Biomedical subjects

Randall S Stafford

Publications and source records attributed to Randall S Stafford.

At least 19 recordsLinked to original sources

PubMed2006

Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics.

BACKGROUND: Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD). However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. METHODS: The Stanford and San Mateo Heart to Heart (HTH) project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. RESULTS: We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL) cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or stroke, and 16% were current smokers. CONCLUSION: We have recruited an ethnically diverse, low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness. HTH will advance the scientific understanding of better strategies for CHD prevention among these priority subpopulations and aid in guiding future practice that will reduce health disparities.

Journal Article↗

PubMed2006

Changes in antihypertensive prescribing during US outpatient visits for uncomplicated hypertension between 1993 and 2004.

Monitoring national patterns of antihypertensive drug therapy is essential to assessing adherence to treatment guidelines and the impact of major scientific publications on physician prescribing. We analyzed data from 2 US National Ambulatory Care Surveys to examine trends between 1993 and 2004 in the prescription of antihypertensive drug classes for uncomplicated hypertension and the association between thiazide and beta-blocker prescribing and physician and patient characteristics. Diuretic prescriptions remained level through 2001 (39%; 95% CI: 34% to 44%) but increased to 53% (48% to 58%) in 2003, largely because of a 72% increase in thiazide prescriptions in the first quarter of 2003 (50%; 95% CI: 40% to 59%). However, these increases did not sustain in 2004. Beta-blocker prescriptions increased modestly from 1993 (24%; 95% CI: 19% to 29%) to 2004 (33%; 95% CI: 28% to 39%). Prescription of calcium channel blockers and angiotensin-converting enzyme inhibitors declined significantly following the sixth Joint National Committee report, but both subsequently rebounded to prereport levels. Prescription of angiotensin II receptor blockers increased continuously from 1% in 1995 to 23% by 2004. Polytherapy prescriptions, particularly those involving > or = 3 drug classes, became increasingly prevalent, accounting for 60% of antihypertensive drug visits by 2004. Prescriptions of thiazides and beta-blockers were both more likely in 1998-2004 (versus 1993-1997). Blacks, women, and hospital outpatients were more likely to receive thiazides. Also, cardiologists were more likely to prescribe beta-blockers. Evidence-based guidelines for antihypertensive drug therapy do impact physician prescribing, but the impact seems to be short lived. Future interventions are imperative for promoting long-term adherence to published guidelines.

Adult↗

PubMed2006

Long-term and short-term changes in antihypertensive prescribing by office-based physicians in the United States.

Medication choices for the treatment of elevated blood pressure have a large potential impact on both patient outcomes and health care costs. Historic trends of prescribing for hypertension will advance the understanding of physician practice of evidence-based medicine. This study describes both long- and short-term trends in US antihypertensive prescribing from 1990 through 2004. Data were extracted from the National Disease and Therapeutic Index, a continuing survey of a national sample of US office-based physicians. Cox and Stuart and z tests were performed. Diuretics ranked among the top 3 antihypertensive drug classes throughout the entire study time span. Angiotensin-converting enzyme (ACE) inhibitors and calcium channel blockers (CCBs) were preferred over diuretics beginning in 1993, with diuretics surpassing CCBs in 2000. Beta-blockers were consistently the fourth most common class until 2002, when exceeded by angiotensin II receptor antagonists (ARBs). Most recent trends indicated an immediate but short-lived increase in the prescription of thiazide diuretics after the new clinical evidence released in December 2002 demonstrating clinical equivalence of thiazides to ACE inhibitors and CCBs. In contrast, prescription of ACE inhibitors declined, accompanied by continuation of a pre-existing increase in the prescription of ARBs, whereas prescription of CCBs remained essentially stable after the new evidence was released. The recorded long- and short-term trends indicate that evidence-based clinical recommendations had an impact on antihypertensive prescribing practices, but the magnitude of impact may be smaller and of more limited duration than desired.

Adrenergic alpha-Antagonists↗

PubMed2006

Off-label prescribing among office-based physicians.

BACKGROUND: Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. METHODS: We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use. RESULTS: In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription. CONCLUSIONS: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

Adult↗

PubMed2006

What are the public health effects of direct-to-consumer drug advertising?

BACKGROUND TO THE DEBATE: Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines, although New Zealand is planning a ban. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease). Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits.

Advertising↗

PubMed2005

Underutilization of aspirin persists in US ambulatory care for the secondary and primary prevention of cardiovascular disease.

