BackgroundComplicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.MethodsIn this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).ResultsIn the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.ConclusionsTigecycline was generally safe and effective in the treatment of cSSSIs.Trial registrationClinicalTrials.gov NCT00368537
Background and Objective:Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM).Methods:In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202) or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103) for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c). Secondary endpoints were change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body mass index (BMI) and to assess overall safety profile.Results:At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42%) as compared to sitagliptin group (0.30%) (P = 0.001). Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.008). There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m2 vs. 0.08 ± 0.31 kg/m2) in glimepiride and sitagliptin groups, respectively, (P = 0.644) between both the groups. The incidences of hypoglycemic events were also comparable among both the groups.Conclusion:In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.
A 62-year-old male with the previous history of uncontrolled diabetes and hypertension on irregular treatment presented with a history of fever, dysuria, and urinary retention with progressive painful loss of vision over a period of 2 days. His eye examination showed hypopyon, and he was diagnosed to have rapidly progressive endogenous endophthalmitis. He was started on vancomycin and piperacillin-tazobactam empirically. His blood and urine cultures grew methicillin-resistant Staphylococcus aureus (MRSA). Transesophageal echocardiography ruled out infective endocarditis. Intravitreal injection of vancomycin and ceftazidime was given. Vitreous culture also grew MRSA. A workup for possible source revealed multiple prostatic abscesses on the transrectal ultrasound. Antibiotic was changed to daptomycin in view of high vancomycin minimum inhibitory concentration. His vision was improved at the time of discharge.
e 31Conclusion: Telephone and network remote health education to middle-aged and elderly hypertension can control hypertension effectively, decrease the incidence of cardio-cerebrovascular complication.Background: Drugs with complementary mechanisms, even at low-doses, may produce synergistic action resulting in equivalent/superior efficacy with better therapeutic outcome & clinical response.Objective: To determine the safety and efficacy of two strengths of fixed dose combination (TAH)Telmisartan 20/40 mg+Amlodipine 2.5/5 mg+ Hydrochlorothiazide(HCTZ)6.25/12.5 mg administered o.d in patients with essential hypertension compared to TH-Telmisartan40/80mg+HCTZ12.5 mg to achieve normalization of blood pressure (NBP). Method:In this Phase 3, Double-Blind, Double-Dummy, 8weekstudy, subjects were randomized into four groups based on their BP stratification. Therapy was initiated with low dose of medicationsfor four weeks. If N-BP was achieved at week4, same was continued till week8; if not, dose was up-titrated.Result: Enrolled subjects (n = 512) with uncontrolled hypertension and on medications(s), had a mean duration of disease of 47.7 months. Dose up-titration required in was less with TAH(27.34%, 70/256) compared to TH(35.16%, 90/256). NBP was seen in 346 subjects(TAH-183&TH-163) in Intent to treat(ITT) population at week8. There was a statistically significant improvement in NBP in the Modified ITT(mITT, p = 0.041) and Per Protocol (PP, p = 0.041) populations. Among nondiabetics, significantly better NBP was seen in ITT (p = 0.025), mitt (p = 0.015), PP population (p = 0.016). Early therapeutic response was seen among diabetic subjects in ITT(p = 0.043), mITT(p = 0.036), PP population (p = 0.041) at week4 and overall in ITT (p = 0.22), mITT (p = 0.015) populations. There were significant diastolic BP responders in TAH (PP population, p = 0.046) arm. There were 77(50 subjects)non-serious adverse events (AE) and six serious AEs.Conclusion: TAH,with constituents half the strength of comparatordemonstratedequi-efficacyas that of TH(attributed to possible complimentary action and physiological synergy), good safety profileand better tolerability.Background: Hypertension is the silent killer. Approximately 85% to 90% of hypertension cases have unknown cause (primary hypertension). Previous studies revealed that prooxidant effect of uric acid causes an increase in blood pressure. However, other studies revealed that uric acid was not an independent risk factor of hypertension. The difference in these results lead the author interested in conducting this research.
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