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A retrospective and prospective study on the safety of discharging selected patients with duodenal ulcer bleeding on the same day as endoscopy.

BACKGROUND: Low risk of rebleeding has been observed in patients with gastrointestinal bleeding due to peptic ulcer without high-risk stigmata of recent hemorrhage. We aimed to evaluate the safety and acceptability of an aggressive early discharge policy in those patients admitted with upper gastrointestinal bleeding due to duodenal ulcers without high-risk stigmata of recent hemorrhage. METHOD: Retrospective analysis was carried out in bleeding ulcer patients less than 60 years of age with stable vital signs and no stigmata or only flat spots on endoscopy. A prospective study was then performed that included only duodenal ulcer patients less than 60 years of age with stable vital signs, no concomitant serious medical illness, and no stigmata of recent hemorrhage. These patients were discharged on the same day that endoscopy was performed. RESULTS: During a period of 18 months, 72 patients satisfied the criteria in the retrospective study. The mean hospital stay was 1.4 days (range, 1 to 5). There were no episodes of rebleeding nor significant drops in hemoglobin level 2 weeks after discharge (10.8 gm/dL +/- 1.4 vs 11.0 gm/dL +/- 1.5). Seventy-five patients were recruited into the prospective study. None of them had rebleeding nor significant drops in hemoglobin 1 week after discharge (12.1 gm/dL +/- 1.8 vs 11.7 gm/dL +/- 2.5). CONCLUSION: We conclude that patients with gastrointestinal bleeding who have clean-based duodenal ulcers and are stable on admission can be safely discharged on the same day as endoscopy.

Adolescent↗

Sexual dimorphism in trauma? A retrospective evaluation of outcome.

PURPOSE: Multiple studies have demonstrated a heightened immune response in female animals subjected to trauma-hemorrhage models and have implied a subsequent survival advantage. PROCEDURES: A retrospective review of outcome in 15,170 trauma admissions over a 5-year-period (1993-1997) at a level 1-trauma center was performed. A comparison of outcome by gender, age, injury severity score (ISS), mechanism of injury, location of injury (AIS), and length of hospitalization (intensive care unit and total hospitalization) was performed. FINDINGS: There were 12,456 male and 2714 female patients included in the study. Overall survival rates (male = 90.2%, female = 90.8%) and survival of serious (ISS > or = 15) trauma (male = 63.5%, female = 60.5%) were not statistically different. Logistic regression analysis identified age, mechanism and ISS as factors associated with survival. CONCLUSION: Retrospective evaluation of our trauma population failed to show a difference in outcome between male and female trauma patients. Age, mechanism and severity of injury-but not gender-were identified as factors influencing survival.

Adolescent↗

The relationship of smoking on peri-implant tissue: a retrospective study.

The term "peri-implantitis" is used to describe the formation of deep mucosal pockets around dental implants, inflammation of the peri-implant mucosa, and increased resorption of peri-implant bone. It has been speculated that when left untreated, peri-implantitis can result in implant failure. This retrospective study examines a possible correlation between smoking and the appearance of peri-implantitis. The clinical and radiographic observations of 366 implants in 107 patients who smoke were compared with those of a group of 1000 implants in 314 nonsmoking patients. Despite the retrospective nature of this study, a comparison between the two groups was possible. The mean follow-up period, mean patient age, implant locations, and percentages of fixed partial dentures and overdentures were consistent in both groups. There was no significant difference in the mean maxillary and mandibular hygienic indices between the group of smokers and that of nonsmokers. However, the group of smokers showed a higher score in the bleeding index, the mean peri-implant pocket depth, the degree of peri-implant mucosal inflammation, and radiographically discernible bone resorption mesial and distal to the implant. In the maxilla of the smoking group, these observations were significantly higher than both the mandibular observations for smokers and the maxillary observations of the group of nonsmokers (p < 0.01). No differences between the two groups were observed in the mandible. Aside from the systemic effects of tobacco smoking on the human organism, local cofactors seem to be responsible for the higher incidence of peri-implantitis in smokers and have a particularly negative effect on the maxilla. These findings confirm that smokers treated with dental implants have a greater risk of development of peri-implantitis.

Adolescent↗

Retrospective review of 1170 endosseous implants placed in partially edentulous jaws.