BACKGROUND: Despite the proven benefits of aspirin therapy in the primary and secondary prevention of cardiovascular disease (CVD), utilization rates of aspirin remain suboptimal in relation to recommendations. We studied national trends of aspirin use among intermediate- to high-risk patients in the US ambulatory care settings and compared the priority given to aspirin versus statins for CVD risk reduction. We also examined patient and health care provider contributors to the underuse of aspirin. METHODS AND FINDINGS: We used the 1993-2003 US National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey to estimate aspirin use by cardiovascular risk. Physician-noted cardiovascular diseases defined high risk. Intermediate risk was defined as having diabetes mellitus or multiple major risk factors. The proportion of patient visits in which aspirin was reported increased from 21.7% (95% confidence interval: 18.8%-24.6%) in 1993-1994 to 32.8% (25.2%-40.4%) in 2003 for the high-risk category, 3.5% (2.0%-5.0%) to 11.7% (7.8%-15.7%) for visits by patients diagnosed with diabetes, and 3.6% (2.6%-4.6%) to 16.3% (11.4%-21.2%) for those with multiple CVD risk factors. Beginning in 1997-1998, statins were prioritized over aspirin as prophylactic therapy for reducing CVD risk, and the gaps remained wide through 2003. In addition to elevated CVD risk, greater aspirin use was independently associated with advanced age, male gender, cardiologist care, and care in hospital outpatient departments. CONCLUSION: Improvements in use of aspirin in US ambulatory care for reducing risks of CVD were at best modest during the period under study, particularly for secondary prevention, where the strongest evidence and most explicit guidelines exist. Aspirin is more underused than statins despite its more favorable cost-effectiveness. Aggressive and targeted interventions are needed to enhance provider and patient adherence to consensus guidelines for CVD risk reduction.

Adult↗

PubMed2005

Quality of US outpatient care: temporal changes and racial/ethnic disparities.

BACKGROUND: The current national measure set for the quality of health care underrepresents the spectrum of outpatient care and makes limited use of readily available national ambulatory care survey data. METHODS: We examined 23 outpatient quality indicators in 1992 and again in 2002 to measure overall performance and racial/ethnic disparities in outpatient care in the United States. The National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey yielded information about ambulatory services provided in private physician offices and hospital outpatient departments, respectively. Quality indicator performance was defined as the percentage of applicable visits receiving appropriate care. RESULTS: In 2002, mean performance was 50% or more of applicable visits for 12 quality indicators, 7 of which were in the areas of appropriate antibiotic use and avoiding unnecessary routine screening. The performance of the remaining 11 indicators ranged from 15% to 42%. Overall, changes between 1992 and 2002 were modest, with significant improvements in 6 indicators: treatment of depression (47% vs 83%), statin use for hyperlipidemia (10% vs 37%), inhaled corticosteroid use for asthma in adults (25% vs 42%) and children (11% vs 36%), avoiding routine urinalysis during general medical examinations (63% vs 73%), and avoiding inappropriate medications in the elderly (92% vs 95%). After adjusting for potential confounders, race/ethnicity did not seem to affect quality indicator performance, except for greater angiotensin-converting enzyme inhibitor use for congestive health failure among blacks and less unnecessary antibiotic use for uncomplicated upper respiratory tract infections among whites. CONCLUSIONS: Measurable quality deficits and modest improvements across time call for greater adherence to evidence-based medicine in US ambulatory settings. Although significant racial disparities have been described in a variety of settings, we observed that similar, although less than optimal, care is being provided on a per-visit basis regardless of patient racial/ethnic background.

Adult↗

PubMed2005

National trends in statin use by coronary heart disease risk category.

BACKGROUND: Only limited research tracks United States trends in the use of statins recorded during outpatient visits, particularly use by patients at moderate to high cardiovascular risk. METHODS AND FINDINGS: Data collected between 1992 and 2002 in two federally administered surveys provided national estimates of statin use among ambulatory patients, stratified by coronary heart disease risk based on risk factor counting and clinical diagnoses. Statin use grew from 47% of all lipid-lowering medications in 1992 to 87% in 2002, with atorvastatin being the leading medication in 2002. Statin use by patients with hyperlipidemia, as recorded by the number of patient visits, increased significantly from 9% of patient visits in 1992 to 49% in 2000 but then declined to 36% in 2002. Absolute increases in the rate of statin use were greatest for high-risk patients, from 4% of patient visits in 1992 to 19% in 2002. Use among moderate-risk patients increased from 2% of patient visits in 1992 to 14% in 1999 but showed no continued growth subsequently. In 2002, 1 y after the release of the Adult Treatment Panel III recommendations, treatment gaps in statin use were detected for more than 50% of outpatient visits by moderate- and high-risk patients with reported hyperlipidemia. Lower statin use was independently associated with younger patient age, female gender, African American race (versus non-Hispanic white), and non-cardiologist care. CONCLUSION: Despite notable improvements in the past decade, clinical practice fails to institute recommended statin therapy during many ambulatory visits of patients at moderate-to-high cardiovascular risk. Innovative approaches are needed to promote appropriate, more aggressive statin use for eligible patients.

