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Efectos a largo plazo de los fármacos para reducir el peso en los pacientes con hipertensión

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DOI:
https://doi.org/10.1002/14651858.CD007654.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 02 marzo 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Hipertensión

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Andrea Siebenhofer

    Correspondencia a: Institute of General Practice and Evidence‐Based Health Services Research, Medical University of Graz, Graz, Austria / Institute of General Practice, Goethe University, Frankfurt am Main, Germany

    [email protected]

    [email protected]

  • Klaus Jeitler

    Institute of General Practice and Evidence‐Based Health Services Research / Institute of Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria

  • Karl Horvath

    Institute of General Practice and Evidence‐Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria

  • Andrea Berghold

    Institute of General Practice and Evidence‐Based Health Services Research / Institute of Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria

  • Nicole Posch

    Institute of General Practice and Evidence‐Based Health Services Research, Medical University of Graz, Graz, Austria

  • Jutta Meschik

    Institute of General Practice and Evidence‐Based Health Services Research, Medical University of Graz, Graz, Austria

  • Thomas Semlitsch

    Institute of General Practice and Evidence‐Based Health Services Research, Medical University of Graz, Graz, Austria

Contributions of authors

Andrea Siebenhofer: protocol development, quality assessment of trials, data extraction, development of final review and review update, corresponding author

Klaus Jeitler: protocol development, searching for trials, quality assessment of trials, data extraction, development of review update

Karl Horvath: protocol development, quality assessment of trials, data extraction, development of final review and review update

Andrea Berghold: statistical analysis, development of final review and review update

Nicole Posch: selection of studies, development of review update

Jutta Meschik: selection of studies, development of review update

Thomas Semlitsch: searching for trials, selection of studies, quality assessment of trials, data extraction, development of review update

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Medical University of Graz, Austria.

Declarations of interest

Andrea Siebenhofer, Klaus Jeitler, and Karl Horvath were involved in the preparation of a report on the evaluation of the benefits and harms of non‐drug treatment strategies in people with essential hypertension: weight reduction for the Institute for Quality and Efficiency in Health Care (http://iqwig.de/).

Andrea Berghold: none known

Nicole Posch: none known

Jutta Meschik: none known

Thomas Semlitsch: none known

Acknowledgements

We would like to thank Douglas Salzwedel for helping to update the literature search, Phillip Elliott for the final editing of the manuscript, and Ulrich Siering for assisting in the development of the original review.

Version history

Published

Title

Stage

Authors

Version

2021 Jan 17

Long‐term effects of weight‐reducing drugs in people with hypertension

Review

Andrea Siebenhofer, Sebastian Winterholer, Klaus Jeitler, Karl Horvath, Andrea Berghold, Cornelia Krenn, Thomas Semlitsch

https://doi.org/10.1002/14651858.CD007654.pub5

2016 Mar 02

Long‐term effects of weight‐reducing drugs in people with hypertension

Review

Andrea Siebenhofer, Klaus Jeitler, Karl Horvath, Andrea Berghold, Nicole Posch, Jutta Meschik, Thomas Semlitsch

https://doi.org/10.1002/14651858.CD007654.pub4

2013 Mar 28

Long‐term effects of weight‐reducing drugs in hypertensive patients

Review

Andrea Siebenhofer, Klaus Jeitler, Karl Horvath, Andrea Berghold, Ulrich Siering, Thomas Semlitsch

https://doi.org/10.1002/14651858.CD007654.pub3

2009 Jul 08

Long‐term effects of weight‐reducing drugs in hypertensive patients

Review

Andrea Siebenhofer, Karl Horvath, Klaus Jeitler, Andrea Berghold, Anne K Stich, Eva Matyas, Nicole Pignitter, Ulrich Siering

https://doi.org/10.1002/14651858.CD007654.pub2

2009 Jan 21

Long‐term effects of weight‐reducing drugs in hypertensive patients

Protocol

Andrea Siebenhofer, Karl Horvath, Klaus Jeitler, Andrea Berghold, Anne K Stich, Eva Matyas, Nicole Pignitter, Ulrich Siering

https://doi.org/10.1002/14651858.CD007654

Differences between protocol and review

Two authors (Anne Stich and Eva Matyas) did not contribute to the 2013 update of this review and were removed from the list of authors.

Thomas Semlitsch joined the team of review authors for the 2013 version of this review and provided substantive intellectual contributions that justify his inclusion as authors.

