Sigurnost i djelotvornost azitromicina u liječenju infekcija donjih dišnih putova: međunarodna multicentrična ne-usporedna studija

The aim of this study was to describe clinical effectiveness of azithromycin in the management of lower respiratory tract infections in daily clinical practice, to examine duration of symptoms after therapy initiation, and to record any possible adverse effects of azithromycin treatment. A total of 153 patients were included in the analysis of the effectiveness of azithromycin: 94 patients with community acquired pneumonia (CAP) and 59 with acute exacerbation of chronic bronchitis (AECB). Clinical effectiveness was assessed as improvement, cure or failure after three-day treatment with azithromycin. The assessment was based on a calculation of clinical score for each diagnosis before treatment and on days 4, 10 and 28 after treatment initiation. Clinical effectiveness of azithromycin was 93.6% in CAP group and 94.9% in AECB group. Azithromycin led to relief of symptoms within three days in 88.6% of CAP patients and 77.2% of AECB patients. Overall, 15 adverse events were reported in 14 (9.1%) patients. The most common adverse events were abdominal pain, diarrhea and vomiting, each reported in four (2.6%) patients. Accordingly, azithromycin was found to have high clinical effectiveness and a small number of adverse events in the treatment of lower respiratory tract infections. ISRCTN38391551.Ciljevi ove studije bili su opisati kliničku djelotvornost azitromicina u liječenju infekcija donjih dišnih putova u kliničkoj praksi, ispitati trajanje simptoma nakon početka terapije te prikupiti podatke o neželjenim događajima. Uispitivanje su bila uključena 153 bolesnika: 94 bolesnika s pneumonijom iz opće populacije te 59 bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Klinička djelotvornost je ocijenjena kao poboljšanje, izlječenje ili neuspjeh liječenja trodnevnom terapijom azitromicinom. Procjena se osnivala na izračunu kliničkog indeksa za svaku dijagnozu prije početka terapije te nakon 4, 10 i 28 dana. Uovom ispitivanju klinička djelotvornost azitromicina bila je 93,6% u skupini bolesnika s pneumonijom iz opće populacije te 94,9% u bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Azitromicin je doveo do olakšanja simptoma unutar 3 dana kod 88,6% bolesnika s pneumonijom i 77,2% bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Zabilježeno je 15 neželjenih događaja kod 14 (9,1%) bolesnika. Najčešći neželjeni događaji su bili dijareja i povraćanje, od kojih je svaki zabilježen u 4 (2,6%) bolesnika. Rezultati ispitivanja pokazuju da azitromicin ima visoku djelotvornost u liječenju infekcija donjih dišnih putova i izaziva mali broj nuspojava. ISRCTN38391551

Thirty years of SUMAMED® - The Beginnings of Promotion of PLIVA\u27s Original Antibiotic

Skupina istraživača-znanstvenika iz PLIVE stvorila je 1981. godine novi antibiotik pod nazivom azitromicin, po svemu različit od ostalih do tada primjenjivanih antibiotika. U rujnu 1988. godine registriran je PLIVIN originalni antibiotik, azitromicin, poznatiji pod zaštićenim imenom Sumamed. Osobine azitromicina od samih početaka upućivale su na to da se radi po svemu jedinstvenom antibiotiku koji ima izvrsnu učinkovitost na najčešće uzročnike infekcija, ciljano djelovanje na mjestu infekcije, vrlo se jednostavno i kratko primjenjuje i ima odličnu podnošljivost. Iz farmakoloških osobina i kliničkih istraživanja proizišle su i originalne marketinške kampanje koje su mijenjale paradigmu razumijevanja antimikrobnog učinka i djelovanja na mjestu infekcije, kao i način uzimanja antimikrobnih lijekova. Marketinške kampanje odnosile su se na jednostavnost i kratkoću primjene lijeka te izvrsnu učinkovitost i podnošljivost Sumameda. U radu su prikazani počeci promocije Sumameda.In 1981 a group of researchers at Pliva created azithromycin, a new antibiotic completely different from the antibiotics in use at the time. In September 1988 PLIVA registered azithromycin as its original antibiotic under the brand name Sumamed. From the very beginning the properties of azithromycin indicated that this was a unique antibiotic with excellent efficacy against the most common infectious agents, targeted action at the site of infection, simple dosing, short-term use and excellent tolerability. Pharmacological characteristics and results of clinical trials were used in the original advertising campaigns which resulted in a paradigm shift in the understanding of antimicrobial activity and action at the site of infection, as well as of administration of antimicrobial drugs. Advertising campaigns referred to the simple and short-term use as well as excellent efficacy and tolerability of Sumamed. The paper focuses on the beginnings of promotion of Sumamed

