Mike R Sather

University of New Mexico, Albuquerque, NM, United States

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Publications (19)20.07 Total impact

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    ABSTRACT: To compare angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) for end-stage renal disease (ESRD) development and all-cause mortality in veterans with macroalbuminuria and with newly documented type 2 diabetes. A retrospective cohort study utilizing data from the national Department of Veterans Affairs (VA) databases. The study followed 5166 subjects without a history of use of ACEIs or ARBs. To control for differences in baseline characteristics between groups, comparisons of subjects ACEIs and ARBs were made by incorporating propensity scores analysis into multivariate logistic regression. This resulted in adjusted odds ratios and 95% confidence intervals for ESRD development and all-cause mortality. The sample was followed up to five years with a mean follow-up of three years. Subjects taking ACEIs has lower odds of ESRD development (OR, 0.33 [95% CI, 0.13-0.82]) and all-cause mortality (OR, 0.10 [95% CI, 0.04-0.21]) than ARBs. This study shows that ACEIs are associated with lower ESRD development and all-cause mortality than ARBs. This may have implications for guidelines which currently suggest that these two therapeutic classes provide similar benefits in people with newly diagnosed type 2 diabetes and macroalbuminuria.
    Diabetes research and clinical practice 10/2013; · 2.74 Impact Factor
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    ABSTRACT: Few studies have described improvement in health-related quality of life (HRQOL) associated with opioid dependence treatment with buprenorphine (ODT-B). To evaluate HRQOL changes in domain scores, physical and mental component summaries, and health utilities (HUs) associated with ODT-B using the Short Form 36 (SF-36). We assessed HRQOL changes in a substudy of a pharmacokinetic study that compared buprenorphine oral tablet and liquid dosage formulations over 16 weeks. Individuals, aged 18-65 years, were screened for opioid dependence. They were excluded if they would not agree to birth control or had a serious medical condition. Subjects received psychosocial counseling and weekly group therapy. The SF-36 was administered upon enrollment and at 4-week intervals. We used the SF-6D to estimate HUs. We performed intention to treat (ITT) analyses based on the last observation available for each subject. Paired t tests of each domain and HU, limited to remaining patients at each 4-week interval, were also conducted. Of 96 subjects enrolled, cumulative dropouts over time resulted in 80, 69, 59, and 44 subjects remaining at 4, 8, 12, and 16 weeks. There were no significant differences in opioid-positive urines, dropout rates, or dosage changes between formulations. In the ITT analyses, HRQOL improvements over time were bodily pain (62.1 vs. 69.1, P = 0.017), vitality (49.8 vs. 56.5, P = 0.001), mental health (59.9 vs. 66.0, P = 0.001), social function (66.4 vs. 74.7, P = 0.001), role emotional (59.4 vs. 71.9, P = 0.003), role physical (60.9 vs. 70.6, P = 0.005), and mental component summary (41.9 vs. 45.4, P<0.001). HU scores also improved (0.674 vs. 0.715, P = 0.001). Results from paired t tests, with only concurrently enrolled patients, showed similar improvements from baseline to 4, 8, 12, or 16 weeks. Buprenorphine, accompanied with psychosocial counseling, was associated with improved HRQOL and HUs.
    Quality of Life Research 10/2011; 21(7):1177-83. · 2.41 Impact Factor
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    ABSTRACT: To assess pharmacy students' knowledge, attitudes, and evaluation of direct-to-consumer advertising (DTCA). A cross sectional, self-administered, 106-item survey instrument was used to assess first, second, and third professional year pharmacy students' knowledge about DTCA regulations, attitudes toward DTCA, and evaluation of DTC advertisements with different brief summary formats (professional labeling and patient labeling) and in different media sources (print and television). One hundred twenty (51.3%) of the 234 students enrolled participated in the study. The mean percentage knowledge score was 48.7% +/- 12.5%. Based on the mean scores per item, pharmacy students had an overall negative attitude toward DTC advertisements. Students had an overall negative attitude toward television and print advertisements using the professional labeling format but an overall positive attitude toward the print advertisement using the patient labeling format. Lectures discussing DTC advertising should be included in the pharmacy curriculum.
