Non-inferiority trial of two commercial zilpaterol HCl brands in <em>Bos indicus</em> cattle under humid tropical conditions

Main Article Content

Agustín Nieto-Carmona
Jeny Aguilar-Acevedo
María de la Salud Rubio-Lozano
Pedro Antonio Alvarado-García
Graciela Tapia
Luis Ocampo-Camberos
Héctor Sumano

Abstract

Veterinaria México OA
ISSN: 2448-6760

Cite this as:

  • Nieto-Carmona A, Aguilar-Acevedo J, Rubio M de la S, Alvarado-García P, Tapia G, Ocampo L, Sumano H. Non-inferiority trial of two commercial zilpaterol HCl brands in Bos indicus cattle under humid tropical conditions. Veterinaria México OA. 2018;5(2). doi: 10.21753/vmoa.5.2.482.

Commercial availability of a generic zilpaterol HCl (ZH) premix preparation for beef cattle in Mexico motivated a non-inferiority trial vs the reference preparation. The trial was conducted on zebu-type cattle (Bos indicus) under humid tropical conditions. Meat production and basic meat quality were assessed for 810 zebu bulls, aged 18-22 months and weighing 430 to 490 kg. Bulls were randomly assigned into one of three groups: ZHg, treated with the generic ZH (Zipamix®) preparation; ZHr, treated with the reference ZH (Zilmax®) preparation, and Cg, the untreated control group. Housing, shade surface, feeding and water availability were highly homogeneous between the animals’ pens. Results for the measured productive and meat quality parameters showed that both ZH-treated groups had higher values than the Cg (P < 0.05), and differences between the ZHg and ZHr groups were not statistically significant, thus fulfilling the criteria of a non-inferior ZH preparation. In this assay, ZH supplementation did not modify the amounts of moisture, fat, protein or ash in the Longissimus dorsi muscle compared with the meat from non-supplemented animals, and the overall meat acceptability was unaffected (P > 0.05).

Figure 2. Sensorial hedonic scale percentages for aroma, flavour, tenderness and juiciness per treatment as follows: ZHg = zilpaterol hydrochloride from Zipamix® (Pisa Agropecuaria México, Guadalajara, Mexico); ZHr = zilpaterol hydrochloride from Zilmax (MSD).
Keywords:
Beef cattle carcass-yield meat-quality non-inferiority humid-tropic zilpaterol hydrochloride

Article Details

References

Hwang IK and Morikawa T. Design issues in noninferiority/equivalence trials. Drug Inf. J. 1999;33(4):1205–1218.

FAO. Overview of the world meat market. 2015. Retrieved January 07, 2017, from http://www.fao.org/ag/againfo/themes/es/meat/background.html

FDA. Freedom of information summary. Original new animal drug application NADA 141–258. ZILMAX (zilpaterol hydrochloride). Type A medicated article for cattle fed in confinement for slaughter. 2006. Retrieved February 07, 2017, from http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm051412.pdf

Norma Oficial Mexicana. NOM-EM-015-ZOO-2002. Especificaciones técnicas para el testigo del uso de beta-agonistas en los animales. http://legismex.mty. itesm.mx/normas/zoo/zoo015em-02.pdf

Avendaño RL, Torres RV, Meraz MF, Perez LC, Figueroa SF, Alvarez VF, Correa CA, Robinson PH. Meat quality of steers treated with two beta-adrenergic agonists. Proc. West Sec. ASAS. 2006;57:211–215.

CFIA. Zilpaterol Hydrochloride - MIB #83 2009 http://www.inspection.gc.ca/ animals/feeds/medicating-ingredients/mib/mib-83/eng/1331130141375/13 31130195394

Plascencia A, Torrentera N, Zinn RA. Influence of the β-agonist, zilpaterol, on growth performance and carcass characteristics of feedlot steers. Proc. West. ASAS. 1999;50:331–334.

Oneida E, Fuenmayor M, Zamorano GL, Ysunza F, Gonzalez MN. Efecto del clorhidrato de zilpaterol y la vitamina D3 sobre la calidad de la carne en novillas comerciales. Revista científica, FCV-LUZ. 2002;XII(6):725–729. http://produccioncientificaluz.org/index.php/cientifica/article/view/14879

Rathmann RJ, Mehaffey JM, Baxa TJ, Nichols WT, Yates DA, Hutcheson JP, Brooks JC, Johnson BJ, Miller MF. Effects of duration of zilpaterol hydrochloride and days on the finishing diet on carcass cutability, composition, tenderness, and skeletal muscle gene expression in feedlot steers. J. Anim. Sci. 2009;87(11):3686- 3701. doi: 10.2527/jas.2009-1818.

