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1. Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study

Author

Mautalén, Carlos Alfredo, Man, Zulema, Zanchetta, Jose Ruben, Magaril, Clelia Haydee, Sambrook, Philip, Reginster, Jean-Yves, Geusens, Piet, Goemaere, Stefan, Albergaria, Ben Hur, Zerbini, Cristiano Augusto de Freitas, Castro, Marise Lazaretti, Gregorio, Luiz Henrique, Stoilov, Rumen, Borissova, Anna-Maria I, Hristozov, Kiril Hristov, Temelkova, Nataliya L, Daskalova, Ivona Kirilova, Kuzmanova, Stefka Ivanova, Yaneva-Bichovska, Daniela, Batalov, Anastas Zgurov, Riedemann, Pablo, Rodriguez Portales, José Adolfo, Tang, Hai, Zhu, hanmin, Zhang, Zhenlin, Chao, Aijun, Hu, Yali, Liu, Zhiming, Lu, Juming, Qiu, Mingcai, Gao, Xin, Zhang, Shaofen, Xu, Ling, Xia, Weibo, Liao, Eryuan, Yang, Wenying, Wu, Wen, Dai, Kerong, Hu, Renming, Jaller, Juan Jose, Cabal, Francisco, Molina, José Fernando, Cure Cure, Carlos A, Yupanqui-Lozno, Hernan, Chalem, Philippe, Londono, John, Abello, Mauricio, Tobias, Edgardo D, Otero, William, Nikolic, Tatjana, Miskic, Blazenka, Stepan, Jan, Vyskocil, Vaclav, Novosad, Libor, Slesinger, Jan, Novosad, Pavel, Vlckova, Erika, Bortlik, Ladislav, Dokoupilova, Eva, Hala, Tomas, Jensen, Jens-Erik Beck, Brixen, Kim Torsten, Langdahl, Bente Lomholt, Schwarz, Peter, Eskildsen, Peter Claes, Eiken, Pia Agnete, Hermann, Anne Pernille, Gram, Jeppe, Schou, Maiken Brix, Alexandersen, Peter, Nedergaard, Bettina, Mejía, Dolores Magdalena, Estrella De Henriquez, Lourdes, Páez, Norka, Velazco, Casimiro, Valter, Ivo, Vahula, Kadri-Liina, Kull, Ingrid, Maasalu, Katre, Chapurlat, Roland, Fardellone, Patrice, Benhamou, Claude Laurent, Roux, Christian, Weryha, Georges, Herkt, Volkmar, Martz, Rene, Nischik, Ruth, Spieler, Wolfgang, Contzen, Christel, Felsenberg, Dieter, Frieling, Isolde, Frahm, Eike, Briones, Henry, Sandoval, Boris, Barrios, Patricia, García, Abraham, Avendaño, Carlos, González, Magdalena, Guerra, Jeremías, Tuna, Maria, Díaz, Olga Marina, Samayoa, Eduardo, López, Edgar, Barrera, José Raúl, Palencia, Mainor, Cifuentes, Mayra, Alvarado, Georgina, López, Miriam, Chavez, Nilmo, Haase, Franklin, Rivera, Ruddy, González, Claudio, Tan, Kathryn, Leung, Ping Chung, Mandalam, Sheshadri, Pitale, Shailesh Umakant, Bantwal, Ganapathi, Ammini, Ariachery Chinamma, Shaikh, Shehla Sajid Akhta, Kanakatte Mylariah, Prasanna Kumar, Dharmalingam, Mala, Mukhopadhyay, Satinath, Jain, Arpit, Singh, Parminder, Shetty, Naresh, Sathyanarayana, Srikanta Shamanna, Shah, Nalini, Chadha, Manoj Dharam, Bhandankar, Rajendra, Velayutham, Kumaravel, Marwah, Sudha, John, Mathew, Sahay, Rakesh