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3. Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.

Author

Povsic, TJ, Korjian, S, Bahit, MC, Chi, G, Duffy, D, Alexander, JH, Vinereanu, D, Tricoci, P, Mears, SJ, Deckelbaum, LI, Bonaca, M, Ridker, PM, Goodman, SG, Cornel, JH, Lewis, BS, Parkhomenko, A, Lopes, RD, Aylward, P, Lincoff, AM, Heise, M, Sacks, F, Nicolau, JC, Merkely, B, Trebacz, J, Libby, P, Nicholls, SJ, Pocock, S, Bhatt, DL, Kastelein, J, Bode, C, Mahaffey, KW, Steg, PG, Tendera, M, Bainey, KR, Harrington, RA, Mehran, R, Duerschmied, D, Kingwell, BA, Gibson, CM, AEGIS-II Committees and Investigators, Povsic, TJ, Korjian, S, Bahit, MC, Chi, G, Duffy, D, Alexander, JH, Vinereanu, D, Tricoci, P, Mears, SJ, Deckelbaum, LI, Bonaca, M, Ridker, PM, Goodman, SG, Cornel, JH, Lewis, BS, Parkhomenko, A, Lopes, RD, Aylward, P, Lincoff, AM, Heise, M, Sacks, F, Nicolau, JC, Merkely, B, Trebacz, J, Libby, P, Nicholls, SJ, Pocock, S, Bhatt, DL, Kastelein, J, Bode, C, Mahaffey, KW, Steg, PG, Tendera, M, Bainey, KR, Harrington, RA, Mehran, R, Duerschmied, D, Kingwell, BA, Gibson, CM, and AEGIS-II Committees and Investigators

Abstract

BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. RESULTS: The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). CONCLUSIONS: Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.

Published
2024

13. Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia

Author

Wiegman, A, primary, Ruzza, A, additional, Hovingh, G K, additional, Santos, R D, additional, Mach, F, additional, Stefanutti, C, additional, Luirink, I, additional, Bridges, I, additional, Wang, B, additional, Bhatia, A K, additional, Raal, F J, additional, Kastelein, J J P, additional, and Gaudet, D, additional

Published
2022
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15. MED-PED: An Integrated Genetic Strategy for Preventing Early Deaths

Author

Williams, R. R., Hamilton-Craig, I., Kostner, G. M., Hegele, R. A., Hayden, M. R., Pimstone, S. N., Faergeman, O., Schuster, H., Steinhagen-Thiessen, E., Beisiegel, U., Keller, C., Czeizel, A. E., Leitersdore, E., Kastelein, J. C., Defesche, J. J. P., Ose, L., Leren, T. P., Seftel, H. C., Raal, F. J., Marais, A. D., Eriksson, M., Keller, U., Miserez, A. R., Jeck, T., Betterridge, D. J., Humphries, S. E., Day, I. N. M., Kwiterovich, P. O., Lees, R. S., Stein, E., Illingworth, R., Kane, J., Boulyjenkov, V., Berg, Kare, editor, Boulyjenkov, Victor, editor, and Christen, Yves, editor

Published
1996
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16. Obicetrapib Does Not Accumulate in Adipose Tissue: Results from Studies in Man and Non-Human Primates.

Author

Kastelein, J., Ditmarsch, M., Hsieh, A., Dicklin, M., and Davidson, M.

Abstract

Background and Aims: Previous CETP inhibitors were highly lipophilic with logP of 7.2–9.2, leading to adipose tissue accumulation in the case of anacetrapib. In contrast, obicetrapib is characterized by a logP of 4.9 and terminal half-life of ∼135 hours. Studies in monkeys and humans were undertaken to determine the definitive elimination of obicetrapib. Methods: Obicetrapib was administered at doses up to 50 mg/kg/day in cynomolgus monkeys. A phase 1 trial administered doses of 1-25 mg to healthy humans, and 3 placebo-controlled, phase 2 studies in dyslipidemic humans administered obicetrapib (on background statin therapy) at 5 or 10 mg/d for 8 weeks (ROSE; n=120), 10 mg/d monotherapy or with ezetimibe for 12 weeks (ROSE2; n=119), and 2.5, 5, or 10 mg/d for 8 weeks (Japan; n=102). Plasma concentrations of obicetrapib were measured during the studies and post-treatment. Results: In monkeys, obicetrapib was not detected in any adipose tissue. A period of 13 weeks was sufficient for complete elimination from systemic circulation. The terminal half-life of obicetrapib was 121-151 hours in healthy humans. Across phase 3 studies, the median plasma concentration of obicetrapib reached 384-472 μg/L and decreased by up to 93-99% by 4 to 15 weeks post-treatment. Conclusions: Obicetrapib shows no evidence of accumulation in adipose tissue or delayed elimination from the systemic circulation supporting once daily, chronic dosing of 10 mg. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Obicetrapib Demonstrates Significant Deductions of LP(A) on Top of High-Intensity Statins.

Author

Tsimikas, S., Yang, X., Hsieh, A., Ditmarsch, M., Davidson, M., and Kastelein, J.

