Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review
ConclusionThe analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 24, 2023 Category: Drugs & Pharmacology Source Type: research
OCE-205, A Novel, Selective Vasopressin Receptor Mixed Agonist-Antagonist: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics from a Phase 1 Study in Healthy Volunteers
ConclusionOCE-205 was safe and well tolerated, with a pharmacodynamic profile achieving submaximal partial agonism consistent with mixed agonism-antagonism of the V1a receptor. OCE-205 shows promise as a treatment for some complications of end-stage liver disease. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 22, 2023 Category: Drugs & Pharmacology Source Type: research
Avacopan, a Novel Competitive C5a Receptor Antagonist, for Severe Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis
AbstractAvacopan is a relatively novel drug with complement antagonizing properties, and it has demonstrated promising outcomes in treating antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. This review article seeks to investigate the current standard of care for ANCA vasculitis with the combination of avacopan. The current standard therapy involves the usage of daily corticosteroids in addition to either cyclophosphamide or rituximab; however, prolonged use of corticosteroids is known to be associated with various adverse effects. Avacopan was introduced as a possible substitution to alleviate high-cor...
Source: Clinical Drug Investigation - August 18, 2023 Category: Drugs & Pharmacology Source Type: research
Expanded Access Study of Palbociclib Plus Letrozole for Postmenopausal Women with HR+/HER2 − Advanced Breast Cancer in Latin America for Whom Letrozole Therapy is Deemed Appropriate
ConclusionPalbociclib in combination with letrozole was generally well tolerated with a clinically manageable safety profile; the observed ORR supported treatment benefit in Latin American women with HR+/HER2 − ABC.Trial RegistryClinicalTrials.gov, NCT02600923. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 18, 2023 Category: Drugs & Pharmacology Source Type: research
Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment for Chinese Patients with Advanced Esophageal Squamous Cell Carcinoma: A Cost-Effectiveness Analysis
ConclusionOur lifetime simulation study demonstrated that, in the case of advanced ESCC, the combination of tislelizumab and chemotherapy offers increased effectiveness compared to chemotherapy alone, albeit at a higher cost. Moreover, considering the current WTP threshold in China, the addition of tislelizumab to chemotherapy is considered a cost-effective approach. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 5, 2023 Category: Drugs & Pharmacology Source Type: research
Does Opioid Use Disorder Matter for Health Care Utilization Among Lung Cancer Patients? Evidence from U.S. Hospitals During 2016 –2020
ConclusionsResearch conducted has identified gaps in care in rural and suburban areas and a lack of equal care given to minority and low-income patients. These vulnerable groups access health care less often, are charged more for the care they receive, and often face multiple barriers to treatment. Unless these issues are addressed with a focus on socioeconomic factors, race, and region, the opioid epidemic will continue to negatively decimate these populations. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 4, 2023 Category: Drugs & Pharmacology Source Type: research
Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?
ConclusionsA considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS and QoL. With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 28, 2023 Category: Drugs & Pharmacology Source Type: research
Evaluating the Association of Montelukast Use on Neuropsychiatry-Related Healthcare Utilization and Depression in COVID-19-Hospitalized Veterans: A Nationwide VA Observational Cohort Study
ConclusionsPatients with prior montelukast use who were hospitalized with COVID-19 appeared to have increased rate of neuropsychiatry-related healthcare utilization. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 27, 2023 Category: Drugs & Pharmacology Source Type: research
Correction to: Olipudase Alfa in Non-CNS Manifestations of Acid Sphingomyelinase Deficiency: A Profile of Its Use
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 26, 2023 Category: Drugs & Pharmacology Source Type: research
Anthracyclines versus No Anthracyclines in the Neoadjuvant Strategy for HER2+ Breast Cancer: Real-World Evidence
ConclusionThis study reports real-world evidence showing similar pCR and EFS outcomes with treatment regimens with and without AC and raises awareness of possible overtreatment and long-term toxicity in some patients with HER2+ EBC with the use of AC. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 21, 2023 Category: Drugs & Pharmacology Source Type: research
Elevations in Creatine Kinase are Not Related to the Choice or Dose of Statins in Patients Taking Colchicine 0.5 mg Daily: Insights from the LoDoCo2 Trial
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 20, 2023 Category: Drugs & Pharmacology Source Type: research
Dose Recommendations for Common Drugs in Patients with Liver Cirrhosis: A Systematic Literature Review
ConclusionsAs the majority of dose recommendations were not sufficiently specific or even contradictory, there is an urgent need for the definition of standard parameters for a uniform assessment of drugs in liver cirrhosis. In addition, dose recommendations should be aligned by suitable methods. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 18, 2023 Category: Drugs & Pharmacology Source Type: research
Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis
ConclusionsTanezumab IV or SC had an increased incidence of AEs of APS, such as paresthesia and hypoesthesia, and diagnoses of mononeuropathy compared with placebo. However, tanezumab was not associated with generalized peripheral neuropathy.ClinicalTrials.gov identifiersNCT00733902, NCT00744471, NCT00830063, NCT00863304, NCT00863772, NCT01089725, NCT00985621, NCT02697773, and NCT02709486. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 18, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Naftifine Hydrochloride 2% Gel in Interdigital Tinea Pedis: A Phase III Randomised, Double-Blind, Parallel-Group, Active-Controlled Study in Indian Adult Patients
ConclusionsNaftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel.Trial RegistrationClinical Trials Registry of India: CTRI/2021/01/030753. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 18, 2023 Category: Drugs & Pharmacology Source Type: research
Association Between Migraine and Ischemic Cardio-Cerebrovascular Disease (CCVD) and Effects of Triptans and Ergotamine on the Risk of Ischemic CCVD in Patients with Migraine in the Korean NHIS-HEALS Cohort
ConclusionsMigraine increased the risk of ischemic CCVDs in both sexes, and migraineurs treated with triptans and ergotamine were at lower risk of ischemic CCVDs than migraineurs who did not take those medications, especially in women. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 17, 2023 Category: Drugs & Pharmacology Source Type: research
