Troglitazone use in insulin-treated type 2 diabetic patients. The Troglitazone Insulin Study Group.

OBJECTIVE: To determine the ability of troglitazone to reduce requirements for injected insulin while maintaining blood glucose levels in insulin-treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This 26-week double-blind study with open-label extension included patients who had failed previous oral antidiabetic medication and took > or =30 but <150 U of insulin daily The 222 patients in the double-blind study received 200 or 400 mg troglitazone once daily or matching placebo. The primary end point was the proportion of patients meeting the target of > or =50% reduction in injected insulin and either a 15% reduction in fasting blood glucose or a blood glucose <7.8 mmol/l. Insulin dose was reduced 25% based on a study-specific algorithm whenever fasting blood glucose was reduced 5% from baseline. Also of interest were changes in insulin dose and HbA1c. The open-label extension included 173 patients. They received 200 mg of troglitazone with optional titration to 400 mg, and insulin dose was adjusted based on investigators' standards of care. Open-label measures were change in insulin dose, HbA1c, and fasting serum glucose (FSG). RESULTS: In the double-blind phase, 22 and 27% of the 200- and 400-mg troglitazone groups, respectively, reached target, compared with placebo (7%) (P < 0.01). Insulin dose reductions of 13 +/- 3, 30 +/- 3, and 41 +/- 3 U were observed for placebo, 200-, and 400-mg troglitazone groups, respectively HbA1c decreased 0.09 +/- 0.14% for placebo, 0.13 +/- 0.14% for 200 mg, and 0.41 +/- 0.14% for 400 mg (P < 0.05) troglitazone. In the open-label extension, troglitazone treatment resulted in >50% reduction from baseline in daily insulin dose and decreases in HbA1c of 1% and in FSG of >17%. CONCLUSIONS: Troglitazone decreases daily injected insulin dose requirements and improves glycemic control in insulin-treated patients with type 2 diabetes.

Cardiac and glycemic benefits of troglitazone treatment in NIDDM. The Troglitazone Study Group.

Troglitazone is a thiazolidinedione under development for the treatment of NIDDM and potentially other insulin-resistant disease states. Treatment with troglitazone is associated with an improvement in hyperglycemia, hyperinsulinemia, and insulin-mediated glucose disposal. No significant side effects have been observed in humans. Because of reported cardiac changes in animals treated with drugs of this class, this multicenter 48-week study was conducted to evaluate whether NIDDM patients treated with troglitazone develop any cardiac mass increase or functional impairment. A total of 154 NIDDM patients were randomized to receive troglitazone 800 mg q.d. or glyburide titrated to achieve glycemic control (< or =20 mg b.i.d. or q.d.). Two-dimensional echocardiography and pulsed Doppler were used to measure left ventricular mass index (LVMI), cardiac index (CI), and stroke volume index (SVI). All echocardiograms were performed at each center (baseline, 12, 24, 36, and 48 weeks), recorded on videotape, and forwarded to a blinded central echocardiographic interpreter for analysis. The results showed that LVMI of patients treated with troglitazone was not statistically or clinically different from baseline after 24 or 48 weeks. Statistically significant increases in SVI and CI and a statistically significant decrease in diastolic pressure and estimated peripheral resistance were observed in troglitazone-treated patients. These results were not sex-specific. Glycemic benefits of troglitazone treatment were observed as evidenced by long-term improvement of HbA1c and C-peptide levels. Furthermore, triglycerides were significantly lower, and HDL was significantly higher at weeks 24 and 48. In conclusion, NIDDM patients treated with troglitazone do not show any cardiac mass increase or cardiac function impairment. Conversely, patients on troglitazone benefited from enhanced cardiac output and stroke volume, possibly as a result of decreased peripheral resistance. Treatment with troglitazone appears to have a favorable impact on known cardiovascular risk factors and could potentially lower cardiovascular morbidity in NIDDM patients.

Factors associated with fissure sealant delegation: dentist characteristics and office staffing patterns.

The purpose of this research was to identify dentist characteristics and dental office staffing patterns related to delegation of sealant applications. Results from a 1989 mailed survey were used to characterize Michigan general dentists (N = 300) who did or did not delegate sealant applications to auxiliaries and to identify factors associated with delegation. Nearly 50 percent of respondents were applying all sealants themselves. In offices that delegated the procedure, the mean proportion of sealants being applied by dentists was 39.9 percent. Registered dental hygienists were applying 51 percent, while registered dental assistants were applying 6.5 percent. Delegating dentists were more knowledgeable about sealant procedures, held more favorable attitudes, treated more young patients, placed more sealants, and were better informed about the legality of delegation according to the state practice act. Logistic regression analysis found that employing a registered dental hygienist was the most significant factor associated with sealant delegation, followed by employing a registered dental assistant. Findings suggest that dental auxiliaries, and particularly registered dental assistants, are underutilized for applying sealants. Approaches to increasing delegation of sealants may include changing dentists' traditional hiring patterns, highlighting the skills of auxiliaries such as the registered dental hygienist (RDH) and the registered dental assistant (RDA), and increasing awareness of legally allowable procedures that RDHs and RDAs can perform.

