Evaluation of the antiplatelet effect of generic ticagrelor 90 mg (ticaspan®) alone and in combination with aspirin 75 mg as compared to ticagrelor (innovator): An in vitro study.

Objective: To evaluate an in vitro antiplatelet effect of generic ticagrelor 90 mg (ticaspan) alone and in combination with aspirin 75 mg as compared to the innovator formulation of ticagrelor alone and in combination with aspirin among healthy Indian volunteers. Methods: 18 volunteers were enrolled and platelet viability was tested using lactate dehydrogenase (LDH) assay in six of 18 volunteers. In 12 volunteers, maximum platelet aggregation (MPA) and percentage inhibition of platelet aggregation (PI) were assessed using a platelet aggregometer in six study groups. Results: There was no significant increase in LDH levels when platelets were incubated with an innovator or generic drug alone and in combination with aspirin as compared to the dimethyl sulfoxide [DMSO] group. All five study groups showed a significant reduction in the MPA values compared to the DMSO group (P < 0.01). The extent of decrease in MPA observed with the generic drug was not significantly different from the innovator drug (P = 0.325). Similarly, the MPA observed with the two combination groups did not differ from each other (P = 1.000), but it was significantly different from the MPA observed with aspirin (P = 0.039, each). The PI of platelet aggregation was significantly more in four study groups [generic drug alone; innovator alone; generic drug + aspirin; and innovator drug + aspirin] (P < 0.01) as compared to the aspirin group. Conclusion: The generic ticagrelor and its combination with aspirin demonstrated an antiplatelet effect equivalent to the innovator drug and its combination with aspirin.

Efficacy of anti-scorpion venom serum over prazosin in the management of severe scorpion envenomation.

BACKGROUND: Scorpion venoms cause a massive release of neurotransmitters. Either anti-scorpion venom serum (AScVS) or prazosin has been used in the management of severe scorpion envenomation. AIMS: To compare the time taken for clinical recovery by patients with severe scorpion envenomation after AScVS therapy with that following prazosin therapy. SETTINGS AND DESIGN: A prospective, open-labeled clinical trial was undertaken to compare the effects of the AScVS and/or prazosin on clinical recovery in scorpion-stung patients. MATERIALS AND METHODS: Eighty-one patients from rural districts of Maharashtra presenting with severe scorpion envenomation were assigned to three treatment groups (AScVS: n = 28; prazosin: n = 25; AScVS + prazosin: n = 28). Severity of scorpion envenomation was graded using a proposed composite clinical scoring system to assess the therapeutic efficacy. AScVS was administered as an intravenous slow bolus, ranging from 40 to 100 ml, depending on the severity of envenomation. Prazosin was given as 1 mg every 3 h. STATISTICAL ANALYSIS USED: The non-parametric "Kruskal-Wallis" test was used in the statistical analysis and a P-value of 0.05 was considered significant. RESULTS: Mean composite scores of patients from the three groups at the time of admission were comparable. Complete clinical recovery was noted in 4.14 ± 1.6 h and 19.28 ± 5.03 h in the subjects who were administered AScVS and prazosin, respectively (P < 0.001). There was no incidence of anaphylactic reaction to AScVS. CONCLUSIONS: Intravenous slow bolus of AScVS given based on the clinical severity of envenomation leads to early recovery than prazosin alone and is well tolerated.