STATEMENT OF PROBLEM: Implant-supported restorations in the partially edentulous jaw have been performed at the Mayo Clinic for more than 10 years. Clinical performance of the implants and the prostheses should be reported to ensure effectiveness of this procedure. PURPOSE: This retrospective study described results for implant survival, implant fracture rate, prosthetic complications, and design changes that may impact these results. MATERIAL AND METHODS: A retrospective chart review was conducted of all registered implant patients in a large multispecialty medical center. Patients with a partially edentulous jaw who had received endosseous implants to support and retain dental prostheses were included in this review. Implant survival and fracture, prosthetic complications, and demographic data were recorded and analyzed through Kaplan-Meier methods. RESULTS: A total of 1170 implants were placed in four anatomic locations: anterior maxilla, posterior maxilla, anterior mandible, or posterior mandible. Location of implants was shown to have no effect on implant survival (p = 0.7398), implant fracture rates (p = 0.2385), screw loosening (p = 0.8253), or screw fracture (p = 0.2737). Development of new restorative components has resulted in significantly better rates of implant survival without fracture (p = 0.0054), screw function without loosening (p < 0.0001) and screw function without fracture (p = 0.0013). Implant survival seems to have been improved with the new components (p = 0.0513). CONCLUSIONS: Implant survival in this study was independent of anatomic location of implants. Virtually all clinical performance factors were improved by design changes in implant restorative components that were brought to market in early 1991.

Adolescent↗

[Reappraisal of the Sainte-Anne Hospital classification of oligodendrogliomas in view of retrospective studies].

PURPOSE: Definition of homogeneous tumor groups of oligodendrogliomas or oligo-astrocytomas is a basic condition for an adequate evaluation and comparison of the results of treatments in patients from various institutions. However, increasing discordances are observed in the histological diagnosis of these tumors. The main goal of this study is to assess whether, for retrospective studies, MRI data may serve as a common basis for encompassing asymmetry in diagnosis established according to the WHO or Ste-Anne (SA) classification. PATIENTS AND METHODS: This study included 251 adult patients in whom a SA grade A or B oligodendroglioma or oligo-astrocytoma was newly diagnosed at our institution from 1984 to 2003. Routine histological preparations and post-contrast preoperative MRI/CT-scan were simultaneously reviewed in order to assess the impact on survival of the following features: presence or absence of a polymorphous or gemistocytic astrocytic component, of necrosis and of contrast enhancement (CH); endothelial hyperplasia (EH) assessed as absent, present minor (HE+) or (HE++) when conform to the threshold of HE defined in the SA grading system of oligodendrogliomas. The tumors were graded A: no CH and no EH; in B: CH and /or HE++, and A/B: EH + but no CE. RESULTS: 70.1% of the tumors were classified as "pure" oligodendroglioma, 19.5% as "polymorphous oligo-astroastrocytoma" and 10.3% as "gemistocytic oligo-astrocytoma". In grade A, or B tumors, the presence of a polymorphous or a gemistocytic component had no significant influence on survival; however respectively 53% and 65% of these tumours versus 32% of "pure" oligodendrogliomas were grade B at the time of diagnosis. In either histological subtypes, survival was not significantly different when HE was absent or minor (HE+). After regrouping of the histological subtypes and of the tumors with HE+ or absent, the series included 153 oligodendrogliomas grade A and 98 grade B. Survival in patients with grade A versus grade B tumors was respectively 142 versus 52 months (p<0.0001). In grade B tumors, necrosis had no significant influence on survival. Ring-shaped contrast enhancement surrounding large foci of necrosis was observed in only 4 cases. In tumors with or without CE, patient survival was respectively 148 versus 40 months (p<0.0001). On post contrast MRI done in 235 patients, only 7 tumors (3%) were grade A/B (EH++ but no CH). CONCLUSIONS: From these results and our previous observation that, according to the SA classification of gliomas, only oligodendrogliomas or oligo-astrocytomas may not show CE, we propose that for retrospective studies: 1) tumors diagnosed according to the Ste-Anne classification as oligodendroglioma or oligo-astrocytoma be regrouped in a unique category, 2) independent of their histological type and grade according to the WHO, gliomas that do not show CE be regrouped with SA oligodendrogliomas grade A, 3) concerning gliomas that show CE on MRI: oligodendrogliomas or oligo-astrocytomas WHO grade II or III, as well as WHO secondary glioblastomas or glioblastomas with an oligodendroglial component, be regrouped with SA oligodendrogliomas grade B; however tumors that show ring-like CE surrounding large foci of necrosis and finger-like "peritumoral" edema should be excluded or analysed separately.