    American journal of pharmaceutical education 11/2007; 71(5):86. · 1.21 Impact Factor
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    ABSTRACT: Knowledge of distinct motivations and reasons toward or against future trial participation is invaluable to any organization conducting trial research. Study delays often occur due to lack of recruitment. This study's primary objective was to compare veteran and nonveteran motivations and reasons. People in two outpatient waiting rooms were approached. The questionnaire assessed motivation toward trial involvement through use of five-point Likert-type scales and hypothetical trial scenarios; it also analyzed reasons for participation through subject ranking of reasons. Veterans were more likely to participate in a trial in which all participants received the active treatment (p = 0.025). Veterans had different reasons for participation than nonveterans. Specifically, veterans felt altruism and "paying back" people who treated them were more important (p = 0.024 and p = 0.003) while financial compensation for volunteering was less important (p < 0.001). Knowledge of the varying reasons for participation could potentially aid recruitment efforts.
    Military medicine 01/2007; 172(1):27-30. · 0.77 Impact Factor
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    ABSTRACT: Patient characteristics increase the risk of gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAIDs). Patients at risk may not be prescribed protective therapies that might mitigate their risk of NSAID-associated GI complications. To assess GI risk among Veterans Affairs (VA) patients on NSAID therapy, determine whether therapy conformed to VA guidelines for lessening the risk of GI complications, and identify patient risk factors associated with conformance. Using databases from 3 VA medical centers, we retrospectively identified patients receiving NSAIDs and obtained data regarding age, history of GI bleed over 8 years, GI adverse effects associated with NSAIDs, diagnoses, and medication history over one year. We inferred health status from age-adjusted Charlson comorbidity index values. Each patient's risk of developing GI complications over one year was calculated using these data. Among patients at significant or substantial risk, we assessed conformance to VA guidelines. We used logistic regression to identify risk factors associated with conformance and determine adjusted ORs (AORs) with 95% CIs for each risk factor. There were 19 122 patients receiving NSAIDs. Of 4589 patients at significant risk and 1246 at substantial risk, 1161 (25.3%) and 356 (28.6%), respectively, were prescribed guideline-conformant therapy. Risk factors associated with conformance (p < or = 0.001) among patients at significant risk were rheumatoid arthritis (AOR 1.34; 95% CI 1.13 to 1.58) and GI adverse effects (AOR 1.53; 95% CI 1.42 to 1.64). For substantial risk patients, risk factors associated with conformance (p < or = 0.031) were rheumatoid arthritis (AOR 1.65; 95% CI 1.37 to 1.98), concomitant corticosteroids (AOR 1.21; 95% CI 1.02 to 1.43), GI hospitalization (AOR 2.01; 95% CI 1.57 to 2.59), and GI adverse effects (AOR 1.79; 95% CI 1.47 to 2.18). Many patients at risk for GI adverse events do not receive guideline-conformant therapy. Educational interventions to improve conformance could focus on specific risk factors for GI complications.
    Annals of Pharmacotherapy 12/2006; 40(11):1924-31. · 2.57 Impact Factor
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    ABSTRACT: Patient education in the basic concepts of clinical trials is necessary to promote understanding of the informed consent process and enhance patients' decision-making. It has been suggested that patients' knowledge and attitudes are improved by being given general written information about clinical trials. This pilot study was conducted to determine the effect of a patient education handbook on the knowledge, attitudes, and motivations of pharmacy students regarding clinical trials. A patient clinical trials handbook was developed at a 7th-grade reading level for the Department of Veterans Affairs Cooperative Studies Program and tested in PharmD students. Students were randomized to the experimental group (received handbook) or the control group (no handbook). They were given 15 to 20 minutes to read the handbook, after which they were asked to respond to a questionnaire adapted from previous studies. The questionnaire included 25 true/false questions testing participants' knowledge of clinical trials, 5 questions on attitudes toward clinical trials scored on a 5-point Likert scale, and 6 questions concerning their motivation toward participation in hypothetical clinical trial scenarios scored on a 5-point Likert scale. The experimental group was also asked to rate the informativeness, helpfulness, and clarity of the handbook on a 5-point Likert scale. There were 40 students in the experimental group and 50 in the control group. Knowledge scores were significantly higher in the experimental group compared with the control group (mean [SD] percentage of correct answers, 88.7% [8.0%] vs 82.6% [9.0%], respectively; P < 0.001). Positive attitudes toward clinical trials were also increased in the experimental group compared with the control group; specifically, participants expressed significantly greater clarity of understanding of clinical trials (mean score, 1.4 [0.5] vs 0.8 [0.6]; P < 0.001) and relief associated with knowing about clinical trials (mean score, 0.8 [0.8] vs 0.4 [0.7]; P = 0.017). There were no between-group differences in students' motivation to participate in the hypothetical clinical trial scenarios. A high proportion of students (95%) found the handbook informative, helpful, and understandable. The patient clinical trials handbook increased knowledge and positive attitudes regarding clinical trials among pharmacy students participating in this study.
