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1. Gender differences in asthma perception and its impact on quality of life: a post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair® In the Management of Asthma) study

Author

Colombo, D, Zagni, E, Ferri, F, Canonica, Gw, Astarita, C, Balbo, P, Berlendis, M, Bruni, G, Bucca, C, Corsico, Ag, Foresi, A, Macciocchi, B, Michetti, G, Montera, M, Palange, P, Pareo, C, Polla, B, Polosa, R, Puddu, E, Rogliani, P, Romano, A, Rottoli, P, Sabato, E, Santus, P, Schiavino, D, Spanevello, A, Trovato, A, and Zappa, Mc

Subjects
lcsh:Immunologic diseases. Allergy, Quality of life, medicine.medical_specialty, Severe allergic asthma, Settore MED/10 - Malattie dell'Apparato Respiratorio, Disease perception, Omalizumab, 03 medical and health sciences, 0302 clinical medicine, Statistical significance, Internal medicine, Asthma control, Post-hoc analysis, medicine, Gender differences, 030212 general & internal medicine, Asthma, business.industry, Research, Repeated measures design, General Medicine, medicine.disease, 030228 respiratory system, Asthma Control Questionnaire, Cohort, Observational study, business, lcsh:RC581-607
Abstract

Background Gender differences in asthma perception and control have been reported. The PROXIMA observational study assessed these outcomes in a cohort of Italian severe allergic asthma (SAA) patients. This post hoc analysis of the PROXIMA results was aimed at assessing gender differences in SAA in a real-world setting, focusing on disease perception and impact on quality of life (QoL). Methods The PROXIMA study was an observational, multicenter study, consisting of a cross-sectional and a prospective longitudinal phase, including adult outpatients diagnosed with SAA at step 4 requiring a therapeutic step-up. Patients on omalizumab treatment at baseline were included in the 12-month longitudinal phase. Disease control was assessed by the Asthma Control Questionnaire (ACQ) score, patients’ disease perception by the Brief Illness Perception Questionnaire (BIPQ), and QoL by the EuroQoL five-dimensional three-level questionnaire (EQ-5D-3 L) at baseline and after 6 and 12 months. Two regression models were used to evaluate the association between gender and BIPQ total score and EQ-5D-3L score, respectively. Results 357 patients (65% females) were analyzed for the cross-sectional phase and 99 (62.6% females) for the longitudinal phase. The prevalence of perennial and seasonal aeroallergens was similar between genders. ACQ score decreased similarly during omalizumab treatment at 6 and 12 months in both genders; no gender differences were observed in control rates. Asthma perception was worse among females at all study visits reaching statistical significance at 12 months (mean (SD) B-IPQ total score 41.8 (9.4) vs 35.6 (12.0); T test p-value (males vs females) Conclusions In this real-world setting, females confirmed to have a worse perception of asthma, feel it as more symptomatic and suffer a greater impact on their QoL, even though having similar baseline severity and obtaining similar level of control.

Published
2019

2. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone

Author

Stempel, Da, Raphiou, Ih, Kral, Km, Yeakey, Am, Emmett, Ah, Prazma, Cm, Buaron, Ks, Pascoe, Sj, Austri, Investigators, Altieri, Hh, Antuni, Jd, Bergna, Ma, Cuadrado, Ja, De Gennaro MS, Fazio Lizandrelo CL, Gattolin, G, Gosn, Am, Larrateguy, Ld, Marcipar, Am, Maspero, Jf, Medina, Iv, Perez Chada RD, Silva, D, Victorio, Cf, Bardin, Pg, Carroll, Pa, Clements, Bs, Dore, Nd, Robinson, Pd, Fitzgerald, Da, Robinson, Pj, Russo, Ma, Sajkov, D, Thomas, Ps, Upham, Jw, Forstner, B, Kaik, G, Koeberl, Gh, Studnicka, M, Wallner, G, Balthazar, Y, Bauler, A, Dupont, Lj, Martinot, Jb, Ninane, V, Peché, R, Pilette, C, Dimitrova, R, Dimova, D, Kissyova Ibrishimova, G, Loboshka Becheva, M, Machkovska, M, Madjarov, S, Mandazhieva Pepelanova, M, Naidenova, I, Noleva, K, Takovska, N, Terziev, C, Aggarwal, Nk, Chapman, Kr, Csanadi, Ma, Dhillon, R, Henein, S, Kelly, Aj, Lam, As, Liem, Jj, Lougheed, Md, Lowe, Dw, Rizvi, Q, van den Berg, L, Zidel, B, Barros Monge MJ, Calvo Gil MA, Castillo Hofer CR, Diaz Amor PV, Lezana Soya, V, Quilodran Silva CN, Bolivar Grimaldos, F, Solarte-Rodriguez, I, Butkovic-Tomljanovic, R, Hegedus-Jungvirth, M, Ivkovic-Jurekovic, I, Simunov-Karuza, G, Buresova, M, Bursova, J, Fratrik, J, Guttlerova, E, Hartman, P, Jirmanova, I, Kalina, P, Kolman, P, Kucera, M, Povysilova, L, Pravda, P, Svabkova, A, Zakova, L, Backer, V, Maltbaek, N, Johnsen, Cr, Aries, Sp, Babyesiza, A, Barth, D, Benedix, A, Berg, P, Bergtholdt, B, Bettig, U, Bindig, Hw, Botzen, U, Brehler, R, Breyer, Go, Bruckhaus-Walter, M, Dapper, T, Eckhard, Jg, Engelhard, R, Feldmeyer, F, Fissan, H, Franz, Kh, Frick, Bs, Funck, J, Gessner, Cm, Ginko, T, Grigat, Ce, Grimm-Sachs, V, Groth, G, Hampf, J, Hanf, G, Havasi-Jost, G, Heinz, Gu, Helm, K, Hoeltz, S, Hofmann, S, Jander, R, Jandl, M, Jasch-Hoppe, B, Jung, T, Junggeburth, Jj, Kardos, P, Knueppel, W, Koch, T, Kolorz, C, Korduan, M, Korth-Wiemann, B, Krezdorn, Hg, Kroker, A, Kruell, M, Kuehne, P, Lenk, U, Liefring, E, Merke, J, Micke, L, Mitlehner, W, Mueller, H, Naudts, If, Neumann, G, Oldenburg, W, Overlack, A, Panzer, F, Reinholz, N, Remppis, R, Riegel, P, Rueckert, P, Schaetzl, Rj, Schauer, U, Hamelmann, E, Schenkenberger, I, Schlegel, V, Scholz, G, Schroers, M, Schwittay, A, Sebert, M, Tyler, K, Soemantri, Pa, Stock, P, Stuchlik, G, Unland, M, von Mallinckrodt, C, Wachter, J, Weber, U, Weberling, F, Wehgartner-Winkler, S, Weimer, J, Wiemer, S, Winkelmann, Ej, Zeisler, Kh, Ziegner, A, Zimny, Hh, Andrasofszky, Z, Bartha, A, Farkas, M, Gömöri, K, Kis, S, Major, K, Mészáros, I, Mezei, M, Rakvacs, M, Szalai, Z, Szántó, J, Szentesi, M, Szolnoki, E, Valyon, E, Zibotics, H, Anwar, J, Arimah, C, Djajalaksana, S, Rai, Ib, Setijadi, Ar, Setyanto, Db, Susanti, F, Syafiuddin, T, Syamsi, Ln, Wijanarko, P, Yunus, F, Bonavia, M, Braga, M, Chetta, Aa, Cerveri, I, Luisetti, M, Crimi, N, Cutrera, R, De Rosa, M, Esposito, S, Foresi, A, Gammeri, E, Iemoli, E, Legnani, Dl, Michetti, G, Pastorello, Ea, Pesci, A, Pistolesi, M, Riva, E, Romano, A, Scichilone, N, Terracciano, L, Tripodi, S, Choi, I, Kim, C, Kim, Js, Kim, Wj, Koh, Yy, Kwon, Ss, Lee, Sh, Lee, S, Lee, Sk, Park, Cs, Cirule, I, Eglite, R, Petrova, I, Poga, M, Smiltena, I, Chomiciene, A, Davoliene, I, Griskeviciene, V, Naudziunas, A, Naudziunas, S, Rudzeviciene, O, Sitkauskiene, B, Urbonas, G, Vaicius, D, Valavicius, A, Valiulis, A, Vebriene, J, bin Abdul Aziz FA, Daud, M, Ismail, Ai, Tengku Saifudin TI, Md Kassim RM, Mohd Fadzli FB, Wan Mohamad WH, Aguilar Dominguez PE, Aguilar-Orozco, Ra, Garza-Salinas, S, Ramirez-Diaz, Sp, Sánchez Llamas, F, Soto-Ramos, M, Velarde-Mora, Hj, Aguirre Sosa, I, Cisneros, Am, Estrella Viladegut RA, Matsuno Fuchigami, A, Adiaz-Baui, Tt, Bernan, Ap, Onia, Af, Sandagon, Mj, S-Naval, S, Yu, Cy, Bartuzi, Z, Bielous-Wilk, A, Błażowski, Ł, Bożek, A, Brzostek, J, Chorostowska-Wynimko, J, Ciekalska, K, Ziora, D, Cieslicki, J, Emeryk, A, Folcik, K, Gałuszka-Bilińska, A, Gawlik, R, Giejlo, M, Harat, R, Hofman, T, Jahnz-Różyk, K, Jedrzejczak, M, Kachel, T, Kamiński, D, Kelm Warchol, A, Konieczny, Z, Kwasniewski, A, Leszczyński, W, Mincewicz, G, Niezgoda, K, Olszewska-Ziąber, A, Onasz-Manitius, M, Pawlukiewicz, M, Piotrowicz, P, Piotrowski, W, Pisarczyk-Bogacka, E, Piskorz, P, Prokop-Staszecka, A, Roslan, A, Słomka, A, Smalera, E, Stelmach, I, Swierczynska-Krepa, M, Szmidt, M, Tarnowska-Matusiak, M, Tłuczykont, B, Tyminska, K, Waszkuc-Golonko, J, Wojciechowska, I, Alexandrescu, Ds, Neamtu, Ml, Todea, D, Alekseeva, E, Aleksandrova, E, Asherova, I, Barbarash, Ol, Bugrova, O, Bukreeva, Eb, Chermenskiy, A, Chizhova, O, Demko, I, Evdokimova, A, Giorgadze, Ml, Grigoryev, S, Irkhina, I, Khurkhurova, Nv, Kondyurina, Eg, Kostin, Vi, Kudelya, L, Laleko, Sl, Lenskaya, L, Levashov, S, Logvinenko, N, Martynov, A, Mizernitski, Y, Nemtsov, B, Novozhenov, Vg, Pavlishchuk, S, Popova, Vv, Reshetko, Ov, Sherenkov, A, Shirinsky, Vs, Shpagina, L, Soloviev, Ki, Tkachev, A, Trofimov, Vi, Vertkin, Al, Vorobeva, E, Idrisova, E, Yakushin, S, Zadionchenko, V, Zhiglinskaya, O, Zykov, K, Dopudja Pantic, V, Nadaskic, R, Nestorovic, B, Skodric Trifunovic, V, Stojanovic, A, Vukcevic, M, Vujic, T, Mitic Milikic, M, Banovcin, P, Horvathova, H, Karako, P Sr, Plutinsky, J, Pribulova, E, Szarazova, M, Zlatos, A, Adams, L, Badat, A, Bassa, A, Breedt, J, Bruning, A, Ellis, Gc, Emanuel, S, Fouche, Lf, Fulat, Ma, Gani, M, Ismail, Ms, Jurgens, Jc, Nell, H, Nieuwoudt, G, Noor, F, Bolliger, Ct, Puterman, As, Siddique, N, Trokis, Js, Vahed, Ya, Van Der Berg BJ, Van der Linden, M, Van Zyl, L, Visser, Ss, Antépara Ercoreca, I, Arnedillo Muñoz, A, Barbe Illa, F, Barreiro López, B, Blanco Aparicio, M, Boada Valmaseda, A, Bosque García, M, Bustamante Ruiz, A, Carretero Anibarro, P, Del Campo Matias, F, Echave-Sustaet, Jm, Espinosa de los Monteros Garde MJ, Garcia Hernandez GM, López Viña, A, Lores Obradors, L, Luengo Planas MT, Monsó Molas, E, Navarro Dourdil, A, Nieto García AJ, Perpina Tordera, M, Picado Valles, C, Rodriguez Alvarez Mdel, M, Saura Vinuesa, A, Serra Batlles, J, Soler Sempere MJ, Toran Montserrat, P, Valdés Cuadrado LG, Villasante Fernandez-Montes, C, Cheng, Sl, Chern, Jh, Chiu, Mh, Chung, Cl, Lai, Rs, Lin, Ck, Liu, Yc, Wang, Cc, Wei, Yf, Amer, L, Berenfus, Vi, Besh, L, Duka, Kd, Fushtey, Im, Garmash, N, Dudnyk, O, Godlevska, O, Vlasenko, Ma, Hospodarskyy, I, Iashyna, L, Kaladze, M, Khvelos, Si, Kostromina, Vp, Krakhmalova, O, Kryuchko, T, Kulynych, Ov, Krasko, Mp, Levchenko, O, Litvinova, T, Panina, Ss, Pasiyeshvili, Lm, Prystupa, Ln, Romaniuk, Li, Sirenko, I, Synenko, Vi, Vynnychenko, Lb, Yatsyshyn, Ri, Zaitsev, I, Zhebel, V, Zubarenko, O, Arthur, Cp, Brown, V, Burhan, H, Chaudhuri, R, Collier, D, Barnes, Nc, Davies, Ej, Ellery, A, Kwok, S, Lenney, W, Nordstrom, M, Pandya, Hc, Parker, Iw, Rajakulasingam, K, Seddon, P, Sharma, R, Thomas, Ec, Wakeling, Ja, Abalos-Galito, M, Abboy, C, Abreu, E, Ackerman, If, Acosta, Ia, Adaoag, Aa, Ahmed, M, Ali, Mi, Allen, Dr, Allen GG Jr, Diogo, Jj, Allison, Dc, Alwine, Lk, Apaliski, Sj, Arastu, Rs, Arora, Cm, Auerbach, D, Azzam, Sj, Badar FL 3rd, Baker, Jw, Barasch, Jp, Barber, Ma, Bardinas-Rodriguez, R, Barreiro, Tj, Baumbach, Rr, Baur, Ce, Baxter, Bs, Beach, Jl, Beasley, Rl, Beavins, Je, Beliveau, Wj, Benbow, Mj, Bennett, Nl, Bennett, Rl, Bernal, H, Bernstein, Di, Blaiss, Ms, Blumenthal, Kw, Boas, Sr, Borders, Jl, Boscia, Ja, Boulware, Wn, Bowling, Bt, Brabec, Ba, Bramlet, Dg, Figueroa, Dp, Brautigam, Df, Brownell, Jm, Bruce, Tr, Call, Rs, Campbell, Ca, Canaan, Ya, Cannon, Df, Carpio, Jm, Cathcart, Ws, Cevallos, Jp, Chauhan, Av, Chuang, Rb, Chevalier, D, Christensen, J, Christensen, Ta, Christina, Mo, Chrzanowski, Rr, Civitarese, Fa, Clark, Jp, Clifford, Dp, Lapidus, Rj, Coggi, Ja, Lenz, Jj, Cohen, Kr, Collins, Bg, Collins, H, Comellas, A, Condit, J, Cordasco EM Jr, Corder, Cn, Covar, Ra, Coverston, Kd, Croce, Sa, Cruz, H, Curtis, Ct, Daftary, Pk, Dalan, D, Dalawari, Sp, Daly, Wc, Davis, Kc, Dawes, Kw, Decotiis, Ba, Deluca, Rf, Desantis, Dm, De Valle OL, Diaz, Jl, Diaz, Jd, Dice, Jp, Elizalde, A, Hosler, Mr, Dixon, C, Dobkin, La, Dobrusin, Rs, Dransfield, Mt, Ebbeling, Wl, Edwards, Jd, Elacion, Jm, Elkayam, D, Ellison, Wt, Elsen, Jr, Engel, Lr, Ensz, Dj, Ericksen, Cl, Ervin, Je, Fang, C, Abrahamian, F, Farrah, Vb, Field, Jd, Fishman, Hj, Florea, R, Nayyar, S, Focil, A, Focauld, F, Franco MA Jr, Frandsen, Br, Ganti, K, Garcia, Fl, Lee, Wm, Garscadden, Ag, Gatti, Ea, Gellady, Am, George, Ar, Gibbon, Gw, Gleason, Gp, Goldberg, P, Goldstein, Mf, Gonzalez, Ge, Gower, Rg, Grande, Ja, Gregory, D, Grubb, Sd, Guthrie, Rp, Haas, Ta, Haft, Ks, Hajal, R, Hammond, Gd, Hansel, Nn, Hansen, Vr, Harris, Af, Hartman, An, Harvey, Rr, Hazan-Steinberg, S, Headley, Dm, Heigerick, Gc, Heller, Bn, Hendrix, El, Herrod, Jn, Hewitt, Mj, Hines, Rl, Hirdt, Ap, Hirschfield, Ja, Hoffman, Ks, Hogan, Ad, Howland, Wc, Hsu, Cc, Hsu, Fj, Hubbard, Wm, Hudson, Jd, Huffman, C, Hussain, M, Ioachimescu, Oc, Ismail, Ym, Jaffrani, Na, Jiang, N, Jones, Sw, Jordan, Rs, Joshi, Ke, Kaashmiri, Mw, Kalafer, M, Kamdar, Ba, Kanuga, Jg, Kao, Nl, Karetzky, M, Katsetos, Jc, Kay, Js, Kimmel, Ma, Kimura, Sh, Kingsley, Jk, Mahmood, Sm, Subich, Dc, Kirstein, Jl, Kleerup, Ec, Klein, Rm, Koh, Dw, Kohli, N, Koura, Fa, Kovacs, Sp, Kratzer, J, Kreit, Ci, Kreutter, Fm, Kubicki, Tm, Labuda, Jm, Latorre, Aj, Lara, Mm, Lechin, Ae, Lee, Jj, Lee, Md, Lentnek, Al, Lesh, Kw, Levins, Pf, Anspach, Rb, Levinsky, Dm, Lillestol, Mj, Lim, H, Livezey, Md, Lloyd-Turney, Cw, Lockey, Rf, Long, Ra, Lynch, Mj, Macgillivray, Bk, Mahadevan, Kp, Makam, Sk, Maloney, Mj, Mapel, D, Margolis, Bd, Margulies, J, Martin, Ef, Martin, Ee, Mascolo, M, Mataria, H, Sunbuli, M, Mathur, Rn, Mattar, Pn, Maynard, Km, Maynard, N, Mccormick, B, Mcelya, M, Mcevoy, Ce, Mckenzie, Wc, Medwedeff, Le, Mehta, Kd, Melamed, Ir, Meli, Jv, Merrick, Bh, Meyers, Pj, Miller, Bt, Minton, Sm, Miranda, Fg, Mohar, De, Montenegro, Ch, Morris, Fa, Morrison, Bs, Moss, Mh, Munoz, F, Naini, Gr, Nakamura, Ct, Naseeruddin, S, Nassim, C, Navazo, Lj, Nissim, Je, Norman, D, Oberoi, Ms, O'Connor, Tm, Offenberger, J, Orr, Rr, Osea, Ea, Paine, Wj, Rasmussen, Nl, Palatnik, M, Pangtay, D, Panuto, Ja, Patel, M, Perera, Ms, Perez, A, Peters PH Jr, Pimentel SM Jr, Pluto, Tm, Pollock, Mt, Posner, Ls, Pritchard, Jc, Pudi, Kk, Puig, Cm, Qaqundah, Py, Radbill, Mk, Rahman, St, Raikhel, M, Raissy, Hh, Ramstad, Ds, Ranasinghe, Es, Rangel, Os, Rapo, Se, Raschal, Sp, Reddy, Dg, Rehman, Sm, Reyes, Sr, Rhodes, Rb, Riffer, E, Rihal, Ps, Riley ED 4th, Rodriguez, Dh, Rogers, Cm, Rohlf, Jl, Romeu, H, Roney, Cw, Ronsick, So, Rosen, Jb, Rowe, Ms, Ruoff, Ge, Ryan, Eh, Saff, Rh, Saini, N, Anand, S, Balakrishnan, K, Samuels, Bs, Samuelson, Rj, Saniuk, Rj, Sargeant, Wo, Saunders, Mk, Saway, W, Scarupa, Md, White, Mv, Schear, Mj, Schwarz, Cm, Scott, Rb, Segall, N, Seibert, Af, Seidmeyer, V, Seidner, Mr, Seifer, Fd, Serje, J, Shah, Ms, Shah, Sb, Shapero, Pa, Shearer, Sd, Sheikh, Sq, Shepherd, Ts, Sher, Er, Sher, Ld, Short, Bh, Silas, Pe, Alvey, Jc, Silverfield, Jc, Simon, Sj, Sitar, S, Skoner, Dp, Smallow, Sa, Smart, Ba, Smith, Ca, Smith, Ke, Smith, Sk, Snyders, Gc, Soong, W, Soufer, J, Spangenthal, S, Stahlman, Je, Steele, Lg, Stegemoller, Rk, Stocks, J, Storms, Ww, Suen, J, Surowitz, Rz, Swauger, Jr, Taber, La, Tan, Ae, Pratt, Se, Tanus, T, Tarpay, Mm, Tarshis, Ga, Tenney, Jw, Tilghman, Kg, Trevino, Me, Troyan, Be, Twiddy, Sk, Updegrove, Jd, Urval, Kr, Uusinarkaus, Kt, Vaela, R, Van Cleeff, M, Varano, S, Vo, Qd, Wainz, Rj, Wald, Ja, Wall, Sj, Wasserman, Rl, Weinstein, Dl, Welker, Ja, Wellmon, B 2nd, Wells, T, Wenocur, Hs, Williams, Dl, Williams, Sl, Win, Ph, Wingo, Td, Wisman PP Jr, Wyszomierski, Da, Yamada, Hm, Yarows, S, Yunger TM Jr, Ziering, Rw., the AUSTRI Investigators, Stempel, D., Raphiou, I., Kral, K., Yeakey, A., Emmett, A., Prazma, C., Buaron, K., and Pascoe, S. Scichilone N tra i collaboratori

