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2. 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

4. 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

6. Italian Survey on adjuvant treatment of non-small cell lung cancer (ISA)

Author

Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, Zanon E., Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, and Zanon E.

Abstract

Background: A recent pooled analysis of randomized trials indicated significant improvement in overall survival from cisplatin-based adjuvant chemotherapy for non-small cell lung cancer (NSCLC), depending on disease stage (only in stages II and III) and PS (≤1). Post-operative radiotherapy (RT) is optional for pN2 tumours. Patients and methods: To evaluate opinions and daily clinical practice of Italian Oncologists about adjuvant treatment of NSCLC, a 46-item questionnaire was delivered via e-mail. Results: Seventy-eight physicians from 68 Centers (out of 98 contacted) returned their questionnaire. Seventy-four, 86, 94, and 78% of them give the indication for adjuvant chemotherapy for stage IIA, IIB, IIIA, and IIIB disease, respectively and 14% in stage IB disease. Stage, PS, and age are taken into consideration evaluating adjuvant approach by 97, 95 and 73%, respectively. Cisplatin-vinorelbine (64%) and cisplatin-gemcitabine (33%), for 4 cycles (81%), are the preferred regimens, while 32% use different regimens. Ninety-two percent indicate RT in pN2 disease and/or positive resection margins. Real Number of patients Needed to Treat (NNT) is probably not completely known/understood and/or used by physicians. Conclusions: A substantial adherence between clinical daily practice in Italy and scientific progresses is described in this paper, even with some discordances regarding the most appropriate adjuvant chemotherapy regimen.

Published
2011

7. 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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9. Effectiveness of direct egfr mutations research at time of diagnostic biopsy for lung cancer: a single institution outcome research

Author

Ghilardi, L., primary, Massazza, G., additional, Bonomi, L., additional, Ciaravino, G., additional, Michetti, G., additional, Oprandi, B., additional, Lucianetti, A., additional, Candiago, E., additional, Bertuletti, C., additional, Gianatti, A., additional, Tondini, C.A., additional, Labianca, R., additional, and Bettini, A.C., additional

Published
2015
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10. 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

13. 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

14. 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

15. 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

16. Changes in body weight and composition, metabolic parameters, and quality of life in patients with type 2 diabetes treated with subcutaneous semaglutide in real-world clinical practice.

Author

Pantanetti P, Cangelosi G, Alberti S, Di Marco S, Michetti G, Cerasoli G, Di Giacinti M, Coacci S, Francucci N, Petrelli F, Ambrosio G, and Grinta R

Subjects
Humans, Female, Male, Middle Aged, Aged, Prospective Studies, Injections, Subcutaneous, Weight Loss drug effects, Blood Glucose analysis, Blood Glucose drug effects, Diabetes Mellitus, Type 2 drug therapy, Quality of Life, Glucagon-Like Peptides administration & dosage, Glucagon-Like Peptides therapeutic use, Body Composition drug effects, Body Weight drug effects, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents administration & dosage
Abstract

Subcutaneous once-weekly (ow) semaglutide is a recent treatment option for type 2 diabetes (T2D) and obesity, but real-world data on weight loss and associated changes in body composition, nutrients intake, and quality of life are still scarce. This observational, prospective clinical study involved all T2D patients starting ow semaglutide according to routine care between December 2021 and February 2022. Clinical information was collected after 6 months (T6) and 12 months (T12) from semaglutide initiation (T0). Bioelectrical Impedance Analysis (BIA) was performed to measure changes in body composition. Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the 36 - items Short Form Health Survey (SF-36) were administered as patient-reported outcomes (PROs). Changes in continuous endpoints (weight, body composition, nutrients intake, other clinical parameters, and PROs) were assessed using mixed models for repeated measurements. Overall, 90 patients (age 63.0 ± 10.0 years; diabetes duration 7.6 ± 5.9 years; 58.9% men; HbA1c 7.7 ± 1.1%; weight 95.4 ± 19.4 Kg, BMI 34.6 ± 6.4 Kg/m 2 ; 36.7% naïve to diabetes treatment, 43.3% on metformin, 10.0% on dual oral therapy, and 10.0% treated with schemes including insulin) were included in the study. After 6 months from semaglutide initiation, body weight significantly decrease by -4.69 Kg (95%CI -6.19;-3.19) (primary endpoint). After 12 months, body weight was further reduced (-5.38 Kg; 95%CI -7.79;-2.97). At BIA, fat mass was significantly reduced by 2.1 Kg after 6 months but only slightly reduced after 12 months vs. baseline; lean mass was also significantly reduced by over 3 Kg both at 6 and 12 months. Intake of all nutrients declined in the first 6 months of therapy, although only lipids reduction reached the statistical significance (-6.73 g; p=0.02). Statistically significant improvements in BMI, waist circumference, glycemic control, blood pressure and lipid profile were documented. Satisfaction with treatment (DTSQ questionnaire) and mental health (MCS score of SF-36 questionnaire) significantly increased during the follow-up. The study documented real-world benefits of semaglutide for treating obesity in T2D subjects, with important changes on clinical and patient-reported outcomes. Loss of lean mass associated with weight loss warrants attention; parallel strategies to preserve skeletal muscle and improve physical function, i.e. nutritional education and structured exercise, are of great importance., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Pantanetti, Cangelosi, Alberti, Di Marco, Michetti, Cerasoli, Di Giacinti, Coacci, Francucci, Petrelli, Ambrosio and Grinta.)

