In ADPKD patients, seven lanreotide recipients developed eight hepatic cyst infections during 342 patient-years (0.23 cases per 10 patient-years), exclusively with lanreotide (p<0.001).
In plain wordsHepatic cyst infections occurred only in lanreotide recipients, compared with standard care.
- Peptide
- Lanreotide
- Outcome
- IncreaseHepatic cyst infection
- Study
n = 309
- Comparator
- Standard care
- Outcome group
- Adverse events · Liver
- Studied dose
- 120 mg every 28 days · subcutaneous · 120 weeksAs given in this study (human).
Measurements
- Patients with hepatic cyst infection
- 7 patients
- lanreotide use
- Hepatic cyst infection episodes
- 8 episodes
- lanreotide use
- Exposure to lanreotide
- 342 patient-years
- lanreotide use
- Hepatic cyst infection rate
- 0.23 cases per 10 patient-years
- lanreotide use
- P value
- < 0.001
- vs standard care
Source sentences
seven (median age 53 years [interquartile range: 48-55], 71% female, median estimated glomerular filtration rate 42 mL/min/1.73 m2 [interquartile range: 41-58]) developed eight episodes of hepatic cyst infection during 342 patient-years of lanreotide use (0.23 cases per 10 patient-years).
3 context sentences(design, population, supporting numbers)
These events were limited to patients receiving lanreotide (p < 0.001 vs. standard care).
The DIPAK-1 Study is an ongoing investigator-driven, randomized, controlled, open-label multicenter trial.
Patients (ADPKD, ages 18-60 years, estimated glomerular filtration rate 30-60 mL/min/1.73 m2) were randomized 1:1 to receive lanreotide 120 mg subcutaneously every 28 days or standard care during 120 weeks.