Lassen et al. (2009) aimed to demonstrate that Apixaban at a dose of 2.5mg twice daily is just as safe and effective as enoxaparin when administered at a dose of 30mg subcutaneously every 12 hours. While Lassen et al. (2010a) observed Apixaban at the same dose but against enoxaparin 40mg once daily. The treatment period for both studies lasted between 10-14 days. The primary efficacy outcome for the above mentioned studies included the following scenarios; symptomatic or non-symptomatic DVT, pulmonary embolisms that do not result in death and all-cause mortality. It transpired in 8.8% of patients receiving enoxaparin with a mere 0.2% increased rate of occurrence with those receiving Apixaban in the ADVANCE-1 trial. Regardless of the similar
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Furthermore when NICE were reviewing the evidence the results of this study were considered less significant as the standard mainstay of treatment in a UK clinical setting is a low molecular weight heparin (LWMH) subcutaneous enoxaparin at the a dose of 40mg (NICE 2013). Conversely the results from ADVANCE-2 were weighed. They indicated that Apixaban significantly reduces the manifestation of total VTE and all-cause mortality by 9.3% against the comparator. Similar favourable results for Apixaban over enoxaparin were documented in ADVANCE-3. The incidence of total VTE was 1.4% for Apixaban showing superior efficacy over enoxaparin where the total incidence of VTE was 3.9% (Lassen et al. 2010b). The principal differences between ADVANCE-3 and ADVANCE 1 and 2 was a longer treatment period of 35 days was employed, patients were enduring THR and enoxaparin was administered as 40mg four times a day. All three studies again support a good safety profile for Apixaban as major or clinically relevant bleeding events were consistently lower than the comparator …show more content…
2014). This poses extreme risks to patients suffering from serious bleeds. However it has driven a lot of interest in developing an antidote and currently “Andexanet alfa” is entering into phase III trials after promising results achieved in phase II trials (Portola Pharmaceuticals 2015). NICE guidance although content with the available evidence recommends further clarification of certain aspects of the studies. For instance there is limited evidence comparing Apixaban directly with other low molecular weight heparins or the new oral anticoagulants (NICE 2012). These would prove to strengthen any concerns surrounding cost effectiveness or ambiguity of the trials. To summarise Apixaban has gone through the lengthy drug discovery process and has proven to be successful providing an attractive treatment option for the aforementioned conditions according to both NICE guidance and a Cochrane review (Bruins Slot and Berge
Furthermore when NICE were reviewing the evidence the results of this study were considered less significant as the standard mainstay of treatment in a UK clinical setting is a low molecular weight heparin (LWMH) subcutaneous enoxaparin at the a dose of 40mg (NICE 2013). Conversely the results from ADVANCE-2 were weighed. They indicated that Apixaban significantly reduces the manifestation of total VTE and all-cause mortality by 9.3% against the comparator. Similar favourable results for Apixaban over enoxaparin were documented in ADVANCE-3. The incidence of total VTE was 1.4% for Apixaban showing superior efficacy over enoxaparin where the total incidence of VTE was 3.9% (Lassen et al. 2010b). The principal differences between ADVANCE-3 and ADVANCE 1 and 2 was a longer treatment period of 35 days was employed, patients were enduring THR and enoxaparin was administered as 40mg four times a day. All three studies again support a good safety profile for Apixaban as major or clinically relevant bleeding events were consistently lower than the comparator …show more content…
2014). This poses extreme risks to patients suffering from serious bleeds. However it has driven a lot of interest in developing an antidote and currently “Andexanet alfa” is entering into phase III trials after promising results achieved in phase II trials (Portola Pharmaceuticals 2015). NICE guidance although content with the available evidence recommends further clarification of certain aspects of the studies. For instance there is limited evidence comparing Apixaban directly with other low molecular weight heparins or the new oral anticoagulants (NICE 2012). These would prove to strengthen any concerns surrounding cost effectiveness or ambiguity of the trials. To summarise Apixaban has gone through the lengthy drug discovery process and has proven to be successful providing an attractive treatment option for the aforementioned conditions according to both NICE guidance and a Cochrane review (Bruins Slot and Berge