Abstract:
BACKGROUND:Inhaled dry powder insulin (IDPI) is the first inhaled insulin approved for the treatment of type 1 and type 2 diabetes mellitus (DM). OBJECTIVE:This article reviews available information on IDPI, focusing on its clinical pharmacokinetics, comparative efficacy, tolerability, adverse events, dosage and administration, and cost. METHODS:MEDLINE (1966-July 2006) and Web of Science (1995-July 2006) were searched for original research and review articles published in English. The search terms used were inhaled insulin, inhaled human insulin, rDNA origin inhalation powder, inbaled dry powder insulin, and IDPI. All published comparative efficacy studies were included in the review, as well as selected information from the package insert for IDPI. RESULTS:IDPI is an inhaled dry powder form of regular human insulin (RHI) that is used as a premeal insulin to improve glycemic control by reducing postprandial glucose excursions. The literature search identified 5 efficacy trials comparing reductions in glycosylated hemoglobin (HbA(1c)) in a total of 582 patients with type 1 DM who received either premeal IDPI plus neutral protamine Hagedorn (NPH) or Ultralente insulin or injectable RHI plus NPH or Ultralente insulin. The search identified 5 comparative efficacy studies of IDPI monotherapy or the addition of IDPI to the current regimen in a total of 1413 patients with type 2 DM that was uncontrolled with diet and exercise, metformin, a sulfonylurea, metformin and a sulfonylurea, or a secretagogue plus an insulin sensitizer. The use of IDPI as a mealtime insulin in these studies was associated with absolute changes in HbA(1c) ranging from -0.6% to +0.1% in patients with type 1 DM and from -1.4% to -2.9% in patients with type 2 DM. HbA(1c) values <7% were achieved in 16.9% to 28.2% of patients with type 1 DM and 16.7% to 44.0% of patients with type 2 DM. The most common nonrespiratory adverse event noted during clinical trials of IDPI was hypoglycemia (type 1 DM: 8.6-9.3 episodes/subject-month; type 2 DM: 0.3-1.4 episodes/subject-month), and the most common adverse event involving the pulmonary system was cough (21.9%-29.5%). CONCLUSIONS:IDPI is the first available inhaled insulin. It provides an additional option for the achievement of HbA(1c) goals with a premeal insulin.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Setter SM,Levien TL,Iltz JL,Odegard PS,Neumiller JJ,Baker DE,Campbell RKdoi
10.1016/j.clinthera.2007.05.015subject
Has Abstractpub_date
2007-05-01 00:00:00pages
795-813issue
5eissn
0149-2918issn
1879-114Xpii
S0149-2918(07)00144-0journal_volume
29pub_type
杂志文章,评审abstract:BACKGROUND:Avanafil is a selective phosphodiesterase type 5 inhibitor being developed for the treatment of erectile dysfunction. OBJECTIVE:This study was conducted to meet Korean regulatory requirements for the marketing of avanafil. To this end, tolerability and pharmacokinetic properties of single and multiple oral ...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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abstract:BACKGROUND:Many patients with asthma require an inhaled long-acting beta(2)-agonist (LABA) in addition to an inhaled corticosteroid to adequately control their disease. OBJECTIVE:The purpose of this study was to assess the long-term tolerability of a salmeterol xinafoate/ fluticasone propionate (SFC) hydrofluoroalkane...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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更新日期:1980-01-01 00:00:00
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更新日期:2013-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:1988-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2006.09.006
更新日期:2006-09-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.02.011
更新日期:2007-02-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(02)80027-3
更新日期:2002-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/s0149-2918(96)80046-4
更新日期:1996-09-01 00:00:00
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更新日期:1995-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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更新日期:2017-05-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2017-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1980-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:2010-03-01 00:00:00
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journal_title:Clinical therapeutics
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更新日期:2020-07-01 00:00:00
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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更新日期:1988-01-01 00:00:00