Ulrich Siering did not contribute to the 2015 update of this review and was removed from the list of authors.

Jutta Meschik joined the team of review authors for the 2015 version of this review and provided substantive intellectual contributions that justify her inclusion as authors.

Since current guidelines for the pharmacological management of obesity quote four additional medications (liraglutide, lorcaserin, phentermine/topiramate, or naltrexone/bupropion) for long‐term weight reduction, the search was extended to include these drugs in the 2015 version of this review.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.1 Change in systolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.1 Change in systolic blood pressure from baseline to endpoint [mm Hg].

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.2 Change in diastolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.2 Change in diastolic blood pressure from baseline to endpoint [mm Hg].

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.3 Change in body weight from baseline to endpoint [kg].
Figuras y tablas -
Figure 6

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.3 Change in body weight from baseline to endpoint [kg].

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.1 Change in diastolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 7

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.1 Change in diastolic blood pressure from baseline to endpoint [mm Hg].

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.2 Change in body weight from baseline to endpoint [kg].
Figuras y tablas -
Figure 8

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.2 Change in body weight from baseline to endpoint [kg].

Comparison 1 Orlistat versus placebo, Outcome 1 Change in systolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 1.1

Comparison 1 Orlistat versus placebo, Outcome 1 Change in systolic blood pressure from baseline to endpoint.

Comparison 1 Orlistat versus placebo, Outcome 2 Change in diastolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 1.2

Comparison 1 Orlistat versus placebo, Outcome 2 Change in diastolic blood pressure from baseline to endpoint.

Comparison 1 Orlistat versus placebo, Outcome 3 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 1.3

Comparison 1 Orlistat versus placebo, Outcome 3 Change in body weight from baseline to endpoint.

Comparison 2 Sibutramine versus placebo, Outcome 1 Change in diastolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 2.1

Comparison 2 Sibutramine versus placebo, Outcome 1 Change in diastolic blood pressure from baseline to endpoint.

Comparison 2 Sibutramine versus placebo, Outcome 2 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 2.2

Comparison 2 Sibutramine versus placebo, Outcome 2 Change in body weight from baseline to endpoint.

Summary of findings for the main comparison. Summary of findings for orlistat versus placebo

Orlistat compared with placebo for weight reduction

Patient or population: Men and non‐pregnant women ≥ 18 years old with essential hypertension

Intervention: Orlistat

Comparison: Placebo

Outcomes

Illustrative comparative risks (per 1000 patients)

Effect estimate
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Change in systolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD ‐2.46 [‐4.01, ‐0.90]

2058
(4 studies)

⊕⊕⊝⊝
low1,2

Change in diastolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD ‐1.92 [‐2.99, ‐0.85]

2058
(4 studies)

⊕⊕⊝⊝
low1,2

Change in body weight as compared to placebo

[kg] from baseline to end of study

Not applicable

MD ‐3.73 [‐4.65, ‐2.80]

2080
(4 studies)

⊕⊕⊕⊝
moderate1

CI: confidence interval; MD: mean difference

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1High risk of bias in included studies.

2Wide confidence intervals include non‐clinically important effect.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings for orlistat versus placebo
Summary of findings 2. Summary of findings for sibutramine versus placebo

Sibutramine compared with placebo for weight reduction

Patient or population: Men and non‐pregnant women ≥ 18 years old with essential hypertension

Intervention: Sibutramine

Comparison: Placebo

Outcomes

Illustrative comparative risks (per 1000 patients)

Effect estimates
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Change in systolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

Not estimable

See comment

See comment

Variability measurements not available;
no meta‐analysis possible

Change in diastolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD 3.16 [1.40, 4.92]

428
(2 studies)

⊕⊕⊝⊝
low1,2

Change in body weight as compared to placebo

[kg] from baseline to end of study

Not applicable

MD ‐3.74 [‐4.84, ‐2.64]

574
(4 studies)

⊕⊕⊝⊝
low1,2

CI: confidence interval; MD: mean difference

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1High risk of bias in included studies.

2Small number of participants and studies.