Adult↗

PubMed2005

National trends in cyclooxygenase-2 inhibitor use since market release: nonselective diffusion of a selectively cost-effective innovation.

BACKGROUND: The withdrawal of rofecoxib has highlighted concerns regarding the safety of cyclooxygenase-2 (COX-2) inhibitors. In some patients COX-2 inhibitors may be safer than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs); however, the public health benefit of COX-2 inhibitors depends on their use in patients at higher than normal risk from NSAIDs. We examined trends in COX-2 inhibitor use based on risk for adverse events from NSAIDs. METHODS: We analyzed data from the National Ambulatory Medical Care Survey (1999-2002) and National Hospital Ambulatory Medical Care Survey (1999-2001), nationally representative surveys of community and hospital-based outpatient practices. The main outcome measure was the proportion of patient visits in which COX-2 inhibitors were prescribed, stratified by risk of adverse gastrointestinal (GI) events from NSAIDs. RESULTS: Of the visits in which either a COX-2 inhibitor or NSAID was prescribed, the frequency of COX-2 inhibitor use increased from 35% (1999) to 55% (2000) to 61% (2001 and 2002). Among patients with the lowest risk for adverse events from NSAIDs, the proportion receiving a COX-2 inhibitor increased from 12% in 1999 to 35% in 2002. Overall, increases in COX-2 inhibitor use among patients in whom NSAIDs could be used accounted for more than 63% of the growth in COX-2 inhibitor use during the period examined. CONCLUSIONS: Marked increases in COX-2 inhibitor use have occurred since their release, primarily among patients at low risk for adverse events from NSAIDs. These findings demonstrate the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally beneficial.

Adult↗

PubMed2005

Fluoroquinolone prescribing in the United States: 1995 to 2002.

PURPOSE: To measure changes in the rate and type of fluoroquinolones prescribed in the United States from 1995 to 2002. METHODS: We performed a longitudinal analysis of the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey of adult visits to physicians in ambulatory clinics and emergency departments throughout the United States from 1995 to 2002. The main outcomes were fluoroquinolone prescribing rates and prescribing in accordance with Food and Drug Administration approval as of December 2002. RESULTS: Between 1995 and 2002, fluoroquinolones became the most commonly prescribed class of antibiotics to adults in the United States. Fluoroquinolone prescribing rose threefold, from 7 million visits in 1995 to 22 million visits in 2002 (P < 0.0001). Fluoroquinolone prescribing increased as a proportion of overall antibiotic prescribing (from 10% to 24%; P < 0.0001) and as a proportion of the U.S. population (from 39 to 106 prescriptions per 1000 adults; P < 0.001). These increases were due to the use of newer fluoroquinolones with activity against Streptococcus pneumoniae. Forty-two percent of fluoroquinolone prescriptions were for nonapproved diagnoses. Among patients receiving antibiotics, nonapproved fluoroquinolone prescribing increased over time (odds ratio = 1.18 per year; 95% confidence interval: 1.13 to 1.24). CONCLUSION: Fluoroquinolone prescribing increased threefold in outpatient clinics and emergency departments in the United States from 1995 to 2002. Fluoroquinolones became the most commonly prescribed class of antibiotics to adults in 2002. Nonapproved fluoroquinolone prescribing was common and increased over time. Such prescribing patterns are likely to be followed by an increasing prevalence of fluoroquinolone-resistant bacteria.

Adult↗

PubMed2005

U.S. adolescents receive suboptimal preventive counseling during ambulatory care.