Kumar, Adami, Silvano, Nuti, Ranuccio, Bianchi, Gerolamo, Brandi, Maria Luisa, Minisola, Salvatore, Fiore, Carmelo Erio, Rubinacci, Alessandro, Miyajima, Hisayuki, Yamane, Hiroo, Nakatani, Yuji, Okamoto, Sumiaki, Kuroda, Koji, Fujimori, Motoaki, Itabashi, Akira, Katayama, Kuniaki, Nakajo, Satoru, Somekawa, Yoshiaki, Ohsawa, Yoshimitsu, Tajima, Wataru, Mizuno, Katsunori, Mori, Shigeru, Kanabuchi, Takato, Hashizume, Hiroyuki, Oka, Nobuyuki, Hamada, Kazutoshi, Yamaguchi, Motoi, Hirahara, Fumiki, Atobe, Masaaki, Ohtake, Yoshiharu, Ichikawa, Shuichi, Onishi, Tomoyuki, Matsumoto, Kou, Nakamura, Tetsuro, Shirasawa, Eishi, Katayama, Ko, Takahashi, Mitsugu, Oguma, Tadanori, Matsui, Hideo, Katoh, Yoshiharu, Shigenobu, Keiichi, Onishi, Tsutomu, Shibukawa, Masato, Ikeda, Satoshi, Osaka, Kazuhiro, Kanda, Ryosuke, Inobe, Yoshito, Shigenobu, Masaharu, Hasegawa, Morimasa, Yamaji, Tetsuo, Miyazaki, Yu, Ito, Takayasu, Nakamura, Eisuke, Nagai, Shinji, Lim, Sung-Kil, Chung, Yoon-Sok, Shin, Chan-Soo, Min, Yong-Ki, Kim, Ghi Su, Yoon, Hyun Koo, Kang, Moo-Il, Yang, Kyu-Hyun, Park, Hyoung Moo, Kim, In Joo, Chung, Dong Jin, Chung, Ho Yeon, Jaundzeikare, Sandra, Andersone, Dace, Medne, Agita, Yaghi, Yasser, Alekna, Vidmantas, Kasiulevicius, Vytautas, Purtokaite - Labutiniene, Irina, Krasauskiene, Aurelija, Varanaviciene, Jurate, Basijokiene, Vida, Abraitiene, Agne, Radzeviciene, Lina, Walliser, Jesus, García Hernández, Pedro Alberto, Araujo, Maria Frida, Avila Armengol, Hilario Ernesto, De la Peña, Pilar, Tamayo, Juan, Zazueta, Beatriz, Cons, Fidencio, Gilchrist, Nigel Leslie, Reid, Ian Reginald, Leikis, Robert, Jones, Peter, Singh, Joe Gragrath Pradeep, Halse, Johan Inge, Syversen, Unni, Høivik, Hans Olav, Øfjord, Erik Snorre, Gulseth, Hans Christian, Elle, Sigbjørn, Norheim, Paal Dag, Calvo Quiroz, Armando A., Cesar Augusto, Pastor A., León Portocarrero, Manuel Gustavo, Vidal Neira, Luis Fernando, Chavez, Jose, Garro Barrera, Boris, Kuroiwa Sampei, Rita, Luis Fernando, Bellatín V., Oquelis Cabredo, Rogger, Castillo, Sonia, Morales, Agustin Miguel G, Tan, Perry Pua, Leagogo, Liberato Antonio C, Jr., Wang, Edward HM, Li-Yu, Julie T, Sawicki, Andrzej Z, Stasiuk, Barbara, Kania, Grzegorz, Lorenc, Roman, Sidorowicz-Bialynicka, Anna, Szczepanski, Leszek, Franek, Edward, Filip, Rafal, Sekula, Jan, Blicharski, Tomasz, Leszczynski, Piotr, Sewerynek, Ewa, Miazgowski, Tomasz, Milewicz, Andrzej, Dabrowska, Magda, Romaszko, Jerzy, Pluskiewicz, Wojciech, Wojnowski, Lukasz, Codreanu, Catalin, Bolosiu, Horatiu, Ionescu, Ruxandra, Zosin, Ioana, Macovei, Liviu, Bojinca, Mihai, Radulescu, Florin, Pop, Simona, Sarbu, Adrian, Benevolenskaya, Lidia I, Nasonov, Evgeny L, Rozhinskaya, Lyudmila