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Biomedical subjects

Robert J Valuck

Publications and source records attributed to Robert J Valuck.

10 recordsLinked to original sources
PubMed2007

Systematic review and meta-analysis of clinically relevant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982 to present.

PURPOSE: Our objective was to determine the association of clinically relevant adverse events from a systematic review and meta-analysis of statin randomized controlled trials (RCT). METHODS: We performed the meta-analysis in the manner of a Cochrane Collaboration systematic review. Outcomes were discontinuances of therapy or muscle-related symptoms due to adverse events. We searched for articles from 1982 through June 2006 in MEDLINE and other databases. The main inclusion criteria were double blind, placebo controlled RCTs with a monotherapy intervention of any marketed statin and active surveillance of adverse events. We excluded studies of drug interactions, organ transplants, or exercise, or those not meeting all of the study quality criteria. The primary analysis was a statin formulation stratified fixed-effect model using Peto odds-ratios (POR). Secondary analyses explored the stability of the primary results. RESULTS: Over 86,000 study participants from 119 studies were included. Available statins were associated with a lower POR of discontinuance (overall: 0.88 [0.84, 0.93], largest effect with pravastatin: 0.79 [0.74, 0.84]), an elevated POR of rhabdomyolysis (1.59 [0.54, 4.70]) and myositis (2.56 [1.12, 5.85]), and null odds of myalgia (1.09 [0.97, 1.23]). Cerivastatin by comparison demonstrated larger PORs for discontinuances and muscle-related adverse events. Secondary analyses demonstrated the stability of the results. CONCLUSIONS: Overall, discontinuation of statin therapy due to adverse events was no worse than placebo. The risks of muscle-related adverse events were in general agreement with the known risks of statins.

Humans↗
PubMed2004

A case-control study on adverse effects: H2 blocker or proton pump inhibitor use and risk of vitamin B12 deficiency in older adults.

OBJECTIVE: Acid-suppressant drugs are commonly prescribed for elderly patients, a population in which vitamin B(12) deficiency is a common disorder. The purpose of this study was to examine the possible association between use of prescription histamine H-2 receptor antagonists (H2RA) or proton pump inhibitors (PPI) and vitamin B(12) deficiency in older adults. STUDY DESIGN AND SETTING: This was a case-control study in a University-based geriatric primary care setting. Among patients aged 65 years or older with documented serum vitamin B(12) studies between 1990 and 1997, 53 vitamin B(12)-deficient cases were compared with 212 controls for past or current use of prescription H2RA/PPI according to information in subjects' medical records. RESULTS: Controlling for age, gender, multivitamin use, and Helicobacter pylori infection, chronic (#10878;12 months) current use of H2RA/PPI was associated with a significantly increased risk of vitamin B(12) deficiency (OR 4.45; 95% CI 1.47-13.34). No association was found between past or short-term current use of H2RA/PPI and vitamin B(12) deficiency. CONCLUSION: These findings support an association between chronic use of H2RA/PPI by older adults and development of vitamin B(12) deficiency. Additional studies are needed to confirm these findings.

Aged↗
PubMed2004

Antidepressant treatment and risk of suicide attempt by adolescents with major depressive disorder: a propensity-adjusted retrospective cohort study.

