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Professional Practice


Professional Practice

Information relevant to pharmacy practice such as expanded roles of pharmacists, advancements in pharmacy practice, professional resources to share with patients or enhance practice knowledge and more.

COVID-19 Testing and Caveats

In a recent webinar from TRC Healthcare Healthcare’s Emerging Recommendations Panel on July 16, 2020, an expert panel discussed COVID-19 types of tests and caveats. The panel consisted of Lori Dickerson, Pharm.D., FCCP as the moderator, joined by Reid Blackwelder, M.D., FAAFP, Jehan Budak, M.D., Steven Nissen, M.D., MACC and Craig Williams, Pharm.D., FNLA, BCPS. They noted that pharmacists are getting more involved with testing as pharmacists in every state are authorized to order and administer SAR-COV-2 testing.

The first set of tests is the diagnostic tests. These tests use swabs to obtain specimen from the nasopharyngeal, nasal or oropharyngeal cavity. One type of most common diagnostic tests is polymerase chain reaction (PCR) testing. PCR is a molecular test that detects viral RNA presence in a sample. Most tests must show a 95 percent sensitivity and 100 percent specificity in order to be eligible for the emergency use authorization (EUA). Although during some cross studies, some tests were shown to be only 79 percent sensitive but results may have been from faults with the transport media being utilized. Point of care (POC) antigen testing is another diagnostic test that tends to have a turnaround time under 30 minutes verses hours for a PCR test. While being faster to generate an answer, they tend to only be 80 percent sensitive. PCR testing is more accurate, but POC antigen testing provides quicker results. Some institutions are screening with the antigen testing and confirming negative tests with PCR in order to rule out false negatives. For patients who test negative in the community but are still experiencing symptoms, TRC Healthcare recommended retesting immediately if an antigen test was used originally or to retest two-three days after a molecular test. Dr. Budak recommended utilizing molecular testing as the preferred retest if at all possible.

The sample collection can also lead to false negatives as the different tests can be difficult to perform. Nasopharyngeal is preferred, but harder to collect. Dr. Budak’s practice considers oropharyngeal the lowest tier sample to collect. Sputum tests in the pipeline were mentioned. This expert panel acknowledged that many physicians and pharmacists are not always able to pick which test their facility is utilizing, but recommends any test over not testing.. It is also worth noting that the tests can return a false negative if swabbed too early in the viral process where the viral load is too low as the nasal viral load can vary for each individual.

They recommended against re-testing a patient who had previously tested positive for SARS-COV-2 to see if the virus has cleared. This is because the dead virus may still be present in the nares for some time after the infection has completed. Consistent with the Centers for Disease Control and Prevention, TRC Healthcare recommended and the panel agreed that isolation can end after 10 days of symptom onset if symptom free for at least 72 hours.

The other type of testing is the antibody test to determine if someone had a previous infection. It is collected by blood sample or venipuncture. Obtaining a EUA from the Food and Drug Administration for antibody testing assumes 90 percent sensitivity and 95 percent specificity. A negative test indicates that a patient likely did not have COVID-19. The positive test from antibody testing cannot guarantee that a patient had COVID-19 specifically is exposure is uncertain due to false positives. When disease presence is low, the chance for false positives is high. There is not currently an area in the U.S. where the disease is common enough to make the positive predictive value much over 50 percent. With this, patients are cautioned against assuming immunity due to a presumed true positive test.

Posted in: Professional Practice
Pharmacy’s Role in Addressing Stewardship in Dentistry

Elaine M. Bailey, Pharm.D., Executive Director, Michigan Antibiotic Resistance Reduction Coalition

Antibiotic resistance is a serious public health threat requiring a multifaceted approach. Approximately 10 percent of outpatient antibiotics in the U.S. are prescribed by dentists, amounting to nearly 25 million courses each year.1 Approximately 1.5 million additional antibiotic courses are prescribed to patients presenting in emergency departments with dental pain.2. There are increasing reports of inappropriate antibiotic prescribing in dental patients as well as dental patients experiencing Clostridiodes (formerly Clostridium) difficile diarrhea. 3,4. Given these findings, the American Dental Association (ADA) committed to the U.S. Antimicrobial Resistance Challenge by creating and disseminating guidance to help clinicians appropriately prescribe antibiotics. 5 The American Academy of Orthopedic Surgeons (AAOS) also committed to increase awareness of when antibiotics should and should not be used for patients with hip and knee implants who are undergoing dental procedures. (https://www.cdc.gov/drugresistance/intl-activities/amr-challenge.html