Figuras y tablas -
Summary of findings 2. Summary of findings for sibutramine versus placebo
Table 1. Adverse events

Study

Adverse events

Results

Orlistat vs placebo

Bakris

2002

total

thereof leading to withdrawal

serious

gastrointestinal

thereof leading to withdrawal

musculoskeletal

89% of P [O] vs 71% of P [P], P < 0.001

7% [O] vs 7% [P]

14 P (12%) [O] vs 15 P (9%) [P]

200 P (73%) [O] vs 120 P (44%) [P], P < 0.001

15 P (8%) [O] vs 6 P (5%) [P]

23% of P [O] vs 16% [P], P < 0.05

Cocco

2005

total

serious

gastrointestinal

nr

0 P [O] vs 0 P [P]

16 P (36%) [O]a vs 11 P (24%) [P]a

Guy‐Grand

2004

total

serious

nrb

nrb

XENDOS

2001‐2006

total

leading to withdrawal

serious

gastrointestinal

musculoskeletal

nervous system

dermatological

vascular

99% of P [OD] vs 96% of P [PD]

99% of P [OS] vs 97% of P [PS]

9% of P [OD] vs 4% of P [PD]

9% of P [OS] vs 4% of P [PS]

18% of P [OD] vs 12% of P [PD]

18% of P [OS] vs 12% of P [PS]

93% of P [OD] vs 70% of P [PD]

93% of P [OS] vs 71% of P [PS]

65% of P [OD] vs 62% of P [PD]

65% of P [OS] vs 63% of P [PS]

39% of P [OD] vs 39% of P [PD]

40% of P [OS] vs 37% of P [PS]

20% of P [OD] vs 17% of P [PD]

22% of P [OS] vs 17% of P [PS]

17% of P [OD] vs 19% of P [PD]

17% of P [OS] vs 19% of P [PS]

Sibutramine vs placebo

Fanghaenel

2003

total

constipation

dizziness

dry mouth

headache

insomnia

restlessness

14 P (21 E) [S] vs 13 P (20 E) [P]

4 P [S] vs 2 P [P]

1 P [S] vs 1 P [P]

4 P [S] vs 2 P [P]

5 P [S] vs 2 P [P]

1 P [S] vs 1 P [P]

1 P [S] vs 0 P [P]

Faria

2002‐2005

total

dry mouth

arthralgia

nr

37% of P [S] vs 9% of P [P], P < 0.005

16% of P [S] vs 2% of P [P], P = 0.03

McMahon

2002

total

serious

treatment related

leading to withdrawal

(mostly hypertension)

dry mouth

headache

141 P (97%) [S] vs 65 P (88%) [P]

9 P (6%) [S] vs 5 P (7%) [P]

2 E [S] vs 0 E [P]

23 P (16%) [S] vs 4 P (5%) [P]

30 P (21%) [S] vs 0 P [P]

41 P (28%) [S] vs 17 P (23%) [P]

McMahon

2000

total

leading to withdrawal

(mostly hypertension)

dry mouth

headache

constipation

rash

nr

30 P (20%) [S] vs 8 P (11%) [P]

29 P (19%) [S] vs 2 P (3%) [P], P < 0.05

37 P (25%) [S] vs 21 P (28%) [P]

25 P (17%) [S] vs 2 P (3%) [P], P < 0.05

16 P (11%) [S] vs 2 P (3%) [P]

Phentermine/topiramate vs placebo

CONQUER 2013

total

leading to withdrawal

serious

cardiac adverse events

dry mouth

paresthaesia

constipation

upper respiratory tract infection

nasopharyngitis

dysgeusia

insomnia

headache

dizziness

sinusitis

85.4% vs 88.8% vs 77.3%

11.9% vs 19.8% vs 9.7%

3.4% (Phen/Top [LD]) vs 3.7% (Phen/Top [HD]) vs 4.2% [P]

0.8% vs 1.2% vs 0.6%

14.2% (Phen/Top [LD]) vs 22.7% (Phen/Top [HD]) vs 2.3% [P]

14.2% (Phen/Top [LD]) vs 22.3% (Phen/Top [HD]) vs 2.3% [P]

15.7% (Phen/Top [LD]) vs 18.1% (Phen/Top [HD]) vs 5.5% [P]

12.6% (Phen/Top [LD]) vs 12.1% (Phen/Top [HD]) vs 11.8% [P]

10.3% (Phen/Top [LD]) vs 10.2% (Phen/Top [HD]) vs 8.8% [P]

7.7% (Phen/Top [LD]) vs 11.0% (Phen/Top [HD]) vs 0.8% [P]

5.7% (Phen/Top [LD]) vs 11.0% (Phen/Top [HD]) vs 4.8% [P]

5.0% (Phen/Top [LD]) vs 10.8% (Phen/Top [HD]) vs 8.4% [P]