    Clinical Therapeutics 02/2005; 27(2):238-45. · 2.23 Impact Factor
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    ABSTRACT: To assess the perceptions and attitudes of pharmacists and pharmacy technicians involved in an office-based opioid dependence treatment program using buprenorphine/naloxone. Cross-sectional attitudinal assessment. Community, outpatient hospital, and clinic pharmacies. Pharmacists and technicians participating in a clinical trial of opioid dependence treatment using buprenorphine/naloxone. Written and telephone surveys followed by interviews with open-ended items. Attitudes and perceptions regarding opioid-dependent patients and use of buprenorphine/naloxone for treatment of opioid dependence. Pharmacies in seven states (New York, Virginia, Illinois, Florida, Texas, California, and Washington) participated in the clinical trial. A total of 40 pharmacists and pharmacy technicians responded to the initial written survey, representing 27 of the 32 pharmacies (84%). Follow-up interviews were obtained from one individual at 30 of those pharmacies (93.8%). Most pharmacy personnel (77.5%) involved with this study were not more concerned about theft or break-ins and would be willing to participate in opioid dependence treatment as the medication became available commercially (70%). The majority of respondents (85%) indicated that patients did not cause problems at their pharmacies. Compared with their experiences in administering other narcotic medications, most respondents did not express increased concern regarding prescription forgery (75%) or diversion (80%) of buprenorphine/naloxone. The majority of respondents expressed positive attitudes and perceptions regarding patients treated for opioid dependence with buprenorphine/naloxone.
    Journal of the American Pharmacists Association: JAPhA 01/2005; 45(1):23-32. · 1.16 Impact Factor
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    ABSTRACT: Large simple trials (LSTs) emerged in response to the need for large sample sizes to answer important clinical questions in which treatments have a moderate effect on clinical endpoints. Between 1991 and 1996 the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program conducted an LST entitled "Digitalis Investigation Group (DIG): Trial to Evaluate the Effect of Digitalis on Mortality in Heart Failure." The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center served as the DIG pharmacy coordinating center (PCC). As a direct result of involvement in the DIG trial, the PCC identified the need for an increased emphasis on computerization and automated support of clinical trials, especially LSTs.
    Controlled Clinical Trials 01/2004; 24(6 Suppl):289S-297S.
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    ABSTRACT: The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP. Data from reviews were compared for two time periods, a 2-year implementation period (FYs 1999/2000, n=204) and a continuing follow-up period (FY 2001, n=131). Overall, high GCP adherence was exhibited by 11.3% (n=23) of study sites in FY 1999/2000 versus 20.6% (n=27) in FY 2001, average to good adherence was exhibited by 84.3% (n=172) in FY 1999/2000 versus 77.0% (n=101) in FY 2001, and below average adherence was exhibited by 4.4% (n=9) versus 1.5% (n=3) in these two periods. These changes were statistically significant by chi square analysis (p=0.029). Moreover, GCP adherence was assessed within eight GCP focus areas: patient informed consent, protocol adherence, safety monitoring, institutional review board interactions, regulatory document management, patient records in investigator file, drug/device accountability, and general site operations. Median assessment scores for all 62 GCP review elements improved from 0.82 to 0.89 (p<0.001). Median assessment scores for the 14 selected critical GCP items improved from 0.78 to 0.89 (p<0.001). Median scores for five of the eight GCP focus areas improved significantly (p<0.001) between the two time periods. These data suggest that the site-oriented activities of SMART combined with centralized quality assurance activities of the coordinating centers represent an integrated, versatile program to promote and assure GCP adherence and data integrity in Cooperative Studies Program trials.