PURPOSE: To examine U.S. adolescents' (age 13-18) utilization of ambulatory care and the likelihood of receiving preventive counseling from 1993 through 2000. METHODS: The National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey provided visit-based data on counseling services that occurred in private physician offices and hospital outpatient departments. Main outcome measures included adolescents' use of outpatient care and their likelihood of being counseled on 3 health promotion topics (i.e., diet, exercise, and growth/development) and 5 risk reduction topics (i.e., tobacco use/exposure, skin cancer prevention, injury prevention, family planning/contraception, and HIV/STD transmission). RESULTS: Adolescents had the lowest rates of outpatient visits among all age groups, with particularly low rates among boys and ethnic minorities. Most frequently, adolescent visits were for upper respiratory tract conditions, acne, routine medical or physical examinations, and, for girls, prenatal care. In 1997-2000, counseling services were documented for 39% (99% CI: 32-46%) of all adolescent general medical/physical examination (GME) visits. Diet [26% of GME visits (20-32%)] and exercise [22% (17-28%)] were the most frequent counseling topics. The counseling rates of the other six topics ranged from as low as 3 to 20%, with skin cancer prevention, HIV/STD transmission, and family planning/contraception ranking the lowest. These rates represented minimal improvements from 1993-1996 both in absolute term and in relation to the gaps between practices and recommendations. CONCLUSIONS: Adolescents underutilize primary care, and even those who do receive care are underserved for their health counseling needs. The noted lack of change over time suggests that satisfactory improvement is unlikely unless substantial interventions are undertaken.

Adolescent↗

PubMed2005

Depression treatment during outpatient visits by U.S. children and adolescents.

PURPOSE: Depression affects approximately 2-8% of all children and adolescents, and treatment of depression in children and adolescents has been the center of recent serious debates. We examined national trends in depression visits and treatment among outpatients aged 7 to 17 years. METHODS: We analyzed visit-based data between 1995 and 2002 in two national ambulatory care surveys. RESULTS: The number of visits by children and adolescents during which depression was reported more than doubled from 1995-1996 (1.44 million) to 2001-2002 (3.22 million). The proportion of these visits during which antidepressants were prescribed rose slightly from 47% in 1995-1996 to 52% in 2001-2002, whereas the proportion during which psychotherapy or mental health counseling was provided declined from 83% to 68%. Selective serotonin reuptake inhibitors (SSRI) represented 76% of all antidepressants prescribed in 1995-1996 and 81% in 2001-2002. In absolute terms, SSRIs were reported in 1.35 million visits in 2001-2002, reflecting a 2.6-fold increase from 1995-1996. Fluoxetine was prescribed in 207,914 visits in 1995-1996 and increased 100% to 415,580 visits in 2001-2002. The use of sertraline increased by 62% to 345,576 visits and paroxetine by 269% to 279,275 visits. CONCLUSIONS: We observed a declining trend in the provision of psychotherapy/mental health counseling during outpatient visits by children and adolescents diagnosed with depression. Although the likelihood of receiving antidepressants remained essentially unchanged, the number of children and adolescents whose visits involved prescription of antidepressants, particularly SSRIs, has increased markedly through 2002. Although fluoxetine remained the most commonly prescribed, other SSRIs were increasingly prescribed through 2002. These trends raise concerns regarding the widespread off-label use of antidepressants lacking reliable evidence of safety and efficacy for use in children and adolescents.

Adolescent↗

PubMed2005

The who, what, and why of risk adjustment: a technology on the cusp of adoption.

Risk adjustment (RA) consists of a series of techniques that account for the health status of patients when predicting or explaining costs of health care for defined populations or for evaluating retrospectively the performance of providers who care for them. Although the federal government seems to have settled on an approach to RA for Medicare Advantage programs, adoption and implementation of RA techniques elsewhere have proceeded much more slowly than was anticipated. This article examines factors affecting the adoption and use of RA outside the Medicare program using case studies in six U.S. health care markets (Baltimore, Seattle, Denver, Cleveland, Phoenix, and Atlanta) as of 2001. We found that for purchasing decisions, RA was used exclusively by public agencies. In the private sector, use of risk adjustment was uncommon and scattered and assumed informal and unexpected forms. The most common private sector use of RA was by health plans, which occasionally employed RA in negotiations with purchasers or to allocate resources internally among providers. The article uses classic technology diffusion theory to explain the adoption and use of RA in these six markets and derives lessons for health policy generally and for the future of RA in particular. For health policy generally, the differing experiences of public and private actors with RA serve as markers of the divergent paths that public and private health care sectors are pursuing with respect to managed care and risk sharing. For the future of RA in particular, its history suggests the need for health service researchers to consider barriers to use adoption and new analytic technologies as they develop them.

Diffusion of Innovation↗

PubMed2005

National patterns of calcium use in osteoporosis in the United States.