6.5% (Phen/Top [LD]) vs 12.1% (Phen/Top [HD]) vs 3.1% [P]

5.4% (Phen/Top [LD]) vs 8.3% (Phen/Top [HD]) vs 6.5% [P]

E: events. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine.

aNo data on adverse events were reported for the whole study duration. The data above refer to 4 and 3 weeks of treatment in the orlistat and placebo group, respectively. After 3 months, the number of participants with events decreased to 5(11%)[O] with flatulence and mild abdominal cramps versus 6(13%)[P] with nausea and hunger feeling.

bData were not available for the hypertensive subgroup, only for the whole study population (withdrawal due to defecation troubles in 10 [O] versus 2 [P] participants).

Figuras y tablas -
Table 1. Adverse events
Table 2. Body weight

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

101 (1)c

102 (1)c

nr

nr

nr

nr

P < 0.001

‐5.4 (6.4)

‐2.7 (6.4)

Cocco 2005

Orlistat

Placebo

107 (6)

106 (6)

102 (4)

104 (5)

P < 0.001

‐5.4d

‐2.5d

Guy‐Grand 2004

Orlistat

Placebo

94 (1)c

94 (1)c

nr

nr

P < 0.0001

‐5.8 (0.3)

‐1.8 (0.2)

XENDOS 2001‐2006

Orlistat [OD]

Placebo [PD]

Orlistat [OS]

Placebo [PS]

117 (18)

115 (18)

117 (17)

116 (18)

106 (17)

108 (18)

106 (17)

109 (18)

105 (18)

108 (19)

105 (17)

110 (19)

110 (19)

111 (20)

110 (18)

113 (19)

P < 0.001

‐6.6 (8.6)

‐3.8 (7.8)

P < 0.001

‐6.8 (8.7)

‐3.2 (7.4)

Sibutramine vs placebo

Fanghaenel 2003

Sibutramine

Placebo

75 (10)

78 (9)

70 (10)

75 (9)

significant

‐5.5 (‐3.8; ‐7.1)e

‐3.4 (‐1.9; ‐5.0)e

Faria 2002‐2005

Sibutramine

Placebo

100 (19)

97 (14)

93 (18)

94 (15)

P < 0.001

‐6.8 (2.3)

‐2.4 (4.2)

McMahon 2002

Sibutramine

Placebo

97 (16)

99 (14)

nr

nr

nr

nr

P < 0.05

‐4.5

‐0.4

McMahon 2000

Sibutramine

Placebo

97 (13)

96 (17)

nr

nr

nr

nr

P < 0.05

‐4.4

‐0.5

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

104 (18)f

nr

nr

nr

nr

nr

nr

P < 0.0001g

‐8.1%

‐10.1%

‐1.9%

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean kg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cReported as being the standard deviation but probably the standard error due to its small number.

dPublished values are different, but data were corrected after personal communication with the author.

e95% confidence interval.

fReported only combined for all three study groups.

gFor each intervention group versus placebo.

Figuras y tablas -
Table 2. Body weight
Table 3. Systolic blood pressure

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

154 (13)

151 (13)

nr

nr

nr

nr

ns

‐13.3 (15.2)

‐11.0 (15.0)

Cocco 2005

Orlistat

Placebo

146 (10)

142 (6)

142 (13)

141 (9)

P = 0.025

‐4.3

‐0.9

Guy‐Grand 2004

Orlistat

Placebo

150 (1)c

152 (1)c

nr

nr

ns

‐9.8 (1)

‐9.8 (1)

XENDOS 2001‐2006

Orlistat [OD]d

Placebo [PD]d

Orlistat [OS]d

Placebo [PS]d

146 (13)

146 (12)

149 (10)

149 (8)

135 (14)

136 (15)

125 (14)

138 (14)

135 (14)

138 (16)

135 (14)

140 (14)

137 (15)

139 (16)

138 (15)

140 (15)

P = 0.024

‐8.8 (14.8)

‐6.4 (15.1)

P < 0.002

‐11.5 (14.9)

‐8.6 (14.3)

Sibutramine vs placebo

Fanghaenel 2003e

Sibutramine

Placebo

139 (9)

139 (13)

125 (9)

123 (10)

ns

‐13.9f

‐16.5f

Faria 2002‐2005

Sibutramine

Placebo

150 (18)

150 (15)

146 (15)