Educating dentists about fissure sealants: effects on knowledge, attitudes, and use.

This study evaluated the effects of three modes of education on dentists' knowledge, attitudes, and use of pit and fissure sealants. A randomly selected group of dentists was invited to participate in a sealant education initiative. During a 12-month period, a total of 662 dentists either (1) attended continuing education courses, (2) received written materials and videotapes by mail, or (3) received only written materials by mail. A comparison group (n = 337) received no materials until after the education phase and evaluation had been completed. Pre- and postintervention surveys were used to measure changes in knowledge, attitudes, and sealant use. Response rates to the two surveys were 62 percent and 76 percent, respectively. Preintervention values for knowledge scores, an attitude scale, and sealant use were similar among the four groups. At followup, the three education groups had significantly higher knowledge scores than the comparison group. Attitude values for all but one group were not significantly different, and sealant use by all groups was identical. The numbers of respondents not using sealants declined slightly between surveys in the three education groups while rising slightly in the No-Education Group. Because program outcomes were similar to those of another sealant initiative, it can probably be concluded that continuing education will increase dentists' knowledge about sealants, but have little effect upon their attitudes or their use of the technique. The changes observed in this investigation may be due to the particular capacity for cognitive and affective changes of participants, characteristics of the technology being promoted, and external forces in the professional environment.

Oral health knowledge and sources of information among elementary schoolchildren.

The dental health knowledge and sources of health information of 848 elementary schoolchildren (aged 9-12) in southwestern Michigan were assessed. Demographic parameters (education level, percent below poverty level, median income level) of the area were similar to state and national averages. The children were found to have some knowledge of caries and periodontal disease prevention, yet basic misconceptions were evident. More than one-third of the children thought that plaque should only be removed by a dentist. While 75 percent of the subjects knew that fluoride protected teeth from decay, only 4 percent of the children identified fluoridated water as the best source of this preventive agent. Knowledge of pit and fissure sealants was limited. Extent of correct dental knowledge was not related to age, sex, or mean DMFS scores. Children who answered the most questions correctly named parents and family as their source of information; dentist's office was the second most frequently mentioned source. Findings suggest a need to correct basic misinformation about dental health and to inform children about current efficacious preventive agents.

Oral health knowledge and attitudes of elementary schoolteachers in Michigan.

Teachers at elementary schools in two areas (urban and rural) of Michigan were surveyed to determine their sources of information about oral health and their knowledge and attitudes about dental diseases and disease prevention. Questionnaires were completed by 404 teachers (62% response rate). More than 80 percent of respondents from both areas were female. Demographic characteristics that were significantly different between groups included: median ages of urban and rural respondents (P less than .01), median numbers of years in teaching (P less than .01), and median years in residence (P less than .03). Despite these differences, responses to the questionnaire varied little. For both groups, the most frequently cited sources of information about dental health were dentist's office (82%), followed by magazines and books (74%). The teachers considered preventing tooth decay as the most important reason for good oral hygiene. When asked to rank the effectiveness of ten methods of preventing caries in children, teachers ranked efficacious methods such as fluoridated water and pit and fissure sealants lower than making regular dental visits and reducing intake of sugared foods. Asked to rank the most effective method for children to receive fluoride, urban respondents ranked fluoridated water first, while rural respondents ranked this measure third. Findings suggest that teachers' knowledge about oral health and current methods of prevention is incomplete, is inaccurate in some instances, and varies little by geographic area.

Relation of sources of systemic fluoride to prevalence of dental fluorosis.

The prevalence of dental fluorosis in a nonfluoridated area was determined and related to the reported fluoride ingestion histories of the children examined. A convenience sample of 543 schoolchildren in rural areas of Michigan was examined for fluorosis using the Tooth Surface Index of Fluorosis. Questionnaires that asked about previous use of fluorides were sent to parents of all children examined. The response rate was 76 percent (412 usable questionnaires). A criterion for inclusion in the data analysis stipulated that only fluorosed surfaces that occurred bilaterally would be included. Fluorosis was found on 7 percent of all tooth surfaces and only in the mild form. Twenty-two percent of the subjects were classified as having fluorosis. Dietary supplement was the only fluoride that was found to be significantly related to the occurrence of fluorosis. A greater proportion of the subjects with fluorosis listed physicians, rather than dentists, as the source of fluoride prescriptions. The results demonstrate similarities to the fluorosis reported in other studies in nonfluoridated areas, but also suggest the need to minimize the occurrence of fluorosis through proper assessment of a child's fluoride exposure and the judicious use of additional fluoride.