Pilot research on the efficacy and tolerability of Cefalexin in the treatment of urinary tract infections

Infekcije mokraćnog sustava (IMS) najčešći su opravdan razlog za propisivanje antimikrobnih lijekova. Cilj ovog prospektivnog rada bio je istražiti kliničku djelotvornost i podnošljivost cefaleksina u liječenju simptomatskih nekompliciranih IMS. U šestmjesečnom razdoblju u 50 ordinacija obiteljske medicine u gradovima Republike Hrvatske i u Urološkoj ambulanti u Klinici za infektivne bolesti »Dr. Fran Mihaljević« u Zagrebu, cefaleksinom u dozi 2×1 g po. kroz 8 dana liječeno je 1000 epizoda simptomatskih nekompliciranih IMS u 920 žena starijih od 18 godina. Klinička djelotvornost i podnošljivost primijenjenog lijeka ocijenjene su 5–9 dana nakon završenog liječenja. Od ukupno 1000 liječenih epizoda IMS, bilo je 894 epizode akutnog nekompliciranog cistitisa (ANC), 26 epizoda akutnog nekompliciranog pijelonefritisa (ANP), 80 rekurentnih IMS od čega 61 epizoda rekurentnog ANC i 19 epizoda rekurentnog ANP. Kliničko izlječenje postiglo se u 920 (92 %) epizoda IMS. Od 80 neizliječenih epizoda u 53 je terapija cefaleksinom prekinuta unutar prvih 72 sata liječenja, u 12 radi izoliranog enterokoka, a u 41 epizodi radi kliničkih neuspjeha. U 27 je ocjena neizlječenja postavljena na redovitoj kontroli. Nije bilo nuspojava liječenja. Urinokultura je prije započete terapije bila učinjena u 380 epizoda. Izolirani uzročnici su bili E. coli u 315, P. mirabilis u 10 i Enterococcus u 12 epizoda IMS. Ovo naše ispitivanje je pokazalo da je cefaleksin u simptomatskim nekompliciranim IMS djelotvorna, dobro podnošljiva i farmakoekonomski prihvatljiva terapija, te da zaslužuje mjesto u empirijskoj antimikrobnoj terapiji ANC.Urinary tract infections (UTI) are the most common reason for justified prescription of antimicrobial drugs. The aim of this prospective research was to investigate clinical efficacy and tolerability of cefalexin in the treatment of symptomatic uncomplicated UTI. In a six month period, in 50 general practitioners’offices throughout Croatia as well as in the Outpatient Department for Urinary Tract Infections at the University Hospital for Infectious Diseases »Dr. Fran Mihaljevic« in Zagreb, cefalexin 2×1 g p.o. was used for 8 days to treat 1000 episodes of symptomatic uncomplicated UTIs in 920 women older than 18 years. Clinical efficacy and tolerability of the drug were rated 5–9 days after completion of treatment. Out of the total of 1000 treated UTI episodes, 894 accounted for acute uncomplicated cystitis (AUC), 26 for acute uncomplicated pyelonephritis (AUP), 80 recurrent UTIs of which 61 episodes of recurrent AUC and 19 episodes of recurrent AUP. Clinical cure was recorded in 920 (92 %) of UTI episodes. Out of 80 uncured episodes, in 53 cefalexin therapy was terminated within the first 72 hours of treatment, in 12 episodes due to an isolated enterococcus, and in 41 due to clinical failure. In 27 episodes the uncured outcome was recorded during regular follow-up visit. There were no treatment side effects recorded. Urine culture was analysed in 380 episodes before the initiation of therapy. Isolated pathogens were E. coli in 315, P. mirabilis in 10 and Enterococcus in 12 episodes of UTI. This research has shown that cefalexin in symptomatic uncomplicated UTIs is an efficacious, well tolerated and pharmacoeconomically acceptable therapy and that it deserves its place in the empirical antimicrobial therapy of AUC