Published
2024
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17. Study of the Performance Enhancement of Sc-Doped AlN Super High Frequency Cross-Sectional Lamé Mode Resonators.

Author

Assylbekova M, Pirro M, Zhao X, Michetti G, Simeoni P, and Rinaldi M

Abstract

The increasing use of mobile broadband requires new acoustic filtering technologies that can operate efficiently at frequencies above 6 GHz. Previous research has shown that AlN Super High Frequency (SHF) Cross-Sectional Lamé Mode resonators (CLMRs) can address this challenge, but their performance is limited by the piezoelectric strength of AlN. In this work, we explore the use of substitutional doping of Al in AlN with Sc to enhance the kt2 values of SHF CLMRs. Our results showed that the measured kt2·Qm product of Al72Sc28N CLMRs was four times greater than that of AlN CLMRs operating at the same frequency. Additionally, the measured fractional bandwidth (FWB) of Al72Sc28N 2nd order ladder filters was 4.13%, a fourfold improvement over AlN filters with the same design. We also discuss other aspects of the technology, such as power handling, losses, and spurious mode suppression, and identify potential areas for future research.

Published
2023
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18. A ±0.5dB, 6nW RSSI Circuit with RF Power-to-Digital Conversion Technique for Ultra-low Power IoT Radio Applications.

Author

Mittal A, Mirchandani N, Michetti G, Colombo L, Haque T, Rinaldi M, and Shrivastava A

Abstract

This paper presents a new technique of radio frequency (RF) signal strength detection with a received signal strength indicator (RSSI) circuit which can be deployed in an internet-of-things (IoT) network. The proposed RSSI circuit is based on a direct conversion of RF to digital code indicating the signal strength. The direct conversion is achieved by the repeated switching of a rectifier's output voltage using an ultra-low power comparator. A 5-bit programmable feedback circuit is used to correct detection inaccuracies. The RSSI circuit is implemented in a 65-nm CMOS process and consumes 6nW power. It has a linear dynamic range of 26dB and exhibits an error of ±0.5dB with a wide bandwidth of 750MHz. A detailed analysis of the RSSI circuit is presented and verified with simulation and measurement results. The high detection accuracy with ultra-low power consumption of our RSSI circuit is favourable for IoT applications including localization, beamforming, hardware security and other low-power applications.

Published
2022
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19. Radio Frequency Angular Momentum Biased Quasi-LTI Nonreciprocal Acoustic Filters.

Author

Cassella C, Michetti G, Pirro M, Yu Y, Kord A, Sounas DL, Alu A, and Rinaldi M

Abstract

We report on the design and operation of a novel class of nonreciprocal acoustic filters operating in the radio frequency (RF) range. These devices use the spectral characteristics of commercial acoustic filters placed in angular momentum biased networks to achieve large nonreciprocity, low insertion loss (I.L.), and wideband operation. Owing to the high rejection exhibited by acoustic filters, these novel devices can achieve an unprecedented suppression of undesired intermodulation products, thus approaching the spectral purity attained by conventional linear-time-invariant (LTI) filtering components. In addition, a new analytical model suitable to capture the behavior of any angular-momentum-biased nonreciprocal device is presented. This model allows us to identify the main characteristics of the transfer function (poles and zeroes) relative to this new class of nonreciprocal filters, thus enabling new synthesis capabilities through standard numerical methods. Ultimately, the performance of a built 1.1-GHz nonreciprocal acoustic filter prototype is reported. This device relies on a modulation implemented through switched capacitors and shows I.L., isolation, and half-power bandwidth values of 4.5 dB, 28 dB, and 20 MHz, respectively, achieved through the use of a 40-MHz modulation frequency. Moreover, by showing an intermodulation distortion lower than -34 dBc, it approaches the operation of LTI circuits.

Published
2019
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20. Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study.

