Messin Roger
Therabel Pharma S.A., Rue Egide Van Ophem 108, 1180, Brussels, Belgium,
Adv Ther. 2014 Jan;31(1):91-106. doi: 10.1007/s12325-013-0079-3. Epub 2013 Dec 4.
The direct nitric oxide donor molsidomine is commonly used to relieve symptoms in chronic angina thanks to its vasodilatory properties that induce both a reduction in myocardial oxygen demand and an increase in coronary blood flow. The objective of this study was to compare the short-term effect of molsidomine 16 mg once daily (Coruno(®), Therabel Pharmaceuticals Ltd, Dublin, Ireland) in patients with stable angina previously on molsidomine 8 mg twice daily, in care of general practitioners (GPs) versus cardiologists.
A total of 53 and 80 patients treated by GPs and cardiologists, respectively, took part in this multicenter, open-label clinical trial. Frequency of anginal attacks, short-acting nitroderivative tablets consumption, and subjective clinical status were evaluated, as was tolerability to molsidomine through the reporting of adverse events (AEs), the recording of vital parameters-resting blood pressure, heart rate, and electrocardiogram-and routine blood analyses.
Although demographic and clinical characteristics were significantly different in GPs' compared with cardiologists' patients, the effect of either the 8 mg or the 16 mg molsidomine formulation on anginal crises and nitroderivatives consumption was similar in both patient cohorts, with a trend for the 16 mg formulation to be more efficient on symptoms in elderly patients. Subjective assessment of the beneficial effect of molsidomine 16 versus 8 mg was comparable in GPs' and cardiologists' patients independently of age, "no change" being the most often reported item. Self-evaluation of functional capacity in elderly showed on the whole no difference between the two patient cohorts, only magnitude of pace and total score on molsidomine 16 mg being higher in cardiologists' compared with GPs' patients, and total score in cardiologists' patients higher on molsidomine 16 mg compared with 8 mg. Incidences of AEs and drug-related AEs, as well as proportions of patients reporting such AEs, were similar between GPs' and cardiologists' patient cohorts as between molsidomine 8 and 16 mg formulations. Molsidomine 16 mg once daily had no clinically significant effect on blood pressure, heart rate, electrocardiogram or blood parameters, and compliance with treatment was excellent in whatever patient cohort.
Despite significant demographic and clinical differences between patients in care of GPs and cardiologists, molsidomine was equally efficient in these two patient cohorts, with a trend towards less anginal attacks in the elderly when treated with the 16 mg compared with the 8 mg formulation. Compliance and tolerability to the drug were excellent in both patient cohorts.
直接一氧化氮供体莫西赛利因其血管舒张特性常用于缓解慢性心绞痛症状，该特性可降低心肌需氧量并增加冠状动脉血流量。本研究的目的是比较每日一次服用16毫克莫西赛利（Coruno(®)，爱尔兰都柏林Therabel制药有限公司）对先前每日两次服用8毫克莫西赛利的稳定型心绞痛患者的短期疗效，该研究由全科医生（GP）与心脏病专家负责。
分别由全科医生和心脏病专家治疗的53名和80名患者参与了这项多中心、开放标签的临床试验。评估了心绞痛发作频率、短效硝基衍生物片剂的服用情况、主观临床状态，以及通过不良事件（AE）报告、生命体征参数（静息血压、心率和心电图）记录和常规血液分析对莫西赛利的耐受性。
尽管全科医生治疗的患者与心脏病专家治疗的患者在人口统计学和临床特征上存在显著差异，但8毫克和16毫克莫西赛利制剂对两个患者队列中心绞痛发作和硝基衍生物服用的影响相似，16毫克制剂对老年患者症状的缓解效果有更明显的趋势。无论年龄如何，全科医生和心脏病专家治疗的患者对16毫克与8毫克莫西赛利有益效果的主观评估相当，“无变化”是最常报告的项目。老年患者功能能力的自我评估总体上显示两个患者队列之间没有差异，与全科医生治疗的患者相比，心脏病专家治疗的患者在服用16毫克莫西赛利时仅步幅大小和总分更高，与服用8毫克相比，心脏病专家治疗的患者在服用16毫克莫西赛利时总分更高。全科医生和心脏病专家治疗的患者队列之间的AE和药物相关AE发生率，以及报告此类AE的患者比例，与8毫克和16毫克莫西赛利制剂之间相似。每日一次服用16毫克莫西赛利对血压、心率、心电图或血液参数无临床显著影响，且无论哪个患者队列，治疗依从性都很好。
尽管全科医生和心脏病专家治疗的患者在人口统计学和临床方面存在显著差异，但莫西赛利在这两个患者队列中同样有效，与8毫克制剂相比，16毫克制剂治疗老年患者时心绞痛发作有减少趋势。两个患者队列对该药物的依从性和耐受性都很好。
