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Evenity safer than Tymlos / Forteo for Cardio Vascular Risk?
Hey Everyone,
I know this is a huge topic on the site so I wanted to share a new study that was discussed at the 2024 World Congress of Osteoporosis. The study came to the conclusion "In a diverse real-world setting, prescription of romosozumab for osteoporosis is associated with less adverse CV events when compared to PTH analog therapy". You can find it here https://pubmed.ncbi.nlm.nih.gov/38482603/
Mike
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Could that be because those at risk of CV events are steered away from Evenity so would not be included in the study?
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Hug
2 ReactionsGood point, could be. I only have the abstract to go by right now but it does state "matched cohorts were created 1:1 using demographic variables, comorbidities, and medications". Not much to go by. Maybe someone will pay the $41 to get the full study 🙂
I have learned to look at exclusion criteria for trials. I was rejected because of my bone marrow disorder for one that was evaluating the use of EQUOL for addressing arterial stiffness. Recently there was a post about one looking at alternating Evenity with ReClast. That one listed having a bone marrow disorder as an exclusion.
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Hug
2 ReactionsI have posted several times about the FRAME and ARCH studies. Evenity was no different from placebo regarding cardiovascular events, and was slightly worse than alendronate, maybe, according to the study, because alendronate is slightly protective.
@michaellavacot I wonder if the study comparing it with PTH meds is apples and oranges. In my experience Forteo and Tymlos speed up the heart and lower blood pressure. Evenity, on the other hand, seemed to be a concern regarding atherosclerosis of blood vessels. Kind of different.
With Evenity I am more concerned about the effects of sclerostin inhibition NOT studied enough, including bone marrow edema @normahorn and effect on B cell production.
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4 ReactionsHi @windyshores - Not sure if it's a fair comparison. It would be nice to see the full study paper. Another factor might be male versus female. The PTH studies would have many more males than the Evenity since Evenity is not approved for males. Males have more CVD events than females in general.
@michaellavacot
Have you heard or read (in regards to starting Evenity) that Sclerostin levels should be measured before using Evenity. As those with naturally lower levels of Sclerostin may be at greater risk of a cardiac adverse event.
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1 ReactionI haven't heard or read about measuring sclerostin levels before taking Evenity. I have heard that the risk of a cardiac adverse event is very low if any signal while taking Evenity. There was a trial of Evenity versus alendronate where there was a signal, but the belief is that alendronate might be cardio protective. A placebo was not included in that trial.
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1 ReactionWere those at highest risk of cardiac events precluded from the study because of the already existing black box warning?
The study was named ARCH with 4054 participants. It was double blinded so participants were randomly placed into either group. Also, since this was the study that prompted the black box warning, it would not have existed at the time. I don't see pre-selection as the reason for the difference.
I will attempt to add the reference later
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In July 2017, the FDA rejected the Biologics License Application (BLA) for Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis. The FDA's decision was widely expected after the companies reported a higher rate of serious adverse cardiovascular events with the drug compared to the bisphosphonate alendronate. In randomized controlled studies, patients treated with Evenity have shown an increase in serious cardiovascular events (myocardial infarction and stroke), compared to controls.