Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy.

The importance of serum immunoglobulin (Ig)G concentration in IgG replacement therapy for primary immunodeficiency diseases is established in certain settings. Generally, IgG is infused via the intravenous (IVIG) or subcutaneous (SCIG) route. For IVIG infusion, published data demonstrate that higher IgG doses and trough levels provide patients with improved protection from infection. The same conclusions are not yet accepted for SCIG; data from two recent Phase III studies and a recent post-hoc analysis, however, suggest the same correlation between higher SCIG dose and serum IgG concentration and decreased incidence of infection seen with IVIG. Other measures of clinical efficacy have not been considered similarly. Thus, combined analyses of these and other published SCIG studies were performed; a full comparison of the 13 studies was, however, limited by non-standardized definitions and reporting. Despite these limitations, our analyses indicate that certain clinical outcomes improve at higher SCIG doses and associated higher serum IgG concentrations, and suggest that there might be opportunity to improve patient outcomes via SCIG dose adjustment.

Coping strategies and health care-seeking behavior in a US national sample of adults with symptoms suggestive of overactive bladder.

BACKGROUND: Although millions of individuals have symptoms suggestive of overactive bladder (OAB), few ever seek or receive medical treatment for their condition. OBJECTIVE: The purpose of this study was to describe coping strategies and health care-seeking behavior in a community-based sample of adults with symptoms suggestive of OAB. METHODS: A cross-sectional household telephone survey of an age- and sex-stratified sample of adults was conducted. The survey consisted of general health-related questions as well as questions related to OAB symptoms. A total of 4896 adults completed the interview Respondents were considered to have OAB if they reported > or = 1 symptom of urinary urgency, frequency, or urge incontinence. A follow-up questionnaire was then mailed to a subsample of the telephone interview respondents. The mailed questionnaire contained questions related to type and severity of OAB symptoms, coping strategies, medical care/treatment, feelings/beliefs about OAB, and quality of life. Half of the phone respondents with urinary incontinence (n = 638) and a random sample of all other phone respondents received the mailed questionnaire (n = 873); 1,034 questionnaires were returned. RESULTS: Of the respondents with OAB, 69.6% tried > or = 1 nonmedical coping strategy. Respondents with incontinent OAB were significantly more likely than those with continent OAB or those with no OAB (controls) to use nonmedical coping strategies (incontinent OAB, 76.1%; continent OAB, 59.0%; controls, 31.9%; P < 0.001). Fewer than half of the respondents with OAB (43.5%) had spoken with a provider about OAB in the previous 12 months. Medical consultation was associated with sex, type and severity of OAB, number of nonmedical coping strategies tried, number of OAB information sources consulted, inclination to try new OAB medications, and feelings/beliefs about OAB. In 90% of patient-provider discussions about OAB, the patient initiated the topic. CONCLUSIONS: Individuals manage symptoms suggestive of OAB primarily by using nonmedical coping strategies rather than consulting health care providers. Results of this study support the need for improved clinical recognition of OAB and increased patient-provider communication about this condition.

Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study.

BACKGROUND: Although most persons with migraine treat their headaches with over-the-counter medication, systematic data on the safety and efficacy of widely used treatment, including acetaminophen, are sparse. METHODS: This is a randomized, double-blind, placebo-controlled study comparing oral acetaminophen, 1000 mg (two 500-mg Extra Strength Tylenol tablets), with identical placebo in the treatment of a single acute migraine attack. Eligible subjects met International Headache Society diagnostic criteria for migraine with or without aura. Patients who usually required bed rest with their headaches or who vomited more than 20% of the time were excluded. MAIN OUTCOME MEASURES: The percentage of subjects who, at 2 hours after dosing, experienced a change in baseline pain intensity from severe or moderate pain to mild or no pain (headache response); and pain intensity difference from baseline at the 2-hour postmedication assessment. RESULTS: The headache response rate 2 hours after dosing was 57.8% in the acetaminophen group and 38.7% in the placebo group (P =.002). Pain-free rates at 2 hours were 22.4% in the acetaminophen group and 11.3% in the placebo group (P =.01). The mean pain intensity difference from baseline 2 hours after dosing was 1.08 in the acetaminophen group and 0.73 in the placebo group (P<.001). At 2 hours, other migraine headache characteristics, such as functional disability (P =.002), photophobia (P =.02), and phonophobia (P =.08), were significantly improved after treatment with acetaminophen vs placebo. CONCLUSIONS: Acetaminophen was highly effective for treating pain, functional disability, photophobia, and phonophobia in a population-based sample of persons with migraine, excluding the most disabled persons with migraine. The drug also had an excellent safety profile and was well tolerated. Arch Intern Med. 2000;160:3486-3492.