Subjects
Male, asthma, serious events, fluticasone, salmeterol, AUSTRI, Exacerbation, Intention to Treat Analysi, INHALED CORTICOSTEROIDS, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, immune system diseases, Ús terapèutic, Broncodilatadors, 030212 general & internal medicine, Child, Fluticasone, RISK, ACTING BETA-AGONISTS, EXACERBATIONS, METAANALYSIS, MORTALITY, SAFETY, DEATH, FDA, Medicine (all), Hazard ratio, General Medicine, Bronchodilator agents, Middle Aged, Fluticasone-Salmeterol Drug Combination, Bronchodilator Agents, Intention to Treat Analysis, Anesthesia, Female, Salmeterol, medicine.drug, Human, Adult, medicine.medical_specialty, Adolescent, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Fluticasone propionate, 03 medical and health sciences, Double-Blind Method, Internal medicine, Administration, Inhalation, medicine, Humans, Asma, Bronchodilator Agent, Asthma, Aged, Proportional Hazards Models, business.industry, Therapeutic use, medicine.disease, respiratory tract diseases, 030228 respiratory system, Fluticasone Propionate, Salmeterol Xinafoate Drug Combination, Proportional Hazards Model, business
Abstract

BACKGROUND The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of lifethreatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone–salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone–salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthmarelated event in the fluticasone–salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P = 0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthmarelated intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone–salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone–salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P

