GC-C=Guanylate cyclase-C
Strength of recommendation: Strong=Most patients should receive the recommended course of action.1
Quality of evidence: High=The estimate of effect is unlikely to change with new data.1
In Study 1 of CIC patients, the percentage of overall efficacy responders* (durable complete spontaneous bowel movement) was 21% for Trulance vs 10% for placebo (P<0.001).2 In Study 3 of IBS-C patients, the percentage of overall efficacy responders* (abdominal pain and stool frequency) was 30% for Trulance vs 18% for placebo (P<0.001).5
regular, well-formed bowel
movements2,4,5
IBS-C-related abdominal
pain5
incidence of diarrhea
(≤5%)2
*In Study 1 of CIC patients, a responder was defined as a patient who had at least 3 complete spontaneous bowel movements in a given week and an increase of at least 1 complete spontaneous bowel movement from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study. In Study 3 of IBS-C patients, a responder was defined as a patient who met both the abdominal pain intensity and stool frequency responder criteria in the same week for at least 6 of the 12 treatment weeks, which were defined as an abdominal pain intensity responder (a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score [measured daily] of at least 30% compared to weekly baseline average) and stool frequency responder (a patient who experienced an increase of at least 1 complete spontaneous bowel movement per week from baseline).2
Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,775 adult patients who met Rome III criteria for CIC and were randomized 1:1 to either placebo (n=892) or Trulance 3 mg (n=883) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis in an electronic diary.2
Complete spontaneous bowel movements† per week
Spontaneous bowel movements‡ per week
Stool consistency
(Bristol Stool Form Scale)§
Straining score
(0=none; 4=very severe)||
†A complete spontaneous bowel movement is a spontaneous bowel movement with the sense of complete evacuation.
‡A spontaneous bowel movement is a bowel movement that occurs in the absence of laxative use within the previous 24 hours.
§Measured on 7-point Bristol Stool Scale: 1=separate, hard lumps, like nuts (hard to pass); 7=watery, no solid pieces (entirely liquid)
||Straining was reported in Daily Symptom Diary using 5-point Likert Scale: 0=none; 4=very severe
Study 2 is a similar 12-week, double-blind, placebo-controlled, randomized, multicenter clinical study of adult patients who met Rome III criteria for CIC and were randomized 1:1 to either placebo or Trulance 3 mg.2 Patients who were administered Trulance demonstrated similar baseline characteristics for patients on Trulance (n=439), with 0.28±0.55 complete spontaneous bowel movements/week, 1.79±2.05 spontaneous bowel movements/week, a stool consistency of 2.16±1.03, and a straining score of 2.45±0.85.2
Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,453 adult patients who met Rome III criteria for IBS-C and received placebo (n=729) or Trulance 3 mg (n=724) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis through an electronic phone diary system.2
Complete spontaneous bowel movements† per week
Abdominal pain
(0=none; 10=worst possible)
Stool
consistency§
Straining (0=none; 10=worst possible)¶
†A complete spontaneous bowel movement is a spontaneous bowel movement with the sense of complete evacuation.
§Measured on 7-point Bristol Stool Scale: 1=separate, hard lumps, like nuts (hard to pass); 7=watery, no solid pieces (entirely liquid)
¶Measured on 11-point numeric rating scale: 0=none; 10=worst possible
Study 2 is a similar 12-week, double-blind, placebo-controlled, randomized, multicenter clinical study of adult patients who met Rome III criteria for IBS-C and were randomized 1:1 to either placebo or Trulance 3 mg. Patients who were administered Trulance demonstrated similar baseline characteristics for patients on Trulance (n=377), with 0.3 (0.5) complete spontaneous bowel movements/week, 6.6 (1.6) abdominal pain, a stool consistency of 1.9 (0.9), and a straining score of 6.8 (1.9).4
See how Trulance helped IBS-C and CIC patients across the
following efficacy measures
A responder was defined as a patient who had at least 3 complete spontaneous bowel movements in a given week and an increase of at least 1 complete spontaneous bowel movement from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study.2
Study 2 demonstrated similar numbers of responders for complete spontaneous bowel movement, with 21% (n=430) of patients showing a durable response to Trulance vs 13% (n=440) with placebo.2
#Trulance-treated patients generally returned to baseline for these study endpoints during the post-treatment period.2
Percentage of patients who were overall responders in Study 3. The overall number needed to treat was 10.3 for Trulance.5
Study 4 demonstrated similar numbers of overall efficacy responders: 21% found response on Trulance vs 14% on placebo (P<0.009).2,5
#Trulance-treated patients generally returned to baseline for these study endpoints during the post-treatment period.2
Study 2 also demonstrated a statistically significant change from baseline for all treatment weeks through Week 12 for Trulance vs placebo, 2.27 vs 1.37 (P<0.001).3
Changes from baseline in weekly complete spontaneous bowel movement frequency. Values are least squares (LS) mean.4
Study 2 demonstrated a statistically significant change from baseline in mean weekly spontaneous bowel movement frequency for all treatment weeks through Week 12 for Trulance vs placebo, 2.59 vs 1.50 (P<0.001).3
Changes from baseline in mean weekly spontaneous bowel movement frequency. Values are LS mean.4
Study 2 demonstrated a statistically significant improvement in the percentage of patients having complete spontaneous bowel movements within 24 hours of the first dose of Trulance vs placebo, 21.4% vs 12.1% (P<0.001).3 Similar results were seen with spontaneous bowel movements within 24 hours of the first dose vs placebo, 43.6% vs 36.4% (P<0.05).3
Study 4 demonstrated a statistically significant improvement in the percentage of patients having spontaneous bowel movements within 24 hours of the first dose of Trulance vs placebo, 41.6% vs 31.4% (P<0.005).3
Study 2 demonstrated a statistically significant change in stool consistency vs placebo as early as Week 1, which remained consistent through Week 12, 1.49 vs 0.87 (P<0.001).3
Stool consistency was measured in weekly BSFS scores; values are LS mean.4
cP<0.001 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4.
Change from baseline in stool consistency by time point. Values are LS mean ± standard error.5
Improvements in straining score were observed early in treatment and were maintained throughout the study, with Trulance significantly reducing straining scores by 40% vs 26% with placebo (P<0.001).4
Study 2 demonstrated significantly less straining in Trulance-treated patients, beginning as early as Week 1 and remaining consistent through Week 12 vs placebo, -0.89 vs -0.61 (P<0.001).3
dStraining was reported in Daily Symptom Diary using 5-point Likert Scale: 0=none; 4=very severe4
dP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of straining during bowel movement was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).3
eP≤0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal pain was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).3
fP<0.05 for Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal bloating was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).3
gP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal discomfort was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).3
hP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal cramping was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).3
iP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal fullness was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible). 3
Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Please also see the full Prescribing Information, including BOXED Warning, for additional risk information.