Garmyn AJ, Miller MF. Implant and beta agonist impact on meat palatability. J. Anim. Sci. 2014;92(1):10–20. doi: 10.2527/jas2013-7097.

Van Hoof N, Schilt R, Van Der Vlis E, Boshuis P, Van Baak M, De Wasch K, Van de Wiele M, Van Hende J, Courtheyn D, Draaijer A, De Brabander H. Detection of zilpaterol (zilmax®) in calf urine and faeces with liquid chromatography–tandem mass spectrometry. Anal. Chim. Acta. 2005;529:189–197.

INTERVET. Productividad animal. Boletín veterinario de intervet. 2005. http:// www.msd-salud-animal.mx/binaries/Bolet_n_T_cnico_Zilmax_tcm92-66507. pdf

Méndez RD, Meza CO, Berruecos JM, Garcés P, Delgado EJ, Rubio MS. A survey of beef carcass quality and quantity attributes in Mexico. J. Anim. Sci. 2009;87(11):3782–3790. doi: 10.2527/jas.2009-1889.

Avendaño RL, Meraz MFJ, Pérez LC, Figueroa SF, Correa A, Álvarez VFD, Guerra LJE, López RG, Macías CU. Evaluation of the efficacy of Grofactor, a beta-adrenergic agonist based on zilpaterol hydrochloride, using feedlot finishing bulls. J. Anim. Sci. 2016;94:2954–2961. doi: 10.2527/jas2015-9878.

Norma Oficial Mexicana. NOM-051-ZOO-1995. Trato humanitario en la movilización de animales. http://www.ordenjuridico.gob.mx/Publicaciones/ CDs2007/CDAgropecuaria/pdf/47NOM.pdf

NORMA Oficial Mexicana. NOM-033-ZOO-1995. Sacrificio humanitario de los animales domésticos y silvestres. http://www.cuautitlan.unam.mx/descargas/ cicuae/normas/Norma033.pdf.

VICH GL9 (GCP). Pharmaceuticals, Efficacy, Good clinical practice. trilateral (EU-Japan-USA) programme. June 2000 - Implemented in July 2001. http://www. vichsec.org/guidelines/pharmaceuticals/pharma-efficacy/good-clinical-practice. html

INEGI. Compendio de información geográfica municipal. 2010. Topografía; productos y servicios. p 2-5. http://www.inegi.org.mx/geo/contenidos/topografia/ compendio.aspx

Köppen-Geiger. Clasificación climática de koppen. 1936. http://meteo.fisica.edu.uy/Materias/climatologia/practico%20climatologia%202012/Practico%207/Clasificacion%20Koppen.pdf

Castellanos RAF, Rosado RJG, Chel GLA, Betancur ADA. Empleo del zilpaterol en novillos con alimentación intensiva en Yucatán, México. Arch. Latinoam. Prod. Anim. 2006;14(2):56–59.

Avendaño RL, Meraz MFJ, Pérez LC, Figueroa SF, Correa A, Álvarez VFD, Guerra LJE, López RG, Macías CU. Evaluation of the efficacy of Grofactor, a beta-adrenergic agonist based on zilpaterol hydrochloride, using feedlot finishing bulls. J. Anim. Sci. 2016;4:2954–2961. doi: 10.2527/jas2015-9878.

Irving KH, Toshihiko M. Design issues in noninferiority/equivalence trials. 1999. Drug Inf. J. 33:1205–1218.

Norma Oficial Mexicana. NOM-009-Z00-1994. Proceso sanitario de la carne. http://www.porcimex.org/NORMAS/NOM-009-ZOO-1994.pdf

Norma Oficial Mexicana. NOM-033-SAG/ZOO-2014. Métodos para dar muerte a los animales domésticos y silvestres. http://www.dof.gob.mx/nota_detalle. php?codigo=5405210andfecha=26/08/2015

[AOAC] Association of Official Analytical Chemists. Official methods of analysis. 15th ed. Arlington, Virginia: 1990. Chapter 39. https://www.cabdirect.org/ cabdirect/abstract/19720492404

[AMSA] American Meat Science Association. Research guidelines for cookery, sensory evaluation, and instrumental tenderness measurements of meat. 2nd ed. Champaing, Illinois: 2015. http://www.meatscience.org/docs/default-source/ publications-resources/amsa-sensory-and-tenderness-evaluation-guidelines/research-guide/2015-amsa-sensory-guidelines-1-0.pdf?sfvrsn=6

D’Agostino RB, Massaroand JM, Sullivan LM. Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Statist. Med. 2003;22:169–186. doi: 10.1002/sim.1425.

