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

Manaktala C, Singh AK, Verma M, Sachdeva A, Sharma H, Roy A, Jalali RK, Gowrishankar R, Kumar A, Kumar AS, Jayaraman AM, Swarnkar B, Srinivas CR, Nayak C, Duttaroy D, Umrigar D, Jesudanam M, Maheshwari N, Shetty P, Singh RP, Ghate S, Sacchidanand S, Tolat S, Bhoira S, Marfatia Y - Indian J Dermatol (2009)

Bottom Line: 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.Cefditoren pivoxil 200 mg b.i.d. was effective and well tolerated in the treatment of uSSSI.

View Article: PubMed Central - PubMed

Affiliation: Medical Affairs and Clinical Research, Ranbaxy Laboratories Ltd, 77-B, IFFCO Road, Sector-18, Udyog Vihar Industrial Area, Gurgaon, Haryana, India. charu.manaktala@ranbaxy.com

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus

Microbiological efficacy of cefditron pivoxil and cefdinir in the per protocol population (n = 105)
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Figure 0003: Microbiological efficacy of cefditron pivoxil and cefdinir in the per protocol population (n = 105)

Mentions: The efficacy data, as measured by clinical and bacteriological outcomes at the end of treatment, are presented in Tables 7–9 and Figures 1–3. In the mITT population, clinical cure or improvement was achieved in 73 of 75 patients (97.33%) treated with cefditoren pivoxil and 76 of 79 patients (96.20%) treated with cefdinir (P = 1.0000) [Table 7]. The mean difference and 95% CI for (T – R) was 1.13% (95% CI - 4.44 + 6.70%). In the patients evaluable for PP analysis of clinical outcome, clinical cure or improvement was achieved in 49 of 50 patients (98.00%) treated with cefditoren pivoxil and 54 of 55 patients (98.18%) treated with cefdinir (P = 1.0000) [Table 8]. The mean difference and 95% CI for (T – R) was - 0.18% (95% CI - 5.43 + 5.06%). Microbiological eradication or presumed eradication was achieved in 44 of 50 patients (88.00%) treated with cefditoren pivoxil and 52 of 55 patients (94.55%) treated with cefdinir (P = 0.3038) [Table 9]. The mean difference and 95% CI for (T – R) was – 8.3% (95% CI - 18.62 + 2.02%). The above differences in both the clinical and microbiological outcome rates between the two drugs were not statistically significant (Fisher's Exact test).


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

Manaktala C, Singh AK, Verma M, Sachdeva A, Sharma H, Roy A, Jalali RK, Gowrishankar R, Kumar A, Kumar AS, Jayaraman AM, Swarnkar B, Srinivas CR, Nayak C, Duttaroy D, Umrigar D, Jesudanam M, Maheshwari N, Shetty P, Singh RP, Ghate S, Sacchidanand S, Tolat S, Bhoira S, Marfatia Y - Indian J Dermatol (2009)

Microbiological efficacy of cefditron pivoxil and cefdinir in the per protocol population (n = 105)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2807712&req=5

Figure 0003: Microbiological efficacy of cefditron pivoxil and cefdinir in the per protocol population (n = 105)
Mentions: The efficacy data, as measured by clinical and bacteriological outcomes at the end of treatment, are presented in Tables 7–9 and Figures 1–3. In the mITT population, clinical cure or improvement was achieved in 73 of 75 patients (97.33%) treated with cefditoren pivoxil and 76 of 79 patients (96.20%) treated with cefdinir (P = 1.0000) [Table 7]. The mean difference and 95% CI for (T – R) was 1.13% (95% CI - 4.44 + 6.70%). In the patients evaluable for PP analysis of clinical outcome, clinical cure or improvement was achieved in 49 of 50 patients (98.00%) treated with cefditoren pivoxil and 54 of 55 patients (98.18%) treated with cefdinir (P = 1.0000) [Table 8]. The mean difference and 95% CI for (T – R) was - 0.18% (95% CI - 5.43 + 5.06%). Microbiological eradication or presumed eradication was achieved in 44 of 50 patients (88.00%) treated with cefditoren pivoxil and 52 of 55 patients (94.55%) treated with cefdinir (P = 0.3038) [Table 9]. The mean difference and 95% CI for (T – R) was – 8.3% (95% CI - 18.62 + 2.02%). The above differences in both the clinical and microbiological outcome rates between the two drugs were not statistically significant (Fisher's Exact test).

Bottom Line: 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.Cefditoren pivoxil 200 mg b.i.d. was effective and well tolerated in the treatment of uSSSI.

View Article: PubMed Central - PubMed

Affiliation: Medical Affairs and Clinical Research, Ranbaxy Laboratories Ltd, 77-B, IFFCO Road, Sector-18, Udyog Vihar Industrial Area, Gurgaon, Haryana, India. charu.manaktala@ranbaxy.com

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus