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FIGURE A1 Table A1 Incidence and Number of Coughs in the EXU and SC Insulin Treatment Groups Period n EXU Incidence (% subjects) Total number of cough events 0–3 Months >3–6 Months >6–9 Months >9–12 Months >12–15 Months >15–18 Months >18–21 Months >21–24 Months 316 289 278 269 263 252 242 232 73 (23.1) 24 (8.3) 15 (5.4) 15 (5.6) 7 (2.7) 10 (4.0) 7 (2.9) 10 (4.3) 84 25 15 16 7 10 7 10 311 297 290 285 270 259 250 244 11 (3.5) 14 (4.7) 2 (0.7) 4 (1.4) 6 (2.2) 6 (2.3) 4 (1.6) 6 (2.5) n SC Insulin Incidence (% subjects) Total number of cough events 12 14 2 4 6 6 4 6 The majority of coughs were mild in severity: only 1 patient in each group reported severe cough. Changes in FEV1 were similar between EXU-treated subjects with and without cough (data not shown). A cough questionnaire was used in all patients at baseline, and subsequently in patients reporting cough that could not be explained by a concomitant condition such as respiratory infection. This questionnaire assessed 6 domains of cough on a 5-point scale ranging from 0 (none) to 4 (constant or severe). The domains were: cough frequency at night, frequency during the day, severity during the day, severity related to short-acting insulin dosing, timing related to short-acting insulin dosing, and cough productivity. Analysis of the cough questionnaire data showed that in the EXU group cough usually developed seconds or minutes after insulin inhalation and was seldom productive. Most patients reported that they rarely, or only occasionally, experienced cough during the day, and rarely or never at night. Table A2 Incidence (Number (%)) of Normal and Abnormal High Resolution Computerized Tomography (HRCT) Scans in Subjects who Underwent a Baseline and at Least 1 Postbaseline HRCT Scan of the Thorax Normal HRCT scan at: Baseline Specified Time Point Yes Yes No No Yes No - No significant change - More abnormal - Less abnormal 1 (1·1) 3 (3.1) 0 1 (1.4) 0 2 (2.0) 0 2 (2.1) 0 1 (1.4) 0 2 (2.0) 20 (21.1) 11(11.3) 17 (23.9) 7 (9.6) 19 (19.4) 10 (10.2) EXU (n = 95) 64 (67.4) 4 (4.2) 6 (6.3) 21 (22.1) Month 12 SC Insulin (n = 97) 63 (64.9) 13 (13.4) 5 (5.2) 16 (16.5) Month 24 EXU (n = 71) 41 (57.7) 9 (12.7) 4 (5.6) 17 (23.9) SC Insulin (n = 73) 49 (67.1) 9 (12.3) 6 (8.2) 9 (12.3) Month 24 LOCF EXU (n = 98) 62 (63.3) 9 (9.2) 8 (8.2) 19 (19.4) SC Insulin (n = 98) 62 (63.3) 15 (15.3) 7 (7.1) 14 (14.3) LOCF, last observation carried forward. A subgroup of patients from both treatment groups underwent high resolution computerized tomography (HRCT) of the thorax. To ensure comparability between the 2 treatment groups, baseline HRCTs were performed prior to randomization but after subjects had met all respiratory entry criteria. Subjects with abnormal HRCT findings at baseline that were judged to be clinically insignificant were allowed into the study. Follow-up HRCTs were performed at Months 12 and 24 or at time of discontinuation. All HRCTs were interpreted as either normal or abnormal by a third party radiologist without knowledge of treatment group assignment. For subjects with normal baseline scans, the incidence of abnormal HRCT results was comparable between treatment groups at Month 24. For subjects with abnormal baseline scans, no additional worsening of HRCT results occurred in EXU subjects at Month 24. The types of HRCT abnormalities identified were similar between groups (data not shown). Pfizer Statement On October 18, 2007, Pfizer Inc announced that it would cease marketing Exubera because it did not meet customers’ needs or financial expectations. On April 9, 2008, Pfizer Inc announced that it was updating the Exubera Product Insert to include the following statement: In studies of Exubera in people with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All of the people in these studies who developed lung cancer used to smoke cigarettes. There were too few cases to know if the lung cancer was related to Exubera. Study Investigators Study investigators were: Marie A. Adamczyk, Sallie O. Adams, Jorge L. Aguilera-Montalvo, Richard F. Arakaki, Stephen L. Aronoff, Gordon R. Bailey, Andre Belanger, Richard I. Bernstein, Jeffrey M. Bloom, Makram A. Boctor, Michael A. Bolognese, Robert R. Boomer, Gerard W. Boynton, Christina R. Bratcher, John B. Buse, Edwin Camilo-Vazquez, William T Cefalu, Merl A. Charles, Sidney E. Clevinger, Martin J. Conway, Larry C. Deeb, Jerry Drucker, Steven V. Edelman, Daniel Einhorn, Freddy G. Eliaschewitz, Norman Fishman, David Fitzpatrick, Vivian A. Fonseca, Miguel A. Franco Jr., David L. Fried, Jeffrey G. Geohas, Jorge L. Gross, George A. Grunberger, Jean-Pierre Halle, Lane T. Handke, Kenneth S. Hershon, Priscilla A. Hollander, Barry S. Horowitz, Edward S. Horton, Robert C. Hood, Irene M. Hramiak, Rajeev K. Jain, Philip B. James, Howard J. Kerstein, Charles Kilo, Steven Landgarten, Robert Lang, David C. Lau, Samuell Lerman, Seymour R. Levin, Peter A. Lewitt, Mark K. Lindley, Thomas W. Littlejohn III, Heather A. Lochnan, Sergio R. Mather, Avishai Mendelson, Joseph L. Milburn Jr., David B. Miller, Liam J. Murphy, Paul C. Norwood Jr., William A. Petit Jr., John R. Pullman, Efrain Rodriquez-Vigil, Julio Rosenstock, Stuart A. Ross, Richard C. Rowe, Joel J. Schnure, Sherwyn L. Schwartz, Terry W. Sherraden, Rubens Sievert, Jay Silverberg, James W. Snyder, Norman G. Soler, Joseph Soufer, David C. Subich, Daniel H. Sugimoto, Allen M. Sussman, Jose A. Tavarez-valle, Barbara E. Troupin, Clarence N. Uy, Mervyn U. Weerasinghe, Richard L. Weinstein, Peter N. Weissman, James P. Wigand, Jean-Francois Yale.
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