Effectiveness and safety of azithromycin in the treatment of upper respiratory tract infections

Cilj studije bio je opisati kliničku učinkovitost azitromicina u liječenju infekcija gornjeg dijela dišnog sustava, ispitati duljinu simptoma nakon početka terapije i pokazati moguće nuspojave liječenja azitromicinom. U studiju je uključeno 422 ispitanika: 184 s dijagnozom akutnog faringitisa, 156 s dijagnozom akutnog sinuitisa, te 82 bolesnika s akutnom upalom srednjeg uha. Klinička učinkovitost nakon tri dana liječenja azitromicinom temeljila se na poboljšanju kliničke slike i izlječenju bolesnika. Za svaku dijegnozu je izračunat klinički zbroj prije početka liječenja, te četvrti i dvanaesti dan nakon početka liječenja. Studija je pokazala kako je trodnevno liječenje azitromicinom dovelo do smanjenja simptoma u 93,6% bolesnika. Godinu dana prije uključenja u studiju antibiotici su bili prethodno propisivani u 56,6% bolesnika, a 20,5% bolesnika je bilo liječeno makrolidima. Klinička učinkovitost je bila pozitivna u 95,6% bolesnika, a neuspjeh liječenja zabilježen je u 4,4% bolesnika. Prijavljeno je 48 nuspojava kod 38 (9,1%) bolesnika. Najčešćee nuspojave bile su: bol u trbuhu zabilježena kod 14 (1,1%) bolesnika, proljev kod 12 (0,9%), mučnina kod 5 (0,4%), te povraćanje kod 5 (0,4%) bolesnika. Prekid terapije zbog nuspojava zabilježen je kod jednog bolesnika. Rezultati studije pokazuju da u liječenju infekcija gornjeg dišnog sustava azitromicinom ima visoku učinkovitost i mali broj nuspojava. Azitromicin je pouzdan lijek izbora u liječenju infekcija gornjeg dijela dišnog sustava, s brzim povlačenjem simptoma infektivne bolesti i relativno malim brojem nuspojava.The aim of the study was to describe clinical effectiveness of azithromycin in the management of upper respiratory tract infections, to examine the duration of symptoms after beginning of therapy and to mark possible adverse events of azithromycin treatment. The overall intention-to-treat (ITT) study population included 422 patients: 184 with diagnosis of acute pharyngitis (AP), 156 with acute sinusitis (AS) and 82 with acute otitis media (AOM). Clinical effectiveness was based on the results of clinical improvement and cure after three day treatment with azithromycin, calculating the clinical score for each diagnosis before treatment (at the inclusion), at the 4th day (end of the therapy) and at the 12th (end of the study). In this study azithromycin led to the relief of symptoms after three days in the 93.6% of patients. Antibiotics were prescribed within one year before inclusion in 56.6% of patients and 20.5% were previously treated with macrolides. Clinical effectiveness in ITT population was 95.6% and there were 4.4% failures. Overall, 38 (9.1%) patients reported 48 adverse events. The most common were: abdominal pain reported in 14 (1.1%) patients, diarrhea in 12 (0.9%), nausea in 5 (0.4%), vomiting in 5 (0.4%). The therapy was withdrawn because of an adverse event in one patient. The results of our study show that azithromycin in the treatment of upper respiratory tract infections has a high clinical effectiveness and small number of adverse events. Azithromycin is a reliable antibiotic treatment in upper respiratory tract infections, giving fast resolution of symptoms with little adverse events in patients with presumed bacterial infections

Effectiveness and Pharmacokinetic evaluation of Geonistin® (Oxytetracyline and Nystatin) Vaginal Tablets for Unspecific and Mixed Vulvovaginal Infections (GENIE Study)