    Controlled Clinical Trials 10/2003; 24(5):570-84.
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    ABSTRACT: OBJECTIVE: To determine if quality of life, as measured by the Short Form-36 (SF-36), improved during the treatment of opiate dependence and to identify which dimensions of the SF-36 were impacted by treatment.METHODS: The SF-36 was administered via computer to 100 patients enrolled in a clinical trial of a new drug for opiate dependence. The trial compared two dosage forms of the drug. The five time points for administration were upon enrollment (T1) and monthly (T2-T5) for the 16-week trial. The study was conducted at a drug abuse treatment clinic in a large metropolitan area. Data were analyzed using paired t-tests.RESULTS: Significant improvement in health-related quality of life (P < .013, one tailed) occurred in the dimensions of bodily pain (T3, T4 > T1), general health (T2, T3 > T1), mental health (T2, T3, T5 > T1), social function (T2, T3, T4, T5 > T1), and vitality (T3, T4, T5 > T1 and T3 > T2). Changes in measures of physical functioning and role physical dimensions were not affected by addiction treatment. Changes in general health, mental health, and social function occurred between the enrollment assessment and the first month of treatment (T1 versus T2). However, significant improvement in bodily pain and vitality did not occur until the second month and after (T1 versus T3–T5).CONCLUSION: Quality of life measures improved during opiate dependence treatment. Fewer measures of physical dimensions improved than mental dimensions. The SF-36 was sensitive to improvements in quality of life in patients treated for opiate dependence; therefore it was helpful in measuring patient outcomes.
    Value in Health 03/2003; 1(1):78 - 78. · 2.19 Impact Factor
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    ABSTRACT: To review opioid dependence (OD) and its treatment. Pharmacologic treatments, including the use of buprenorphine/naloxone, are presented. Pharmaceutical care functions for outpatient OD treatment are discussed. Primary and review articles were identified by MEDLINE and HEALTHSTAR searches (from 1966 to November 2000) and through secondary sources. Tertiary sources were also reviewed regarding general concepts of OD and its treatment. Relevant articles were reviewed after identification from published abstracts. Articles were selected based on the objectives for this article. Studies of the treatment of OD with buprenorphine were selected based on the topic (pharmacology, pharmacokinetics, adverse reactions) and study design (randomized, controlled clinical trials in patients with OD with active/placebo comparisons and/or comparisons of active OD treatments). Articles regarding pharmacists' activities in the treatment and prevention of OD were reviewed for the pharmaceutical care section. OD is considered a medical disorder with costly adverse health outcomes. Although methadone maintenance treatment (MMT) is cost-effective for OD, only about 12% of individuals with OD receive this treatment. Psychological and pharmacologic modalities are used to treat OD, but patients often relapse. Drug therapy includes alpha 2-agonists for withdrawal symptoms, detoxification regimens with or without opioids, opioid antagonists, and opioid replacement including methadone, levomethadyl acetate, and buprenorphine. The Drug Addiction Treatment Act of 1999 allows for office-based opioid replacement therapies. Sublingual buprenorphine with naloxone can be used in this milieu. Buprenorphine with naloxone is currently under new drug application review with the Food and Drug Administration. Clinical research shows buprenorphine to be equal in effectiveness to methadone, but safer in overdose due to its ceiling effect on respiratory depression. It has lower abuse potential and fewer withdrawal symptoms when discontinued. Naloxone is included to decrease diversion and injection of the tablets. Pharmacists in outpatient settings who are familiar with OD have opportunities to provide pharmaceutical care to patients receiving this treatment. Pharmaceutical care functions for OD include ensuring appropriate drug administration, monitoring adverse effects, alleviating withdrawal symptoms, treating intercurrent illnesses, minimizing diversion, and preventing relapse. OD is a critical unmet health problem in the US. Buprenorphine combined with naloxone represents an innovative treatment for OD in outpatient settings. This new treatment has advantages over MMT.
