Drug safety data mining with a tree-based scan statistic.

Purpose: In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease.

The safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis: a meta-analysis.

Purpose: We estimated the absolute risks of treatment termination and incidence of adverse liver outcomes among all commonly used oral antifungal treatments for superficial dermatophytosis and onychomycosis.

Methods: MEDLINE, EMBASE, and Cochrane Library were searched to identify randomized and nonrandomized controlled trials, case series, and cohort studies published before December 31, 2005. Two reviewers independently applied selection criteria, performed quality assessment, and extracted data.

Compliance with a statin treatment in a usual-care setting: retrospective database analysis over 3 years after treatment initiation in health maintenance organization enrollees with dyslipidemia.

Background: Patients treated in a usual-care setting often do not comply with prescribed treatment regimens as closely as those treated in a clinical trial, for a variety of reasons.

Objectives: We sought to describe compliance over 3 years with a statin treatment in an observational study in a usual-care setting and to investigate potential risk factors for poor compliance.

Methods: Enrollees in a Massachusetts health maintenance organization (HMO) who presented with baseline low-density lipoprotein cholesterol (LDL-C) > or =130 mg/dL and who started statin treatment between January 1, 1994, and July 1, 1999, were followed until death, termination of membership in the HMO, or July 1, 1999, whichever came first, as documented by the HMO's drug-dispensing electronic records.

The long-term course of low-density lipoprotein cholesterol after initiation of statin treatment: retrospective database analysis over 3 years in health maintenance organization enrollees.

Objectives: Our primary objective was to obtain robust estimates of the low-density lipoprotein cholesterol (LDL-C) decrease from baseline over a long period (ie, 3 years) after initiation of statin treatment in a usual-care setting. Our secondary objective was to investigate the predictors of the LDL-C time course.

Methods: We retrospectively analyzed the data for a sample of enrollees in a health maintenance organization (HMO) who started statin treatment between October 1, 1995, and December 31, 1998.

Determinants of the differences in LDL-cholesterol after initiation of statin treatment.

Background: Randomized clinical trials may not accurately predict drug benefit in clinical practice because the patients and conditions of therapy almost always differ between those settings.

Objective: To determine whether differences in low-density lipoprotein cholesterol (LDL-C) time curves between clinical trial results and usual care experience after initiation of statin therapy could be explained fully in terms of observable characteristics of patients and practice in usual care.

Methods: We compared LDL-C measurements for 3 years after initiation of statin treatment in individuals enrolled in a health maintenance organization (HMO), with enrollees in the active treatment arm of the CARE (Cholesterol and Recurrent Events) trial.