CONTEXT: The US FDA has issued an advisory warning of a possible link between antidepressant treatment for paediatric patients with major depressive disorder (MDD) and an increased risk of suicidal behaviour. A large database of paid health insurance claims for adolescents with MDD provided the opportunity to examine this possible relationship. OBJECTIVE: To examine the potential empirical link between antidepressant treatment and suicide attempts among adolescents aged 12-18 years using a community sample of managed care enrollees across the US. DESIGN: A retrospective longitudinal cohort using paid insurance claims for all healthcare and prescription fills for adolescents who were newly diagnosed with MDD and had at least 6 months of follow-up data. A multivariate Cox proportional hazards regression analysis was used to test the hypothesis that antidepressant use increased the risk of suicide attempt, adjusting for propensity for allocation to each treatment group and for demographic and clinical characteristics. SETTING: Managed care plans including both commercial and Medicaid plans in the east, midwest, south and western regions of the US from January 1997 to March 2003. PARTICIPANTS: All adolescent insurance members aged 12-18 years at first diagnosis of MDD. MAIN OUTCOME MEASURES: Suicide attempts as indicated by medical utilisation with International Classification of Diseases (9th edition) [ICD-9] or 10th edition (ICD-10) codes in any healthcare setting or by any covered provider. RESULTS: 24 119 adolescents met inclusion criteria (63% female). Crude suicide attempt rates ranged from 0.0-2.3% by index treatment group. Treatment with SSRIs (hazard ratio) [HR] = 1.59; CI 0.89, 2.82), other antidepressants (HR = 1.03; CI 0.43, 2.44), or multiple antidepressants (HR = 1.43; CI 0.70, 2.89) after index MDD diagnosis resulted in no statistically increased risk of suicide attempt. Treatment with antidepressant medication for at least 180 days (6 months) reduced the likelihood of suicide attempt compared with antidepressant treatment for <55 days (8 weeks) [HR = 0.34; CI 0.21, 0.55]. Other variables that were independently associated with greater risk of suicide attempts included female gender, severity of illness indicators, younger age at time of MDD diagnosis, and living in the midwest or west. CONCLUSIONS: Antidepressant medication use had no statistically significant effect on the likelihood of suicide attempt in a large cohort of adolescents across the US after propensity adjustment for treatment allocation and controlling for other factors. The relationship between suicidal behaviour and antidepressant medication use is complex and requires further investigation.

Adolescent↗
PubMed2004

Consumer responses to a pharmacy benefit report card.

As pharmacy benefits become an increasingly important component of rising health care costs, report cards critically need to be developed to inform consumers about the availability of their medications, what these medications cost them, and additional pharmacy benefit services that can enhance the management of their disease. This study is a preliminary step for developing such a card and assessing its impact on health plan enrollment choices in a small employee sample. Findings indicate that while individuals generally had positive comments about the pharmacy benefit report card, the card had little effect on their health plan enrollment decisions. The higher the prescription use reported by individuals, more likely they were to report that the card influenced their health plan enrollment decisions. The pharmacy benefit report card could be an useful tool for specific populations such as those with an increased need for medication.

Consumer Behavior↗
PubMed2003

A retrospective cohort study of correlates of response to pharmacologic therapy for hyperlipidemia in members of a managed care organization.

BACKGROUND: Few studies have examined the effectiveness of statins in a managed care setting. OBJECTIVE: The aim of this study was to identify demographic, clinical, and pharmacotherapy-related factors associated with response to drug therapy for hyperlipidemia among members of a managed care organization. METHODS: Claims data from a large US managed care organization from July 1, 1998, through June 30, 2000, were analyzed for adult members with continuous enrollment, >or=1 prescription drug claim, >or=2 sets of fasting low-density lipoprotein cholesterol (LDL-C) laboratory results, and no lipid-lowering prescription claims at any time or=41%). Multiple regression and logistic regression models were developed to identify significant predictors of percentage change in LDL-C from baseline and of >or=10% reduction in LDL-C. RESULTS: A total of 6247 members met the inclusion criteria. The mean (SD) age was 59.6 (12.4) years (range, 21-93 years), and 3003 individuals (48.1%) were women. Furthermore, 337 members (5.4%) received high-efficacy statins, 2633 (42.1%) received moderate-efficacy statins, 934 (15.0%) received low-efficacy statins, and 86 (1.4%) received low-efficacy lipid-lowering drugs from other therapeutic classes during the study period. Compliance with therapy was high (range, 85%-92%), and upward titration of therapy was found in only 160 members (2.6%). Multiple regression analysis indicated that receiving statin therapy compared with other lipid-lowering therapy was a significant predictor of percentage reduction in LDL-C (P < 0.001). Logistic regression analysis indicated that compared with high-efficacy statin regimens, low-efficacy statin regimens (odds ratio [OR] = 0.619; 95% CI, 0.436-0.877) and low-efficacy regimens from other therapeutic classes (OR = 0.171; 95% CI, 0.099-0.295) were less effective in lowering LDL-C by >or=10%. Similar results were observed for subanalyses of subjects with diabetes mellitus or coronary heart disease (CHD); individuals who received more efficacious statin regimens were more likely to reach the National Cholesterol Education Program Adult Treatment Panel II LDL-C goal of <or=100 mg/dL (P < 0.05 for moderate- or low-efficacy regimens vs high-efficacy statins in each model). CONCLUSION: The results of the present study suggest that improvement is needed in hyperlipidemia management, especially in identification and use of lipid-lowering therapy in individuals at high risk for CHD.

