BACKGROUND.During the first year that the rhesus rotavirus tetravalent vaccine (RRV-TV) was licensed, the Vaccine Adverse Event Reporting System received several reports of intussusception after ...vaccination. To evaluate the risk of intussusception, we conducted a retrospective cohort study in ten managed care organizations.
METHODS.Cases of intussusception were identified by searching electronic databases for diagnoses of intussusception (ICD-9 Code 560.0) in infants 1 to 11 months of age and confirmed by medical chart review. Vaccination and enrollment data were obtained from administrative databases. Incidence rate ratios (RR) of intussusception were computed by dividing incidence rates in prespecified risk intervals after vaccination by the background rate of intussusception and adjusted for age by Poisson regression. Cox proportional hazard regression was used to evaluate risk by vaccine dose.
RESULTS.Of 463 277 children 56 253 had been vaccinated with a total of 91 371 doses of RRV-TV. The incidence rate of intussusception was 25/100 000 person years among unexposed infants and 340/100 000 person years 3 to 7 days postvaccination. In the interval 3 to 7 days after vaccination, the age-adjusted RR was 16.0 (95% confidence interval, 5.5 to 46.7) for all doses combined and 30.4 (95% confidence interval, 8.8 to 104.9) after the first dose. RRs for the 8- to 14- and 15- to 21-day risk intervals were >1.0, but the confidence intervals substantially overlapped 1.0. The attributable risk was one case of intussusception per 11 073 children vaccinated.
CONCLUSIONS.RRV-TV is associated with an increased risk of intussusception. The risk is greatest 3 to 7 days after the first vaccination dose.
Study Objective. To investigate the occurrence of tramadol‐associated seizures.
Design. Retrospective cohort and case‐control studies.
Setting. UnitedHealth Group‐affiliated independent practice ...model health plans, from different regions of the United States, contracting with large networks of physicians.
Intervention. Analysis of administrative data from a large U.S. managed care population.
Patients. A cohort of 9218 adult tramadol users and 37,232 concurrent nonusers.
Measurements and Main Results. Fewer than 1% of users (80) had a presumed incident seizure claim after the first tramadol prescription. Risk of seizure claim was increased 2‐ to 6‐fold among users adjusted for selected comorbidities and concomitant drugs. Risk was highest among those aged 25–54 years, those with more than four tramadol prescriptions, and those with history of alcohol abuse, stroke, or head injury. A case‐control study among users was conducted to validate incident seizure outcomes from medical records. Only eight cases were confirmed, and all had cofactors associated with increased seizure risk.
Conclusion. In a general population, risk of seizure may be associated with long‐term therapy with tramadol or the presence of cofactors, or confined to a small sensitive population subset.
This prospective, multicenter study was designed to investigate the efficacy and outcome of spinal cord stimulation using a variety of clinical and psychosocial outcome measures. Data were collected ...before implantation and at regular intervals after implantation. This report focuses on 70 patients who had undergone 1 year of follow-up treatment at the time of data analysis.
To provide a more generalizable assessment of long-term spinal cord stimulation outcome by comparing a variety of pain and functional/quality-of-life measures before and after management. This report details results after 1 year of stimulation.
The historically diverse methods, patient selection criteria, and outcome measures reported in the spinal cord stimulation literature have made interpretation and comparison of results difficult. Although short-term outcomes are generally consistent, long-term outcomes of spinal cord stimulation, as determined by prospective studies that assess multidimensional aspects of the pain complaint among a relatively homogeneous population, are not well established.
Two hundred nineteen patients were entered at six centers throughout the United States. All patients underwent a trial of stimulation before implant of the permanent system. Most were psychologically screened. One hundred eighty-two patients were implanted with a permanent stimulating system. At the time of this report, complete 1-year follow-up data were available on 70 patients, 88% of whom reported pain in the back or lower extremities. Patient evaluation of pain and functional levels was completed before implantation and 3, 6, 12, and 24 months after implantation. Complications, medication usage, and work status also were monitored.
All pain and quality-of-life measures showed statistically significant improvement during the treatment year. These included the average pain visual analogue scale, the McGill Pain Questionnaire, the Oswestry Disability Questionnaire, the Sickness Impact Profile, and the Back Depression Inventory. Overall success of the therapy was defined as at least 50% pain relief and patient assessment of the procedure as fully or partially beneficial and worthwhile. Using this definition, spinal cord stimulation successfully managed pain in 55% of patients on whom 1-year follow-up is available. Complications requiring surgical intervention were reported by 17% (12 of 70) of patients. Medication usage and work status were not changed significantly.
This prospective, multicenter study confirms that spinal cord stimulation can be an effective therapy for management of chronic low back and extremity pain. Significant improvements in many aspects of the pain condition were measured, and complications were minimal.
