|
|
Meta-analysis of safety and tolerability of prostacyclin analogues for pulmonary arterial hypertension |
YIN Dawei1,2, SHI Hanyu1,2, WEI Luqing1 |
1. Department of Pulmonary and Critical Care Medicine, Characteristic Medical Center of the Chinese People’s Armed Police Force, Tianjin 300162, China; 2. Logistics University of Chinese People’s Armed Police Force, Tianjin 300309, China |
|
|
Abstract Objective To evaluate the safety and tolerability of prostacyclin analogues (PA) in the treatment of pulmonary arterial hypertension (PAH).Methods Such databases as CNKI, WanFang Data, VIP, PubMed and Embase were searched for randomized controlled trials (RCTs)in which PAs were used in the treatment of PAH. Literature was screened, data was extracted and the quality of the study was assessed. RevMan5.3 and StataV12.0 software were used for meta-analysis.Results Sixteen RCT studies involving 3,726 patients were included in this research. The result of meta-analysis showed that the incidence of at least one adverse events (AEs)[RR=1.05, 95%CI(1.00, 1.10), P=0.04] and discontinuation [RR=1.81, 95%CI(1.08, 3.05), P=0.02] in the test group was higher than that in the control group, and the difference was statistically significant. The chance of specific AEs in the test group was also higher than in the control group. The incidence rates of at least one serious adverse event [RR=0.93, 95%CI(0.83, 1.04), P=0.20] was not significantly different between the two groups.Conclusions PAs are relatively safe, but there is still the risk of tolerability in PAH patients.
|
Received: 11 November 2019
|
|
|
|
|
[1] |
Mclaughlin V, Shah J, Souza R, et al. Management of pulmonary arterial hypertension[J]. J Am Coll Cardiol, 2015, 65(18):1976-1997.
|
[2] |
Mancia G, De Backer G, Dominiczak A, et al. 2007 ESH-ESC practice guidelines for the management of arterial hypertension: ESH-ESC Task Force on the Management of Arterial Hypertension[J]. J Hypertens, 2007, 25(9):1751-1762.
|
[3] |
Simonneau G, Torbicki A, Hoeper M, et al. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension[J]. J Med Chem, 2012, 58(18):7128-37.
|
[4] |
刘永贵,赵丽嘉,肖桂芝. Selexipag[J].现代药物与临床,2010,25(6):469-471.
|
[5] |
Said, S. I. Mediators and modulators of pulmonary arterial hypertension[J]. Am J Physiol-lung C, 2006, 291(4):L547-L558.
|
[6] |
Higgins T, Greene S. Cochrane handbook for systematic reviews of interventions. www.handbook.cochrane.org. Accessed November 5, 2015.
|
[7] |
Barst J, Rubin J, Long A, et al. A Comparison of Continuous Intravenous Epoprostenol (Prostacyclin) with Conventional Therapy for Primary Pulmonary Hypertension[J]. New Engl J Med, 1996, 334(5):296-302.
|
[8] |
Badesh B, Tapson F, McGoon D, et al. Continuous intravenous epoprostenol for pulmonary hypertension due to the scleroderma spectrum of disease. A randomized, controlled trial[J]. Ann Inter Med, 2000, 132(6):425-434.
|
[9] |
Galie N, Humbert M, Vachiery L, et al. Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial[J]. J Am Coll Cardiol, 2002, 39(9):1496-1502.
|
[10] |
Olschewski H, Simonneau G, Galie N, et al. Inhaled iloprost for severe pulmonary hypertension[J]. New Engl J Med, 2002, 347(5):322-329.
|
[11] |
Simonneau G, Barst J, Galie N, et al. Continuous subcutaneous infusion of treprostinil a prostacyclin analogue in patients with pulmonary arterial hypertension[J]. Am J Resp Crit Care, 2002, 165(6):800-804.
|
[12] |
Barst J, Mcgoon M, Mclaughlin V, et al. Beraprost therapy for pulmonary arterial hypertension[J]. J Am Coll Cardiol, 2003, 41(12):2119-2125.
|
[13] |
Hoeper M, Leuchte H, Halank M, et al. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension[J]. Eur Respir J, 2006, 28(4):691-694.
|
[14] |
Mclaughlin V, Oudiz J, Frost A, et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension[J]. Am J Resp Crit Care, 2006, 174(11):1257-1263.
|
[15] |
Rubenfire M, Mclaughlin V, Allen P, et al. Transition from Ⅳ epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension[J]. Chest, 2007, 132(3):757-763.
|
[16] |
Hiremath J, Thanikachalam S, Parikh K, et al. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial[J]. J Heart Lung Transpl, 2010, 29(2):137-149.
|
[17] |
Mclaughlin V, Benza L, Rubin J, et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial[J]. J Am Coll Cardiol, 2010, 55(18):1915-1922.
|
[18] |
Simonneau G, Torbicki A, Hoeper M, et al. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension[J]. Eur Respir J, 2012, 40(4):874-880.
|
[19] |
Tapson F, Torres F, Kermeen F, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (The FREEDOM-C Study)[J]. Chest, 2012, 142(6):1383-1390.
|
[20] |
Jing C, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial[J]. Circulation, 2013, 127(5):624-633.
|
[21] |
Tapson F, Jing C, Xu F, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (The FREEDOM-C2 Study)[J]. Chest, 2013, 144(3):952-958.
|
[22] |
Sitbon O, Channick R, Chin M, et al. Selexipag for the treatment of pulmonary arterial hypertension[J]. New Engl J Med, 2015, 373(26):2522-2533.
|
[23] |
Edda S, Steven M, Vinicio A, et al. New and emerging therapies for pulmonary arterial hypertension[J]. Annu Rev Med, 2019, 70:45-59.
|
[24] |
Galiè N, Humbert M, Vachiery L, et al. 2015 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension[J]. Eur Respir J, 2015, 46:903-975.
|
[25] |
O’Connell C, Amar D, Athénaïs B, et al. Comparative safety and tolerability of prostacyclins in pulmonary hypertension[J]. Drug Safety, 2016, 39(4):287-294.
|
[26] |
Babic T, Browning N. The role of vagal neurocircuits in the regulation of nausea and vomiting[J]. Eur J Pharmacol, 2014, 722:38-47.
|
[27] |
Corboz R, Li Z, Malinin V, et al. Preclinical pharmacology and pharmacokinetics of inhaled hexadecyl-treprostinil (C16TR), a pulmonary vasodilator prodrug[J]. J Pharmacol Exp Ther, 2017, 363(3):348-357.
|
[28] |
Sadushi-Kolici R, Skoro-Sajer N, Zimmer D, et al. Long-term treatment, tolerability, and survival with sub-cutaneous treprostinil for severe pulmonary hypertension[J]. J Heart Lung Transpl, 2012, 31(7):735-743.
|
|
|
|