使用吸入性Prostacyclin治療PAH獲致長期的反應


  May 27, 2005 (聖地亞哥) - 在美國胸腔醫學會的2005年國際年會上,研究人員發表一項研究結果,以吸入性的prostacyclin治療肺動脈高血壓(PAH)患者,經過兩年以後,仍然顯現出正面的效果,避免了注射藥物的使用。
  
  澳洲Graz大學肺部醫學系主任Horst Olschewki醫師表示,對於肺動脈高血壓患者,吸入性的iloprost(Ventavis)有著長期的治療效果,效果的持續期長達兩年。
  
  52位紐約心臟學會(NYHA)的患者在接受治療後,肺功能方面皆有著明顯的改善,六分鐘行走距離的能力也有顯著的加強。
  
  Olschewki醫師表示,吸入性prostacyclin在第一次的12-週試驗中即已顯示出良好的效果;現在,研究人員發現,這些效果可以持續到兩年,患者因此而改善了症狀,死亡率也有了降低;Olschewki醫師在德國Giessen的大學醫院主導本項研究的進行。
  
  哥倫比亞大學小兒科學系教授Robyn J. Barst醫師表示,在肺動脈高血壓患者無法使用口服及注射藥物的情形下,吸入性prostacyclin的出現,滿足了他們的需求;以其他的prostacyclin作吸入投予,長期是否有著更好的效果,目前尚不清楚。
  
  該開放性標記的研究納入了203位NYHA第2至4級的高血壓患者,試驗期為12週;另有一項52名患者參與的兩年期試驗,每日夜間就寢前,使用25到45微克的吸入性iloprost 6到9次;這一組患者中,有36位患有嚴重的肺動脈高血壓,並都完成了630天的治療期;試驗終點,包含六分鐘行走的運動能力增加10%,NYHA症狀等級的改善,危害感消失等;研究人員指出,Iloprost治療的患者中,在12週內,有13%符合臨床上的反應標準,這項臨床反應持續了兩年;同樣的,在第12週的時候,對照組中沒有人符合反應標準,但是,有5位達到吸入性iloprost的長期治療目標。
  
  39位原發性肺動脈高血壓患者的兩年期存活率為91%;根據國家保健登錄機構的資料顯示,未受治療的存活率為63%。
  
  Olschewki醫師表示,這項週期性的治療可以改善運動能力及肺功能;另外,以吸入的方式投予prostacyclin可以避免長期植入導管所產生的併發症。
  
  17%的iloprost治療患者獲致總合反應標準,對照組只有5%;第4級的嚴重肺動脈高血壓患者,藥物反應率更高,有32%符合總合反應標準,對照組中則只有5%。
  
  根據NYHA定義,在六分鐘行走距離上,平均的基線標準,第4級為278公尺,第3級為355公尺。
  
  第二年時,第4級的患者在使用iloprost後,行走距離較之基線增加了27公尺,而對照組則減少了9.5公尺;在經過安慰劑校正過後,結果顯示,第4級的患者在六分鐘行走距離上有著最明顯的進步,亦即,第12週至2年的期間內,進步了59公尺。
  
  Olschewki表示,持續參與試驗的患者中,有4位(7.7%)在兩年的期間內死亡;先前的12週試驗中,也有4位死亡。
  
  Olschewki總結指出,吸入性的iloprost可以安全有效的長期使用。

Long-Term Response Achieved Wi

By
Medscape Medical News

May 27, 2005 (San Diego) — An inhaled prostacyclin continues to show positive results at two years and may aid patients with pulmonary arterial hypertension in avoiding parentally administered therapy, researchers reported here at the 2005 American Thoracic Society International Conference.

Inhaled iloprost (Ventavis) is effective for the long-term treatment of pulmonary arterial hypertension with patients having a sustained clinical benefit for up to two years, said Horst Olschewki, MD, current chairman of the Department of Pulmonary Medicine, Graz University of Austria.

Treated patients had a significant improvement in New York Heart Association (NYHA) functional class as well as improvement in the six-minute walking distance, the study of 52 pulmonary hypertension patients showed.

The drug, an inhaled prostacyclin, was first proven efficacious in a 12-week study, but now researchers have seen those benefits continue up to two years with patients having improved symptoms and decreased mortality, said Dr. Olschewki, who was lead investigator of the study conducted at the University Hospital, Giessen, Germany.

"Having an inhaled prostacyclin available for the treatment of pulmonary arterial hypertension may offer an unmet need between oral therapies and parentally administered therapies," commented Robyn J. Barst, MD, professor of pediatrics, Columbia University College of Physicians and Surgeons, New York, NY. "Whether other prostacyclins administered by inhalation will prove superior in the long term is unknown."

The open-label study included 203 patients with NYHA class 2 to 4 hypertension in a 12-week initial study. A longer, two-year study was then conducted in which 52 patients were enrolled and treated with 25 to 45 μg of inhaled iloprost six to nine inhalations a day and then an overnight rest. Thirty-six patients of the group had primary pulmonary hypertension and completed 630 days of therapy. The endpoints included exercise tolerance of at least a 10% increase in the six-minute walk, symptom improvement (NYHA class), and lack of deterioration. The 13% of iloprost-treated patients who met the composite clinical response criteria in the first 12-week study, all maintained their response after two years, the researchers reported. None of the patients in the control group met the response criteria at 12 weeks; however, five met the criteria on long-term treatment with inhaled iloprost.

The 39 patients with primary idiopathic pulmonary hypertension had a two-year survival rate of 91% compared with a predicted survival of 63% for an untreated historical cohort based on the National Institutes of Health registry, Dr. Olschewki said.

The intermittent therapy both improved exercise tolerance as well as pulmonary function, Dr. Olschewki said. Additionally, the inhaled format of prostacyclin avoids complications associated with chronic indwelling catheters, Dr. Olschewki also said.

Seventeen percent of the iloprost patients achieved the composite response vs only 5% of placebo patients. Patients with primary pulmonary hypertension class 4 had an even higher response rate with 32% meeting the composite response compared with 5% of those taking placebo.

The mean baseline six-minute walking distance among NYHA class 4 patients was 278 m, while it was 355 m for class 3.

At two years, class 4 patients treated with iloprost showed a 27-m improvement from baseline vs a 9.5-m deterioration for the controls. When placebo-corrected improvement was determined, the class 4 primary pulmonary hypertension group had the most improvement in the six-minute walking distance with an improvement of 59 m between 12 weeks and two years.

Of those patients who remained in the study, 4 (7.7%) died during the two-year study period compared with four who died during the initial 12-week phase, Dr. Olschewki said.

Inhaled iloprost can be safely and effectively administered long term, Dr. Olschewki said.

2005 ATS International Conference: Poster K29. Presented May 22, 2005.

Reviewed by Gary D. Vogin, MD

Linda Little is a freelance writer for Medscape.

    
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