PMID- 17090282
OWN - NLM
STAT- MEDLINE
DCOM- 20061212
LR  - 20121115
IS  - 0002-9270 (Print)
IS  - 0002-9270 (Linking)
VI  - 101
IP  - 11
DP  - 2006 Nov
TI  - Safety, tolerability, and efficacy of tegaserod over 13 months in patients with 
      chronic constipation.
PG  - 2558-69; quiz 2671
AB  - OBJECTIVE: To assess the long-term safety and tolerability of tegaserod in 
      patients with chronic constipation (CC). METHODS: This 13-month, uncontrolled 
      extension study enrolled CC patients who completed a 12-wk randomized, 
      double-blind, placebo-controlled core study. Patients receiving tegaserod 6 or 2 
      mg b.i.d. during the core study continued on the same dose; those receiving 
      placebo were switched to tegaserod 6 mg b.i.d (placebo-to-tegaserod). Safety and 
      tolerability were assessed by monitoring adverse events (AEs), laboratory 
      parameters, vital signs, and electrocardiograms. Symptom evaluations included 
      patient satisfaction with bowel habit and bothersomeness of constipation, 
      abdominal distension/bloating, and abdominal discomfort/pain. RESULTS: A total of 
      842 patients entered the extension study; 451 (54%) completed. AEs typically 
      occurred within the first month of tegaserod treatment. Long-term treatment 
      neither increased AE incidence nor revealed new safety risks. Headache (11.3%, 
      14.5%, and 16.1% in the tegaserod 6 mg b.i.d., 2 mg b.i.d., and 
      placebo-to-tegaserod groups, respectively) and abdominal pain (8.8%, 8.8%, 10.9%) 
      were the most common AEs. Diarrhea, the most common drug-related AE (4.9%, 2.5%, 
      8.0%), rarely led to discontinuation (0.7%, 0.0%, 2.2%). Diarrhea was transient, 
      resolved without treatment interruption or rescue medication, and had no 
      clinically significant consequences. Of 27 serious AEs, none were considered 
      treatment related. No deaths or reports of ischemic colitis occurred in 
      tegaserod-treated patients. No clinically relevant changes occurred in other 
      safety parameters. Safety findings were similar in patients switched from placebo 
      to tegaserod and those maintained on tegaserod. CONCLUSIONS: Tegaserod has a 
      favorable safety profile and is well tolerated during continuous long-term 
      treatment in patients with CC.
FAU - Muller-Lissner, Stefan
AU  - Muller-Lissner S
AD  - Park-Klinik Weissensee, Berlin, Germany.
FAU - Kamm, Michael A
AU  - Kamm MA
FAU - Musoglu, Ahmet
AU  - Musoglu A
FAU - Earnest, David L
AU  - Earnest DL
FAU - Dunger-Baldauf, Cornelia
AU  - Dunger-Baldauf C
FAU - Shetzline, Michael A
AU  - Shetzline MA
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Indoles)
RN  - 458VC51857 (tegaserod)
SB  - IM
CIN - Am J Gastroenterol. 2007 Jun;102(6):1327-8; author reply 1328. PMID: 17531019
MH  - Abdominal Pain/chemically induced
MH  - Constipation/*drug therapy
MH  - Diarrhea/chemically induced
MH  - Double-Blind Method
MH  - Drug Tolerance
MH  - Female
MH  - Gastrointestinal Agents/*administration & dosage/adverse effects
MH  - Headache/chemically induced
MH  - Humans
MH  - Indoles/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
EDAT- 2006/11/09 09:00
MHDA- 2006/12/13 09:00
CRDT- 2006/11/09 09:00
PHST- 2006/11/09 09:00 [pubmed]
PHST- 2006/12/13 09:00 [medline]
PHST- 2006/11/09 09:00 [entrez]
AID - AJG789 [pii]
AID - 10.1111/j.1572-0241.2006.00789.x [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2006 Nov;101(11):2558-69; quiz 2671. doi: 
      10.1111/j.1572-0241.2006.00789.x.