Electronic Monitoring of Oral Therapies in Ethnically Diverse and Economically Disadvantaged Patients With Rheumatoid Arthritis: Consequences of Low Adherence.

Electronic Monitoring of Oral Therapies in Ethnically Diverse and Economically Disadvantaged Patients With Rheumatoid Arthritis: Consequences of Low Adherence.

Arthritis Rheum. 2013 Jun; 65(6): 1421-1429
Waimann CA, Marengo MF, de Achaval S, Cox VL, Garcia-Gonzalez A, Reveille JD, Richardson MN, Suarez-Almazor ME

OBJECTIVE: To quantify adherence to oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis (RA), using electronic medication monitoring, and to evaluate the clinical consequences of low adherence. METHODS: A total of 107 patients with RA enrolled in a 2-year prospective cohort study agreed to have their oral RA drug therapy intake electronically monitored using the Medication Event Monitoring System. Adherence to disease-modifying antirheumatic drugs (DMARDs) and prednisone was determined as the percentage of days (or weeks for methotrexate) on which the patient took the correct dose as prescribed by the physician. Patient outcomes were assessed, including function measured by the modified Health Assessment Questionnaire, disease activity measured by the Disease Activity Score in 28 joints (DAS28), health-related quality of life, and radiographic damage measured using the modified Sharp/van der Heijde scoring method. RESULTS: Adherence to the treatment regimen as determined by the percentage of correct doses was 64% for DMARDs and 70% for prednisone. Patients who had better mental health were statistically more likely to be adherent. Only 23 of the patients (21%) had an average adherence to DMARDs ?80%. These patients showed significantly better mean DAS28 values across 2 years of followup than those who were less adherent (3.28 versus 4.09; P = 0.02). Radiographic scores were also worse in nonadherent patients at baseline and at 12 months. CONCLUSION: Only one-fifth of RA patients had an overall adherence to DMARDs of at least 80%. Less than two-thirds of the prescribed DMARD doses were correctly taken. Adherent patients had lower disease activity across the 2 years of followup. HubMed – drug

Integrating tristimulus colorimetry into pharmaceutical development for color selection and physical appearance control: A quality-by-design approach.

J Pharm Sci. 2013 May 31;
Hetrick EM, Vannoy J, Montgomery LL, Pack BW

The color of pharmaceutical dosage forms can be an important aspect of product branding and patient compliance with a dosing regimen. During the development of drug products, it is important to understand the stability of not only the active pharmaceutical ingredient but also the color and appearance of the tablet or capsule. Currently, the most common method to ensure color stability is to conduct a visual test throughout a stability study. This visual test is subjective and can be expensive, especially if there is a failure late in development or after marketing approval. This work describes a series of studies using accelerated conditions (i.e., heat, humidity, and light) and logistic regression analyses that have been developed to determine the relative stability ranking of multiple color coatings early in development to provide an increased probability of technical success on long-term stability studies and to avoid coatings whose visual appearance may change over time. Once this relative stability ranking has been established, the stability advantages can be assessed versus any manufacturing/processing liabilities of the selected coating in order to make a data-driven decision around coating selection. This work reviews the basic fundamentals of colorimetry, followed by the description of a consistent experimental approach to correlate a visual rating with an instrumental measurement (e.g., dE(*) from a colorimeter) to remove the subjectivity from the assessment. This approach represents a novel strategy for establishing a probabilized correlation between the quantitative instrumental color measurement and the visual rating of the same color change. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci. HubMed – drug

The impact of polyelectrolyte structure on the shape of nanoassemblies with cationic peptides.

J Pharm Sci. 2013 May 31;
Ferstl M, Drechsler M, Rachel R, Rischer M, Engel J, Backofen M, Goepferich A

We investigated how the structure of nanofibers, resulting from interactions between anionic polyelectrolytes and cationic peptides, relies on the properties of the polyelectrolyte component. By using hyaluronate (H), carboxymethylcellulose (CMC), xanthan (X), and ozarelix (O), a cationic decapeptide, we determined the influence of characteristic polyelectrolyte parameters such as size and charge density on the formation of polyelectrolyte-peptide complexes. Transmission electron microscopy of unstained, frozen hydrated, or negatively stained samples revealed that the interaction between different anionic polyelectrolytes and ozarelix led to the formation of distinctly shaped nanofibers. CMC formed rather flexible structures with alternating thin and thick segments within the nanofibers with diameters ranging from 10 to 16?nm and a length of up to 1??m. Hyaluronate, a high-molecular-mass molecule, formed extra-long aggregates of more than 5??m. Individual fibers with a diameter of 8?nm aggregated to bigger strands. The nonlinear polysaccharide xanthan gum led to highly coiled structures. The diameter of the respective nanofibers varied between 15 and 25?nm. Isothermal titration calorimetry was used to determine the binding constants and the thermodynamic parameters of the different polyelectrolyte-peptide complexes. The binding constant, which was of the order of 10(6) M(-1) , indicated a strong binding affinity, but also showed differences among the polyelectrolytes. These differences might be useful for prospective applications as drug delivery systems. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci. HubMed – drug

Economic Evaluation of 3-Drug Antiretroviral Regimens for the Prevention of Mother-to-Child HIV Transmission in Thailand.

Asia Pac J Public Health. 2013 May 30;
Werayingyong P, Phanuphak N, Chokephaibulkit K, Tantivess S, Kullert N, Tosanguan K, Butchon R, Voramongkol N, Boonsuk S, Pilasant S, Kulpeng W, Teerawattananon Y

The current program for prevention of mother-to-child HIV transmission in Thailand recommends a 2-drugs regimen for HIV-infected pregnant women with a CD4 count >200 cells/mm(3). This study assesses the value for money of 3 antiretroviral drugs compared with zidovudine (AZT)+single-dose nevirapine (sd-NVP). A decision tree was constructed to predict costs and outcomes using the governmental perspective for assessing cost-effectiveness of 3-drug regimens: (1) AZT, lamivudine, and efavirenz and (2) AZT, 3TC, and lopinavir/ritonavir, in comparison with the current protocol, AZT+sd-NVP. The 3-drug antiretroviral regimens yield lower costs and better health outcomes compared with AZT+sd-NVP. Although these 3-drug regimens offer higher program costs and health care costs for premature birth, they save money significantly in regard to pediatric HIV treatment and treatment costs for drug resistance in mothers. The 3-drug regimens are cost-saving interventions. The findings from this study were used to support a policy change in the national recommendation. HubMed – drug

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