McCulloch CE, Searle SE, Neuhaus JM. Generalized, linear, and mixed models. 2nd ed. West Sussex, UK: Ed. Wiley 2006. ISBN: 978-0-470-07371-1.

Littell RC, Milliken GA, Stroup WW, Wolfinger RD. SAS® System for mixed models. Cary, NC: SAS Inst. Inc., 1996. pp. 31−63.

IBM. SPSS Statistics®. Version 21 for Windows® (IBM, México).

Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika. 1965;52:591−611.

Vestergaard M, Sejrsen K, Klastrup S. Growth, composition and eating quality of Longissimus dorsi from young bulls fed the β-agonist cimaterol at consecutive developmental stages. Meat Sci. 1994;38(1):55−66.

Avendaño RL, Torres RV, Meraz MFJ, Pérez LC, Figueroa SF, Robinson PH. Effect of two β-adrenergic agonists on finishing performance, carcass characteristics, and meat quality of feedlot steers. J. Anim. Sci. 2006;84:3259–3265. doi: 10.2527/jas.2006-173.

Kellermeier JD, Tittor AW, Brooks JC, Galyean ML, Yates DA, Hutcheson JP, Nichols WT, Streeter MN, Johnson BJ, Miller MF. Effects of zilpaterol hydrochloride with or without an estrogen-trenbolone acetate terminal implant on carcass traits, retail cutout, tenderness, and muscle fiber diameter in finishing steers. J. Anim. Sci. 2009;87:3702–3711. doi: 10.2527/jas.2009-1823.

Montgomery JL, Krehbiel CR, Craston JJ, Yates DA, Hutcheson JJ, Nichols WT, Streeter MN, Bechtol DT, Johnson E, Terhune T, Montgomery TH. Dietary zilpaterol hydrochloride. I. Feedlot performance and carcass traits of steers and heifers. J. Anim. Sci. 2009;87:1374–1383. doi: 10.2527/jas.2008-1162.

Baxa TJ, Hutchenson JP, Miller MF, Brooks JC, Nicholset WT. Additive effects of a steroidal implant and zilpaterol hydrochloride on feedlot performance, carcass characteristics, and skeletal muscle messenger ribonucleic acid abundance in finishing steers. J. Anim. Sci. 2010;88(1):330–337. doi: 10.2527/ jas.2009-1797.

Garmyn AJ, Shock JN, Van Overbeke DL, Beckett JL, Delmore RJ, Yates DA, Allen DM, Hilton GG. The effects of zilpaterol hydrochloride on carcass cutability and tenderness of calf-fed Holstein steers. J. Anim. Sci. 2010;88(7):2476–2485. doi: 10.2527/jas.2009-2635.

Lawrence TE, Gasch CA, Hutcheson JP, Hodgen JM. Zilpaterol improves feeding performance and fabrication yield of concentrate-finished cull cows. J. Anim. Sci. 2011;89(7):2170–2175. doi: 10.2527/jas.2010-3422.

Rathmann RJ, Bernhard BC, Swingle RS, Lawrence TE, Nichols WT, Yates DA, Hutcheson JP, Streeter MN, Brooks JC, Miller MF, Johnson BJ. Effects of zilpaterol hydrochloride and days on the finishing diet on feedlot performance, carcass characteristics, and tenderness in beef heifers. J. Anim. Sci. 2012:90(9):3301– 3311. doi: 10.2527/jas.2011-4375.

Choi CB, Jung KK, Chung KY, Yang BS, Chin KB, Suh SW, Oh DH, Jeon MS, Baek KH, Lee SO, Kim SI, Lee YH, Yates DA, Hutcheson JP, Johnson BJ. Administration of zilpaterol hydrochloride alters feedlot performance, carcass characteristics, muscle, and fat profiling in finishing Hanwoo steers. 2013. Livestock Science 157:435–441. doi.org/10.1016/j.livsci.2013.06.035

Arp TS, Howard ST, Woerner DR, Scanga JA, McKenna DR, Kolath WH, Chapman PL, Tatum JD, Belk KE. Effects of dietary ractopamine hydrochloride and zilpaterol hydrochloride supplementation on performance, carcass traits, and carcass cutability in beef steers. J Anim Sci. 2014;92(2):836-43. doi: 10.2527/ jas.2013-7122.

