s not worry about that unpleasantness now.

 

Since that phase III study in Lancet Diabetes and Endocrinology, everything’s just been coming up Jardiance! They shot a big-budget commercial that the public has just enthusiastically embraced. You all know the lyrics:

 

I have type 2 diabetes but I’m wearing it well

It’s a little pill with a big story to tell

I take once daily Jardiance at each day’s start

 

As time goes on, it’s easy to see

I’m lowering my A1c

Jardiance is really swell

The little pill with the big story to tell!

 

No need to thank me for giving you this earworm today. Anyway, America can’t get enough of this commercial! They made it a big, splashy musical and hired an actress to do all these amazing dance moves (seriously, the way she waves her arms and jumps from side to side is worthy of the late Tina Turner) on top of this fountain in a town square. Then, just when you think it can’t get any better, she changes into this dazzling yellow dress and keeps on dancing! And everybody is just controlling their A1c and losing weight and diabetes is just a big party!

 

I’m Jardiance, the swell little pill, and that’s my story!

 

THE END

 

Reference

1. Laffel LM, Danne T, Klingensmith GJ, Tamborlane WV, Willi S, Zeitler P, Neubacher D, Marquard J; DINAMO Study Group. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):169-181. doi: 10.1016/S2213-8587(22)00387-4. Epub 2023 Feb 1. PMID: 36738751.