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Biomedical subjects

Diane K Wysowski

Publications and source records attributed to Diane K Wysowski.

At least 19 recordsLinked to original sources
PubMed2006

Trends in outpatient prescription drug use and related costs in the US: 1998-2003.

OBJECTIVE: To present a brief synopsis of trends in the number of prescriptions and retail costs of outpatient drugs dispensed in the US between 1998 and 2003. METHODS: Data were extracted from IMS Health, the National Prescription Audit Plus and the National Disease and Therapeutic Index databases. RESULTS: In 1998, 2.7 billion outpatient prescriptions were dispensed versus 3.6 billion in 2003. This equates to a 33.3% increase over the 6-year period. Of the top 20 most dispensed drugs by volume, 40% were launched in the 1990s or 2000s. Retail costs for the total market of dispensed outpatient prescription drugs were 96.1 billion US dollars in 1998 and 196 billion US dollars in 2003, a 104% increase. Of the top 20 most dispensed drugs by retail cost, all were tradename drugs and were launched in the 1990s or 2000s. CONCLUSIONS: These data indicate a large increase in the US over a short time period in dispensed outpatient prescriptions and their associated retail costs.

Databases, Factual↗
PubMed2006

Deaths attributed to X-ray contrast media on U.S. death certificates.

OBJECTIVE: The objectives of our study were to determine the number, rate, and types of deaths attributed to specific X-ray contrast media on the basis of U.S. death certificates and to attempt to assess the comparative safety of commonly used diagnostic X-ray contrast agents using death certificate information. CONCLUSION: From 1999 through 2001, deaths attributed to the International Classification of Diseases (ICD) code for contrast media occurred at the rate of 1.1-1.2 per million contrast media packages distributed. An analysis of 1999 death certificates indicated that most deaths attributed to contrast media predictably were associated with renal failure or nephropathy and anaphylaxis or allergic reactions. Risk assessment of the comparative safety of classes or agents was limited by lack of specific contrast media names. Names of administered contrast agents should be recorded in patients' medical records and communicated to primary care physicians and certifiers of death in the event of serious sequelae after an identified recent radiologic procedure.

Cause of Death↗
PubMed2005

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions.

BACKGROUND: The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems. METHODS: We analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002. We documented drug withdrawals and restricted distribution programs based on safety concerns. RESULTS: During the 33-year period from 1969 when adverse drug event reporting was initiated through 2002, about 2.3 million case reports of adverse events for the cumulative number of approximately 6000 marketed drugs were entered in the database. Most reports were for female patients. During this period, numerous drug reactions have been identified and added to the product labeling as boxed warnings, warnings, precautions, contraindications, and adverse reactions. More than 75 drugs/drug products have been removed from the market due to safety problems. In addition, 11 drugs have special requirements for prescriptions or have restricted distribution programs. Drugs withdrawn or restricted represent a small proportion (about 1%) of marketed drugs. CONCLUSIONS: The Food and Drug Administration's Adverse Event Reporting System is the primary surveillance database used for the identification of safety problems of marketed drugs. Despite the limitations of underreporting, differential reporting, and uneven quality, submitted reports often allow the identification of serious adverse events that are added to the product labeling information. In rare instances, additional regulations, up to and including market removal, have been required. We encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adverse drug reactions to manufacturers and the Food and Drug Administration.

Adolescent↗
PubMed2005

Use of menopausal hormones in the United States, 1992 through June, 2003.

PURPOSE: The Women's Health Initiative (WHI) study that documented an unfavorable benefit to risk ratio of Prempro and subsequently an increased risk of stroke with menopausal estrogen prompted us to investigate the use during 1992 through June 2003 of menopausal hormones in the United States. METHODS: Two pharmaceutical research databases from IMS Health, the National Prescription Audit Plus and the National Disease and Therapeutic Index, were accessed and analyzed. RESULTS: The number of dispensed outpatient prescriptions for oral menopausal estrogens and oral combination estrogen-progestins increased 2.5-fold (153%) from 34.5 million dispensed in 1992 to a high of 87.3 million in 2000. For July 2002 through June 2003, the year following the publication of the results of the WHI trial, prescriptions for these products declined to 59.6 million, a 32% decrease from their peak in 2000. Prescriptions for transdermal estrogen and transdermal combination estrogen-progestin products increased from 5.2 million dispensed in 1992 to their peak of 8.3 million in 2000, and declined 10% to 7.5 million during July 2002 through June 2003. By contrast, prescriptions for oral menopausal progestins rose to 17.5 million in 1995 and then steadily declined. In the year after the WHI, prescriptions for oral progestins decreased 49% to 8.9 million from their peak in 1995. The earlier decline in oral progestin prescriptions was primarily due to the marketing in 1995 of the popular oral combination estrogen-progestin drugs. CONCLUSIONS: Prescriptions dispensed for menopausal hormones increased substantially between 1992 and peaked in 2000. By June 2003, prescriptions for oral menopausal estrogens and oral combination estrogen-progestins had declined by about one-third from their peak year.