Published
2016

3. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003
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4. Supportive care in patients with advanced non-small-cell lung cancer

Author

DI MAIO, Massimo, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, De Maio, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolò, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, V, Altavilla, G, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, Giorgio Vittorio, Novello, Silvia, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, De Marinis, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferraù, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, Di Costanzo, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nisticò, C, Aschelter, A, Foa, P., DI MAIO, M, Perrone, F, Gallo, Ciro, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, and Gridelli, C.

Subjects
Adult, Male, concomitant drugs, Cancer Research, medicine.medical_specialty, Aging, Palliative care, Lung Neoplasms, medicine.medical_treatment, Vinorelbine, Vinblastine, Deoxycytidine, Clinical, Quality of life, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, polypharmacotherapy, medicine, Humans, Lung cancer, Survival rate, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Palliative Care, Middle Aged, medicine.disease, Gemcitabine, Surgery, Survival Rate, supportive care, lung cancer, Oncology, Concomitant, Quality of Life, Antiemetics, Female, Cisplatin, business, medicine.drug
Abstract

The present study describes supportive care (SC) in patients with advanced non-small-cell lung cancer (NSCLC), evaluating whether it is affected by concomitant chemotherapy, patient's performance status (PS) and age. Data of patients enrolled in three randomised trials of first-line chemotherapy, conducted between 1996 and 2001, were pooled. The analysis was limited to the first three cycles of treatment. Supportive care data were available for 1185 out of 1312 (90%) enrolled patients. Gastrointestinal drugs (45.7%), corticosteroids (33.4%) and analgesics (23.8%) were the most frequently observed categories. The mean number of drugs per patient was 2.43; 538 patients (45.4%) assumed three or more supportive drugs. Vinorelbine does not produce substantial variations in the SC pattern, while cisplatin-based treatment requires an overall higher number of supportive drugs, with higher use of antiemetics (41 vs 27%) and antianaemics (10 vs 4%). Patients with worse PS are more exposed to corticosteroids (42 vs 30%). Elderly patients require drugs against concomitant diseases significantly more than adults (20 vs 7%) and are less frequently exposed to antiemetics (12 vs 27%). In conclusion, polypharmacotherapy is a relevant issue in patients with advanced NSCLC. Chemotherapy does not remarkably affect the pattern of SC, except for some drugs against side effects. Elderly patients assume more drugs for concomitant diseases and receive less antiemetics than adults.