The ADA guideline for treatment of oral infections addresses many stewardship principles. The guideline encourages a paradigm shift in the use of antibiotics in dentistry from a “just in case” approach to using only when absolutely necessary. For example, when the patient is able to obtain interventional treatment (e.g. pulpotomy, pulpectomy, nonsurgical root canal treatment, or incision and drainage) within 24 hours, antibiotics are generally not recommended. The ADA suggests practicing “Delayed Prescribing/Watchful Waiting” in situations where antibiotic treatment is unlikely to be of benefit. If a decision is made to prescribe antibiotics, then the maximum duration is seven days and the patient should discontinue antibiotics after they have been symptom-free for 24 hours. The ADA has also attempted to curb the use of clindamycin, which has been shown to be highly associated with Clostridiodes Difficile Infection (CDI)6, by following the guidance of the CDC in terms of evaluating penicillin allergy and suggesting the use of azithromycin as an alternative to prescribing clindamycin in the face of a true (anaphylactic) penicillin allergy. 

For infective endocarditis prophylaxis in patients undergoing dental procedures, current guidelines support premedication for only a small subset of patients.7 Unfortunately, in the case of patients with prosthetic joint replacements who are undergoing dental procedures, the guidelines developed by the ADA and AAOS have changed over the past 17 years, at times being incongruent particularly related to how long after the implant the patient should continue to receive prophylaxis before a dental procedure. The AAOS Appropriate Use Criteria (AUC) online tool indicates that it is rarely appropriate to prophylax patients who have undergone joint replacement more than one year before the dental procedure. The antibiotics prescribed are generally aligned with the American Hospital Association (AHA) guidelines with the exception of the removal of clindamycin as a choice (Table 2). Unfortunately, several dental providers in Michigan have shared that their orthopedic colleagues are often not in compliance with the AAOS guidance. 

Comprehensive guidelines exist for the development of stewardship programs in inpatient settings but despite the majority of antibiotics being prescribed in the outpatient setting, stewardship guidelines are generally lacking. The CDC include dentists in their list of intended audiences in the Core Elements of Antibiotic Stewardship for outpatient settings. 8 However, guidance is not provided on how to implement the Antimicrobial Stewardship Program (ASP) in the unique setting of dental offices.

Dentists have little opportunity to observe firsthand the adverse events associated with antibiotic prescribing, such as CDI, so they are generally unaware of the impact of their prescribing habits. The majority of dentists are solo practitioners with variably trained support staff and collectively the dental office has limited knowledge of antibiotic pharmacology. 9 Here are just a few suggestions of how our profession can support dentists, their staff and patients, to be better antibiotic stewards:

  1. Talk to all the staff in your dentist’s office about their important role in antibiotic stewardship. Advise them about the resources available through the Michigan Antibiotic Resistance Reduction (MARR) Coalition and other organizations (Table 3).
  2. When filling an outpatient prescription for treatment of an oral infection, insure that it is consistent with the ADA guideline.5 In particular, focus on the duration of therapy and the prescribing of clindamycin. Provide patients with information on how to dispose of unused antibiotics in the event that their symptoms resolve before completing seven days of therapy.
  3. Advise patients with prosthetic devices that in many cases the risk of antibiotics outweigh the benefits of taking them before dental manipulation and therefore they should consider discussing the need for antibiotics not only with their dentists but with their other healthcare providers. In some cases, their general practitioner (GP) may have assumed the responsibility for writing the prescription if the patient is over a year out of their implant and the GP may not be aware of the change in the guidelines. Dentists have shared that referring their medical colleagues to the AAOS AUC tool has been a helpful communication tactic.
  4. Incorporate dental stewardship principles, particularly regarding prophylaxis, in systemwide ASPs. Focus on educating orthopedic surgeons on the increasing incidence of community-associated CDI and the association with dental antibiotics. Policies should be implemented in emergency departments and urgent care centers consistent with the ADA treatment guidelines.
  5. Critically evaluate cases of penicillin allergy since the majority of dental patients with a penicillin allergy are prescribed clindamycin. If the patient’s allergy history is dated, recommend that they discuss with their regular physician.

 

Given the numerous stakeholders involved, implementing antibiotic stewardship in dentistry is going to be challenging. Pharmacy has an opportunity to positively influence dental stewardship by educating all the stakeholders, particularly the patients. Please review these helpful resources.

