Colistimethate sodium for the treatment of chronic pulmonary infection in cystic fibrosis: an evidence-based review of its place in therapy

Figures & data

Clinical impact summary for colistimethate sodium in the treatment of chronic pulmonary infection in cystic fibrosis

Outcome measure	Evidence	Implications
Disease-oriented evidence	Demonstrates efficacy for the treatment of chronic pulmonary Pseudomonas aeruginosa infection in CF	May be used when other agents lack sufficient clinical response and/or are resistant
	Other agents might have a bigger effect on lung function Shows efficacy for the intravenous treatment of P. aeruginosa-related pulmonary exacerbations	Nephro-/neurotoxicity is a manageable risk
Patient-oriented evidence	Fewer randomized clinical trials exist than for alternative drugs	Careful monitoring for potential adverse events is mandatory
	Lacking data on optimal dosing	Dosing should be within the range of actual recommendations
	Dry-powder preparation available with proven efficacy	Treatment with optimized patient ease is possible
Economic evidence	Within the range of the costs of alternative drugs	Cost-effective

Figure 1 Chemical structure of colistin.

Table 1 Randomized controlled trials on inhaled antibiotics in patients with CF

Source^a	Study type	Duration(weeks)	Treatments
Konstan et al^46	DB, PC, MC	24 (three 4-week-cycles)	TIP vs Plac
Konstan et al^47	OL, MC	24 (three 4-week-cycles)	TIP vs TIS-T
Ramsey et al^11	DB, PC, MC	24 (three 4-week-cycles)	TIS-T vs Plac
Nasr et al^52	DB, PC	24 (three 4-week-cycles)	TIS-T vs Plac
Hodson et al^42	OL, MC	4	TIS-T vs Col
Jensen et al^28	DB, PC	13	Col vs Plac
Lenoir et al^40	DB, PC, MC, PG	8 (one 4-week cycle)	TIS-B vs Plac
Chuchalin et al^41	DB, PC, MC, PG	24 (three 4-week cycles)	TIS-B vs Plac
McCoy et al^14	DB, PC, MC	4 + 8 follow-up	AZLI vs Plac
Retsch-Bogart et al^15	DB, PC, MC	4	AZLI vs Plac
Oermann et al^16	OL, PC, MC	24 (three 4-week cycles)	AZLI vs TIS-T
Schuster et al^45,b	OL, MC	24	ColP vs TIS-T

Note: ^aStudies included in the network analysis by Littlewood et al,⁵¹ and ^bone study not included.

Abbreviations: AZLI, aztreonam lysine inhalation solution; CF, cystic fibrosis; Col, colistimethate sodium inhalation solution; ColP, colistimethate sodium dry powder; DB, double blind; MC, multicenter; OL, open label; PC, placebo controlled; PG, parallel group; Plac, placebo; TIP, tobramycin dry powder; TIS-B, tobramycin inhalation solution (Bramitob^®); TIS-T, tobramycin inhalation solution (Tobi^®); vs, versus.