We evaluated the positive predictive values (PPVs) of specific criteria based upon International Classification of Diseases, 9th revision (ICD-9-CM) codes documented in health plan administrative ...databases for identification of cases of serious myopathy and rhabdomyolysis.
We conducted a retrospective study among patients enrolled in 11 geographically dispersed managed care organizations. Cohorts of new users of specific statins and fibrates were identified by selecting patients with an initial dispensing of the drug during the period 1 January 1998 to 30 June 2001. Potential cases of serious myopathy or rhabdomyolysis were identified using specific criteria based upon ICD-9-CM codes suggesting a muscle disorder or acute renal failure.
A total of 194 hospitalizations meeting the criteria for chart review selection were identified among 206,732 new users of statins and 15,485 new users of fibrates. Overall, 31 cases of serious, clinically important myopathy or rhabdomyolysis (18%) were confirmed through chart review. Of these, 26 (84%) had a claim including codes for myoglobinuria (ICD-9-CM 791.3) or other disorders of muscle, ligament, and fascia (ICD-9-CM 728.89). A PPV of 74% (26 of 35 patients meeting criteria) was found for a composite definition that included (1) a primary or secondary discharge code for myoglobinuria, (2) a primary code for “other disorders of muscle,” or (3) a secondary code for “other disorders of muscle” accompanied by a claim for a CK test within 7 days of hospitalization or a discharge code for acute renal failure.
For rare adverse events such as serious myopathy or rhabdomyolysis, large population-based databases that include diagnosis and laboratory test claims data can facilitate epidemiologic research.
CONTEXT Lipid-lowering agents are widely prescribed in the United States. Reliable
estimates of rhabdomyolysis risk with various lipid-lowering agents are not
available. OBJECTIVE To estimate the ...incidence of rhabdomyolysis in patients treated with
different statins and fibrates, alone and in combination, in the ambulatory
setting. DESIGN, SETTING, AND PATIENTS Drug-specific inception cohorts of statin and fibrate users were established
using claims data from 11 managed care health plans across the United States.
Patients with at least 180 days of prior health plan enrollment were entered
into the cohorts between January 1, 1998, and June 30, 2001. Person-time was
classified as monotherapy or combined statin-fibrate therapy. MAIN OUTCOME MEASURE Incidence rates of rhabdomyolysis per 10 000 person-years of treatment,
number needed to treat, and relative risk of rhabdomyolysis. RESULTS In 252 460 patients treated with lipid-lowering agents, 24 cases
of hospitalized rhabdomyolysis occurred during treatment. Average incidence
per 10 000 person-years for monotherapy with atorvastatin, pravastatin,
or simvastatin was 0.44 (95% confidence interval CI, 0.20-0.84); for cerivastatin,
5.34 (95% CI, 1.46-13.68); and for fibrate, 2.82 (95% CI, 0.58-8.24). By comparison,
the incidence during unexposed person-time was 0 (95% CI, 0-0.48; P = .056). The incidence increased to 5.98 (95% CI, 0.72-216.0)
for combined therapy of atorvastatin, pravastatin, or simvastatin with a fibrate,
and to 1035 (95% CI, 389-2117) for combined cerivastatin-fibrate use. Per
year of therapy, the number needed to treat to observe 1 case of rhabdomyolysis
was 22 727 for statin monotherapy, 484 for older patients with diabetes
mellitus who were treated with both a statin and fibrate, and ranged from
9.7 to 12.7 for patients who were treated with cerivastatin plus fibrate. CONCLUSIONS Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin,
pravastatin, and simvastatin; combined statin-fibrate use increased risk,
especially in older patients with diabetes mellitus. Cerivastatin combined
with fibrate conferred a risk of approximately 1 in 10 treated patients per
year.Published online November 22, 2004 (doi:10.1001/jama.292.21.2585).
Spinal cord stimulation (SCS) has been used for more than 20 years in the treatment of diverse pain conditions. Although recent studies have identified more clearly those conditions for which ...SCSoffers a favorable prognosis, the identification of a patient population in whom reasonably long-term success can be expected has been difficult. In an effort to improve patient selection and increase the overall success rate of treatment, we have examined various physical, demographic, and psychosocial variables as predictors of SCS outcome. The study population consisted of 40 patients with chronic low back and/or leg pain, 85% of whom were diagnosed with failed back surgery syndrome. Medical history and demographic data were collected as part of an initial assessment along with patient responses to the Minnesota Multiphasic Personality Inventory, the visual analogue pain rating scale (VAS), the McGill Pain Questionnaire, the Oswestry Disability Questionnaire, the Beck Depression Inventory, and the Sickness Impact Profile. Treatment outcomes were examined and found to improve significantly after 3 months of stimulation. Subsequent regression analysis revealed that patient age, the Minnesota Multiphasic Personality Inventory depression subscale D, and the evaluative subscale of the McGill Pain Questionnaire (MPQe) were important predictors of posttreatment pain status. Increased patient age and D subscale scores correlated negatively with pain status, as measured by the percentage of changes in pretreatment and posttreatment VAS scores, % delta VAS. In contrast, higher MPQe correlated with improved pain status. By the use of the following equation and the definition commonly associated with SCS success (at least 50% decrease in the VAS pain level), the success or failure of 3 months of SCS was correctly predicted in 88% of the study population. Our results suggest that patient age, Minnesota Multiphasic Personality Inventory depression, and MPQe may be clinically useful in the prediction of pain status after 3 months of SCS in patients with chronic low back and/or leg pain. % delta VAS = 112.57 - 1.98 (D)-1.68 (Age) + 35.54 (MPQe).