Adult↗
PubMed2003

Calfactant sterility in multiple doses from single-use vials.

BACKGROUND: Calfactant is an exogenous surfactant used to treat and prevent respiratory distress syndrome in the newborn infant. It is available in single-use preservative-free vials, but contains enough volume to provide multiple doses to small infants. OBJECTIVE: To measure the preservation of calfactant sterility at 12- and 24-hour intervals following initial violation of vial contents and to extrapolate cost savings associated with product conservation. METHODS: A prospective sterility study was performed using calfactant suspension obtained from vials prescribed for infants who had received their dose in the delivery room or the neonatal intensive care unit (NICU). After initial vial entry, test vials were stored in the NICU pharmacy satellite under refrigeration (temperature range 2.2-7.2 degrees C). Re-entry of test vials and sample removal was performed 12 and 24 hours after initial entry with an 18- or 20-gauge needle. All samples were removed by a neonatal respiratory therapist and placed into 3-mL latex-free, Leur-lok plastic syringes and examined by 3 culture media: MacConkey agar, blood agar, and thioglycollate broth. RESULTS: A total of 89 surfactant samples from 45 vials were cultured; 45 at a mean time of 13.36 hours (range 11-41) and 44 at a mean time of 25.8 hours (range 22-60) after initial vial entry. These samples represented the technique of multiple respiratory therapists. All samples were negative for bacterial growth at 24 and 48 hours (beta = 0.9). CONCLUSIONS: Results from this short-term sterility study represent an initial step in the evaluation of multiple doses of surfactant from a single-use vial. The data suggest that 1-2 re-entries into a vial of calfactant, within 24 hours after the initial breach, can be a safe and economical method of providing more than a single dose of surfactant to infants weighing <1 kg. We encourage each institution to reproduce these findings before applying this concept to their patients.

Bacteria↗
PubMed2002

Vitamin B(12) deficiency associated with histamine(2)-receptor antagonists and a proton-pump inhibitor.

OBJECTIVE: To report a case of vitamin B(12) deficiency associated with long-term use (approximately 4 1/2 y) of histamine(2) (H(2))-receptor antagonists and a proton-pump inhibitor (PPI) in a patient with gastroesophageal reflux. CASE SUMMARY: A 78-year-old nonvegetarian white woman with symptomatic gastroesophageal reflux (GER) was started on cimetidine 300 mg 4 times daily in February 1990 and took various other antisecretory medications over the course of the next 4 1/2 years. She had a normal serum vitamin B(12) concentration of 413 pg/mL in August 1992. In June 1994, her serum vitamin B(12) concentration was found to be in the low normal range at 256 pg/mL. Biochemical markers of vitamin B(12)-dependent enzyme activity were measured at that time, and methylmalonic acid (MMA) and homocysteine (HCYS) were elevated at 757 nmol/L and 27.3 micromol/L, respectively. Serum folate was within the normal range at 4.9 ng/mL, and serum creatinine was slightly elevated at 1.4 mg/dL. MMA and HCYS concentrations decreased dramatically with oral replacement of vitamin B(12) 1000 microg/d, which confirmed vitamin B(12) deficiency. Oral replacement also demonstrated that the woman was able to adequately absorb nonprotein-bound vitamin B(12) from the gastrointestinal tract, suggesting that her deficiency was a result of food-cobalamin malabsorption. The accumulation of MMA and HCYS was not a consequence of renal dysfunction, since both metabolites dramatically decreased with vitamin B(12) replacement. DISCUSSION: Malabsorption of dietary protein-bound vitamin B(12) has been demonstrated with the use of H(2)-receptor antagonists and PPIs. One previous case report of vitamin B(12) deficiency resulting from long-term use of omeprazole has been published. The malabsorption of dietary vitamin B(12) is thought to be a result of its impaired release from food protein, which requires gastric acid and pepsin as the initial step in the absorption process. CONCLUSIONS: The use of H(2)-receptor antagonists and/or PPIs may impair the absorption of protein-bound dietary vitamin B(12) and could contribute to the development of vitamin B(12) deficiency with prolonged use. Patients taking these medications for extended periods of time, particularly >4 years, should be monitored for vitamin B(12) status.

Aged↗
PubMedDate not supplied

Impact of multi-tiered pharmacy benefits on attitudes of plan members with chronic disease states.