OBJECTIVE: Although calcium intake is considered integral to appropriate management of osteoporosis, we hypothesized that the recent therapeutic dominance of bisphosphonates in osteoporosis treatment may have led calcium to be neglected as a component of effective management. STUDY DESIGN: Two national databases were used to assess the adequacy of calcium intake in patients with osteoporosis. Trends in reported supplemental calcium use among physician visits by patients with osteoporosis were assessed using nationally representative 1994-2004 IMS HEALTH National Disease and Therapeutic Index data. Quantity of calcium intake, from both supplements and food, among individuals with osteoporosis (n = 38 men and 376 women) was estimated using the 1999-2002 National Health and Nutrition Examination Survey (NHANES). RESULTS: Physician visits for osteoporosis in the United States increased 4.5-fold between 1994 (1.3 million visits) and 2004 (5.8 million visits). During this time the proportion of osteoporosis visits in which bisphosphonates were prescribed increased from 14% to 81%, while reported calcium use fell from 43% to 23% of visits. Among osteoporosis patients in NHANES, 64% reported using calcium-containing supplements. Reported median calcium intake was 433 (interquartile range: 295, 705) mg/d for calcium supplement nonusers and 1,319 (845, 1,874) mg for calcium supplement users. Overall, only 40% of osteoporosis patients had calcium intake exceeding 1,200 mg/d. CONCLUSION: While osteoporosis is increasingly identified and treated with effective medications, calcium is being neglected as a component of osteoporosis management. Despite the fact that the efficacy of new osteoporosis medications depends on adequate calcium intake, reported calcium intake in osteoporosis patients is far below recommended levels.

Bone Density Conservation Agents↗

PubMed2004

Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative.

CONTEXT: Little is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits. OBJECTIVE: To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002. DESIGN AND SETTING: Nationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports. MAIN OUTCOME MEASURES: Trends in quarterly prescriptions for hormone therapy and expenditures on 5 modes of drug promotion: samples, office-based detailing, hospital-based promotion, journal advertisements, and direct-to-consumer advertising. RESULTS: Prior to the WHI E+P report, prescribing rates and promotional spending for hormone therapy were stable. In the quarter before the WHI E+P report (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed and 71 million dollars was spent on promotion (in annual terms, 350 dollars per year per US physician). Within 9 months of the report's publication (quarter 1 of 2003), there was a 32% decrease in hormone therapy prescriptions, and a nadir had been reached for promotional spending (37% decrease compared with pre-WHI E+P levels). Spending decreased for all promotional activities and most hormone therapies. Overall, the greatest declines were for samples (36% decrease as of quarter 1 of 2003) and direct-to-consumer advertising (100% decrease). The greatest declines in promotion occurred for standard-dose Prempro (61% decrease as of quarter 1 of 2003), the agent implicated by the WHI E+P report. More recently, promotional efforts have increased, particularly for lower-dose Prempro, a resurgence associated with modestly increased prescriptions for this newer agent. CONCLUSIONS: Concordant with its widespread use, hormone therapy was among the most heavily promoted medications prior to the WHI E+P report. Following reporting of the evidence of harm from this trial, there was a substantial decline in promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial. Interrelated with the impact of the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions.

Advertising↗

PubMed2004

Estrogen plus progestin and risk of venous thrombosis.

CONTEXT: Postmenopausal hormone therapy increases the risk of venous thrombosis. It is not known whether other factors influencing thrombosis add to this risk. OBJECTIVE: To report final data on incidence of venous thrombosis in the Women's Health Initiative Estrogen Plus Progestin clinical trial and the association of hormone therapy with venous thrombosis in the setting of other thrombosis risk factors. DESIGN, SETTING, AND PARTICIPANTS: Double-blind randomized controlled trial of 16,608 postmenopausal women between the ages of 50 and 79 years, who were enrolled in 1993 through 1998 at 40 US clinical centers with 5.6 years of follow up; and a nested case-control study. Baseline gene variants related to thrombosis risk were measured in the first 147 women who developed thrombosis and in 513 controls. INTERVENTION: Random assignment to 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate, or placebo. MAIN OUTCOME MEASURES: Centrally validated deep vein thrombosis and pulmonary embolus. RESULTS: Venous thrombosis occurred in 167 women taking estrogen plus progestin (3.5 per 1000 person-years) and in 76 taking placebo (1.7 per 1000 person-years); hazard ratio (HR), 2.06 (95% confidence interval [CI], 1.57-2.70). Compared with women between the ages of 50 and 59 years who were taking placebo, the risk associated with hormone therapy was higher with age: HR of 4.28 (95% CI, 2.38-7.72) for women aged 60 to 69 years and 7.46 (95% CI, 4.32-14.38) for women aged 70 to 79 years. Compared with women who were of normal weight and taking placebo, the risk associated with taking estrogen plus progestin was increased among overweight and obese women: HR of 3.80 (95% CI, 2.08-6.94) and 5.61 (95% CI, 3.12-10.11), respectively. Factor V Leiden enhanced the hormone-associated risk of thrombosis with a 6.69-fold increased risk compared with women in the placebo group without the mutation (95% CI, 3.09-14.49). Other genetic variants (prothrombin 20210A, methylenetetrahydrofolate reductase C677T, factor XIII Val34Leu, PAI-1 4G/5G, and factor V HR2) did not modify the association of hormone therapy with venous thrombosis. CONCLUSIONS: Estrogen plus progestin was associated with doubling the risk of venous thrombosis. Estrogen plus progestin therapy increased the risks associated with age, overweight or obesity, and factor V Leiden.