References:

  1. Roberts RM, Bartoces M, Thompson SE, Hicks LA, Antibiotic prescribing by general dentists in the United States, 2013. J Am Dent Assoc 2017;148(3) :172-178
  2. Roberts RM, Hersh AL, Shapiro DJ, Fleming- Dutra KE, Hicks LA. Antibiotic prescriptions associated with dental-related emergency department visits. Ann Emerg Med. 2019;74(1):45-49.
  3.  Suda KJ, Calip GS, Zhou J, Rowan S, Gross AE, Hershow RC, Perez RI, McGregor JC, Evans CT. Assessment of the Appropriateness of Antibiotic Prescriptions for Infection Prophylaxis Before Dental Procedures, 2011 to 2015. JAMA Netw Open. 2019 May 3;2(5):e193909
  4. Bye M, Whitten T, Holzbauer S. Antibiotic Prescribing for Dental Procedures in Community-Associated Clostridium difficile cases, Minnesota, 2009–2015. Open Forum Infect Dis. 2017;4(Suppl 1):S1. Published 2017 Oct 4. doi:10.1093/ofid/ofx162.001
  5. Lockhart PB, Tampi MP, Abt E et al. Evidence-based clinical practice guideline on antibiotic use for the urgent management of pulpal- and periapical-related dental pain and intraoral swelling. J Am Dent Assoc.2019;150:906-921.
  6. Guh AY, Adkins SH, Li O, et al. Risk Factors for Community-Associated Clostridium difficile Infection in Adults: A Case-Control Study. Open Forum Infect Dis. 2017 Oct 26;4(4):ofx171
  7. Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. J Am Dent Assoc 2008;139 Suppl:3S-24S.
  8. Center for Disease Control and Prevention. Core Elements of Outpatient Antibiotic Stewardship. Available at: https://www.cdc.gov/antibiotic-use/community/pdfs/16_268900-A_CoreElementsOutpatient_508.pdf Accessed 3/28/20.
  9. American Dental Association, Survey Center. 2012 Distribution of Dentists survey. Chicago: American Dental Association, 2011.
Posted in: Professional Practice
Moving Forward with Antiretroviral Therapy for Human Immunodeficiency Virus

Shelbye Rose Herbin, Pharm.D., PGY1 Pharmacy Resident, Detroit Receiving Hospital, Detroit

Almost 40 years have passed since the first case of acquired immunodeficiency syndrome (AIDs) was documented. Throughout this time, great strides have been made with the creation of antiretroviral therapy (ART) for the treatment of the human immunodeficiency virus (HIV), which is the cause of AIDS. Adherence to ART regimens is crucial for patients to maintain viral suppression and reduce the risk of drug resistance.1 However, there are many barriers to adherence such as pill burden and side effects including nausea, fatigue and mood alterations. 2,3 Antiviral therapy with three active antiretrovirals from two different drug classes has been the mainstay of therapy for decades for patients living with HIV. Newer agents that have been introduced have a higher potency and genetic barrier to resistance, which has enabled researchers to revisit the idea of two-drug regimens for the use in patients with HIV.4 Additionally, advances in treatment options have also demonstrated the possibility of monthly injectable treatment regimens.

The two-drug regimens currently approved by the Food and Drug Administration (FDA) as complete antiretroviral regimens are dolutegravir-rilpivirine (JULUCA®), for treatment experienced patients, and dolutegravir-lamivudine (DOVATO®), for treatment-naïve patients. Both of these combinations include antiretrovirals with pharmacokinetic profiles suitable for once daily administration.5,6 Dolutegravir-rilpivirine was approved in 2017 and contains the integrase strand inhibitor (INSTI) dolutegravir with the non-nucleotide reverse transcriptase inhibitor (NNRTI) rilpivirine. Dolutegravir and rilpivirine both have a high genetic barrier to resistance and are stable against common resistance mechanisms for their respective class, allowing them to be used as a complete antiretroviral regimen. Dolutegravir also interacts minimally with hepatic enzymes and therefore has fewer drug-drug interactions compared to other antiretrovirals. The approval of dolutegravir-rilpivirine was based on the results from the SWORD-1 and SWORD-2 trials. These two studies included participants ≥ 18 years old, who were treatment experienced and virologically suppressed (viral load < 50 copies/mL) for at least six months. The primary outcome of SWORD-1 and SWORD-2 was the proportion of patients with a plasma viral load of lower than 50 copies/mL at week 48, which was achieved in 95 percent of the study participants in both treatment groups. This confirmed non-inferiority of dolutegravir-rilpivirine to participants who continued on their current ART regimen (CAR).5