Published
2004

5. The medical treatment with pasireotide in Cushing’s disease: an Italian multicentre experience based on 'real-world evidence'

Author

Rosario Pivonello, Carla Giordano, Alessia Cozzolino, Marialuisa Zilio, Adriana Albani, Carla Scaroni, Valentina Guarnotta, Annamaria Colao, Marco Boscaro, Giorgio Arnaldi, Grazia Michetti, S. Cannavò, Laura Trementino, Davide Iacuaniello, Pivonello R., Arnaldi G., Scaroni C., Giordano C., Cannavo S., Iacuaniello D., Trementino L., Zilio M., Guarnotta V., Albani A., Cozzolino A., Michetti G., Boscaro M., Colao A., Pivonello, R., Arnaldi, G., Scaroni, C., Giordano, C., Cannavo, S., Iacuaniello, D., Trementino, L., Zilio, M., Guarnotta, V., Albani, A., Cozzolino, A., Michetti, G., Boscaro, M., and Colao, A.

Subjects
Adult, Male, medicine.medical_specialty, Hydrocortisone, Endocrinology, Diabetes and Metabolism, Urinary system, 030209 endocrinology & metabolism, Disease, Somatostatin analogues, Cushing’s disease, Medical treatment, Pasireotide, Pituitary tumour, Body Mass Index, Young Adult, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Internal medicine, Diabetes mellitus, Humans, Medicine, Pituitary Neoplasms, Pituitary ACTH Hypersecretion, Adverse effect, Aged, medicine.diagnostic_test, business.industry, Cushing's disease, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, Italy, chemistry, 030220 oncology & carcinogenesis, Cushing’s disease, Medical treatment, Pasireotide, Pituitary tumour, Somatostatin analogues, Female, Original Article, Waist Circumference, Somatostatin, business, Lipid profile, Body mass index
Abstract

A phase III study has demonstrated that 6-month pasireotide treatment induced disease control with good safety in 15–26% of patients with Cushing’s disease (CD). The aim of the current study was to evaluate the 6-month efficacy and safety of pasireotide treatment according to the real-world evidence. Thirty-two CD patients started pasireotide at the dose of 600 µg twice a day (bid) and with the chance of up-titration to 900 µg bid, or down-titration to 450 or 300 µg bid, on the basis of urinary cortisol (UC) levels or safety. Hormonal, clinical and metabolic parameters were measured at baseline and at 3-month and 6-month follow-up, whereas tumour size was evaluated at baseline and at 6-month follow-up. At baseline, 31 patients had very mild to moderate disease and 1 patient had very severe disease. Five (15.6%) patients discontinued treatment for adverse events; the remaining 27 patients (26 with very mild to moderate disease and 1 with very severe disease), reached 6-month follow-up. Considering the group of patients with very mild to moderate disease, responsiveness, defined by the normalization (1 and ≤1.1 ULN) of UC levels, was registered in 21 patients (full control in 19 and near control in 2), corresponding to 67.7% and 80.8% according to an “intention-to-treat” or “per-protocol” methodological approach, respectively. Weight, body mass index, waist circumference, as well as total and LDL-cholesterol significantly decreased, whereas fasting plasma glucose and glycated haemoglobin significantly increased. Hyperglycaemia was documented in 81.2%, whereas gastrointestinal disturbances in 40.6% of patients. In conclusion, in the real-life clinical practice, pasireotide treatment normalizes or nearly normalizes UC in at least 68% of patients with very mild to moderate disease, with consequent improvement in weight, visceral adiposity and lipid profile, despite the occurrence or deterioration of diabetes in the majority of cases, confirming the usefulness of this treatment in patients with milder disease and without uncontrolled diabetes.

Published
2019

6. The degree of urinary hypercortisolism is not correlated with the severity of cushing’s syndrome

Author

Davide Iacuaniello, Chiara Simeoli, Roberto Citarrella, Grazia Michetti, Laura Trementino, Alessandro Ciresi, Rosario Pivonello, Carla Giordano, Giorgio Arnaldi, Annamaria Colao, Valentina Guarnotta, Marco Calogero Amato, Guarnotta, V., Amato MC, Pivonello, R., Arnaldi, G., Ciresi, A., Trementino, L., Citarrella, R., Iacuaniello, D., Michetti, G., Simeoli, C., Colao, A., Giordano, C., Guarnotta, Valentina, Amato, Marco C., Pivonello, Rosario, Arnaldi, Giorgio, Ciresi, Alessandro, Trementino, Laura, Citarrella, Roberto, Iacuaniello, Davide, Michetti, Grazia, Simeoli, Chiara, Colao, Annamaria, and Giordano, Carla

