P-433. Impact of Tesamorelin on Cardiovascular Disease Risk Prediction Scores in Phase 3 Studies Treatment Arms: Subanalysis
Notice bibliographique
Résumé
Abstract Background The risk of cardiovascular disease (CVD) is nearly twice as high for persons with HIV (PWH) as the general population. Excess visceral abdominal fat (EVAF), the key characteristic of central adiposity, has also been associated with an increased risk of CVD in PWH. Tesamorelin, a growth hormone-releasing hormone analog, has previously demonstrated significant reductions in EVAF in two phase 3 randomized controlled trials in PWH. Yet, the impact of the reduction of EVAF from tesamorelin on CVD outcomes has been unknown. Tesamorelin Treatment Effect on CV Risk Score Methods To assess this impact, combined datasets from the phase 3 studies’ treatment arms were utilized to calculate 10-year atherosclerotic cardiovascular disease (ASCVD) risk scores at baseline and 26 weeks. A mediation analysis was conducted to characterize the significance of treatment impact via intermediate variables that factor into ASCVD risk prediction changes. Modifiable variables included systolic and diastolic blood pressure, total cholesterol (TC), high-density and low-density lipoprotein (HDL, LDL). The analysis population included 543 subjects randomized to tesamorelin treatment, 86% of which were male and 22% non-white; the median age was 47 years old. The percentage of subjects on lipid-lowering therapies, hypertension treatment, or diabetic were 46%, 37%, and 18%, respectively. Results Although the majority had low CVD risk at baseline, 44% had borderline to high CVD risk. Participants in the tesamorelin treatment arm tended toward a modest reduction in 10-year ASCVD risk prediction with estimated decrease in ASCVD risk of -0.40% (95% CI -0.89%, 0.05%). The reduction in CVD risk was relatively larger among subjects with higher CVD risk at baseline (p=0.038 for overall trend among all participants). Reductions in ASCVD risk score were driven predominantly by reductions in TC, independent of lipid lowering therapies. Conclusion In summary, this analysis provides evidence that reductions in excess visceral fat with tesamorelin lead to a significant reduction in forecasted CVD risk in PWH, resulting from reduction in TC even among a group heavily treated with lipid-lowering therapy. Given the increasing prevalence of obesity and central adiposity in PWH, more attention should be given to targeting visceral fat when considering CVD risk management. Disclosures Steven K. Grinspoon, MD, Gilead: Grant/Research Support|Kowa: Grant/Research Support|Theratechnologies: Advisor/Consultant|Viiv: Grant/Research Support Lindsay Fourman, MD, Chiesi Farmaceutici: Advisor/Consultant|Chiesi Farmaceutici: Grant/Research Support|Theratechnologies: Advisor/Consultant Takara Stanley, MD, Pfizer: Grant/Research Support Colleen McGary, PhD, Theratechnologies: Employee R Brandon Cash, PharmD, Theratechnologies: Employee
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».