Author

Canonica GW, Rottoli P, Bucca C, Zappa MC, Michetti G, Macciocchi B, Caruso C, Santus P, Bartezaghi M, and Rigoni L

Abstract

Background: Data on the prevalence of perennial versus seasonal allergic asthma in Italy are lacking; moreover, there is limited evidence on the effect of omalizumab on patient-reported outcomes in Italian patients with severe allergic asthma. PROXIMA, an observational, multicenter study, was designed to assess the prevalence of perennial versus seasonal allergic asthma (cross-sectional phase) and the effect of omalizumab on improving illness perception, quality of life (QoL) and asthma control of Italian patients with severe allergic asthma (longitudinal phase)., Methods: The study included a cross-sectional phase ( n  = 357) and a longitudinal phase ( n  = 123): during the longitudinal phase, patients received omalizumab (75-600 mg subcutaneously every month) and were followed-up for 12 months. The primary parameter of cross-sectional phase was prevalence of perennial allergic asthma and that of longitudinal phase was proportion of patients with asthma control (assessed using asthma control questionnaire [ACQ]). Secondary parameters assessed were patients' disease perception, level of asthma control, exacerbation rate during both cross-sectional and longitudinal phases, and patients' compliance to and persistence with omalizumab, and patients' QoL during the longitudinal phase., Results: Most patients (95.8%) had perennial allergies; 81% had polysensitization. Of 99 patients in the per-protocol set, 95 (95.96% [95% CI: 89.98-98.89%]) achieved asthma control (ACQ < 4) at both 6 and 12 months of omalizumab treatment; ACQ score decreased after 6 and 12 months ( P  < 0.0001). Omalizumab treatment resulted in a significant improvement in QoL and patients' illness perception and 87% decrease in exacerbation rate. The compliance rate with omalizumab was high (73.2%). No new safety signals were identified during treatment., Conclusion: This study demonstrated that in severe allergic asthma, omalizumab improves patient-reported outcomes such as patients' illness perception and QoL, while confirming improvement of asthma control and exacerbation rate reduction in Italian patients., Competing Interests: The study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and the AIFA Guideline for classification and management of observational studies on drugs. All patients provided informed consent before participating in the study.Not applicable.Giorgio Walter Canonica reports having received research grants as well as lecture or advisory board fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Mundipharma, Novartis, Sanofi-Aventis, Teva. Paola Rottoli reports receiving personal fees and other from Roche, personal fees from Boehringer Ingelheim, grants and personal fees from Novartis, personal fees from TEVA, other from Menarini, from null, outside the submitted work. Bruno Macciocchi reports receiving grants from Boehringer Ingelheim. Pierachille Santus reports receiving personal fees from Astra Zeneca, grants and personal fees from Boehringer ingelheim, grants from Almirall, grants and personal fees from Chiesi Farmaceutici, personal fees from Guidotti, personal fees from GSK, personal fees from Zambon Italia, outside the submitted work. Marta Bartezaghi and Laura Rigoni are the employees of Novartis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Published
2018
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21. Supportive care in patients with advanced non-small-cell lung cancer.

Author

Di Maio M, 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, Barbera S, Renda F, Romano F, Volpintesta A, Robbiati SF, Sannicolò M, Filipazzi V, Esani G, Gambaro A, Ferrario S, Tinessa V, Caprio MG, Zonato S, Cabiddu M, Raina A, Veltri E, 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 G, Novello S, 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, and Foa P

Subjects
Adult, Aged, Aged, 80 and over, Aging, Antiemetics therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung secondary, Cisplatin administration & dosage, Deoxycytidine administration & dosage, Female, Humans, Lung Neoplasms pathology, Lung Neoplasms secondary, Male, Middle Aged, Palliative Care, Quality of Life, Randomized Controlled Trials as Topic, Survival Rate, Vinblastine administration & dosage, Vinorelbine, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Deoxycytidine analogs & derivatives, Lung Neoplasms drug therapy, Vinblastine analogs & derivatives
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
2003
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22. Induced sputum cellularity. Reference values and distribution in normal volunteers.

Author

Spanevello A, Confalonieri M, Sulotto F, Romano F, Balzano G, Migliori GB, Bianchi A, and Michetti G

Subjects
Adult, Cell Count, Eosinophils cytology, Epithelial Cells cytology, Female, Humans, Lymphocytes cytology, Macrophages cytology, Male, Neutrophils cytology, Reference Values, Sputum cytology
Abstract

Sputum induction has recently been proposed as the only direct noninvasive method for measuring airway inflammatory indices. The reference values and the distribution of cells in induced sputum in a control population have not yet been well defined. We therefore evaluated data from a large number of healthy volunteers. One hundred fourteen healthy, nonatopic, nonsmoking volunteers without airway hyperreactivity were enrolled (age: 38 +/- 13 yr [mean +/- SD]; FEV(1): 105 +/- 10% predicted; provocative dose of methacholine inducing a 20% decrease FEV(1) > 3,200 microgram). Ninety-six subjects (84%) produced adequate analysis samples. The subjects had a normal age distribution. Their induced sputum was rich in macrophages (69.2 +/- 13%) and neutrophils (27.3 +/- 13%), and poor in eosinophils (0.6 +/- 0.8%), lymphocytes (1.0 +/- 1.2%), and epithelial cells (1.5 +/- 1.8%). Only macrophages and neutrophils showed a normal distribution; total and differential counts of other cells did not. We propose that these data be used in comparison of the induced sputum cells of normal subjects and those of patients with airway inflammation.

Published
2000
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