Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis

Adler, Jay; Jannetti, William; Schneider, David J.; Zhang, Jie; Palmér, Robert; Notario, Gerard

doi:10.1016/s0149-2918(00)83040-4

Cited by 29 publications

(4 citation statements)

References 9 publications

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“…5 There are few studies comparing the efficacy of extended-release versions with their immediate-release counterpart, rather than a placebo. Those that do exist show a mixture of potential benefits (see, for example, Rudolph and Feiger (1999) and Swanson et al (2004)) and no statistically (or medically) significant differences (see, for example, Adler et al (2000), Dopfner et al (2004), and Schwartz et al (April 2006)). Furthermore, for some classes of drugs such as painkillers, extended-release versions create a heightened risk of abuse because a larger quantity of the drug is contained in one pill.…”

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confidence: 99%

Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less

Huckfeldt

Knittel

2011

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We study the effects of generic entry on prices and utilization using both event study models that exploit the differential timing of generic entry across drug molecules and cast studies. Our analysis examines drugs treating hypertension, high blood pressure, type 2 diabetes, and depression using price and utilization data from the Medical Expenditure Panel Survey. We find that utilization of drug molecules starts decreasing in the two years prior to generic entry and continues to decrease in the years following generic entry, despite decreases in prices offered by generic versions of a drug. This decrease coincides with the market entry and increased utilization of branded reformulations of a drug going off patent. We show case study evidence that utilization patterns coincide with changes in marketing by branded drug manufacturers. While the reformulations---often extended-release versions of the patent-expiring drug---offer potential health benefits, the FDA does not require evidence that the reformulations are improvements over the previous drug in order to grant a patent. Indeed, in a number of experiments comparing the efficacies of the patent-expiring and reformulated drugs do not find statistical differences in health outcomes calling into question the patent-extension policy.

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confidence: 99%

Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less

Huckfeldt

Knittel

2011

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“…In clinical trials of patients with lower respiratory tract infections, the immediate-and extended-release formulations of clarithromycin produced similar bacteriologic responses against isolates of S. pneumoniae. 18,19 Eight patients with macrolide-resistant S. pneumoniae isolated from sputum cultures were treated with extendedrelease clarithromycin. 20 Bacterial eradication was observed in seven of these patients.…”

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Serum Bactericidal Activity of Extended‐Release Clarithromycin Against Macrolide‐Resistant Strains of Streptococcus pneumoniae

Stein

Schooley

2002

Pharmacotherapy

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“…Alongside the very few randomized placebo-controlled studies found in the literature, there are numerous randomized double-blind studies comparing two antibiotics in the treatment of AECBs. Most studies comparing two antibiotics tend to demonstrate that the antibiotics used are of similar clinical efficacy and safety (table 3) [53][54][55][56][57][58][59][60][61]. However, these studies have other drawbacks which prevent them from being used in the development of guidelines (table 4).…”

Section: Data From Randomized Studiesmentioning

confidence: 99%

Acute exacerbation of chronic obstructive pulmonary disease and antibiotics: what studies are still needed?

Sohy¹,

Pilette²,

Niederman³

et al. 2002

Eur Respir J

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The use of antibiotics in acute exacerbations of chronic bronchitis (AECBs) remains the subject of controversy despite considerable medical and socioeconomic implications.First, the contribution of bacterial infection to AECBs is difficult to assess in patients with chronic obstructive pulmonary disease (COPD) who are chronically colonized with respiratory pathogens. In addition, several studies suggest a major role of viral infections in AECBs.Secondly, it is unlikely that all COPD patients will benefit from antibiotics during AECBs. In particular, the benefit in mild COPD remains uncertain. Unfortunately, the number of studies complying with evidence-based medicine requirements is too small for definite recommendations in AECBs to be drawn up.Considering the impact of acute exacerbations of chronic bronchitis on chronic obstructive pulmonary disease patients, as well as the community, and the impact of antibiotic therapy on the development of bacterial resistance, there is an urgent need for the design of appropriate multicentric studies to define the usefulness of this type of treatment in acute exacerbations of chronic bronchitis.

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Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis

Cited by 29 publications

References 9 publications

Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less

Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less

Serum Bactericidal Activity of Extended‐Release Clarithromycin Against Macrolide‐Resistant Strains of Streptococcus pneumoniae

Acute exacerbation of chronic obstructive pulmonary disease and antibiotics: what studies are still needed?

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