Dolutegravir-lamivudine was approved in 2019 and includes the nucleoside transcriptase inhibitor (NRTI) lamivudine, with the INSTI dolutegravir. The approval of dolutegravir-lamivudine was based on the GEMINI-1 and GEMINI-2 trials. Both studies included participants ≥ 18 years old who were treatment naïve. The primary outcome of the GEMINI trials was the proportion of patients with a plasma viral load of lower than 50 copies/mL at week 48. Virological response was achieved in 90 percent of participants in each group and confirmed non-inferiority between dolutegravir-lamivudine and dolutegravir-tenofovir disoproxil fumarate-emtricitabine.6

Cabotegravir-rilpivirine (CABENUVA®) is not FDA-approved but is currently being tested in phase III clinical trials. Cabotegravir is an INSTI that is structurally similar to dolutegravir and is formulated as an oral tablet or a long acting injectable suspension for monthly administration. There are two ongoing phase-III trials for cabotegravir-rilpirivine the ATLAS trial which involves treatment-experienced patients and the FLAIR trial which includes treatment-naïve patients. The primary outcome in both studies is the percent of patients with virologic failure (HIV-1 RNA > 50 copies/mL) at week 48. Preliminary data has shown non-inferiority of cabotegravir-rilpivirine to the participant’s CAR and dolutegravir-abacavir-lamivudine in ATLAS and FLAIR trials, respectively.7,8

HIV treatment is a life-long commitment that patients must endure with a potential heavy pill burden and adverse side effects. Previous attempts at creating two-drug regimens have failed due to the medications inability to reduce viral loads or overcome resistance mechanisms9. When used in combination as two-drug regimens, the newer and more potent antiretrovirals, such as dolutegravir and cabotegravir have the potential to reduce pill burdens, increase adherence and decrease the long-term effects associated with antiretrovirals.

References:

  1. HIV Treatment Adherence Understanding HIV/AIDS. National Institutes of Health. https://aidsinfo.nih.gov/understanding-hiv-aids/facts-sheets/21/54/hiv-treatment-adherence. Published January 15, 2020. Accessed April 26, 2020
  2. HIV Medicines and Side Effects. Understanding HIV/AIDS. National Institutes of Health. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/22/63/hiv-medicines-and-side-effects. Published October 24th, 2019. Accessed April 26, 2020.
  3. Iacob SA et al. Front Pharmacol. 2017;8:831
  4. Cento V et al. J Glob Antimicrob Resis. 2020;20:228-237
  5. Llibre JM et al. Lancet. 2018;391(10123):839-849
  6. Cahn P. Lancet. 2019;333(10167): 143-155
  7. Swindells S et al. NEJM. 2020;382:1112-1123
  8. Orkin C et al. NEJM. 2020;382(12):1124-1135
  9. Corado KC. Drug Design Devel and Ther. 2018;12: 3731-3740
Posted in: Professional Practice
E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI)

Abagail Kirwen, Pharm.D., PGY-1 Pharmacy Resident, Beaumont Royal Oak

E-cigarette, or vaping, product use-associated lung injury (EVALI) has been investigated as a nationwide outbreak since August 2019. Use of e-cigarettes, or vaping, is described as heating a liquid with active agents such as nicotine and tetrahydrocannabinol (THC) as well as inactive ingredients such as flavorings and other additives.1 An algorithm for the diagnosis and management of patients with EVALI symptoms has been created by the Centers for Disease Control and Prevention (CDC) and can be found on their website.2 The most recent update from January 2020 indicates 2,668 EVALI cases have been reported to the CDC. The patients have a median age of 24 years, 66 percent are male, and 82 percent report using any THC-containing product. The majority of cases have been defined as not severe (68 percent) and the mortality rate is currently defined at 2 percent.3

