Table 4 Safety and tolerability of polyethylene glycols from the individual studies
Study | Type of polyethylene glycol | Comparator | Safety signals (Laboratory data, vital signs) | Tolerability (Adverse events) |
|---|---|---|---|---|
Andorsky RI 1990 [12] | PEG3350 + E | Placebo | NA | Adverse events with PEG + E were infrequent and generally tolerable and included; cramping, gas, nausea, loose stools, and unpleasant taste. |
Attar A 1999 [13] | PEG3350 + E | Lactulose | No significant changes in laboratory measurements; except for 1 case of mild hypokalaemia with concurrent diuretics. In the 2 month open label extension study, lower mean serum folate levels, but all values were within the normal range. | No differences in tolerability between the two groups, but flatus was less frequently reported with PEG + E. 2 adverse events leading to PEG + E withdrawal; acute diarrhoea with vomiting and fever; and abdominal pain. Additional 4 adverse events leading to drug withdrawal in the extension study; acute diarrhoea with fever (1), abdominal pain (2); vomiting (1). |
Awad RA 2010 [14] | PEG3350 | Placebo | NA | No difference in tolerability of PEG vs placebo. 1 case of abdominal pain with PEG. |
Bouhnik Y 2004 [15] | PEG4000 | Lactulose | NA | No serious adverse events were reported. 3 PEG patients discontinued therapy due to adverse events; abdominal pain or abdominal distension. |
Chapman RW 2013 [16] | PEG3350 + E | Placebo | NA | More patients taking PEG 3350 + E experienced adverse events compared to placebo (38.8 % vs 32.9 %). No serious adverse events. The most common drug-related adverse events (>3 %); abdominal pain (4.5 %), diarrhoea (4.5 %). 2 patients discontinued PEG + E due to adverse events; abdominal rigidity (1), flatulence and abdominal pain (1). |
Chaussade S 2003 [17] | PEG3350 + E and PEG4000 | PEG4000 | No clinical issues reported. | No differences in tolerability. Common GI adverse events; dose-related diarrhoea, distention, flatulence, abdominal pain. |
Cinca R 2013 [18] | PEG3350 + E | Prucalopride | No clinically significant differences in laboratory measurements, vital signs or ECG. | 68.3 % of patients taking PEG + E experienced a treatment-emergent adverse event, mostly mild-moderate intensity. 5.3 % of the events were possibly or probably related to PEG + E. Events included; headache (36.7 %), nausea (5.8 %), vomiting (2.5 %) and abdominal pain (2.5 %), UTI (3.3 %). Adverse event were generally more common with prucalopride. |
Cleveland MV 2001 [19] | PEG3350 | Placebo | No clinically significant differences in blood chemistry, CBC, or urinalysis. | No serious adverse events. Three cases of loose stools or mild diarrhoea with PEG. |
Corazziari E 1996 [20] | PEG4000 + E | Placebo | NA | No difference in tolerability of PEG + E vs placebo. |
Corazziari E 2000 [21] | PEG4000 + E | Placebo | No significant changes in heart frequency, blood pressure, blood count or laboratory measurements. | No difference in tolerability of PEG + E vs placebo. 2 discontinuations due to adverse events; abdominal bloating and fissura in the anus. Most common adverse events were nausea and epigastric pain/discomfort. |
Di Palma JA 1999 [22] | PEG3350 | Placebo | No clinically significant changes in laboratory measurements. | Ambulatory care patients: dose-related diarrhoea or loose stools. Long-term care patients: 5 serious adverse events, but all were due to pre-existing conditions and not PEG use. |
Di Palma JA 2000 [23] | PEG3350 | Placebo | No statistically or clinically significant differences in laboratory measurements. | No difference in tolerability of PEG vs placebo. |
Di Palma JA 2007A [24] | PEG3350 | Placebo | No clinically significant changes in vital signs, physical examination, weight, or laboratory measurements. | No statistical difference in tolerability of PEG vs placebo. |
Di Palma JA 2007B [25] | PEG3350 | Placebo | No clinically significant changes in laboratory measurements. | No differences in adverse events between PEG and placebo except for gastrointestinal complaints (PEG 39.7 %, placebo 25 %, P = 0.015). GI events included abdominal distension, diarrhoea, loose stools, flatulence, and nausea. Most events were mild or moderate. No difference in tolerability of PEG + E vs placebo amongst elderly patients. |
Di Palma JA 2007C [26] | PEG3350 | Tegaserod | NA | No serious adverse events. Adverse events (>3 %) with PEG were; GI (30.8 %), diarrhoea (20 %) and nausea (5.2 %). |
Freedman MD 1997 [27] | PEG3350 + E | Placebo Lactulose | NA | No difference in frequency of gas or severe cramping with PEG + E vs control. |
Klauser AG 1995 [28] | PEG4000 | Placebo | NA | NA |
Seinela L 2009 [29] | PEG4000 + E and PEG4000 | PEG4000 | Small, but not clinically relevant changes in plasma sodium level; PEG mean decrease from 138.8 to 137.7 mmol/L; PEG + E mean increase from 138.6 to 138.9 mmol/L (P = 0.012). No other significant differences between the groups in any of the other electrolyte or laboratory safety variables, or in heart rate, blood pressure or weight. | Low incidence of mild to moderate adverse events in both groups. Four serious adverse events with PEG + E; 1 leading to discontinuation of PEG + E, but none with PEG. |
Wang H 2005 [30] | PEG3350 + E | Isphagula husk | No change in mean sodium, potassium or chloride ion levels. | No differences in adverse events between PEG + E and isphagula husk. No serious events. Most common adverse event for PEG + E was dizziness (5 %). |
Zangaglia R 2007 [31] | PEG4000 + E | Placebo | No clinically significant changes in haematology, serum biochemistry, or urinalysis. | A higher rate of withdrawals with PEG + E vs placebo (31 % vs. 18 %). 4 drug-related discontinuations were due to nausea, diarrhoea, poor treatment compliance due to the taste or volume of preparation. |