149 (22)

ns

‐4.6f

‐0.6f

McMahon 2002

Sibutramine

Placebo

129 (11)

129 (11)

nr

nr

133

130

P = 0.0497

3.8

1.1

McMahon 2000

Sibutramine

Placebo

134 (10)

134 (11)

nr

nr

nr

nr

ns

2.7

1.5

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

134 (nr)

133 (nr)

135 (nr)

nr

nr

nr

nr

nr

nr

P = 0.0475 [LD]

P < 0.0001 [HD]

‐6.9

‐9.1

‐4.9

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean mm Hg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cReported as being the standard deviation but probably the standard error due to its small number.

dBased on last observation carried forward data on 399 [OD], 423 [PD], 493 [OS], and 504 [PS] participants.

eData at baseline were recorded after a two‐week wash‐out period of antihypertensive drugs for diagnostic confirmation of hypertension.

fCalculated.

Figuras y tablas -
Table 3. Systolic blood pressure
Table 4. Diastolic blood pressure

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

98 (4)

98 (4)c

nr

nr

nr

nr

P = 0.002

‐11.4 (8.3)

‐9.2 (8.4)

Cocco 2005

Orlistat

Placebo

88 (7)

85 (6)

84 (9)

85 (7)

P = 0.012

‐3.6

‐0.8

Guy‐Grand 2004

Orlistat

Placebo

97 (0)d

97 (0)d

nr

nr

ns

‐7.5 (0.6)

‐7.3 (0.6)

XENDOS 2001‐2006

Orlistat [OD]e

Placebo [PD]e

Orlistat [OS]e

Placebo [PS]e

95 (6)

95 (5)

91 (9)

91 (8)

86 (8)

88 (9)

84 (9)

87 (9)

86 (8)

88 (10)

85 (9)

88 (10)

87 (9)

89 (10)

86 (9)

88 (10)

P < 0.006

‐8.1 (9.3)

‐6.2 (9.9)

P < 0.001

‐5.0 (9.9)

‐3.0 (10.4)

Sibutramine vs placebo

Fanghaenel 2003f

Sibutramine

Placebo

93 (7)

92 (8)

82 (5)

80 (5)

ns

‐11.4g

‐11.7g

Faria 2002‐2005

Sibutramine

Placebo

91 (12)

94 (12)

92 (13)

92 (14)

ns

1.0g

‐2.06g

McMahon 2002

Sibutramine

Placebo

82 (6)

83 (6)

nr

nr

86

83

P = 0.004

3.0

‐0.1

McMahon 2000

Sibutramine

Placebo

84 (5)

84 (6)

nr

nr

nr

nr

P < 0.05

2.0

‐1.3

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

83 (nr)

83 (nr)

85 (nr)

nr

nr

nr

nr

nr

nr

P = 0.0400 [LD]

P = 0.0003 [HD]

‐5.2

‐5.8

‐3.9

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean mm Hg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cThe standard deviation was published as being 35 but should probably be 3.5.

dReported as being the standard deviation but probably the standard error due to its small number.

eBased on last observation carried forward data on 399 [OD], 423 [PD], 493 [OS], and 504 [PS] participants.

fData at baseline were recorded after a two‐week wash‐out period of antihypertensive drugs for diagnostic confirmation of hypertension.

gCalculated.

Figuras y tablas -
Table 4. Diastolic blood pressure
Comparison 1. Orlistat versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in systolic blood pressure from baseline to endpoint Show forest plot

4

2058

Mean Difference (IV, Random, 95% CI)

‐2.46 [‐4.01, ‐0.90]

2 Change in diastolic blood pressure from baseline to endpoint Show forest plot

4

2058

Mean Difference (IV, Random, 95% CI)

‐1.92 [‐2.99, ‐0.85]

3 Change in body weight from baseline to endpoint Show forest plot

4

2080

Mean Difference (IV, Random, 95% CI)

‐3.73 [‐4.65, ‐2.80]

Figuras y tablas -
Comparison 1. Orlistat versus placebo
Comparison 2. Sibutramine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in diastolic blood pressure from baseline to endpoint Show forest plot

2

428

Mean Difference (IV, Fixed, 95% CI)

3.16 [1.40, 4.92]

2 Change in body weight from baseline to endpoint Show forest plot

4

574

Mean Difference (IV, Fixed, 95% CI)

‐3.74 [‐4.84, ‐2.64]

Figuras y tablas -
Comparison 2. Sibutramine versus placebo