The most common presentation includes respiratory symptoms such as hypoxia and tachypnea as well as gastrointestinal symptoms such as nausea, emesis and abdominal pain.1,4 EVALI remains a diagnosis of exclusion and might co-occur with respiratory infections, so it is important for providers to consider other bacterial or viral causes of the patients’ symptoms. Chest imaging typically reveals ground glass opacities and may appear similar to pneumonia. Bronchoalveolar lavage (BAL) may be performed to collect fluid specimens from patients to aid in diagnosis. BAL specimens were collected from hospitalized patients in August-October 2019 to be analyzed for toxins and active compounds. Of 29 BAL specimens sent to the CDC to be analyzed, vitamin E acetate was detected in all 29 samples.5 Based on this evidence, it was determined that vitamin E acetate is likely associated with EVALI. Although the mechanism for EVALI is not well understood, there are some mechanisms that have been proposed. The heating element used to aerosolize particles may be made of heavy metals known to cause lung disease. It is also noted that e-cigarettes still produce high levels of free radicals, similar to traditional cigarettes, which lead to oxidative stress in the lung and may contribute to pathogenesis of the disease.6 It has also been hypothesized that deposition of oils into the lower airways may be resulting in lipoid pneumonia.4

Management of patients who are diagnosed with EVALI include discontinuation of vaping products, cessation counseling and cautious use of corticosteroids.2 Use of corticosteroids for management of these patients comes with a cautious recommendation due to limited literature. A recently published case series unfortunately did not show a difference in outcomes for patients treated with intravenous corticosteroids transitioned to an oral taper.4 However, another prospective observational cohort believed addition of corticosteroids at moderate doses for relatively short courses led to a more rapid clinical improvement.1

Fortunately, the number of hospital admissions for EVALI peaked during the week of Sept. 15, 2019, and has continued to steadily decline since then.3 The decline in cases may be due to increased awareness of the risks associated with vaping and identification of vitamin E acetate and subsequent removal of this ingredient from products. Despite the steady downtrend in EVALI occurrences, healthcare providers should remain vigilant when patients present with the aforementioned symptoms and a history of e-cigarette or vape use.

References

  1. Blagev DP, Harris D, Dunn AC, Guidry DW, Grissom CK, et al. Clinical presentation, treatment and short-term outcomes of lung injury associated with e-cigarettes or vaping: a prospective observational cohort study. Lancet. 2019;294:2073-83.
  2. Algorithm for management of patients with respiratory, gastrointestinal, or constitutional symptoms and e-cigarette, or vaping, product use (12/20/2019). Centers for Disease Control and Prevention. 2019.
  3. Krishnasamy VP, Hallowell BD, Ko JY, Board A, Hartnett KP, et al. Update: characteristics of a nationwide outbreak of e-cigarette, or vaping, product use-associated lung injury - United States, August 2019-January 2020. MMRW. 2020;69(3):90-4.
  4. Kalininskiy A, Bach CT, ENacca N, Ginsbert G, Maraffa J, et al. E-cigarette, or vaping, product use associated lung injury (EVALI): case series and diagnostic approach. Lancet Respir Med. 2019;7:1017-26.
  5. Blount BC, Karwowski MP, Morel-Espinosa M, Rees J, Sosnoff C, et al. Evaluation of bronchoalveolar lavage fluid from patients in an outbreak of e-cigarette, or vaping, product use-associated lung injury - 10 states, August-October 2019. MMRW. 2019;68(45):1040-1.
  6. Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, et al. Radiologic, Pathologic, Clinical, and Physiologic findings of electronic cigarette or vaping product use-associated lung injury (EVALI): evolving knowledge and remaining questions. Radiology. 2020;294:491-505.
Posted in: Professional Practice
Controversy Behind Selinexor’s Approval

By Polly Luo, Pharm.D. candidate 2020, University of Michigan, Ann Arbor

Patients with multiple myeloma often develop relapsed or refractory multiple myeloma (RRMM) and have a median overall survival rate of 1.3 to 3.5 months.1 Selinexor was approved July 3, 2019, for adults patients with RRMM who are penta-exposed and triple class refractory to at least two proteasome inhibitors, two immunomodulatory agents and an Anti-CD38 monoclonal antibody.2 Selinexor is a selective inhibitor of nuclear export that binds to the nuclear export protein (XP01) that mediates the nuclear export of proteins and upregulates certain malignancies.1,3 By binding to XP01, the accumulation of tumor suppressor proteins amplifies the tumor suppressor function, leading to apoptosis in cancer cells and sparing normal cells. The Food and Drug Administration (FDA) granted accelerated approval of selinexor based off part two of the Selinexor Treatment of Refractory Myeloma (STORM) trial which represents the largest, most heavily treated patient population to date.4 This approval, however, was not without controversy.

