By K. Quadir. Spalding University.
Diabetes Page 55 of 99 Final Report Drug Effectiveness Review Project • Though formal statistical analyses were not conducted for glipizide-or metformin monotherapy compared with sitagliptin monotherapy discount 30gm himcolin free shipping, it appears that sitagliptin may be comparable to glipizide and metformin 1 g/d in lowering A1c based on estimated magnitude of difference between groups order himcolin 30 gm line. Additional trials are needed to verify the findings. Patients receiving glipizide or rosiglitazone gained weight compared with patients on sitagliptin who lost weight during the course of the trial. Harms • Weight generally decreased for both sitagliptin-treated and placebo-treated patients (range for change in weight from baseline: sitagliptin -0. Adjunctive therapy with sitagliptin also did not negatively affect weight, particularly in persons taking metformin; however, small increases in weight were seen when sitagliptin was added to sulfonylureas, pioglitazone, or rosiglitazone. There were 20 reports of severe hypoglycemia in 2 of 9 trials, mostly in patients taking glipizide (90%). The rates for total withdrawal were slightly lower with sitagliptin than compared with placebo (pooled RR 0. Diabetes Page 56 of 99 Final Report Drug Effectiveness Review Project Detailed Assessment Key Question 1 and 2. For children and adults with type 2 diabetes, does sitagliptin differ in efficacy, effectiveness, and in harms for achieving glycemic control when compared to placebo, when compared to other hypoglycemic agents as monotherapy or combined therapy, or when added to other hypoglycemic agents? Eight randomized controlled trials were rated fair-quality and 1 fair-poor. This review is organized by how sitagliptin was used (mono- or combined therapy compared with placebo or active control). Diabetes Page 57 of 99 Final Report Drug Effectiveness Review Project Table15. Characteristics of sitagliptinplacebo-controlledtrials inadults with type 2diabetes a Baseline Age(years)(SD) a a O ther % M ale A1c (%)(SD) Sam ple a a Dietand size(N ) % W hite F PG (m g/dL ) exercise? Diabetes Page 59 of 99 Final Report Drug Effectiveness Review Project Table16. Characteristics of sitagliptinactive-controlledtrials with orwithout placebo studyarm s inadults with type2diabetes a O ther Age(years)(SD) Baseline a a Dietand % M ale A1c (%)(SD) Sam ple a a exercise? Author, size(N ) % W hite F PG (m g/dL ) % noton a a year F ollow- % Hispanic PPG (m g/dL ) O HA a Country up Diabetes duration W eight(kg) Intervention R escue a 2 a Q uality (weeks) (years) BM I (kg/m ) Dosages m edication? Diabetes Page 60 of 99 Final Report Drug Effectiveness Review Project Sitagliptin monotherapy Sitagliptin compared with placebo Five fair-quality trials ranging from 12-24 weeks in duration compared sitagliptin 100 mg/d to 47, 48, 53, 54, 56 placebo (Table 15). Patients randomized to receive sitagliptin 100 mg/d showed significant reductions in A1c (placebo-corrected change 0. For patients who volunteered to participate in a meal-tolerance test, sitagliptin lowered postprandial glucose relative to placebo (placebo-corrected change 54. A greater proportion of patients receiving sitagliptin than placebo reached the A1c goal of <7%, although 9%-21% of subjects on sitagliptin required the use of a second medication. Weight generally decreased in both treatment arms (range for change from baseline: sitagliptin -0. Overall, however, subjects randomized to sitagliptin lost slightly less weight than subjects randomized to placebo (weighted mean difference: 0. Approximately 50% of subjects were on 1 or more oral hypoglycemic agents at screening. These agents were discontinued before diet and exercise run-in periods. Patients not responding to diet and exercise were eligible for study inclusion but were required to participate in a 2-week single-blind, placebo run-in period prior to randomization. Three trials allowed use of prespecified rescue medications based on certain glycemic criteria. Sitagliptin compared with an active agent In 2 fair-quality trials that evaluated sitagliptin 100 mg/d, active treatment arms of glipizide 5-20 53, 54 mg/d or metformin 1000-2000 mg/d were included in the studies (Table 16). Overall, patients on glipizide and metformin 1-2g/d monotherapy showed numerically larger reductions in A1c, fasting plasma glucose, and postprandial glucose than compared with sitagliptin monotherapy (Table 18). However, based on the estimated magnitude of difference between groups, it appears that sitagliptin may be comparable to glipizide and metformin 1 g/day for lowering A1c (sitagliptin- glipizide difference: +0. The estimated magnitude of difference between sitagliptin and metformin 2 g/d was greater (+0. Hence, these results should be considered with caution since neither trial performed statistical analyses for these comparisons and power may not have been adequate to detect the between-group differences in A1c, fasting plasma glucose, or postprandial glucose. With regard to changes in weight, patients randomized to glipizide gained about 1 kg 53 from baseline compared with a nominal increase in weight for those on sitagliptin (0.
