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Control of calf DVT favors anticoagulants
Guideline recommendations for caring for patients with calf deep vein thrombosis (DVT) include provisions for serial imaging without treatment, primarily because distal or calf DVT most often has low rates of propagation, embolization, and recurrence. Researchers at the Foundation for Medical Education and Research compared outcomes among patients treated with anticoagulants and those monitored using ultrasound only.
Records from patients with ultrasound-confirmed acute DVT involving the calf veins between January 1, 2016, and August 1, 2018, were reviewed and outcomes analyzed based on two management categories: anticoagulation treatment and serial ultrasound surveillance without anticoagulation. Outcomes included venous thromboembolism (VTE) recurrence, bleeding, death, and net clinical benefit.
Almost 500 patients with calf DVT were identified—399 patients were treated with anticoagulation therapy and 84 patients were managed with surveillance ultrasound. Patients in the surveillance group were older (70 years vs. 63 years) and more likely to have had a recent hospitalization (76.2% vs. 45.4%). Common reasons for choosing ultrasound surveillance included treatment guidelines (58.3%), active bleeding (21.4%), and recent surgery (17.9%).
Results of the study, published in the May 1, 2021 issue of Mayo Clinic Proceedings, showed that VTE recurrence was lower for patients treated with anticoagulants (7.3%) compared with surveillance (14.3%). DVT propagation was also less frequent in the group treated with anticoagulants (2.8%) versus the surveillance group (8.3%). There was no difference in bleeding or mortality outcomes between the two groups.
The researchers concluded that net clinical benefit (VTE recurrence plus major bleeding) favored anticoagulant therapy compared with ultrasound surveillance for patients with calf DVT.
Simplifying treatment for type 2 diabetes patients
Although about one-fourth of patients with type 2 diabetes receive insulin therapy, only half of these patients achieve optimal glucose control (A1C <7%) with many patients having A1C levels ≥9%. Basal-bolus insulin (BBI) regimens still represent the best way for patients with type 2 diabetes to achieve the desired level of glycemic control, but simplification of intensive insulin treatment could improve medication adherence and quality of life for these patients.
Researchers from the University of Campania “Luigi Vanvitelli,” (Naples, Italy) designed a randomized trial in patients with type 2 diabetes to evaluate the effects of replacing a BBI regimen with either a fixed-combo of insulin plus GLP-1RA or a combination of basal insulin plus SGLT2i. Participants were randomized to three groups: intensification of the BBI regimen (n = 101), fixed ratio of basal insulin plus GLP-1RA (n = 102), and combination of basal insulin plus SGLT2i (n = 102). The primary efficacy outcome was change from baseline A1C at 6 months.
Results of the study, published in the June 2021 issue of Diabetes Care, showed that the baseline characteristics were similar among the three groups with a mean A1C of 8.6%.
At 6 months, patients experienced similar reduction in A1C levels (−0.6, −0.6, and −0.7, respectively) and the number of patients who reached an A1C level of ≤7.5% was also similar (34%, 28%, and 27%). Total insulin dose increased in the BBI group (62 units/day) and decreased in the other two groups (27 units/day in the fixed-combo group and 21 units/day in the basal insulin plus SGLT2i group).
The authors conclude that it is both possible and safe to switch from a BBI regimen to either a once-daily fixed-combo injection or once-daily gliflozin added to basal insulin with similar glucose control, fewer insulin doses, fewer injections daily, and less hypoglycemia.
Minimizing bleeding associated with DOACs
The introduction of direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban as alternatives to vitamin K agonists, such as warfarin, represents a major advance in anticoagulation.
DOACs have been found to be at least as safe and effective as vitamin K antagonists in both randomized, controlled trials and real-world data. Some patients, however, experience major bleeding while receiving DOAC treatment and require reversal agents to control bleeding.
In a study published in the June 2021 issue of the Journal of the American College of Cardiology, researchers from the Spanish Agency for Medicines and Medical Devices in Madrid performed a meta-analysis of clinical outcomes associated with the use of idarucizumab, andexanet, or 4-factor prothrombin complex concentrates for reversal of severe DOAC-associated bleeding.
Mortality rates, thromboembolic events, and hemostatic efficacy were analyzed using a random effects model.
Almost 5,000 patients with severe DOAC-related bleeding in 60 studies were included in the analysis. Of these, 2,688 were treated with 4-factor prothrombin complex concentrates, 1,111 patients were treated with idarucizumab, and 936 patients were treated with andexanet. The mortality rate was 17.7%, the thromboembolism rate was 4.6%, and the effective hemostasis rate was 78.5%.
The rebleeding rate was 13.2% with 78% of rebleeds occurring after resumption of anticoagulation. Finally, the risk of death was significantly associated with failure to achieve effective hemostasis (relative risk: 3.63).
The authors concluded that the comparative clinical trials are needed given the high risk of death after severe DOAC-related bleeding. Failure to achieve effective hemostasis strongly correlated with a fatal outcome, and thromboembolism rates are particularly high with andexanet.
ACG releases clinical guidelines for prevention, diagnosis, and treatment of C. difficile infections
Since publication of the most recent American College of Gastroenterology guidelines on the diagnosis, treatment, and prevention of Clostridium difficile infection in 2013, there have been changes not only in the taxonomic classification to Clostridioides difficile, but also increased recognition of diagnostic challenges and new therapeutic options for treatment and prevention of recurrence. As a result, ACG recently published updated guidelines in the June 2021 issue of the American Journal of Gastroenterology that are intended to be complementary to the recently updated Infectious Disease Society of America (IDSA) and Society of Healthcare Epidemiologists of America (SHEA) guidelines.
Recommendations in the new guidelines are shown below.
Summary of key concept statements for the management of C. difficile
Diagnosis and classification
1. Only individuals with symptoms suggestive of active C. difficile infection (CDI) should be tested (3 or more unformed stools in 24 hrs)
2. We recommend the following criteria, which are predictive of unfavorable outcomes, be used to classify severe CDI at the time of diagnosis: white blood cell ≥15,000 cells/mm3 or serum creatinine >1.5 mg/dL
3. We recommend defining fulminant infection as patients meeting criteria for severe CDI plus presence of hypotension, shock, ileus, or megacolon
Treatment
4. We suggest that for patients who require surgical intervention, either a total colectomy with an end ileostomy and a stapled rectal stump or a diverting loop ileostomy with colonic lavage and intraluminal vancomycin, be used depending on clinical circumstances, the patient’s estimated tolerance to surgery, and the surgeon’s best judgement
Special populations
5. Immunosuppressive inflammatory bowel disease therapy should not be held during anti-CDI therapy in the setting of disease flare and escalation of therapy may be considered if there is no symptomatic improvement with treatment of CDI
6. We recommend using vancomycin to treat pregnant and peripartum patients with CDI
7. We recommend using vancomycin to treat breastfeeding patients with CDI
8. We suggest vancomycin or fidaxomicin be used firstline for treatment of CDI in patients who are immunocompromised