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Lyric of the Week: STUDY DESIGN (of a Radical New Treatment for a Broken Heart)

Ekklaopril, an oral, single-dose emotional stress–caused cardiomyopathy inhibitor, was shown to have potential maximum efficacy as therapy for acute heartbreak syndrome (ACHS), also known as broken heart syndrome (BROKHS).

EX-TREKK (EXperimental TRial of EKKlaopril in acute heartbreak syndrome) was a large, community-based, prospective, randomized, open-label, multicenter, double-blind, double-dummy, placebo-controlled, active-controlled, crossover, head-to-head, single-dose, 24-month study of subjects suffering from acute heartbreak syndrome.

All patients in the EX-TREKK study were adults over 21 years of age with confirmed diagnosis of moderate to severe ACHS for at least 1 year. No patients under the age of 21 were included in the trial due to prevalence of adolescent emotional hyperbolic instability, which usually resolved without treatment between 3 and 12 months after initial trauma.

In the EX-TREKK study, 1407 patients suffering from acute heartbreak/broken heart syndrome were given experimental doses of ekklaopril at 18 mg once daily. In 794 subjects with ACHS/BROKHS resulting from breakup, 420 subjects were treated with ekklaopril and 374 were treated with placebo over the course of 12 months. In 613 subjects with ACHS/BROKHS resulting from divorce, 365 were treated with ekklaopril and 248 with placebo over 24 months.

The primary endpoint was complete cure of a broken heart. Secondary endpoints included getting over the past, moving on, not being tempted to go back to the ex, and avoiding making the same mistakes again.

Primary endpoint for postbreakup patients was reached after 14 weeks of treatment with ekklaopril and 3.5 months of treatment with placebo, and for postdivorce patients, primary endpoint was reached after 78 weeks of treatment with ekklaopril and 1.5 years of treatment with placebo. In other words, six of one, half a dozen of the other.

The most commonly seen adverse reactions included fever, headache, high blood pressure, increased pulse rate, fibrillation, palpitation, lachrymosity, naïveté, gullibility, hoping against all logical hope that the ex will have you back again, looking for someone new who is exactly like the ex, falling for the same old tricks and charms, getting your buttons pushed, relapse, rinse, repeat.

Several cases of congestive heart failure, cardiac arrest, and myocardial infarction were reported. Nobody said this was foolproof. Survivors of extreme adverse events did state desire for being a fool for your lovin’ no more.

Infrequency of adverse events may be minimized by careful individualization upon initiation of therapy.

There are no controlled trials demonstrating an actual clinical benefit, such as improvement in ACHS-related symptoms or increased survival. Results may vary. As with all such treatments, use at your own risk. Best thing to do is lay off the drugs and find other ways to get over it. Everybody does, and you will, too.

But please see full Prescribing Information, including BOXED WARNING and Medication Guide, if you insist on going this route. Don’t say we didn’t warn you.

©2024 The Hesh Inc.

"Study Design #3" - original AI art by The Hesh Inc.
Ad for the new wonder drug.

In July 2007, several years after I got divorced, moved back to the East Coast, and subsequently bumped along underemployed as a limousine driver for a year and a half, I finally got a capital-J Job as an editor for a pharmaceutical ad agency based in Manhattan. I got in on the strength of my knowledge of the English language and my previous job experience in various editorial positions; it didn't hurt that my ex was herself a physician. Needless to say, it was a huge relief after where I had been. It was also a considerable boost to my self-esteem and prestige among my friends and peers, and it was for me an entry into a whole new world.

While I was still driving limos, the music of Tom Waits, particularly his second through seventh albums, became a large part of my soundtrack, especially on deadhead trips back to base from the airport in the wee hours. It was during this time that I wrote "Clogged Arteries," an "emotional traffic report" borrowing its concept from the opening monologue to Tom's Nighthawks at the Diner album. Once I was safely ensconced at my new job and commuting to and from the city via train, I thought of giving a similar treatment to the many pharmaceutical study designs that were incorporated into the materials I edited. But life got in the way, and my assorted trials, tribulations, and displacements were far from over ... and the song languished, unfinished (actually, barely even started). In the spring of 2022, after my father passed away, I became acutely aware of my own mortality, and the thought that there was more behind me than ahead of me jump-started a whole campaign of completing all the unfinished songs and song ideas populating my notebooks. By December 2023 I had finished just about all of them, but only this one remained, and it remained stubbornly intractable. It was as if it knew that I couldn't call my songwriting completion endeavor done until I had turned it from a collection of throwaway lines (begun in red pen in the back of the steno pad I used at work) into a proper Song. But in the last week of the month, when the pharma industry takes a vacation, I took my songwriting notebook with the rough sketch of the song with me to the Allegria Hotel on the boardwalk of my old hometown of Long Beach, New York, took a seat in its lobby lounge looking out at the beach and the spectacular sunset, ordered an espresso martini, and so help me G-d, I finished the song on December 28. It was the final touch, the last hammer hit as it were, to my entire songwriting endeavor that had begun while I was a teenager in high school. This isn't to say that I'll never write another song (as it happens, I had written two new ones since then), but the huge logjam that characterized my songwriting was finally cleared.

As for the music ... I imagine a bluesy groove behind it, one of many that I had come up with and jammed on in my many years of playing in bands. What will become of the song, in terms of recording and production, has yet to be seen.

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