Age Factors↗

PubMed2004

National trends in osteoporosis visits and osteoporosis treatment, 1988-2003.

BACKGROUND: Research is limited on physicians' prescribing practices for osteoporosis treatment. We investigated patterns of pharmacotherapy from 1988 to 2003 and the impact of new medications on identification and treatment of patients with osteoporosis. METHODS: We tracked trends from 1988 through 2003 in the frequency of osteoporosis visits and patterns of pharmacotherapy associated with these visits using nationally representative data on prescribing patterns by office-based US physicians from the IMS HEALTH National Disease and Therapeutic Index. RESULTS: The number of physician visits for osteoporosis increased 4-fold between 1994 (1.3 million visits) and 2003 (6.3 million visits), whereas it had remained stable in prior years. This increase coincided with the availability of oral daily bisphosphonates and the selective estrogen receptor modulator raloxifene. The annualized percentage of osteoporosis visits where medications were prescribed increased from 82% in 1988 to 97% by 2003. Prior to 1994, the leading choices for osteoporosis therapy were calcium and estrogens, with lesser roles played by calcitonins and bisphosphonates. Between 1994 and 2003, the percentage of visits where bisphosphonates and raloxifene were prescribed increased from 14% to 73% and from 0% to 12%, respectively, while prescriptions for other medications declined. CONCLUSIONS: New medications for osteoporosis offering improved efficacy and convenient dosing were associated with increased frequency of patient visits and treatment. This finding suggests that new drug therapy contributed to increased disease recognition and treatment.

Adult↗

PubMed2004

National trends in antiarrhythmic and antithrombotic medication use in atrial fibrillation.

BACKGROUND: Atrial fibrillation is the most common cardiac arrhythmia associated with significant medical complications. We examined trends in the medical therapy of atrial fibrillation in the United States from 1991 through 2000. METHODS: Data from 1355 visits among patients with atrial fibrillation were obtained from the National Ambulatory Medical Care Survey, a nationally representative assessment of office-based practice. We assessed trends in medication use for ventricular rate control (digoxin, beta-blockers, and calcium channel blockers), sinus rhythm maintenance (class IA, IC, and III antiarrhythmics), and thromboembolism prevention (oral anticoagulants and aspirin). RESULTS: Overall rate control medication use decreased from 72% of visits in 1991-1992 to 56% in 1999-2000 (P =.01 for trend) due to declining digoxin use (64% to 37%, P<.001 for trend). beta-Blocker and calcium channel blocker use remained unchanged. Although there was no change in overall sinus rhythm medication use over time, amiodarone hydrochloride use increased from 0.2% to 6.4% (P<.001 for trend), while quinidine use decreased from 5.0% to 0.0% (P =.01 for trend). Oral anticoagulant use increased (28% to 41%, P =.01 for trend), with the greatest increase in patients aged 80 years and older (14% to 48%, P<.001 for trend). Despite this, only 46.5% of patients at high risk for stroke were taking anticoagulants in 1999-2000. CONCLUSIONS: Digoxin use in atrial fibrillation decreased over time, without concomitant increases in beta-blocker or calcium channel blocker use. Amiodarone replaced quinidine as the dominant sinus rhythm medication. Although oral anticoagulant use increased over time, particularly in the oldest patients, fewer than half of the patients at high risk for stroke were anticoagulated.

Administration, Oral↗