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0031729818
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The UK Prospective Diabetes Study. A review
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The late Robert Turner directed and presented the results of the UKPDS study. This is an inclusive review of the trial and its results. These data are very important in the current views of the effectiveness and value of glycaemic control in Type 2 diabetes
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TURNER R: The UK Prospective Diabetes Study. A review. Diabetes Care (1998) 21(12 Suppl. 3):C35-C38. •• The late Robert Turner directed and presented the results of the UKPDS study. This is an inclusive review of the trial and its results. These data are very important in the current views of the effectiveness and value of glycaemic control in Type 2 diabetes.
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DIABETES CONTROL AND COMPLICATIONS TRIAL GROUP: This is the first of many DCCT publications that have established the value of intensive glycaemic control in patients with Type 1 diabetes mellitus
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DIABETES CONTROL AND COMPLICATIONS TRIAL GROUP: The effect of intensive treatment of diabetes on the development and progression of long term complications. N. Engl. J. Med. (1993) 329(14):977-986. •• This is the first of many DCCT publications that have established the value of intensive glycaemic control in patients with Type 1 diabetes mellitus.
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Contributions of basal and post-prandial hyperglycaemia to micro- and macrovascular complications in people with Type 2 diabetes
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Evidence is presented that control of post meal hyperglycaemia is highly correlated with cardiovascular mortality and morbidity, and that therapy specifically targeting this period may be uniquely beneficial in preventing the long-term complications of diabetes
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HOME P: Contributions of basal and post-prandial hyperglycaemia to micro- and macrovascular complications in people with Type 2 diabetes. Curr. Med. Res. Opin. (2005) 21(7):989-998. •• Evidence is presented that control of post meal hyperglycaemia is highly correlated with cardiovascular mortality and morbidity, and that therapy specifically targeting this period may be uniquely beneficial in preventing the long-term complications of diabetes.
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This paper discusses the barriers that delay the initiation of insulin in patients who are failing their initial oral therapies
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KORYTKOWSKI M: When oral agents fail; practical barriers to starting insulin. Int. J. Obes. (2002) 26(Suppl. 3):S18-S24. • This paper discusses the barriers that delay the initiation of insulin in patients who are failing their initial oral therapies.
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Korytkowski, M.1
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Uber inhalation von insulin
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This is the earliest report of insulin inhalation therapy
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GANSSLEN M: Uber inhalation von insulin. Klin. Wochensubcutaeoushr. (1925) 4:71. • This is the earliest report of insulin inhalation therapy.
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Gansslen, M.1
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Inhaled insulin
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John Patton is the inventor of the Exubera system. This is a good review of the technicalities of insulin inhalation
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PATTON JS, NAGARAJAN S: Inhaled insulin. Adv. Drug Deliv. Rev. (1999) 135(2-3):235-247. • John Patton is the inventor of the Exubera system. This is a good review of the technicalities of insulin inhalation.
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Adv. Drug Deliv. Rev.
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Patton, J.S.1
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7
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Drug delivery via the respiratory tract
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Byron presents an inclusive review of drug delivery via the respiratory tract
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BYRON PR: Drug delivery via the respiratory tract. J. Aerosol Med. (1994) 7(1):49-75. •• Byron presents an inclusive review of drug delivery via the respiratory tract.
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Byron, P.R.1
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8
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The AERx aerosol delivery system
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This is an excellent review of the development and principles underlying this aerosol system
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SCHUSTER J, LLOYD RR, LLOYD P: The AERx aerosol delivery system. J. Pharm. Res. (1997) 14(3):354-357. • This is an excellent review of the development and principles underlying this aerosol system.
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ANONYMOUS: This is a progress report of the Novo liquid insulin programme
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ANONYMOUS: Insulin inhalation: NN 1998. Drugs RD (2004) 5(1):46-49. • This is a progress report of the Novo liquid insulin programme.