    Annals of Pharmacotherapy 03/2002; 36(2):312-21. · 2.57 Impact Factor
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    ABSTRACT: Consistent documentation, characterization, and evaluation of adverse events (AEs) are needed during multicenter clinical trials to ensure accuracy of data reported to the US Food and Drug Administration and in the medical literature. The purpose of this study was to identify and characterize variations in the assessment of AEs by clinical trial personnel. During the annual meeting of personnel from a multicenter, controlled clinical trial of an investigational new drug treatment for opioid dependence, an oral presentation of procedures for AE data collection was given to 25 principal investigators and ancillary study personnel who assessed AEs for the study. A post-test using 3 hypothetical AE cases in which AEs were categorized by type of reaction, relatedness to study drug, severity, action taken, and outcome was completed by study participants. Cases and expected responses were reviewed for content and validity by clinical research pharmacists who were not involved with the study. The level of agreement with expected responses was assessed using McNemar symmetry chi-square tests. Assessments of type of AE, relatedness to study drug, and severity were less frequently aligned with expected responses than were action taken and outcome (P < 0.013). Less consistency with expected responses was found in I case than in the other 2, suggesting that certain types of AEs may be more difficult to assess. There was considerable variability in categorization of AEs in an exercise following training for AE data collection. Type of report, relatedness, and severity were found to have more variability in reporting than did action taken or outcome. The results suggest that unless data are gathered to verify reliability of reporting, subcategorization of AE data should be undertaken cautiously. Further research is needed regarding methods for improving consistency in reporting of AEs.
    Clinical Therapeutics 01/2002; 23(12):2011-20. · 2.23 Impact Factor
  • Controlled Clinical Trials - CONTR CLIN TRIAL. 01/1995; 16(3).
  • Controlled Clinical Trials 10/1992; 13(5):384.
  • Clinical Research and Regulatory Affairs - CLIN RES REGUL AFF. 01/1989; 7(3):117-183.
  • Clinical Research and Regulatory Affairs - CLIN RES REGUL AFF. 01/1989; 7(2):69-116.
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    ABSTRACT: The Food, Drug, and Cosmetic Act requires that clinical investigations conducted in the United States involving unapproved drugs be done under an Investigational New Drug Application (IND). INDs are often sponsored by pharmaceutical firms or noncommercial research institutions. Most INDs, however, are sponsored by individual researchers. Since the procedures for filing an IND may not be well understood, this article seeks to clarify these procedures. Specifically, this article describes a "Sponsor-Investigator IND," the conditions under which one is required, and the possible advantages of filing one. The information presented aids the investigator in determining whether an IND need be submitted. The authors have developed an IND workbook that can be used to organize and present the IND application in a form likely to facilitate expeditious review and approval by the FDA. The authors have also developed IND guidelines to assist investigators in preparing, submitting, and maintaining an IND. Obligations and responsibilities of both sponsors and investigators are discussed.
    Controlled Clinical Trials 07/1987; 8(2):101-9.
  • IRB Ethics and Human Research 30(1):6-14.
  • Controlled Clinical Trials 15(3):70.

Publication Stats

88 Citations
20.07 Total Impact Points

Institutions

  • 2002–2007
    • University of New Mexico
      • College of Pharmacy
      Albuquerque, NM, United States
  • 2005–2006
    • U.S. Department of Veterans Affairs
      Washington, Washington, D.C., United States
    • University of Wyoming
      Laramie, Wyoming, United States
  • 2004
    • New Mexico Clinical Research and Osteoporosis Center
      Albuquerque, New Mexico, United States
  • 2003
    • Overton Brooks VA Medical Center
      Shreveport, Louisiana, United States