Ya, Oganov, Raphael G, Rodionova, Svetlana S, Shlyakhto, Eugeny Vladimirovich, Trofimov, Vasiliy, Zotkin, Eugeny G, Zazerskaya, Irina E, Grineva, Elena N, Ershova, Olga, Lesnyak, Olga, Ostroumova, Olga D, Malichenko, Svetlana B, Pikhlak, Eduard G, Pilyaev, Valery G, Raskina, Tatiana, Zonova, Elena V, Shirinsky, Valery S, Dimic, Aleksandar N, Cobeljic, Goran, Vujovic, Svetlana, Ellis, Graham Charlston, Lipschitz, Stanley, De Villiers, Tobias Johannes, De Weerd, Albert Jan, Vally, Tasneem, Trinder, Yvonne, Coetsee, Jacobus Ludewikus, Davis, Charles Pierre, Nayiager, Savithree, Hough, Frans Stephanus, Oelofse, Louis F, van der Walt, Eugene, Lombaard, Johannes Jurgens, Blignaut, Suzanne, Govind, Uttam, Fouche, Leon Frederik, Kruger, Dawid Stephanus, Dalmeyer, Johannes Paul, Ferreira, Mada M, Escudero-Contreras, Alejandro, Muñoz Torres, Manuel, Hawkins Carranza, Federico, Perez Castrillon, Jose Luis, García Meijide, Juan Antonio, Jodar Gimeno, Esteban, Palacios Gil-Antuñana, Santiago, de Teresa Parreno, Luis, Martín Mola, Emilio, Alvarez Sanchez, Carmen, Lippuner, Kurt, Tsai, Keh-Sung, Tu, Shih-Te, Chen, Jung-Fu, Lee, Oscar Kuang-Sheng, Hsu, Wen-Wei, Grygorieva, Natalia Viktorivna, Povoroznyuk, Vladyslav Volodymyrovych, Korzh, Mykola Oleksiiovych, Loskutov, Oleksandr Levgeniiovych, Chukov, Andriy Borysovych, Sarmiento, Rex, Thomas, Hawys, Donnachie, Hugh, Pavel-Knox, Irina, Shaw, Hilary, Hassanin, Hana, Abdulhakim, Essam Eldin Ahmed, Savani, Naren, Bachmann, Gloria A, Barrett-Connor, Elizabeth, Binkley, Neil C, Bone, Henry G, Brandon, Donald M, Checketts, Darin David, Fraser, Neil J, Watts, Nelson B, Geller, Steven A, Gimbel, Joseph S, Greenwald, Maria White, Holt, Peter A, Johnston, Cyrus Conrad, Fang, Chien, Kiel, Douglas P, Klashman, David J, Lewiecki, E. Michael, Lowenstein, Mitchell B, McClung, Michael Roy, Nattrass, Susan M, Odio, Alberto, Levengood, Julie, Romaguera, Josefina, Saag, Kenneth G, Sebai, Mohamed Bassam, Snyder, Brian, Kutner, Mark Eliot, Streja, Dan, Schwartz, Elliott P, Christiansen, Mark G, McClung, Michael R, O'Donoghue, Michelle L, Papapoulos, Socrates E, Bone, Henry, Langdahl, Bente, Reid, Ian R, Cavallari, Ilaria, Bonaca, Marc P, Wiviott, Stephen D, de Villiers, Tobias, Ling, Xu, Nakamura, Toshitaka, Rodriguez-Portales, Jose Adolfo, Zanchetta, José, Zerbini, Cristiano A F, Park, Jeong-Gun, Im, KyungAh, Cange, Abby, Grip, Laura T, Heyden, Norman, DaSilva, Carolyn, Cohn, Dosinda, Massaad, Rachid, Scott, Boyd B, Verbruggen, Nadia, Gurner, Deborah, Miller, Deborah L, Blair, Micki L, Polis, Adam B, Stoch, S Aubrey, Santora, Arthur, Lombardi, Antonio, Leung, Albert T, Kaufman, Keith D, and Sabatine, Marc S