Adult↗

[Mac Farland fractures: a retrospective study of 26 cases].

PURPOSE OF THE STUDY: MacFarland fractures are known to have poor prognosis. There is a major risk of misalignment due to the formation of an epiphysiodesis bridge. The purpose of this study was to evaluate the functional and radiological outcome of these fractures in a retrospective series of patients. MATERIAL AND METHODS: We analyzed retrospectively the cases of 26 patients (14 boys and 12 girls), mean age 11 years 6 months (range 7-15) with MacFarland fractures. The Salter and Harris classification was Salter III (n = 17) and Salter IV (n = 9). Surgery was used for 21 patients and cast immobilization for five. Mean follow-up was 28.4 months (19-63 months). None of the children were lost to follow-up. Outcome was noted good (no stiffness, no pain, no limp, no misalignment, no surgical complication, no healing problem), fair (stiffness and/or pain and/or limp and/or healing problem without misalignment, no surgical complication), or poor (misalignment or surgical complication). RESULTS: The three-months postoperative assessment showed three patients with ankle pain, five with stiff ankles, one with a medial problem (snapping) and two with wound healing complications. The long-term outcome was considered good for 24 patients and fair in two (one wound adherence and one hypertrophic scar tissue). There were no poor outcomes. DISCUSSION: We used surgery more than is generally reported by other teams, opting for surgery when the displacement was 1 mm rather than the 2 mm used by others. Surgical treatment was arthrotomy in all cases to achieve anatomic reduction under direct view, followed by osteosynthesis. For some, this therapeutic scheme may be considered too surgical. In order to achieve anatomic reduction, we use an epiphyseal lag screw for cancellous bone to achieve better compression of the fracture line. A washer is also used to improve compression and maintain perfect reduction. Theoretically, the washer could raise the risk of perichondral virola and consequently an iatrogenic epiphysiodesis bridge, but we have not had any problems in our experience. Arthrotomy did not lead to ankle stiffness, which is feared by some, in any of our patients.

Adolescent↗

[Analysis of meniscal lesions accompanying anterior cruciate ligament tears: A retrospective analysis of 156 patients].

PURPOSE OF THE STUDY: The purpose of this retrospective study of a continuous series was to document preferential types and localizations of meniscal lesions accompanying anterior cruciate ligament tears and to demonstrate the relationships between meniscal lesions, patient age and time from trauma to surgery. MATERIAL AND METHODS: One hundred fifty-six patients with no history of meniscal lesions underwent ligamentoplasty in 2003. All procedures were performed by the same operator. The time from trauma to surgery was 31.6 months on average. This was a retrospective continuous series using data from detailed operative reports. RESULTS: An isolated lesion of the medial meniscus was observed in 25.6% of cases. There was an isolated lesion of the lateral meniscus in 21.8% and lesions of both menisci in 9%. The most frequent injury was a longitudinal fissuration, for both menisci. Patient age and time from trauma to surgery were statistically correlated with presence of a medial lesion. There was no statistical relationship for the lateral meniscus nor for type of meniscal injury. DISCUSSION: The proportion of lesions to the lateral meniscus appeared to be unaffected by age or time to surgery after trauma, suggesting that lateral meniscal lesions occurred at the time of the initial curciate injury. On the contrary, the incidence of medial lesions increased with time and patient age, confirming the important role of the medial meniscus to block anterior displacement of the knee. We thus recommend early repair of anterior cruciate ligament tears in order to avoid medial meniscectomy which would increase with increasing time from injury to surgery and thus affect the postoperative outcome.

Adolescent↗

The formaldehyde-fixed and paraffin-embedded tissues for diagnostic transmission electron microscopy: a retrospective and prospective study.

