First round benefit-risk assessment First round assessment of benefits See Table 4. Table 4: First round assessment of benefits Indication Benefits Strengths and Uncertainties Compared with placebo, weight based Reduction in DVT was modest; the dosing with nadroparin at recommended difference in incidence of total DVT doses significantly lowers incidence of was barely statistically significant DVT by 45%; (nadroparin versus placebo: 13 versus 23, p=0.045). The distribution of proximal (3 versus 7, p=1.00) and distal (10 versus 17, p > 0.05) thrombi was not statistically different between groups. No PE was reported in this pivotal study mainly due to lack of objective testing. Nadroparin showed comparable efficacy Interpretation was limited by low to UFH in preventing DVT and PE incidence of primary endpoint and lack (Harenberg, 1996). of details (95% CI not presented). Furthermore, incidence of deaths was higher in the nadroparin treatment group.. This was on indirect evidence Requires once daily administration from a MTC (Dooley, 2014) and there compared to thrice daily with UFH. is lack of studies which directly compare one LMWH against another. Enoxaparin, nadroparin and certoparin LMWHs are not clinically were found to be similar in preventing PE interchangeable and so the general and DVT in hospitalised medical patients, evidence provided for heparin (UFH with similar rates of major and minor and LMWH) and for all LMWHs cannot bleeding. be extrapolated as evidence for Similar or better safety profile in terms of efficacy/ safety of nadroparin for haemorrhagic side effects compared to proposed new indication of UFH thromboprophylaxis of medical patients bedridden due to acute illness. Compared to UFH, significantly lower rate of withdrawals, thrombocytopenia, haematomas and local reactions (Forette, 1995).
First round benefit-risk assessment First round assessment of benefits See Table 4. Table 4: First round assessment of benefits Indication Benefits Strengths and Uncertainties Compared with placebo, weight based dosing with nadroparin at recommended doses significantly lowers incidence of DVT by 45%; Nadroparin showed comparable efficacy to UFH in preventing DVT and PE (Harenberg, 1996). Requires once daily administration compared to thrice daily with UFH. Enoxaparin, nadroparin and certoparin were found to be similar in preventing PE and DVT in hospitalised medical patients, with similar rates of major and minor bleeding. Similar or better safety profile in terms of haemorrhagic side effects compared to UFH Reduction in DVT was modest; the difference in incidence of total DVT was barely statistically significant (nadroparin versus placebo: 13 versus 23, p=0.045). The distribution of proximal (3 versus 7, p=1.00) and distal (10 versus 17, p > 0.05) thrombi was not statistically different between groups. No PE was reported in this pivotal study mainly due to lack of objective testing. Interpretation was limited by low incidence of primary endpoint and lack of details (95% CI not presented). Furthermore, incidence of deaths was higher in the nadroparin treatment group.. This was on indirect evidence from a MTC (Dooley, 2014) and there is lack of studies which directly compare one LMWH against another. LMWHs are not clinically interchangeable and so the general evidence provided for heparin (UFH and LMWH) and for all LMWHs cannot be extrapolated as evidence for efficacy/ safety of nadroparin for proposed new indication of thromboprophylaxis of medical patients bedridden due to acute illness. Compared to UFH, significantly lower rate of withdrawals, thrombocytopenia, haematomas and local reactions (Forette, 1995).
auspar-nadroparin-180904.docx