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Dose-response relation of liquid aerosol inhaled insulin in Type I diabetic patients
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This paper discusses the inhalation of liquid aerosol insulin using the AERx system
-
BRUNNER G, BALENT B, ELLMERER M et al.: Dose-response relation of liquid aerosol inhaled insulin in Type I diabetic patients. Diabetologia (2001) 44(3):305-308. • This paper discusses the inhalation of liquid aerosol insulin using the AERx system.
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Diabetologia
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Brunner, G.1
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DOI 10.1016/S0149-2918(03)80216-3
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AN B, REINHARDT RR: Effects of different durations of breath holding after inhalation of insulin using the AERx insulin diabetes management system. Clin. Ther. (2003) 25:2233-2244. (Pubitemid 37076316)
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An, B.1
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BRUNNER G, BALENT B, ELLMERER M et al.: Dose-response relation of liquid aerosol inhaled insulin in Type I diabetic patients. Diabetologia (2001) 44(3):305-308. (Pubitemid 32234455)
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Brunner, G.A.1
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Jendle, J.H.6
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13
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0038248882
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A major issue facing the developers of inhaled insulin is dealing with the effects of smoking on insulin absorption
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HIMMELMANN A, JENDLE J, MELLEN A, PETERSEN AH, DAHL UL, WOLLMER P: The impact of smoking on inhaled insulin. Diabetes Care (2003) 26(3):677-682. •• A major issue facing the developers of inhaled insulin is dealing with the effects of smoking on insulin absorption.
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Himmelmann, A.1
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HENRY RR, CHU MS, KIM N et al.: Young and elderly Type 2 diabetic patients inhaling insulin with the AERx insulin diabetes management system: a pharmacokinetic and pharmacodynamic comparison. J. Clin. Pharmacol. (2003) 43(11):1228-1234. •• Henry et al. have conducted a trial demonstrating minor differences if the effects of inhaled insulin in older and younger patients who have Type 2 diabetes. (Pubitemid 37280794)
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Journal of Clinical Pharmacology
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Henry, R.R.1
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An, B.7
Reinhardt, R.R.8
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15
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0038248885
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Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects
-
A vital issue that faces the developers of inhaled insulin is the effects of insulin inhalation in impaired lungs, such as in individuals with asthma, chronic obstructive pulmonary disease and in individuals with an acute respiratory illness. This is an excellent trial in non diabetic individuals with and without asthma
-
HENRY RR, HOWLAND WC III, CHU N, KIM D, AN B, REINHARDT RR: Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care (2003) 26(3):764-769. •• A vital issue that faces the developers of inhaled insulin is the effects of insulin inhalation in impaired lungs, such as in individuals with asthma, chronic obstructive pulmonary disease and in individuals with an acute respiratory illness. This is an excellent trial in non diabetic individuals with and without asthma.
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(2003)
Diabetes Care
, vol.26
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Henry, R.R.1
Howland III, W.C.2
Chu, N.3
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An, B.5
Reinhardt, R.R.6
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16
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DOI 10.1111/j.1365-2125.2005.02366.x
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McELDUFF A, KAM PC, CLAUSON P: Influence of acute respiratory tract infection on the absorption of inhaled insulin using the AERx insulin Diabetes Management System. Br. J. Clin. Pharmacol. (2005) 59(5):546-551. • A trial in healthy individuals during and after recovery from an acute respiratory infection is presented. (Pubitemid 40632245)
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British Journal of Clinical Pharmacology
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KAPITZA C, HOMPESCH M, SCHARLING B, HEISE T: Intrasubject variability of inhaled insulin in Type 1 diabetes: a comparison with subcutaneous insulin. Diabetes Technol. Ther. (2004) 6(4):466-472. (Pubitemid 39121371)
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HERMANSEN K, PETERSEN AH, BELLAIRE S, ADAMSON U: Intensive therapy with inhaled insulin via the AERx insulin diabetes management system: a 12 week proof of concept trial in patients with Type 2 diabetes. Diabetes Care (2004) 27(1):162-167. (Pubitemid 38196726)
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OSBORNE R: Novo Nordisk agrees to $55 M for Aradigm's insulin program. BioWorld Today (2004) 15(189):1-2.