The fine structures of tissues processed routinely for light microscopy were studied retrospectively in 44 tissues and tumors and prospectively in 13 tissues and tumors. In the prospective study, we fixed tissues in an ample amount of fixatives, carefully avoiding crushed and air-dried portions, and processed them by five methods. The fine structures of the retrospective cases were mostly poor or passable, whereas those of the prospective cases were generally good. All formaldehyde-fixed tissues showed varied degrees of tissue extraction, notably of lipids, membranous structures, ribosomes, glycogen, and other loose cellular and intercellular matrix materials, that was related to the status and type of tissue as well as the kind and duration of fixation, dehydration, and tissue clearance. Paraffin embedding per se appeared to cause little alteration of the fine structure. Transmission electron microscopy of the paraffin-embedded tissue appeared most useful to identify infective agents, foreign particles, and densely packed organelles or structures, usually in the differential diagnosis of neoplasms. Although many factors are difficult to control, initial careful thin slicing, judicious selection, and fixation of the tissue (even by regular phosphate-buffered formaldehyde solution) can improve the fine structure of paraffin-embedded tissues and be useful in the direct correlation of light and electron microscopic findings.

Bone Marrow Diseases↗

Retrospective assessment of historic radon concentrations in Norwegian dwellings by measuring glass implanted Po-210--an international field intercomparison.

The first Norwegian study of historic radon concentrations in 17 dwellings in the high radon areas in Norway has been conducted as part of an international field intercomparison during 1998. The retrospective radon concentration is estimated via measurements of Po-210, the long-lived decay product of Rn-222 implanted in glass surfaces of objects like pictures, mirrors, cabinet-glass, etc. the method called 'surface trap'. Three different surface trap techniques to assess the implanted Po-210 activity and two different procedures to estimate retro radon from Po-210 data were used. The Po-210 and the retrospectively estimated radon results agree reasonably well over a wide range of concentrations. Historic radon concentrations were also estimated from analysis of a smaller number of 'volume trap' samples (pieces of spongy materials), and the results compared to those from 'surface traps'. The retro radon results correlate with contemporary radon results with a correlation coefficient of 0.877. To evaluate uncertainty in Po-210 measurements due to varying position on the glass a study of spatial homogeneity of three sample glasses was conducted and variations between 12% and 18% were found.

Air Pollution, Indoor↗

Diagnostic value of the Nycocard, Nycomed D-dimer assay for the diagnosis of deep venous thrombosis and pulmonary embolism: a retrospective study.

The relatively new D-dimer assay from Nycomed Pharma (Nycocard), which has shown both high sensitivity and specificity in diagnosing deep venous thrombosis (DVT) and pulmonary embolism (PE) in earlier studies, was re-evaluated retrospectively. The diagnostic value of the D-dimer assay for DVT was evaluated with contrast venography as reference. The diagnostic value of the D-dimer assay for PE was evaluated with pulmonary scintigraphy as reference. D-dimer tests were examined from 54 consecutive patients. The D-dimer assay was found to have a sensitivity and specificity of 50% and 58%, respectively, for the diagnosis of DVT, with a positive predictive value (PPV) and negative predictive value (NPV) of 55% and 54%, respectively. Using reference diagnostic results of high probability and low probability for the diagnosis of PE, the D-dimer test sensitivity and specificity was found to be 40% and 94%, respectively (PPV: 86%, NPV: 64%). The diagnostic value of the Nycocard(R) assay appears to be very limited for the diagnosis of DVT and PE. This retrospective study suggests that it is unsuitable as a screening method. Further re-evaluation of D-dimer assays is recommended prior to routine clinical use.

Adult↗

Clinical and pathologic tumor characteristics of prostate cancer as a function of the number of biopsy cores: a retrospective study.

OBJECTIVES: Many men with negative prostate biopsies and persistently elevated serum total prostate-specific antigen (tPSA) values will have cancer detected on a repeated biopsy. An important issue is whether the cancer would have been detected on the initial biopsy had more biopsy samples been obtained. The objective of our study was to retrospectively characterize the clinical and pathologic tumor features associated with men who underwent sextant core biopsies compared with men who needed more than six core biopsies during one or more biopsy sessions to detect prostate cancer. Transrectal ultrasound (TRUS)-estimated prostatic volume was evaluated to determine whether the number of biopsy cores needed for prostate cancer detection was influenced by gland size. METHODS: We retrospectively evaluated the number of biopsy core samples obtained in 185 men (mean age 63+/-6 years) enrolled in our PSA-based screening study for prostate cancer who were found to have prostate cancer and elected radical prostatectomy as treatment. Correlation coefficients were calculated and univariate analyses were performed to evaluate clinical (age, tPSA, TRUS volume, PSA density) and pathologic (Gleason score, pathologic weight, organ confinement, "possibly harmless" cancer) characteristics associated with men who required more biopsy cores to detect the cancer. RESULTS: Of the 185 men, 103 (56%) had 6 or fewer total biopsy cores taken and 82 (44%) had more than 6 cores (44 [24%] of 185 had 7 to 12 cores and 38 [20%] of 185 had 13 or more cores). There was a positive correlation between age, serum tPSA, TRUS-determined prostate volume, and pathologic specimen weight and an increasing number of total cores (all P values < 0.05). The number of biopsy cores was not associated with PSA density, Gleason score, cancer volume, organ confinement, or "possibly harmless" cancers (all P values > 0.05). Men with a TRUS volume 30 cc or less (46%) required a mean of 8 total cores to detect the cancer compared with a mean of 11 cores (P = 0.003) in men with a TRUS volume greater than 30 cc (54%). A greater percentage of men with a TRUS prostate volume greater than 30 cc compared with men whose volume was 30 cc or less would have had their cancer missed with only a six-core biopsy (64% versus 46%, P = 0.01). CONCLUSIONS: Sextant core biopsies may be inadequate to detect prostate cancer in some men. These data support the performance of more than six core biopsies to detect clinical prostate cancer. A prospective trial using TRUS-determined prostate volume to determine the number of cores to take is needed to accurately assess this issue.

Adult↗

Oral trazodone as empirical therapy for erectile dysfunction: a retrospective review.

OBJECTIVES: Anecdotal reports of increased libido and sexual function in patients taking trazodone have led to its empirical use in patients with erectile dysfunction. A retrospective review of patient-reported responses to trazodone was performed to outline the efficacy and side-effect profile of this agent. METHODS: Between 1989 and 1994, 182 patients were placed on oral trazodone as empirical therapy for erectile dysfunction. Patients ranged in age from 26 to 85 years, with a mean of 60 years. Patients were evaluated before receiving trazodone with a thorough medical history and physical examination. Known risk factors for erectile dysfunction were assigned based on historical information and the findings of the examination. Patients received trazodone for at least 2 consecutive months, with daily doses starting at 25 mg. RESULTS: One hundred twenty-seven patients were available for follow-up by a standardized questionnaire regarding perceived improvement in erectile function, sexual function, and side effects. In patients less than 60 years of age, with no known risk factors for erectile dysfunction, 21 of 27 (78%) showed significant improvement in erectile ability. Smokers and patients older than 60 years with a history of significant peripheral vascular disease responded poorly to trazodone therapy. The duration of erectile dysfunction was inversely related to a response to trazodone. Of patients with a duration of impotence less than 12 months, 48% reported a positive response. Only 16% of patients with duration of erectile dysfunction greater than 60 months reported improvement in erections and sexual function. Trazodone was well tolerated by this population, with 62% reporting no side effects. CONCLUSIONS: Despite the limitations of a nonrandomized, retrospective study, trazodone appears to benefit younger patients with erectile dysfunction with few known risk factors. A prospective, placebo-controlled trial is needed to confirm the observations of this pilot study.

Administration, Oral↗

Increased risk of abortion following Neospora caninum abortion outbreaks: a retrospective and prospective cohort study in four dairy herds.

Explosive abortion outbreaks in 4 Dutch dairy herds during 1992 to 1994 are reported. In 50 of 51 fetuses submitted during the first 3 wk of the outbreaks characteristic histological lesions compatible for infection with Neospora caninum were seen. Diagnosis of infection was confirmed by immunohistochemistry in 40 fetuses (78%). No evidence for other abortifacients was found. The abortion risk of the herds was investigated in a prospective and retrospective cohort study. The prospective study showed that cows aborting during the outbreaks and N. caninum seropositive nonaborting cows had a two- to three-fold increased risk of abortion compared with N. caninum seronegative cows. Retrospective examination showed that seropositive nonaborting cows had an increased risk of abortion before the outbreaks, which may indicate that these animals were infected with N. caninum prior to the outbreaks. It is concluded that serostatus can be used for selective culling of cows to decrease future risk of abortion in dairy herds.