The STORM trial was a phase 2b, multicenter, single-arm, open-label study of 123 patients with RRMM.1,3 All patients were refractory to at least one immunomodulatory drug, one proteasome inhibitor, daratumumab and glucocorticoids. The study was permissive with the allowance of patients that had baseline thrombocytopenia, neutropenia and reduced renal function. All patients received oral selinexor (80 mg) and dexamethasone (20 mg) twice weekly for a 28-day cycle.1,3 The overall response rate was studied as the primary endpoint. The secondary endpoints included duration of response (DUR), overall survival (OS), progression free survival (PFS) and safety. A partial response or better was seen in 26 percent of patients and the median OS of these patients was 15.6 months.1,3 The overall median survival of the patient population was 8.6 months. The median DUR was 4.4 months and the median PFS was 3.7 months. During this study, 28 patients died from disease progression or an adverse event. The most common adverse events included thrombocytopenia (73 percent), fatigue (73 percent), nausea (72 percent) and anemia (67 percent).1,3 Serious adverse events occurred in 63 percent of the population with pneumonia and sepsis as the most common. Around 88.6 percent required at least one dose modification due to a treatment emergent adverse events (TEAEs).4 The efficacy and safety outcomes were similar across all evaluated subgroups, including the most treatment resistant group that included 83 patients who were refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide and daratumumab.1,3

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to wait for the findings of the phase 3 trial before deciding on an approval.4 The recommendation of ODAC is considered but is non-binding. In a surprising turn of events, the FDA approved selinexor, but due to the severe toxicities and modest benefit seen in the STORM study, the drug was not approved for all RRMM patients. It is indicated only for adult patients who are refractory to at least two proteasome inhibitors, two immunomodulatory agents and an Anti-CD38 monoclonal antibody (ie, the characteristics of the most heavily pretreated 83-patient subset in the STORM trial). It was concluded that this group represents a population who, for all intents and purposes, has no available therapy, and therefore, the benefit-risk profile of selinexor is acceptable in this population. This indication was approved under an accelerated approval and continued FDA approval requires additional clinical trials to verify clinical benefits.5 The approval was controversial because there were several issues noted for this trial. Selinexor’s activity as a monotherapy in the phase 1 trial was not demonstrated and the isolated effects of selinexor is undetermined.4 All patients in the trial experienced at least one adverse event thus toxicity is a concern. The proposed starting dose in phase 2 was not well tolerated because 88.6 percent of patients required at least one dose modification due to TEAEs.4 Lastly, the time frame between previous treatments and selinexor was unknown. Medications can have a lingering effect in the body long after the patient is finished with their therapy. There is reason to question if there were lingering effects from previous therapies.

Several clinical trials are in progress for selinexor. Of note, the results of the phase 3 BOSTON study assessing the use of selinexor with bortezomib and low-dose dexamethasone versus bortezomib plus low-dose dexamethasone are set to be released in early 2020.6 In addition, a phase 2 trial assessing the safety and efficacy of at least two different doses of selinexor, a hepatic impairment trial and a drug interaction trial results are set to be available in late 2021.5

References:

1. Chari, A., Vogl, D. T., Gavriatopoulou, M., et al (2019). Oral Selinexor–Dexamethasone for Triple-Class Refractory Multiple Myeloma. New England Journal of Medicine, 381(8), 727-738.

2. Food and Drug Administration. (2019). FDA grants accelerated approval to selinexor for multiple myeloma. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selinexor-multiple-myeloma

3. Karyopharm Therapeutics. (2018).  Results of the Pivotal STORM Study (Part 2): Deep and Durable Responses with Oral Selinexor plus Low Dose Dexamethasone in Patients with Penta-Exposed and Triple Class Refractory MM [PDF file]. Retrieved from https://www.karyopharm.com/wp-content/uploads/2019/01/STORM-ASH2018-Final-2Dec18-1.pdf

4. Food and Drug Adminstration. (2019). FDA Briefing Document [PDF file]. Retrieved from https://www.fda.gov/media/121667/download

5. Food and Drug Adminstration. (2019). FDA approval letter [PDF file]. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212306Orig1s000ltr.pdf

6. Karyopharm Therapeutics. (2019). Clinical Trials. Retrieved from https://www.karyopharm.com/patient-resources/clinical-trials/

Posted in: Professional Practice
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