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Hydrocortisone, Endocrinology, Diabetes and Metabolism, Urinary system, Cushing, hypercortisolism, Population, Cushing syndrome severity, 030209 endocrinology & metabolism, Gastroenterology, Severity of Illness Index, Dexamethasone, Urinary free cortisol, Settore MED/13 - Endocrinologia, 03 medical and health sciences, Cushing syndrome, Young Adult, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, medicine, Humans, education, Cushing Syndrome, Cushing syndrome comorbiditie, education.field_of_study, S syndrome, business.industry, Degree of hypercortisolism, Middle Aged, medicine.disease, Cross-Sectional Studies, 030220 oncology & carcinogenesis, Dexamethasone suppression test, Cohort, Female, business
Abstract

Cushing syndrome (CS) is characterized by increased morbidity and mortality compared to the general population. However, there are patients who have more clinical aggressive forms than others. Aim of the study is to evaluate whether the degree of hypercortisolism, defined by the number of times urinary free cortisol (UFC) levels exceed the upper limit of the normal range (ULN), is related to the worsening of phenotypic features, as well as metabolic and cardiovascular parameters, in a cohort of CS patients. A cross-sectional study was conducted on 192 patients with active CS, consecutively presenting at the outpatients' clinic of the University Hospitals of Ancona, Naples, and Palermo. Patients were grouped into mild (UFC not exceeding twice the ULN), moderate (2-5 times the ULN), and severe (more than 5 times the ULN) hypercortisolism. Thirty-seven patients (19.3 %) had mild, 115 (59.8 %) moderate, and 40 (20.9 %) severe hypercortisolism. A significant trend of increase among the three groups was demonstrated for 8-, 16-, and 24-h serum cortisol levels (p

Published
2017

7. Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone

Author

A. Masotti, Silvia Novello, Giovanni Selvaggi, M. Fioretti, Mario Spatafora, C. Barone, Roberta Buosi, Paolo Bruzzi, Santi Barbera, P Mazzanti, G.V. Scagliotti, L. Crinò, L. Garetto, V Dongiovanni, G. Michetti, NOVELLO S, BRUZZI P, BARONE C, BUOSI R, MASOTTI A, MICHETTI G, FIORETTI M, BARBERA S, SPATAFORA M, GARETTO L, MAZZANTI P, DONGIOVANNI V, SELVAGGI G, CRINO L, and SCAGLIOTTI GV

Subjects
Oncology, Male, medicine.medical_specialty, Randomization, Lung Neoplasms, Time Factors, medicine.drug_class, medicine.medical_treatment, Antimetabolite, Deoxycytidine, Drug Administration Schedule, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Lung cancer, Neoplasm Staging, Cisplatin, Chemotherapy, business.industry, Hematology, Middle Aged, medicine.disease, Survival Analysis, Gemcitabine, Confidence interval, Surgery, Treatment Outcome, Female, business, medicine.drug, Follow-Up Studies
Abstract

BACKGROUND: This randomised phase III study investigated if in responsive and stable disease (SD) stage IV patients after two courses of cisplatin and gemcitabine, single-agent gemcitabine (experimental arm) was not inferior in terms of overall survival (OS) to cisplatin-gemcitabine (standard arm). PATIENTS AND METHODS: Noninferiority was defined as an increase in the hazard of death (HR) < or = 1.33 in the experimental arm. From January 2001 to February 2004, 340 patients were registered and 250 were randomised. Cisplatin was administered on day 1 at 75 mg/m2 and Gemcitabine on days 1 and 8 at 1250 mg/m2 every 3 weeks. RESULTS: Response rate after two courses was 29%. The 1-year progression-free survival was 13% in both arms. One-year survival was 52% in the standard and 42% in the experimental arm for an HR of 1.21 [90% confidence interval (CI) 0.97-1.51]. Postprogression survival was in favour of the standard arm (HR 1.30, 95% CI 0.99-1.70, P = 0.051). Grades 3-4 toxicity favoured in the experimental arm. CONCLUSION: In responsive and SD patients with stage IV non-small-cell lung cancer it was not possible to demonstrate that three courses of gemcitabine alone are not inferior, in terms of OS, to the standard approach of three courses of cisplatin-gemcitabine.

Published
2007

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