Abstract

Background and Aims: Elevated lipoprotein (a) [Lp(a)] leads to increased cardiovascular disease (CVD) risk. There are no pharmacologic therapies approved for reducing Lp(a). Previous cholesteryl ester transfer protein (CETP) inhibitors and approved lipid agents have modest Lp(a) effects. We examined the effects of obicetrapib, a novel CETP inhibitor, on Lp(a). Methods: ROSE1 and ROSE2 are phase 2 trials of obicetrapib on top of high-intensity statins by persons without CVD and low-density lipoprotein cholesterol >70 mg/dL. In ROSE1 120 subjects received 5 or 10 mg obicetrapib or placebo; in ROSE2 119 received 10 mg obicetrapib, 10 mg obicetrapib + 10 mg ezetimibe or placebo. Lp(a) was measured by immunoturbidimetry in ROSE1 and by the UCSD isoform independent assay using monoclonal antibody LPA-KIV9 in ROSE2. Results: Median baseline Lp(a) for 10 mg obicetrapib and placebo was 29.9 and 45.3 nmol/L in ROSE1 and 44.0 and 37.8 nmol/L in ROSE2, respectively. Median % changes from baseline for obicetrapib 10 mg and placebo, respectively, were -56.5 and +4.00 in ROSE1 and -47.2 and +2.3 in ROSE2. Pooled (N=127) median difference in % change corrected for placebo was 57.1% (p<0.001). In both trials >50% of obicetrapib subjects had a >60% reduction in Lp(a). Conclusions: Obicetrapib 10 mg on top of high-intensity statin significantly lowered Lp(a) by 57% vs. placebo in a pooled analysis, a substantially greater reduction than with proprotein convertase subtilisin kexin type 9 inhibitors (15-30%), niacin (30%) or other CETP inhibitors (25%). [ABSTRACT FROM AUTHOR]

Published
2024
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40. Working group on epidemiology & prevention of the european society of cardiology: Proceedings of meeting held at Shannon May 14th–17th, 1998