Abortion, Veterinary↗

Reporting bias in retrospective ascertainment of drug-induced embryopathy.

The rate of congenital malformations after first-trimester exposure to itraconazole was four times higher when ascertained retrospectively than prospectively (13.0 vs 3.2%, p=0.006). Reporting bias in retrospective studies should be acknowledged in interpretation of such data.

Abnormalities, Drug-Induced↗

A preliminary comparison of the efficacy and tolerability of botulinum toxin serotypes A and B in the treatment of myofascial pain syndrome: a retrospective, open-label chart review.

BACKGROUND: Myofascial pain syndrome (MPS) is characterized by acute or chronic regional muscle pain associated with single or multiple trigger points within taut bands of muscle. Botulinum toxins have clinical utility when sustained focal muscle relaxation is required and may be a useful addition to the treatment armamentarium for MPS. OBJECTIVE: The purpose of the present article was to compare the efficacy and tolerability of botulinum toxin serotypes A and B (BTX-A and BTX-B) in the treatment of MPS. METHODS: This was a retrospective, open-label, single-center chart review. Charts of all patients who received either BTX-A or BTX-B for MPS between January and November 2001 were included in the review. Patients rated the intensity of their pain on a visual analog scale (VAS) from 0 = no pain to 10 = worst pain imaginable before and after receiving BTX-A or BTX-B. RESULTS: The charts of 91 patients (74.7% female, 25.3% male; mean [SD] age, 47 [10.2] years) who received BTX-A (n = 56; mean dose, 256.9 U; range, 100-600 U) or BTX-B (n = 35; mean dose, 9000 U; range, 2500-20,000 U) were included in this retrospective review. Patients who received BTX-A had significantly greater mean reductions in VAS pain scores compared with those who received BTX-B (mean reduction, 2.7 vs 1.8, respectively; P < 0.001). Patients who received BTX-A also reported significantly longer durations of pain relief compared with those who received BTX-B (4.5 vs 2.7) months; P < 0.001). Eight of 56 patients (14.3%) in the group that received BTX-A reported mild adverse events that included flulike symptoms, injection-site pain, and weakness of the neck muscles. Seven of 35 patients (20.0%) in the group that received BTX-B reported adverse events that included mild flulike symptoms, dry eyes, severe visual disturbances, and severe dry mouth. CONCLUSION: Patients with MPS who received BTX-A reported significantly greater reductions in pain for longer durations compared with those who received BTX-B. No patients who received BTX-A experienced severe systemic adverse events, compared with 4 patients who received BTX-B. The results of this comparison are consistent with the US Food and Drug Administration-approved labeling indicating that BTX-A is not interchangeable with any other botulinum toxin in terms of biological activity.

Botulinum Toxins↗

Multicenter retrospective assessment of thiazolidinedione monotherapy and combination therapy in patients with type 2 diabetes: comparative subgroup analyses of glycemic control and blood lipid levels.