OBJECTIVE: To evaluate the effects of 2- and 3-tiered pharmacy benefit plans on member attitudes regarding their pharmacy benefits. METHODS: We performed a mail survey and cross-sectional comparison of the outcome variables in a large managed care population in the western United States. Participants were persons with chronic disease states who were in 2- or 3-tier copay drug plans. A random sample of 10,662 was selected from a total of 25,008 members who had received 2 or more prescriptions for a drug commonly used to treat one of 5 conditions: hypertension, diabetes, dyslipidemia, gastroesophageal reflux disease (GERD), or arthritis. Statistical analysis included bivariate comparisons and regression analysis of the factors affecting member attitudes, including satisfaction, loyalty, health plan choices, and willingness to pay a higher out-of-pocket cost for medications. RESULTS: A response rate of 35.8% was obtained from continuously enrolled plan members. Respondents were older, sicker, and consumed more prescriptions than nonrespondents. There were significant differences in age and health plan characteristics between 2- and 3-tier plan members: respondents aged 65 or older represented 11.7% of 2-tier plan members and 54.7% of 3-tier plan members, and 10.0% of 2-tier plan members were in Medicare+Choice plans versus 61.4% in Medicare+Choice plans for 3-tier plan members (P<0.05). Controlling for demographic characteristics, number of comorbidities, and the cost of health care, 2-tier plan members were more satisfied with their plan, more likely to recommend their plan to others, and less likely to switch their current plans to obtain better prescription drug coverage than 3-tier plan members. While members were willing to purchase higher cost nonformulary and brand-name medications, in general, they were not willing to pay more than 10 dollars (in addition to their copayment amount) for these medications. Older respondents and sicker individuals (those with higher scores on the Chronic Disease Indicator) appeared to have more positive attitudes toward their pharmacy benefit plans in general. Higher reported incomes by respondents were also associated with greater satisfaction with prescription drug coverage and increased loyalty toward the pharmacy benefit plan. Conversely, the more individuals spent for either their health care or prescription medications, the less satisfied they were with their prescription drug coverage and less loyalty they appeared to have for their health plans. An inverse relationship also appeared to exist between the out-of-pocket costs for prescription medications and members' willingness to pay for nonformulary medications. CONCLUSIONS: Three-tier members had lower reported satisfaction with their plans compared to members in 2-tier plans. The financial resources available to members (which may be a function of being older and having more education and higher incomes), the number of chronic disease states that members have, and other factors may influence their attitudes toward their prescription drug coverage.

Journal Article↗
PubMedDate not supplied

Effects of a 3-tier pharmacy benefit design on the prescription purchasing behavior of individuals with chronic disease.

OBJECTIVE: To evaluate the impact of 3-tier (copayment) pharmacy benefit structures on medication utilization behavior. METHODS: A pretest-posttest quasi-experimental design was employed. Chronic disease sufferers (N=8,132) from a health plan were classified into the following groups: (a) 2-tier copayment moving to a 3-tier structure, (.converting. group), (b) 2-tier staying in a 2-tier structure and, (c) 3-tier staying in a 3-tier structure. The latter 2 were.comparison. groups. Two 7-month time periods were determined: the.preperiod. (June through December 2000) and the.postperiod. (January through July 2001) for a change in pharmacy benefit structure. Pharmacy claims data were used for data collection. Statistical analyses included bivariate tests to evaluate predifferences and postdifferences across study groups. Maximum likelihood estimates from a repeated measures model were used to examine changes in formulary compliance and generic use rates. Discontinuation of nonformulary medications was evaluated using logistic regression. RESULTS: Controlling for demographics, number of comorbidities, disease state, and pharmacy benefit structure, the formulary compliance rate increased by 5.6% for the converting group. No significant increases were seen for the comparison groups. Generic use rates increased by 6 to 8 absolute percentage points for all groups (3.3% to 4.9 % adjusted rates). Converting group members were 1.76 times more likely to discontinue their nonformulary medication than those in the 2-tier comparison group and 1.49 times more likely than those in the 3-tier comparison group. CONCLUSIONS: These findings suggest that shifting individuals from a 2-tier to a 3-tier drug benefit copayment structure resulted in changes in medication utilization. Decision makers need to balance these changes with the potential dissatisfaction that members may express in paying higher copayments.

Aged↗