Author

Sullivan, P. A., Murphy, D., Sullivan, P. A., Keogh, S., Sullivan, P. A., Nash, P., Kaarisalo, M. M., Marttila, J., Immonen-Raiha, P., Salomaa, V., Torppa, J., Tuomilehto, J., Siani, A., Racone, R., Ragone, E., Stinga, F., Strazzullol, P., Cappuccio, F. P., Trevisan, M., Farinaro, E., Mellone, C., Fox, K. F., Cowie, M. R., Wood, D. A., Coats, A. J., Poole Wilson, P. A., Sutton, G. C., Yarnell, J., Sweetnam, P., Thomas, H., Piwonski, J., Piotrowski, W., Pytlak, A., Wannamethee, S. G., Shaper, A. G., Walker, M., Sharpe, P. C., Young, I. S., Hasselwander, O., McMaster, D., Mercer, C., McGrath, L. T., Evans, A. E., Thomas, F., Guize, L., Ducimetiere, P., Benetos, A., Rosolova, H., Simon, J., Mayer, O., Sefrna, F., Mayer, O., Šimon, J., Rosolova, H., Racek, J., Trefil, L., Marin-Tarlea, M., Carp, C., Apetrei, E., Ginghina, C., Serban, I., Florica, N., Ceck, C., Patrascoiu, M., Ginghina, C., Carp, C., Apetrei, E., Tarlea, M., Cioranu, R., Florica, N., Ceck, C., Vaduva, M., Mihaescu, D., Lapadat, M., Ashton, W. D., Wood, D., Nanchahahal, K., Kelleher, C. C., Brennan, P. J., Howarth, D., Meade, T. W., Kelleher, C. C., Fallon, U. B., McCarthy, U., O’Donnell, M. M. K., Dineen, B., Jousilahti, P., Vartiainen, E., Tuomilehto, J., Puska, P., Kastarinen, M., Nissinen, A., Salomaa, V., Vartiainen, E., Jousilahti, P., Tuomilehto, J., Puska, P., Rosengren, A., Wedel, H., Wilhelmsen, L., Liese, A. D., Hense, H. W., Keil, U., Keil, U., Liese, A. D., Hense, H. W., Filipiak, B., Döring, A., Stieber, J., Lowel, H., De Laet, C., Brasseur, D., Kahn, A., Wautrecht, J. C., Decuyper, J., Boeynaems, J. M., Jousilahti, P., Vartiainen, E., Tuomilehto, J., Sundvall, J., Puska, P., Marques-Vidal, P., Ferrières, J., Haas, B., Evans, A., Amouyel, P., Luc, G., Ducimetiere, P., Marques-Vidal, P., Ferrieres, J., Arveiler, D., Montaye, M., Evans, A., Ducimetiere, P., Fuentes, R., Notkola, I. -L., Shemeikka, S., Tuomilehto, J., Nissinen, A., Mak, R., De BacquerBacquer, D., De Backer, G., Stam, M., Koyuncu, R., de Smet, P., Kornitzer, M., Braeckman, L., De Backer, G., De Bacquer, D., Claeys, L., Delanghe, J., De Bacquer, D., Kornitzer, M., De Backer, G., Cífkova, R., Pit’ha, J., Červenka, L., Šejda, T., Lanska, V., Škodová, Z., Stavek, P., Poledne, R., Cífková, R., Duskova, A., Hauserová, G., Hejl, Z., Lánská, V., Škodova, Z., Pistulková, H., Poledne, R., Hubáček, J., Pit’ha, J., Stávek, P., Lánská, V., Cífková, R., Faleiro, L. L., Rodrigues, D., Fonseca, A., Martins, M. C., Norris, R. M., Nyyssönen, K., Seppänen, K., Salonen, R., Kantola, M., Salonen, J. T., Parviainen, M. T., De Henauw, S., Myny, K., Doyen, Z., Van Oyen, H., Tafforeau, J., Kornitzer, M., De Backer, G., Benetos, A., Thomas, F., Guize, L., Immonen-Räihä, P., Kaarisalo, M., Marttila, R. J., Torppa, J., Tuomilehto, J., Houterman, S., Hofman, B., Witteman, J. C. M., Verschuren, W. M. M., van de Vijver, L. P. L., Kardinaal, A. F. M., Grobbee, D. E., van Poppel, G., Princen, H. M. G., Kornitzer, M., Doven, M., Koyuncu, R., De Bacquer, D., Myny, K., De Backer, G., Tafforeau, J., Van Oven, H., Doyen, M., Koyuncu, R., Kornitzer, M., De Bacquer, D., Myny, K., De Backer, G., Tafforeau, J., Van Oyen, H., de Bree, A., Verschuren, W. M. M., Blom, H. J., Mulder, I., Smit, H. A., Menotti, A., Kromhout, D., Van den Hoogen, P. C. W., Hofman, A., Witteman, J. C. M., Feskens, E. J. M., Štika, L., Bruthans, J., Wierzbicka, M., Bolinska, H., Voutilainen, S., Nyyssönen, K., Salonen, R., Lakka, T. A., Salonen, J. T., Lakka, H -M., Lakka, T. A., Salonen, J. T., Tuomainen, T-P., Nyyssonen, K., Salonen, J. T., Punnonen, K., Yarnell, J., Patterson, C., Thomas, H., Sweetnam, P., Smith, W. C. S., Campbell, S. E., Cardy, A., Phillips, D. O., Helms, P. J., Squair, J., Smith, W. C. S., Cardy, A., Phillips, D. O., Helms, P. J., Squair, J., Smith, W. C. S., Cardy, A., Phillips, D. O., Helms, P. J., Squair, J., Pytlak, A., Piotrowski, W., Rywik, S., Waskiewicz, A., Sygnowska, E., Szczesniewska, D., Sygnowska, E., Waskiewicz, A., Wagrowska, H., Polakowska, M., Rywik, S., Broda, G., Jasinski, B., Piotrowski, W., Elandt-Johnson, R. C., Wagrowska, H., Kupsé, W., Szczesniewska, D., Platonov, D. Y., Haapanen, N., Miilunpalo, S., Vuori, I., Pasanen, M., Oja, P., Urponen, H., Kopp, M. S., Skrabski, A., Szedmák, S., Boaz, M., Biro, A., Katzir, Z., Matas, T., Smetana, S., Green, M., Whincup, P. H., Morris, R., Walker, M., Lennon, L., Thomson, A., Ebrahim, S. J. B., Refsum, H., Ueland, P. M., Perry, I. J., Boer, J. M. A., Kuivenhoven, J. A., Feskens, E. J. M., Schouten, E. G., Havekes, L. M., Seidell, J. C., Kastelein, J. J. P., Kromhout, D., Oomen, C. M., Feskens, E. J. M., Rasanen, L., Nissinen, A., Fidanza, F., Menotti, A., Kok, F. J., Kromhout, D., Sileikiene, L., Klambienne, J., Milasauskiene, Z., Cappuccio, F. P., Siani, A., Barba, G., Russo, L., Ragone, E., Strazzullo, P., Farinaro, E., Trevisan, M., Schnohr, P., Parner, J., Lange, P., Meleady, R., Graham, I. M., Ueland, P. M., Refsum, H., Blom, H., Whitehead, A. S., Daly, L. E., Stefanovic, B., Boskovic, D., Mitrovic, P., Perunicic, J., Vukcevic, V., Radovanovic, N., Terzic, B., Mrdovic, I., Orilc, D., Matic, G., Vasiljevic, Z., Mitrovic, P., Boskovic, D., Stefanovic, B., Perunicic, J., Vukcevic, V., Mrdovic, I., Radovanovic, N., Orlic, D., Matic, G., Milentijevic, B., Rajic, D., Mitrovic, N., Boskovic, S., Vasiljevic, Z., Marin-Tarlea, M., Carp, C., Apetrei, E., Serban, I., Ceck, C., Patrascsoiu, M., Florica, N., Mihaescu, D., Murphy, C., Meleady, R., Ingram, S., Love, J., Graham, I., Graham, I. M., Meleady, R., van Berkel, T. F. M., Deckers, J. W., and De Bacquer, D.

Published
1998
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