Elam NA, Vasconcelos JT, Hilton G, VanOverbeke DL, Lawrence TE, Montgomery TH, Nichols WT, Streeter MN, Hutcheson JP, Yates DA, Galyean ML. Effect of zilpaterol hydrochloride duration of feeding on performance and carcass characteristics of feedlot cattle. J. Anim. Sci. 2009;87(6):2133–2141. doi: 10.2527/ jas.2008-1563.

Holmer SF, Fernández-Dueñas DM, Scramlin SM, Souza CM, Boler DD, McKeith FK, Killefer J, Delmore RJ, Beckett JL, Lawrence TE, VanOverbeke DL, Hilton GG, Dikeman ME, Brooks JC, Zinn RA, Streeter MN, Hutcheson JP, Nichols WT, Allen DM, Yates DA. The effect of zilpaterol hydrochloride on meat quality of calf-fed Holstein steers. J. Anim. Sci. 2009;87(11):3730–3738. doi: 10.2527/ jas.2009-1838.

Strydom PE, Frylinck L, Montgomery JL, Smith MF. The comparison of three b-agonists for growth performance, carcass characteristics and meat quality of feedlot cattle. Meat Science. 2009;81(3):557–564. doi: 10.1016/j. meatsci.2008.10.011.

Scramlin SM, Platter WJ, Gomez RA, Choat WT, McKeith FK, Killefer J. Comparative effects of ractopamine hydrochloride and zilpaterol hydrochloride on growth performance, carcass traits, and longissimus tenderness of finishing steers. J. Anim. Sci. 2010;88(5):1823–1829. doi: 10.2527/jas.2009-2405.

LeRoy HG. Environmental influences on feed intake and performance of feedlot cattle. In: Symposium. Intake by feedlot cattle. Oklahoma State University, 1995. pp. 207.

Delmore RJ, Hodgen JM, Johnson BJ. Perspectives on the application of zilpaterol hydrochloride in the United States beef industry. J. Anim. Sci. 2010;88(8):2825–2828. doi: 10.2527/jas.2009-2473.

Centner TJ, Alvey JC, Stelzleni AM. Beta agonists in livestock feed: status, health concerns, and international trade. J. Anim. Sci. 2014;92(9):4234–4240. doi: 10.2527/jas.2014-7932.

Moloney AP, Allen P, Ross DB, Olson G, Convey EM. Growth, feed efficiency and carcass composition of finishing Friesian steers fed the β-adrenergic agonist L-644,969. J. Anim. Sci. 1990;68(5):1269-1277. doi: 10.2527/1990.6851269x.

Mersmann HJ. Beta-adrenergic receptor modulation of adipocyte metabolism and growth. J. Anim. Sci. 2002;80(E. Suppl. 1):E24–E29. doi: 10.2527/ animalsci2002.0021881200800ES10005x.

Shook JN, Van Overbeke DL, Kinman LA, Krehbiel CR, Holland BP, Streeter MN, Yates DA, Hilton GG. Effects of zilpaterol hydrochloride and zilpaterol hydrochloride withdrawal time on beef carcass cutability, composition, and tenderness. J. Anim. Sci. 2009;87(11):3677–3685. doi: 10.2527/jas.2009-1816.

Hilton GG, Montgomery JL, Krehbiel CR, Yates DA, Hutcheson JP, Nichols WT, Streeter MN, Blanton JRJr, Miller MF. Effects of feeding zilpaterol hydrochloride with and without monensin and tylosin on carcass cutability and meat palatability of beef steers. J. Anim. Sci. 2009;87(4):1394–1406. doi: 10.2527/ jas.2008-1170.

Wheeler TL, Cundiff LV, Koch RM. Effect of marbling degree on beef palatability in Bos taurus and Bos indicus cattle. J Anim Sci. 1994;72(12):3145–3151.

Leheska JM, Montgomery JL, Krehbiel CR, Yates DA, Hutcheson JP, Nichols WT, Streeter M, Blanton JR, Miller MF. Dietary zilpaterol hydrochloride. II. Carcass composition and meat palatability of beef cattle. J Anim. Sci. 2009;87(4):1384– 1393. doi: 10.2527/jas.2008-1168.

Mills SE. Biological basis of the ractopamine response. J. Anim. Sci. 2002;80(E. Suppl. 2):E28–E32. doi: 10.2527/animalsci2002.80E-Suppl_2E28x.

Sumano LH, Ocampo CL, Gutiérrez OL. Clenbuterol and other β-agonists, are they an option for meat production or threat for public health? Vet. Mex. 2002;33:137–159.