Surgery for pulmonary coccidioidomycosis: a 10-year experience discount 30gm himcolin free shipping. Coccidioidomycosis in patients with HIV-1 infection in the era of potent antiretrovi- ral therapy generic 30 gm himcolin mastercard. Recent advances in our understanding of the environmental, epidemio- logical, immunological, and clinical dimensions of coccidioidomycosis. Posaconazole for chronic refractory coccidioidal meningitis. Coccidioidomycosis in HIV-infected persons in Arizona, 1994-1997: inci- dence, risk factors, and prevention. Opportunistic Infections (OIs) 407 Leishmaniasis (visceral) Leishmaniasis is an infectious disease that is caused by 20 species pathogenic for humans belonging to the genus Leishmania, a protozoa transmitted by sand flies. One must differentiate between the cutaneous and the visceral forms of leishmani- asis (Kalar Azar), the manifestation form depends on the species (L. According to WHO, there are 12 million people infected with leish- mania worldwide, with approximately 350 million living in risk areas. With such numbers, leishmaniasis is one of the most important parasitosis. In Europe, leish- maniasis is common and countries around the Mediterranean, such as Spain, Portugal, France and Italy are affected the most. Visceral leishmaniasis appears more frequently in HIV+ patients. In Spain, on third of all patients with visceral leishmaniasis have HIV (Gil-Prieto 2011). While impor- tant, leishmaniasis is still not an AIDS-defining illness. A review of 15 cases in Germany showed that all HIV patients were significantly immunosuppressed (usually less than 100 CD4 T cells/µl). A few patients had not been in endemic areas for several years (Albrecht 1998). Bone marrow involvement is reflected by the almost obligatory pancytopenia, which may be particularly severe in HIV patients (Pintado 2001). Other symptoms include fever, hepatosplenomegaly, and mucocutaneous lesions. The diagnosis is usually made from bone marrow aspirate. Treatment of visceral leishmaniasis is difficult (Review: Olliaro 2005). Pentavalent antimony compounds such as sodium stibogluconate (Pentostam) or or meglumine antimoniate (Glucantime) have been used for about 60 years (usual dosage: 20 mg/kg IV or IM daily for 28 days). Myalgia, arthral- gia, cardiotoxicity and chemical pancreatitis often lead to discontinuation (Laguna 1999). Combination therapies are possibly more effective and allow for shorter therapy (van Griensven 2010, Sundar 2011). According to a recent meta-analysis, available evidence suggests that amphotericin is superior to antimony treatment in HIV+ patients (Cota 2013). Many guidelines recommend liposomal amphotericin B (AmBisome) as the treatment of choice (2–5 mg/kg daily). However, recent trials have suggested that effectiveness of lipo- somal amphotericin is limited in HIV-coinfected patients (Rijtmeier 2011, Sinha 2011). Classic amphotericin B is also effective (Lachaud 2009). The only orally bioavailable leishmaniasis drug and a promising new drug, due to its good tolerability and efficacy, is miltefosine (Impavido), an alkylphosphocholine analog that was licensed in Europe in 2004. Although clarity is still needed as to how miltefosine inhibits leishmania metabolism, a Phase III study in India demonstrated it as highly effective (Sundar 2002). Another randomized study in Ethiopia showed that among HIV+ patients with leishmaniasis, miltefosine was less effective than sodium stibogluconate, but tolerability was better (Ritmeijer 2006). We have successfully treated some patients with miltefosine to date. Another option may be paromomycin, an aminoglycoside which seems to be effective as at least two randomized studies from India have shown (Sundar 2007+2011). In Europe paramomycin (Humatin) has so far only been licensed as a gastrointestinal drug for local use.
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