Efficacy and tolerability of cefditoren pivoxil in uncomplicated skin and skin structure infections in Indian patients.

BACKGROUND: Uncomplicated skin and skin structure infections (uSSSI) are commonly encountered community-acquired infections and are typically confined to the superficial layers of the skin. Hence, they seldom lead to the destruction of skin structures. AIMS: To evaluate the efficacy and tolerability of cefditoren pivoxil in uSSSI in Indian patients. METHODS: One hundred and seventy-eight patients diagnosed with uncomplicated SSSI were enrolled in this randomized, comparative, multicentric study. Patients received either cefditoren pivoxil or cefdinir for ten days. Efficacy was assessed both clinically and microbiologically. Safety evaluation consisted of reporting of type, frequency, severity, and causal relationship of adverse events. RESULTS: One hundred and fifty-one patients completed the study. Clinical and bacteriological efficacy of cefditoren pivoxil was comparable to that of cefdinir in the treatment of uSSSI. One hundred and five patients were eligible for per protocol (PP) analysis of bacteriological outcome and clinical efficacy. Clinical cure or improvement was achieved in 98.00% patients treated with cefditoren pivoxil and 98.18% patients treated with cefdinir. In the modified Intent to Treat (mITT) patient population, clinical cure or improvement was recorded in 97.33% patients treated with cefditoren pivoxil and 96.20% patients treated with cefdinir. Microbiological eradication (or presumed eradication) was recorded in 88.00% patients treated with cefditoren pivoxil and 94.55% patients treated with cefdinir. The above differences in the outcome rates between the two drugs were not statistically significant. Six adverse events (AEs) (two in cefditoren group and four in cefdinir group) were reported in this study. CONCLUSION: Cefditoren pivoxil 200 mg b.i.d. was effective and well tolerated in the treatment of uSSSI.

Olanzapine and fluoxetine combination in severe or resistant depression.

OBJECTIVE: The purpose of this study was to investigate the efficacy and safety of Fixed Dose Combination (FDC) of olanzapine 5 mg and fluoxetine 20 mg in Indian patients with severe or treatment resistant depression. DESIGN: This was an open, non-comparative study of seven weeks duration with an initial placebo run in period of one week. METHOD: One hundred and fifty three patients were enrolled. One hundred and forty-four patients completed the study as per protocol and 151 patients were safety evaluable. One hundred and eleven patients (77%) received one tablet of FDC of olanzapine 5 mg / fluoxetine 20 mg once daily for 6 weeks, in patients (14%), the dose was stepped up at the end of 2 weeks to 2 tablets of FDC of olanzapine 5 mg/ fluoxetine 20 mg once daily for a further 4 weeks and 13 patients (9%) required dose to be stepped up at the end of 4 weeks to 3 tablets of FDC of olanzapine 5 mg and fluoxetine 20 mg once daily for last 2 weeks. RESULTS: One hundred and thirty four patients (93%) responded to FDC of olanzapine and fluoxetine therapy (a responder was defined as a patient with 50 % reduction over baseline in HDRS total score at the end of therapy).Statistically significant (p < 0.0001) reductions in HDRS total score, MADRS total score and CGI severity scores were seen with olanzapine/ fluoxetine combination. One hundred and four patients (72%) were remitters (HDRS total score of <7) after 6 weeks of therapy. Adverse experiences were reported by thirty one patients (20.5%). Majority of them were mild in intensity. No serious adverse event was recorded with study therapy. Three patients were withdrawn from the therapy due to adverse event. CONCLUSION: Treatment with FDC of olanzapine 5 mg / fluoxetine 20 mg was highly effective and well tolerated in Indian patients with severe or treatment resistant depression.

Sparfloxacin in the treatment of purulent sinusitis-a multicentric study in Indian patients.

Sparfloxacin, a new quinolone antibacterial was used to treat one hundred and thirty two patients with acute purulent sinusitis, at a dosage of 400 mg on the first day followed by 200 mg once daily for a further four days. A clinically successful outcome (defined as disappearance of nasal discharge, fever, pain, tenderness over the sinuses and headache) was recorded in 122 ( 95.3%) patients. Sparfloxacin was well tolerated. Fourteen adverse experiences were reported in 7 patients ( 5.3%); they were mainly gastrointestinal and mild. No phototoxic or cardiological adverse events occurred. An unusual feature was that Staphylococcus aureus and Pseudomonas spp. were the most common bacterial species isolated from middle meatal was of patients in this study.

Risperidone in Indian patients with schizophrenia.

Conventional antipsychotic agents are not effective against negative symptoms of schizophrenia and are also noted for their extrapyramidal side effects. Risperidone is a noval antipsychotic agent whose dual antagonism of dopamine and serotonin receptors is believed to underlie its efficacy against negative symptoms and the low incidence of extrapyramidal side effects. An open, non-comparative study of seven weeks duration was performed to evaluate risperidone in the treatment of schizophrenia in Indian patients. Previous antipsychotic therapy was discontinued for a week before risperidone therapy was initiated. At the end of six weeks of risperidone therapy, clinical improvement (≥ 20% reduction in total score on positive and negative syndrome scale for schizophrenia (PANSS;; was shown by 128 (87.7%) of the 146 evaluable patients. Statistically significant reduction (p < 0.05) occurred in the total score of this scale and in the subscale scores for positive, negative and general psychopathology symptoms and in the clinical global impression severity score. The number of patients with adverse experiences were 108 (65.5%) at baseline and 120 (72.7%) at the end of risperidone therapy. Extrapyramidal symptoms, seen in 65 (39.4%) patients compared to 22 (13.3%) patients at baseline, were largely mild to moderate in intensity.

"Steroid responsive pure red cell aplasia".

A young female with pure red cell aplasia with brisk response to prednisolone therapy is described. The patient has remained in remission on a small dose of prednisolone for 10 months.