Published
2019
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5. Celecoxib‐tramadol co‐crystal in patients with moderate‐to‐severe pain following bunionectomy with osteotomy: A phase 3, randomized, double‐blind, factorial, active‐ and placebo‐controlled trial.

Author

Viscusi, Eugene R., de Leon‐Casasola, Oscar, Cebrecos, Jesús, Jacobs, Adam, Morte, Adelaida, Ortiz, Esther, Sust, Mariano, Vaqué, Anna, Gottlieb, Ira, Daniels, Stephen, Gimbel, Joseph S., Muse, Derek, Winkle, Peter, Kuss, Michael E., Videla, Sebastián, Gascón, Neus, and Plata‐Salamán, Carlos

Subjects
CYCLOOXYGENASE 2, DRUG efficacy, RESEARCH, COMBINATION drug therapy, PAIN measurement, CONFIDENCE intervals, ANALGESIA, NONSTEROIDAL anti-inflammatory agents, TRAMADOL, OSTEOTOMY, ORAL drug administration, BUNION surgery, SEVERITY of illness index, RANDOMIZED controlled trials, RESEARCH funding, BLIND experiment, DESCRIPTIVE statistics, STATISTICAL sampling, POSTOPERATIVE pain, THERAPEUTICS
Abstract

Background: Celecoxib‐tramadol co‐crystal (CTC) is a first‐in‐class analgesic co‐crystal of celecoxib and racemic tramadol with an improved pharmacologic profile, conferred by the co‐crystal structure, compared with its active constituents administered alone/concomitantly. Aim: We evaluated CTC in moderate‐to‐severe acute postoperative pain. Materials and Methods: This randomized, double‐blind, factorial, active‐ and placebo‐controlled phase 3 trial (NCT03108482) was conducted at 6 US clinical research centers. Adults with moderate‐to‐severe acute pain following bunionectomy with osteotomy were randomized to oral CTC (200 mg [112 mg celecoxib/88 mg rac‐tramadol hydrochloride] every 12 h), tramadol (50 mg every 6 h), celecoxib (100 mg every 12 h), or placebo for 48 h. Patients, investigators, and personnel were blinded to assignment. The primary endpoint was the 0–48 h sum of pain intensity differences (SPID0–48) in all randomized patients. Pain intensity was assessed on a 0–10 numerical rating scale (NRS). Safety was analyzed in patients who received study medication. Funded by ESTEVE Pharmaceuticals. Results: In 2017 (March to November), 1323 patients were screened and 637 randomized to CTC (n = 184), tramadol (n = 183), celecoxib (n = 181), or placebo (n = 89). Mean baseline NRS was 6.7 in all active groups. CTC had a significantly greater effect on SPID0–48 (least‐squares mean: −139.1 [95% confidence interval: −151.8, −126.5]) than tramadol (−109.1 [−121.7, −96.4]; p < 0.001), celecoxib (−103.7 [−116.4, −91.0]; p < 0.001), or placebo (−74.6 [−92.5, −56.6]; p < 0.001). Total treatment‐emergent adverse events (TEAEs) were 358 for CTC and 394 for tramadol. Drug‐related TEAEs occurred in 37.7% patients in the CTC group, compared with 48.6% in the tramadol group. There were no serious TEAEs/deaths. Conclusion: CTC provided greater analgesia than comparable daily doses of tramadol and celecoxib, with similar tolerability to tramadol. CTC is approved in the United States. [ABSTRACT FROM AUTHOR]

Published
2023
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9. Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial.

Author

Dakin, Paula, Kivitz, Alan J., Gimbel, Joseph S., Skrepnik, Nebojsa, DiMartino, Stephen J., Emeremni, Chetachi A., Haitao Gao, Neil Stahl, Weinreich, David M., Yancopoulos, George D., Geba, Gregory P., Gao, Haitao, and Stahl, Neil

Abstract

Objectives: To study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).Methods: In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.Results: Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.Conclusions: Fasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit-risk. [ABSTRACT FROM AUTHOR]

Published
2021
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10. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study.

Author

Viscusi, Eugene, Joseph, S Gimbel, Richard, A Pollack, Hu, Jia, Lee, Gwo-Chin, Gimbel, Joseph S, and Pollack, Richard A

Abstract

Background and Objectives: There is a need for local anesthetics that provide consistent analgesia through 72 hours after surgery. This study evaluates the use of HTX-011 (bupivacaine and meloxicam in Biochronomerpolymer technology), an extended-release, dual-acting local anesthetic, in reducing both postoperative pain over 72 hours and postoperative opioid use when compared with bupivacaine hydrochloride (HCl) and saline placebo. Inclusion of low-dose meloxicam in HTX-011 is designed to reduce local inflammation caused by surgery, potentiating the analgesic effect of bupivacaine. Previously, significant synergy has been observed with bupivacaine and meloxicam with both given locally together.Methods: EPOCH 1 was a randomized, double-blind, placebo-controlled and active-controlled phase III study in subjects undergoing a primary unilateral, distal, first metatarsal bunionectomy in which subjects received either a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl or saline placebo.Results: A total of 412 subjects were dosed. The results for the primary and all four key secondary endpoints were statistically significant in favor of HTX-011. HTX-011 demonstrated superior, sustained pain reduction through 72 hours, significantly reduced opioid consumption and resulted in significantly more opioid-free subjects compared with saline placebo and bupivacaine HCl. Safety was similar across groups with fewer opioid-related adverse events observed in the HTX-011 group.Conclusions: HTX-011 demonstrated significant reduction in postoperative pain through 72 hours with significant reduction in opioid consumption and a significant increase in the proportion of opioid-free subjects compared with saline placebo and the most widely used local anesthetic, bupivacaine HCl.Trial Registration Number: NCT03295721. [ABSTRACT FROM AUTHOR]

Published
2019
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