Administration, Cutaneous↗
PubMed2004

Long-term mortality in the United States cohort of pituitary-derived growth hormone recipients.

OBJECTIVE: Patients who received pituitary-derived growth hormone (GH) are at excess risk of mortality from Creutzfeldt-Jakob disease. We investigated whether they were at increased risk of death from other conditions, particularly preventable conditions. STUDY DESIGN: A cohort (N=6107) from known US pituitary-derived GH recipients (treated 1963-1985) was studied. Deaths were identified by reports from physicians and parents and the National Death Index. Rates were compared with the expected rates for the US population standardized for race, age, and sex. RESULTS: There were 433 deaths versus 114 expected (relative risk [RR], 3.8; 95% confidence interval [CI], 3.4-4.2; P<.0001) from 1963 through 1996. Risk was increased in subjects with GH deficiency caused by any tumor (RR, 10.4; 95% CI, 9.1-12.0; P<.0001). Surprisingly, subjects with hypoglycemia treated within the first 6 months of life were at extremely high risk (RR, 18.3; 95% CI, 9.2-32.8; P<.0001), as were all subjects with adrenal insufficiency (RR, 7.1; 95% CI, 6.2-8.2; P<.0001). A quarter of all deaths were sudden and unexpected. Of the 26 cases of Creutzfeldt-Jakob disease, four cases have died since 2000. CONCLUSIONS: The death rate in pituitary-derived GH recipients was almost four times the expected rate. Replacing pituitary-derived GH with recombinant GH has eliminated only the risk of Creutzfeldt-Jakob disease. Hypoglycemia and adrenal insufficiency accounted for far more mortality than Creutzfeldt-Jakob disease. The large number of potentially preventable deaths in patients with adrenal insufficiency and hypoglycemia underscores the importance of early intervention when infection occurs in patients with adrenal insufficiency, and aggressive treatment of panhypopituitarism.

Adrenal Insufficiency↗
PubMed2003

Statin use and the risk of breast cancer.

The study objective was to investigate a possible association between statin use and breast cancer (BRCA). An historical cohort design based on Saskatchewan's population health services databases was used. All eligible women with > or = 1 statin prescription from 1989 to mid-1997 and an age-sex-matched nonexposed group were followed up to 8.5 years (mean 4.2 years). Relative rates (RR) of BRCA were estimated and stratified by age, statin exposure time, and prior hormone use. Thirteen thousand five hundred ninety-two statin users and 53,880 nonexposed subjects were identified. Eight hundred seventy-nine incident BRCA cases were identified. Statins were not associated with BRCA risk in women < or = 55 years. Among subjects >55 years, the RR for BRCA was 1.15 (0.97, 1.37). Stratified analyses revealed increases in risk in short-term statin users and statin users with long-term hormone replacement therapy (HRT) exposure. More studies are needed to determine if short-term statin use and statin use with long-term HRT exposure increases postmenopausal BRCA risk. Published by Elsevier Science Inc.

Adult↗
PubMed2003

Use of medications for erectile dysfunction in the United States, 1996 through 2001.