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A discussion of the merits of large particle delivery to the lung is presented. Such particles are the basis for the Lilly/Alkermes insulin delivery system
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DUNBAR C, SOMMERER K, DE LONG M, VERMA A, BATYCKY R: In vitro and in vivo dose delivery characteristics of large porous particles for inhalation. Int. J. Pharmaceutics (2002) 245:179-189. • A discussion of the merits of large particle delivery to the lung is presented. Such particles are the basis for the Lilly/Alkermes insulin delivery system.
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Int. J. Pharmaceutics
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Dunbar, C.1
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21
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35348990910
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13-week inhalation study to characterize the toxicity and PK/PD of a human inhaled insulin powder (HIIP) in beagle dogs
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This is a nice discussion of the toxicological studies done in the Lilly/Alkermes inhaled insulin programme
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WOLFF RK, WROBLEWSKI VJ, ENGELHARDT JA, DEAVER DR, SHAW ME: 13-week inhalation study to characterize the toxicity and PK/PD of a human inhaled insulin powder (HIIP) in beagle dogs. Diabetes (2004) 53(6 Suppl. 2):A115-A116. • This is a nice discussion of the toxicological studies done in the Lilly/Alkermes inhaled insulin programme.
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Wolff, R.K.1
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Shaw, M.E.5
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22
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Dose delivery characteristics of the AIR® pulmonary delivery system over a range of inspiratory flow rates
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This is a nice discussion of the effects of air flow on insulin delivery using the AIR system
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DE LONG M, DAWSON M, MEYER T, SOMMERER K, DUNBAR C: Dose delivery characteristics of the AIR® pulmonary delivery system over a range of inspiratory flow rates. J. Aerosol Med. (2005) 18(4):452-459. •• This is a nice discussion of the effects of air flow on insulin delivery using the AIR system.
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De Long, M.1
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Dose-response and dose equivalency of human insulin inhalation powder (HIIP) using the Lilly/Alkermes inhaled insulin system compared to subcutaneous (SC) insulin Lispro
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RAVE K, DE LA PENA A, SEGER M, HEINEMANN L, BATYCKY R, MUCHMORE D: Dose-response and dose equivalency of human insulin inhalation powder (HIIP) using the Lilly/Alkermes inhaled insulin system compared to subcutaneous (SC) insulin Lispro. Diabetes (2005) 54(6 Suppl. 1):A89.
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Muchmore, D.6
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24
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Dose-response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro
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This is a beautifully carried out dose-response study using the Lilly/Alkermes insulin powder
-
RAVE KM, DE LA PENA A, SEGER M et al.: Dose-response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro. Diabetes Care (2005) 28(10):2400-2405. •• This is a beautifully carried out dose-response study using the Lilly/Alkermes insulin powder.
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Diabetes Care
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Rave, K.M.1
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Safety and efficacy of preprandial human insulin inhalation powder (HIIP) delivered by the Lilly/Alkermes inhaled insulin system versus injectable insulin in patients with Type 1 diabetes (T1D)
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GARG S, MUCHMORE D, DE LA PENA A, SUN B, SILVERMAN B: Safety and efficacy of preprandial human insulin inhalation powder (HIIP) delivered by the Lilly/Alkermes inhaled insulin system versus injectable insulin in patients with Type 1 diabetes (T1D). Diabetes (2005) 54(6 Suppl. 1):A89.
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ROSENSTOCK J, DE LA PENA A, SUN B, SILVERMAN B: The safety and efficacy of human insulin powder HIIP) versus injectable insulin in patients with Type 1 diabetes (T1D). Diabetologia (2005) 48(Suppl. 1):A30. (Pubitemid 40434505)
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SKYLER JS, KOURIDES IA, LANDSCHULZ WH, BALAGTAS CC, CHENG SL, GELFAND RA: Efficacy of inhaled human insulin in Type 1 diabetes mellitus: a randomized proof-of-concept study. Lancet (2001) 357(9253):331-335. • This is the earliest published report of a trial using the Exubera system. (Pubitemid 32128537)
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WHITE S, CHEU S, CONLEY PW et al.: Exubera: pharmaceutical development of a novel product for pulmonary delivery of insulin. Diabetes Technol. Ther. (2005) 7(12):896-906. •• In a very informative article, White et al. discuss in detail the issues involved in the development of Exubera. (Pubitemid 43133996)
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Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin
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This is a very fine study of the kinetics of pulmonary insulin contrasted with subcutaneous insulin
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RAVE K, HEINEMANN L, SHA S, BECKER RH, WILLAVIZE SA, HEISE T: Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care (2005) 28(5):1077-1082. •• This is a very fine study of the kinetics of pulmonary insulin contrasted with subcutaneous insulin.
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Rave, K.1
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EDGERTON DS, SCOTT M, BOWEN L et al.: Inhalation of insulin (Exubera) is associated with augmented disposal of portally infused glucose in dogs. Diabetes (2005) 54(4):1164-1170. • Edgerton et al. explore the hepatic versus peripheral activity of inhaled insulin in an awake dog model system. (Pubitemid 40446332)
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FINEBERG SE, FINCO-KENT D, LIU C, KRASNER A: Antibody response to inhaled insulin in patients with Type 1 or Type 2 diabetes. An analysis of initial Phase II and III inhale insulin (Exubera) trials and a two-year extension trial. J. Clin. Endocrinol. Metab. (2005) 90(6):3287-3294. •• Fineberg et al. show immunogenicity data from short and long term trials of Exubera and present evidence that insulin antibodies have no clinical impact in inhaled insulin treated patients. (Pubitemid 41014288)
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HEISE T, TYDEK C, STEPHAN JA et al.: The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care (2005) 28(9):2161-2169. •• Heise et al. prospectively studied patients who developed insulin antibodies and showed that no metabolic effects on insulin action could be shown. (Pubitemid 41242462)
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BOSS A, CHEATHAM W: Mimicry of the early phase insulin response in humans with rapidly available inhaled insulin accelerates postprandial glucose disposal compared to slower bioavailable insulin. Diabetes (2005) 54(6 Suppl.1):A333.
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HAUSMANN M, HEINEMANN L, BUCHWALD A, HEISE T: Add-on therapy with Kos inhaled insulin using a metered dose inhaler is as efficacious as add-on therapy with Lantus® in poorly controlled Type 2 diabetic patients treated with sulfonylurea or metformin. Diabetes (2005) 54(6 Suppl. 1):A102-A103.
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HAUSMANN M, HEINEMANN L, BUCHWALD A, HEISE T: Add-on therapy with Kos inhaled insulin using a metered dose inhaler is as efficacious as add-on therapy with Lantus® in poorly controlled Type 2 diabetic patients treated with sulfonylurea or metformin. Diabetologia (2005) 48(Suppl. 1):A297.
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HSIA CCW, RASKIN P: The diabetic lung: relevance of alveolar microangiopathy for the use of inhaled insulin. Am. J. Med. (2005) 118:205-211. •• Hsia and Raskin present an concise review of the pulmonary safety issues regarding insulin inhalation.
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SADRI H, MacKEIGAN LD, LEITER LA, FINARSON TR: Willingness to pay for inhaled insulin: a contingent valuation approach. Parmacoeconomics (2005) 23(12):1215-1227. •• Another vital issue in the development of inhaled insulin systems is the willingness of patients and third-party payers to pay for this more expensive mode of insulin delivery. This paper uses economic modelling to examine this topic.
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