Underreporting tuberculosis (TB) cases can compromise surveillance. We evaluated the contribution of pharmacy data in three different managed-care settings and geographic areas. Persons with more ...than two anti-TB medications were identified by using pharmacy databases. Active TB was confirmed by using state TB registries, medical record review, or questionnaires from prescribing physicians. We identified 207 active TB cases, including 13 (6%) missed by traditional surveillance. Pharmacy screening identified 80% of persons with TB who had received their medications through health plan-reimbursed sources, but missed those treated solely in public health clinics. The positive predictive value of receiving more than two anti-TB medications was 33%. Pharmacy data also provided useful information about physicians' management of TB and patients' adherence to prescribed therapy. Pharmacy data can help public health officials to find TB cases and assess their management in populations that receive care in the private sector.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
CONTEXT Cisapride, a gastrointestinal tract promotility agent, can cause life-threatening
cardiac arrhythmias in patients susceptible either because of concurrent use
of medications that interfere ...with cisapride metabolism or prolong the QT
interval or because of the presence of other diseases that predispose to such
arrhythmias. In June 1998, the US Food and Drug Administration (FDA) determined
that use of cisapride was contraindicated in such patients and informed practitioners
through additions to the boxed warning in the label and a "Dear Health Care
Professional" letter sent by the drug's manufacturer. OBJECTIVE To evaluate the impact of the FDA's 1998 regulatory action regarding
contraindicated use of cisapride. DESIGN AND SETTING Analysis of data for the 1-year periods before (July 1997-June 1998)
and after (July 1998-June 1999) the regulatory action from the population-based,
pharmacoepidemiology research databases of 2 managed care organizations (sites
A and B) and a state Medicaid program (site C). PARTICIPANTS Patients with at least 180 days of prior enrollment in 1 of the 3 sites
who were prescribed cisapride at least once in the period before (n = 24 840)
or after (n = 22 459) regulatory action. Patients could be included in
both cohorts. MAIN OUTCOME MEASURES Proportion of cisapride users in each period for whom cisapride use
was contraindicated by the product label, based on computerized patient medical
encounter records. RESULTS In the year prior to regulatory action, cisapride use was contraindicated
for 26%, 30%, and 60% of users in study sites A, B, and C, respectively. In
the year after regulatory action, use was contraindicated for 24%, 28%, and
58% of users, a reduction in contraindicated use of approximately 2 per 100
cisapride users at each site. When the analysis was restricted to new users
of cisapride after regulatory action, only minor reductions in contraindicated
use were found. CONCLUSION The FDA's 1998 regulatory action regarding cisapride use had no material
effect on contraindicated cisapride use. More effective ways to communicate
new information about drug safety are needed.
Troglitazone, a thiazolidinedione antidiabetic agent, was withdrawn from the U.S. market in March, 2000, after 94 cases of acute liver failure (ALF) were reported with its use. Based on a literature ...review, the estimated background rate of hospitalization for idiopathic acute liver injury is 22 per million person-years and for idiopathic ALF, less than 1 per million person-years. This study was conducted to estimate the incidence rates of hospitalized idiopathic acute liver injury and ALF among troglitazone-treated patients.
An observational retrospective inception cohort of patients treated with troglitazone was assembled using claims data from a large multistate health care organization. Patients with at least 90 days of health plan enrollment before their first troglitazone prescription between April, 1997 and December, 1998 were enrolled. Hospitalized cases of potential troglitazone-induced acute liver injury or ALF were identified from claims data based on International Classification of Diseases, 9th Revision, coding. Primary medical records were reviewed for case validation, and incidence rates of acute liver injury were calculated using person-years of troglitazone exposure as the denominator.
A total of 7568 patients contributed 4020 person-years of troglitazone exposure. Of these, five were hospitalized with acute liver injury attributed to the drug and not explained by other causes. Incidence rates (95% CI) per million person-years of acute idiopathic liver injury were as follows: hospitalization (n = 5), 1244 (404, 2900); hospitalized jaundice (n = 4), 995 (271, 2546); and ALF (n = 1), 240 (6.3, 1385).
Troglitazone use was associated with a marked increase in risk of hospitalized acute idiopathic liver injury and ALF.
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