PURPOSE: We describe the use during 1996 through 2001 of the primary medications approved in the United States for treatment of erectile dysfunction, namely alprostadil injection and urethral suppository, and sildenafil. MATERIALS AND METHODS Two pharmaceutical research data bases, the National Prescription Audit Plus, and National Disease and Therapeutic Index, were accessed and analyzed. Ancillary data were obtained from 2 health plans. RESULTS: Increases in the number of dispensed prescriptions for alprostadil injection and urethral suppository marketed in 1995 and 1996, respectively, were reversed in 1998 by the marketing of sildenafil. From 1998 through 2001 the estimated number of prescriptions for sildenafil increased 1.87-fold or 87% from 7.5 million to 14 million, while those for alprostadil injection decreased 33% from 239,000 to 159,000 and those for alprostadil suppository decreased 67% from 400,000 to 132,000. Sildenafil was prescribed proportionately more frequently for younger men than alprostadil injection or suppository (p <0.0001). Compared with men for whom sildenafil was prescribed in 1998 those prescribed the drug in 2001 were younger (p <0.0001). Alprostadil injection and suppository were prescribed proportionately more frequently by urologists than sildenafil. Ancillary data from 2 health plans indicated a 173% increase in 1 plan and a 25% decrease in the other due to restrictions in sildenafil prescriptions from 1998 through 2001. CONCLUSIONS: Due to the marketing of sildenafil in 1998 through 2001 the use of 2 approved medications for erectile dysfunction, namely alprostadil injection and alprostadil urethral suppository, decreased, while the use of sildenafil increased. Sildenafil was prescribed proportionately more frequently for younger men than alprostadil injection or suppository. Alprostadil was prescribed proportionately more frequently by urologists than sildenafil, which was most commonly prescribed by family and general practitioners, and internists. The data indicate the wide adoption and use of sildenafil for erectile dysfunction.

Adolescent↗
PubMed2003

Rapid increase in the use of oral antidiabetic drugs in the United States, 1990-2001.

OBJECTIVE: To describe the use of oral antidiabetic drugs for management of type 2 diabetes in the U.S. from 1990 through 2001. RESEARCH DESIGN AND METHODS: Data on oral antidiabetic drugs were derived from two pharmaceutical marketing databases from IMS Health, the National Prescription Audit Plus and the National Disease and Therapeutic Index. RESULTS: In 1990, 23.4 million outpatient prescriptions of oral antidiabetic agents were dispensed. By 2001, this number had increased 3.9-fold, to 91.8 million prescriptions. Glipizide and glyburide, two sulfonylurea medications, accounted for approximately 77% of prescriptions of oral antidiabetic drugs in 1990 and 35.5% of prescriptions in 2001. By 2001, the biguanide metformin (approved in 1995) had captured approximately 33% of prescriptions, and the thiazolidinedione insulin sensitizers (rosiglitazone and pioglitazone marketed beginning in 1999) accounted for approximately 17% of market share. Compared with patients treated in 1990, those in 2001 were proportionately younger and they more often used oral antidiabetic drugs and insulin in combination. Internists and general and family practitioners were the primary prescribers of this class of drugs. CONCLUSIONS: Consistent with the reported increase in the prevalence of type 2 diabetes, the number of dispensed outpatient prescriptions of oral antidiabetic drugs increased rapidly between 1990 and 2001. This period was marked by an increase in the treatment of younger people and the use of oral antidiabetic drugs in combination. With the approval in the last decade of several new types of oral antidiabetic medications with different mechanisms of action, options for management of type 2 diabetes have expanded.

Administration, Oral↗
PubMed2002

Use of isotretinoin (Accutane) in the United States: rapid increase from 1992 through 2000.

BACKGROUND: Isotretinoin, a drug approved to treat severe recalcitrant nodular acne, has been marketed in the United States since 1982. The drug is an effective treatment for acne that is refractory to other therapies, but it is a teratogen and can cause serious side effects. OBJECTIVE: Our purpose was to describe trends in the use of isotretinoin in the United States from marketing through year 2000 and summarize characteristics of patients and prescribers. METHODS: Data from 2 pharmaceutical marketing research databases, the National Prescription Audit Plus and the National Disease and Therapeutic Index, and from 2 health plan networks were obtained and analyzed. RESULTS: Retail pharmacies dispensed 19.8 million outpatient prescriptions for isotretinoin from marketing in 1982 through 2000. From 1983 through 1993, the median annual number of prescriptions was just over 800,000; between 1992 and 2000, the number of prescriptions increased 2.5-fold (250%) to nearly 2 million in year 2000. The increases registered in the health plans were somewhat larger: about 275% increases from 1995 through 1999. There is no ICD-9 code for nodulocystic acne; consequently, the type of acne treated with isotretinoin is not determinable from these data. However, between 1993 and 2000, the proportion of isotretinoin treatment for severe acne declined from 63% to 46%, whereas the proportion of treatment for mild and moderate acne increased from 31% to 49%. Data also indicated that the sex distribution of patients was nearly even, and that 63% of male patients prescribed isotretinoin were 15 to 19 years old, whereas 51% of female patients were 15 to 24 years old. CONCLUSION: In the last 8 years, there has been a 2.5-fold (250%) increase in the number of dispensed prescriptions for isotretinoin in the United States. Data also reveal an increasing proportion of isotretinoin use for mild and moderate acne.

Acne Vulgaris↗