The GENIE study was performed to evaluate the effectiveness and systemic exposure to oxytetracycline in local treatment of unspecific and mixed vulvovaginal infections characterized by vaginal discharge with Geonistin® vaginal tablets (100 mg oxytetracycline and 100 000 IU nystatin). The total number of subjects enrolled was 189. The treatment had beneficial effects in 100% of the study population. According to the Nugent score, the treatment had a positive effect in 89.2% of participants. The microbiological cure rate was 78.8%. Oxytetracycline concentration levels were from 13.3 to 32.2 ng/mL in 11 out of 15 subjects, and in four subjects the levels were below 10 ng/mL. Geonistin® had a beneficial effect on the unspecific and mixed vulvovaginal infections characterized by vaginal discharge in all efficacy and safety outcomes. Microbiological and the Nugent score efficacy measures confirmed clinical effectiveness. Beneficial efficacy results were achieved with only a few non-serious adverse events

Safety and Effectiveness of Azithromycin in the Treatment of Lower Respiratory Infections: An International, Multicenter, Non-Comparative Study

The aim of this study was to describe clinical effectiveness of azithromycin in the management of lower respiratory tract infections in daily clinical practice, to examine duration of symptoms after therapy initiation, and to record any possible adverse effects of azithromycin treatment. A total of 153 patients were included in the analysis of the effectiveness of azithromycin: 94 patients with community acquired pneumonia (CAP) and 59 with acute exacerbation of chronic bronchitis (AECB). Clinical effectiveness was assessed as improvement, cure or failure after three-day treatment with azithromycin. The assessment was based on a calculation of clinical score for each diagnosis before treatment and on days 4, 10 and 28 after treatment initiation. Clinical effectiveness of azithromycin was 93.6% in CAP group and 94.9% in AECB group. Azithromycin led to relief of symptoms within three days in 88.6% of CAP patients and 77.2% of AECB patients. Overall, 15 adverse events were reported in 14 (9.1%) patients. The most common adverse events were abdominal pain, diarrhea and vomiting, each reported in four (2.6%) patients. Accordingly, azithromycin was found to have high clinical effectiveness and a small number of adverse events in the treatment of lower respiratory tract infections. ISRCTN38391551

Research of Urinary Tract Infections in Family Medicine Physicians\u27 Offices – Empiric Antimicrobial Therapy of Urinary Tract Infections – Croatian Experience

In the period between October 1st and November 30th, 2006, we investigated a total of 3188 episodes of UTI (802 among males; 2386 among females) recorded in 108 family medicine offices in 20 cities in Croatia. The most common UTIs in women were acute uncomplicated cystitis (62%), complicated UTIs – cystitis and pyelonephritis (14%), urethritis (9%), acute uncomplicated pyelonephritis (6%), recurrent cystitis (5%), asymptomatic bacteriuria (3%) and recurrent pyelonephritis. The most common UTIs in men were complicated UTIs – cystitis and pyelonephritis (48%), urethritis (25%), prostatitis (24%) and asymptomatic bacteriuria (3%). Etiological diagnosis was made in 999 (31%) UTI episodes before antimicrobial therapy was given. The most frequently isolated causative pathogens were Escherichia coli (77%), Enterococcus faecalis (9%), Proteus mirabilis (5%), Klebsiella spp (3%), Streptococcus agalactiae (3%) and Enterobacter (1%). Antimicrobial drug was administered in 2939 (92.19%) UTI episodes, in 1940 (66.01%) as empirical therapy, and in 999 (34%) as targeted antimicrobial therapy. The most commonly administered drug in empirical therapy for acute uncomplicated cystitis, recurrent cystitis and urethritis in women was cephalexin, for acute uncomplicated pyelonephritis and complicated UTIs in women co-amoxiclav, and for UTIs in males ciprofloxacin. The results of this research of 3188 UTI episodes in family medicine physicians\u27 offices provide a confirmatory answer to question whether empirical antimicrobial therapy of UTI prescribed by Croatian family practitioners is in accordance with the national guidelines