Boccuzzi S J, Wogen J, Roehm J B
The Institute for Effectiveness Research, LLC, Bridgewater, New Jersey 08807, USA.
Clin Ther. 2000 Feb;22(2):237-47. doi: 10.1016/S0149-2918(00)88482-9.
This study was undertaken to assess drug-use patterns associated with albuterol delivery via a new propellant device compared with conventional chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) in patients taking asthma medications in a population with pharmacy benefits.
In addition to their ozone-depleting properties, conventional CFC inhalers often deliver inconsistent doses because of loss of prime and temperature instability. A new propellant, hydrofluoroalkane (HFA), incorporates a re-engineered delivery system associated with dosing reproducibility throughout the life of the canister.
Drug markers associated with management of asthma were used to identify a study cohort of new users of inhaled albuterol from a geographically diverse pharmacyclaims database from July 1, 1997, through December 31, 1997. A population of 282,879 members was identified over the 20-month follow-up period. In addition, a subset of chronic albuterol inhaler users (> or = 12 months; n = 96,879) was also identified to support a longitudinal analysis. Disease severity was controlled for by use of inhaled corticosteroids (ICS). To control for canisters received via physician office samples, HFA patient use was corrected by a physician-based canister adjustment based on HFA sample data.
A total of 53.1% of participants were women and 46.1% were men; most of the population (72.5%) was <65 years of age. Canister use for HFA patients was consistently lower (2.7+/-3.2 vs 5.4+/-6.7) than for CFC MDIs for the entire cohort over the 20-month assessment period. This difference was consistently observed for albuterol canister use in patients with and without concomitant ICS use (3.3+/-3.8 HFA vs 7.2+/-7.5 CFC for ICS users and 2.1+/-2.1 HFA vs 4.1+/-5.7 CFC for non-ICS users). Time to next prescription also was longer for HFA patients than for CFC patients (61.6+/-50.9 days HFA vs 47.3+/-40.8 days CFC). When duration of therapy and physician samples associated with product launch were controlled for, similar differences were consistently observed. CFC patients used, on average, 1.3 more canisters per year than did HFA patients (P < 0.001), averaging 10.7 canisters (95% CI, 10.6 to 10.7), compared with 9.4 canisters used by HFA patients (95% CI, 8.9 to 9.9). Further analyses indicated that this finding was consistent when ICS use was controlled for (CFC plus ICS mean, 11.9 canisters vs HFA plus ICS mean, 10.4 canisters; P < 0.001).
This study provides useful information about the effect of use of a new albuterol delivery system on asthma inhaler management. These data suggest that CFC patients use an average of 1.3 more canisters per year compared with HFA patients independent of asthma severity as measured by ICS use. This improvement in dosing characteristics has the potential to translate into enhanced economic outcomes.
本研究旨在评估在有药房福利的人群中，与使用新型推进剂装置输送沙丁胺醇相关的用药模式，并与传统的氯氟烃（CFC）定量吸入器（MDI）进行比较，这些患者正在服用哮喘药物。
传统的CFC吸入器除了具有消耗臭氧层的特性外，还常常由于初始剂量损失和温度不稳定而导致剂量输送不一致。一种新型推进剂氢氟烷烃（HFA）采用了重新设计的输送系统，在整个药罐使用期内具有剂量可重复性。
使用与哮喘管理相关的药物标记物，从1997年7月1日至1997年12月31日地理分布广泛的药房索赔数据库中识别出吸入沙丁胺醇新用户的研究队列。在20个月的随访期内确定了282,879名成员。此外，还识别出一组慢性沙丁胺醇吸入器使用者（≥12个月；n = 96,879）以支持纵向分析。通过使用吸入性糖皮质激素（ICS）来控制疾病严重程度。为了控制通过医生办公室样本获得的药罐，根据HFA样本数据，通过基于医生的药罐调整来校正HFA患者的使用情况。
共有53.1%的参与者为女性，46.1%为男性；大多数人群（72.5%）年龄<65岁。在20个月的评估期内，整个队列中HFA患者的药罐使用量始终低于CFC MDI使用者（2.7±3.2对比5.4±6.7）。在使用和未使用ICS的患者中，沙丁胺醇药罐使用情况均始终观察到这种差异（ICS使用者中，HFA为3.3±3.8对比CFC为7.2±7.5；非ICS使用者中，HFA为2.1±2.1对比CFC为4.1±5.7）。HFA患者下次处方的时间也比CFC患者更长（HFA为61.6±50.9天对比CFC为47.3±40.8天）。当控制与产品推出相关的治疗持续时间和医生样本时，始终观察到类似的差异。CFC患者平均每年比HFA患者多使用1.3个药罐（P < 0.001），CFC患者平均使用10.7个药罐（95% CI，10.6至10.7），而HFA患者使用9.4个药罐（95% CI，8.9至9.9）。进一步分析表明，当控制ICS使用情况时，这一发现是一致的（CFC加ICS平均为11.9个药罐对比HFA加ICS平均为10.4个药罐；P < 0.001）。
本研究提供了关于新型沙丁胺醇输送系统对哮喘吸入器管理影响的有用信息。这些数据表明，与通过ICS使用衡量的哮喘严重程度无关，CFC患者平均每年比HFA患者多使用1.3个药罐。剂量特征的这种改善有可能转化为更好的经济结果。