BACKGROUND: Thiazolidinediones (TZDs) have contributed to the management of patients with type 2 diabetes mellitus as unique insulin-sensitizing agents. When used as monotherapy or in combination therapy, these drugs not only reduce glycosylated hemoglobin (HbA(1c)) levels, but also effect changes in blood lipid concentrations and have the potential to ameliorate cardiovascular disease risk. Although drugs in the TZD class are perceived to be equivalent clinically, prospective and retrospective studies have demonstrated their ability to modify blood lipid levels. OBJECTIVE: We evaluated and compared the effects of pioglitazone and rosiglitazone monotherapy and combination therapy on blood lipid levels and HbA(1c) in patients with type 2 diabetes. METHODS: We conducted a multicenter retrospective chart review of 1115 records of patients with type 2 diabetes who received pioglitazone or rosiglitazone, alone or in combination with other antidiabetic agents, between August 1, 1999, and August 31, 2000. The review was conducted to evaluate pretreatment and posttreatment levels of triglyceride, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and HbA(1c). RESULTS: All observed demographic characteristics, comorbidities, and concomitant drug use were similar in both treatment cohorts. Of the patients who received pioglitazone, 83% also received >/=1 other antihyperglycemic agent and 59% received some form of antihyperlipidemic therapy. Among those who received rosiglitazone, 81% received concomitant antihyperglycemic medication and 60% received some form of antihyperlipidemic therapy. With pioglitazone, mean levels of serum triglyceride, total cholesterol, and LDL-C decreased and HDL-C increased in most patients, with or without concomitant antihyperglycemic medications; with rosiglitazone, with or without other antidiabetic agents, triglyceride and HDL-C levels decreased, whereas total cholesterol and LDL-C levels increased in most patients. Reductions in HbA(1c) levels and increases in body weight related to each study drug were comparable. CONCLUSIONS: This comparative assessment of pioglitazone and rosiglitazone, based on observational data, reveals that use of these TZDs with other antidiabetic agents was similar in 605 primary care practices in the United States. In both monotherapy and combination treatment regimens, pioglitazone was associated with greater beneficial effects on lipids than was rosiglitazone. Additional studies are needed to determine the long-term outcomes of TZD therapy with concomitant antihyperglycemic medications.

Blood Glucose↗

A retrospective assessment of cost avoidance associated with the use of nedocromil sodium metered-dose inhaler in the treatment of patients with asthma.

A retrospective analysis of patient charts was performed for a single, multioffice pulmonary practice in Toronto, Ontario. Canada, to assess hospital care utilization and associated cost reductions after asthma prophylaxis with nedocromil sodium inhalation aerosol. Data were obtained from 310 adult patients with mild, moderate, or severe asthma who were treated in the practice between January 1988 and June 1994 and who had been placed on nedocromil sodium for at least 1 year. The number of office visits increased with nedocromil sodium therapy due to initial surveillance of the new medication, but no other changes were made in the usual protocol for each visit. After initiation of nedocromil sodium therapy, patients showed better asthma control as measured by improvements in pulmonary function scores and by reduced hospital utilization (both emergency department visits and hospital admissions). It is likely that the improvements in asthma control could result in cost savings, and savings projections for the Canadian health care system were made using the retrospective data collected for asthma-related hospital services. Prospective data are needed to confirm our findings.

Administration, Inhalation↗

A retrospective chart review of uncontrolled use of metformin as an add-on therapy in type 2 diabetes.

The hyperglycemia, hyperinsulinemia, insulin resistance, and obesity syndrome associated with type 2 diabetes can have debilitating consequences. The biguanide metformin has a mechanism of action that is complementary to those of insulin and the sulfonylureas, suggesting that combination therapy that includes metformin may result in improved glycemic control. The purpose of this retrospective chart review was to determine the effects of adding metformin in an uncontrolled fashion to existing therapy in obese patients with type 2 diabetes who had suboptimal glycemic control and insulin resistance. For the review, the records of 124 patients were divided into two groups: group 1 included 71 patients who were taking insulin with or without a sulfonylurea, and group 2 consisted of 53 patients who were taking a sulfonylurea alone. Metformin was added to patients' existing therapy in conjunction with downward titration of the sulfonylurea and insulin doses. A retrospective chart review was conducted at the end of 6 months for group 1 and at the end of 12 months for group 2 to determine the change from baseline in measures of diabetes control (ie, insulin and sulfonylurea dose, glycated hemoglobin [Hb A1c] value, body mass index [BMI], and lipid profiles). In group 1, the mean insulin dose decreased from 46.4 U/d at baseline to 6.1 U/d at the end of follow-up. Eighty-three percent of the patients were able to discontinue insulin therapy completely. Similarly, group 2 had statistically significant reductions in mean sulfonylurea dose. Both groups also achieved statistically significant reductions in Hb A1c, BMI, and total cholesterol level. The addition of metformin to treatment with insulin or sulfonylureas, either alone or in combination, significantly improved glycemic control and cholesterol levels and promoted weight loss in obese type 2 diabetic patients with insulin resistance. Less than 5% of patients reported mild, transient gastrointestinal side effects, none of which required cessation of metformin therapy. Five patients discontinued metformin due to lack of efficacy.

Combined Modality Therapy↗